Revised Edition: 2016 ISBN All rights reserved.

Transcription

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2 Revised Edition: 2016 ISBN All rights reserved. Published by: Orange Apple 48 West 48 Street, Suite 1116, New York, NY 10036, United States

3 Table of Contents Chapter 1 - Female Reproductive System (Human) Chapter 2 - Oophorectomy Chapter 3 - Salpingectomy and Tubal Ligation Chapter 4 - Essure and Tubal Reversal Chapter 5 - Hysterectomy Chapter 6 - Pelvic Exenteration and Uterine Artery Embolization Chapter 7 - Hysterosalpingography and Hysteroscopy Chapter 8 - Vacuum Aspiration Chapter 9 - Endometrial Ablation and Myomectomy Chapter 10 - Cervical Cerclage, Vaginectomy and Vulvectomy Chapter 11 - Pap Test Chapter 12 - Female Genital Cutting

4 Chapter 1 Female Reproductive System (Human) Female reproductive system (human) A pictorial illustration of the female reproductive system. Latin systema genitale femininum The female reproductive system (or female genital system) contains two main parts: the uterus, which hosts the developing fetus, produces vaginal and uterine secretions, and passes the male's sperm through to the fallopian tubes; and the ovaries, which produce the female's egg cells. These parts are internal; the vagina meets the external organs at the vulva, which includes the labia, clitoris and urethra. The vagina is attached to the uterus through the cervix, while the uterus is attached to the ovaries via the Fallopian tubes. At certain intervals, the ovaries release an ovum, which passes through the Fallopian tube into the uterus. If, in this transit, it meets with sperm, the sperm penetrate and merge with the egg, fertilizing it. The fertilization usually occurs in the oviducts, but can happen in the uterus itself. The zygote then implants itself in the wall of the uterus, where it begins the processes of embryogenesis and morphogenesis. When developed enough to survive outside the womb, the cervix dilates and contractions of the uterus propel the fetus through the birth canal, which is the vagina.

5 The ova are larger than sperm and have formed by the time a female is born. Approximately every month, a process of oogenesis matures one ovum to be sent down the Fallopian tube attached to its ovary in anticipation of fertilization. If not fertilized, this egg is flushed out of the system through menstruation. Embryonic development Chromosome characteristics determine the genetic sex of a child at conception. This is specifically based on the 23rd pair of chromosomes that is inherited. Since the mother's egg contains an X chromosome and the father's sperm contains either an X or Y chromosome, it is the male who determines the baby's sex. If the baby inherits the X chromosome from the father, the baby will be a female. In such case, testosterone is not made, but the Wolffian duct will degrade and the Müllerian duct will develop into female sex organs. In this case, the female clitoris is the remnants of the Wolffian duct. On the other hand, if the baby inherits the Y chromosome from the father, the baby will be a male. In such case, testosterone will be in charge of stimulating the Wolffian duct in order to develop male sex organs, and the Müllerian duct will degrade. Internal A female's internal reproductive organs are the vagina, uterus, fallopian tubes, cervix and ovary. Vagina The vagina is a fibro muscular tubular tract leading from the uterus to the exterior of the body in female mammals, or to the cloaca in female birds and some reptiles. Female insects and other invertebrates also have a vagina, which is the terminal part of the oviduct. The vagina is the place where semen from the male is deposited into the female's body at the climax of sexual intercourse, commonly known as ejaculation. Around the vagina, pubic hair protects the vagina from infection and is a sign of puberty. The vagina is mainly used for sexual intercourse. Cervix The cervix is the lower, narrow portion of the uterus where it joins with the top end of the vagina. It is cylindrical or conical in shape and protrudes through the upper anterior vaginal wall. Approximately half its length is visible, the remainder lies above the vagina beyond view. The vagina has a thick layer outside and it is the opening where baby comes out during delivery. The cervix is also called the neck of the uterus.

6 Uterus The uterus or womb is the major female reproductive organ of humans. The uterus provides mechanical protection, nutritional support, and waste removal for the developing embryo (weeks 1 to 8) and fetus (from week 9 until the delivery). In addition, contractions in the muscular wall of the uterus are important in ejecting the fetus at the time of birth. The uterus contains three suspensory ligaments that help stabilize the position of the uterus and limits its range of movement. The uterosacral ligaments, keep the body from moving inferiorly and anteriorly. The round ligaments, restrict posterior movement of the uterus. The cardinal ligaments, also prevent the inferior movement of the uterus. The uterus is a pear-shaped muscular organ. Its major function is to accept a fertilized ovum which becomes implanted into the endometrium, and derives nourishment from blood vessels which develop exclusively for this purpose. The fertilized ovum becomes an embryo, develops into a fetus and gestates until childbirth. If the egg does not embed in the wall of the uterus, a woman begins menstruation and the egg is flushed away. endometrium when it reaches the uterus, which signals the beginning of pregnancy. Oviducts The Fallopian tubes or oviducts are two tubes leading from the ovaries of female mammals into the uterus. On maturity of an ovum, the follicle and the ovary's wall rupture, allowing the ovum to escape and enter the Fallopian tube. There it travels toward the uterus, pushed along by movements of cilia on the inner lining of the tubes. This trip takes hours or days. If the ovum is fertilized while in the Fallopian tube, then it normally implants in the Ovaries The ovaries are small, paired organs that are located near the lateral walls of the pelvic cavity. These organs are responsible for the production of the ova and the secretion of hormones. ovaries are the place inside the female body where ova or eggs are produced. The process by which the ovum is released is called ovulation. The speed of ovulation is periodic and impacts directly to the length of a menstrual cycle. After ovulation, the ovum is captured by the oviduct, after traveling down the oviduct to the uterus, occasionally being fertilized on its way by an incoming sperm, leading to pregnancy and the eventual birth of a new human being. The Fallopian tubes are often called the oviducts and they have small hairs (cilia) to help the egg cell travel.

7 External The external components include the mons pubis, pudendal cleft, labia majora, labia minora, Bartholin's glands, and clitoris. Female genital modification There are surgical procedures intended to improve a woman's sexual appearance. The clitoral hood reduction, also known as clitoridotomy, is a procedure intended to reposition the protruding clitoris and reduce the length and projection of the clitoral hood. The procedure is also indicated in those women with mild clitoral enlargement unwilling to undergo a formal clitoris reduction. The clitoral hood removal, also known as hoodectomy, is a cosmetic surgery intended to enhance a woman's sexual experience. This surgery involves the trimming back of the clitoral hood or a complete clitoris hood removal. Removal of the protective hood allows for more clitoral exposure which increases sensitivity in the clitoris. This procedure, sometimes called female circumcision, is different from a clitoral excision and is not intended to prevent a woman from experiencing sexual pleasure. intended to enhance a woman's sexual experience or her physical appearance, female Another surgical procedure is the clitoral reduction. Clitoris may enlarge due to hormonal abnormalities, ingestion of steroids, or birth. Surgery can reduce the glans or shaft of the clitoris through an outpatient procedure. According to WHO, female genital mutilation (FGM) comprises all those procedures that involve partial or total removal of the external female genitalia as well as other injury to the female genital organs for non-medical reasons. Contrary to surgical procedures genital mutilation does not have health benefits and it actually can be very harmful. This kind of procedure may have several complications from severe bleeding, tetanus or sepsis, urine retention, open sores in the genital area and damage to the tissue to potential childbirth complications, infertility, and newborn deaths. This practice is common in the western, eastern and north-eastern regions of Africa. It also takes place in some countries in Asia and the Middle East. It is also known that the procedure is practiced by some immigrant communities in North America and Europe.

8 Chapter 2 Oophorectomy Intervention: Oophorectomy ICD-10 code: 0UB00ZX - 0UB28ZZ ICD-9 code: MeSH D Other codes: Oophorectomy is the surgical removal of an ovary or ovaries. The surgery is also called ovariectomy, but this term has been traditionally used in basic science research describing the surgical removal of ovaries in laboratory animals. Removal of the ovaries in women is the biological equivalent of castration in males; however, the term castration is only occasionally used in the medical literature to refer to oophorectomy in humans. In the veterinary sciences, the complete removal of the ovaries, oviducts, uterine horns, and the uterus is called spaying and is a form of sterilization. Partial oophorectomy is a term sometimes used to describe a diverse variety of surgeries such as ovarian cyst removal or resection of parts of the ovaries. This kind of surgery is fertility preserving although ovarian failure may be relatively frequent. Most of the long term risks and consequences of oophorectomy are not or only partially present with partial oophorectomy. In humans, oophorectomy is most often performed due to diseases such as ovarian cysts or cancer; as prophylaxis to reduce the chances of developing ovarian cancer or breast cancer; or in conjunction with removal of the uterus. The removal of an ovary together with the fallopian tube is called salpingooophorectomy or unilateral salpingo-oophorectomy (USO). When both ovaries and both Fallopian tubes are removed, the term bilateral salpingo-oophorectomy (BSO) is used. Oophorectomy and salpingo-oophorectomy are not common forms of birth control in humans; more usual is tubal ligation, in which the Fallopian tubes are blocked but the ovaries remain intact. In many cases, surgical removal of the ovaries is performed

9 concurrently with a hysterectomy. The formal medical name for removal of a woman's entire reproductive system (ovaries, Fallopian tubes, uterus) is "Total Abdominal Hysterectomy with Bilateral Salpingo-Oophorectomy (TAH-BSO); the more casual term for such a surgery is "ovariohysterectomy". The term "hysterectomy" is often used to refer to removal of any part of the female reproductive system, including just the ovaries; however, the correct definition of "hysterectomy" is removal of the uterus (from the Greek ὑστέρα hystera "womb" and εκτομία ektomia "a cutting out of") without removal of the ovaries or Fallopian tubes. Technique When performed alone (without hysterectomy), an oophorectomy is generally performed by abdominal laparotomy or laparoscopy. Statistics According to the Center for Disease Control, 454,000 women in the United States underwent this type of operation in Indication and benefits Most bilateral oophorectomies (63%) are performed prophylactically without any medical indication at the same time as hysterectomy (87%). Conversely, unilateral oophorectomy is commonly performed for a medical indication (73%; cyst, endometriosis, benign tumor, inflammation, etc.) and less commonly in conjunction with hysterectomy (61%). Special indications include several groups of women with substantially increased risk of ovarian cancer, such as high risk BRCA mutation carriers and women with endometriosis who also suffer from frequent ovarian cysts. Prophylactic bilateral oophorectomy has been traditionally done in the belief that the benefit of preventing ovarian cancer would outweigh the risks associated with removal of ovaries. However, it is now clear that prophylactic oophorectomy without an urgent medical indication decreases long term survival rates substantially and has deleterious long term effects on health and wellbeing. Cancer prevention Oophorectomy can singificantly improve survival for women with high risk BRCA mutations. For women with high risk BRCA1 mutations prophylactic oophorectomy around age 40 reduces the risk of ovarian and breast cancer and provides significant and substantial

10 long-term survival advantage. Earlier intervention does not, on average, provide any additional benefit but increases risks and adverse effects. For women with high risk BRCA2 mutations, oophorectomy around age 40 has a relatively modest benefit on survival; the positive effect of reduced breast and ovarian cancer risk is nearly balanced by adverse effects. The survival advantage is more substantial when oophorectomy is performed together with prophylactic mastectomy. Endometriosis In rare cases, oophorectomy can be used to treat endometriosis by eliminating the menstrual cycle, which will reduce or eliminate the spread of existing endometriosis as well as reducing the pain. Since endometriosis results from an overgrowth of the uterine lining, removal of the ovaries as a treatment for endometriosis is often done in conjunction with a hysterectomy to further reduce or eliminate recurrence. Risks and adverse effects Oophorectomy for endometriosis is used only as last-resort often in conjunction with a hysterectomy, as it has rather severe side effects for women of reproductive age and low success rate. Oophorectomy at age 40 or later might also be used to prevent ovarian cancer although there is currently no evidence that cancer prevention alone is a sufficiently strong indication to justify the surgery. Partial oophorectomy--ovarian cyst removal not involving total oophorectomy--is often used to treat milder cases of endometriosis when non-surgical hormonal treatments fail to stop cyst formation. Removal of ovarian cysts through partial oophorectomy is also used to treat extreme pelvic pain from chronic hormonal-related pelvic problems. Oophorectomy is a minor surgery and serious complications stemming directly from the surgery are rare. Despite this it has very serious long term consequences stemming mostly from the hormonal effects of the surgery and extending well beyond menopause. The reported risks and adverse effects range from premature death, cardiovascular disease, cognitive impairment or dementia, parkinsonism, osteoporosis and bone fractures, decline in psychological wellbeing, and decline in sexual function. Hormone replacement therapy does not always improve the adverse effects. Mortality Oophorectomy is associated with significantly increased all-cause long-term mortality except when performed for cancer prevention in carriers of high risk BRCA mutations. This is particularly pronounced for women who undergo oophorectomy before age 45.

11 Removal of ovaries causes hormonal changes and symptoms similar to, but generally more severe than, menopause. Women who have had an oophorectomy are usually encouraged to take hormone replacement drugs to prevent other conditions often associated with menopause. Women younger than 45 who have had their ovaries removed face a mortality risk 170% higher than women who have retained their ovaries.. Retaining the ovaries when a hysterectomy is performed is associated with better long term survival.. Hormone therapy for women with oophorectomies performed before age 45 improves the long term outcome and all cause mortality rates. Women who have had bilateral oophorectomy surgeries lose most of their ability to produce the hormones estrogen and progesterone, and lose about half of their ability to produce testosterone, and subsequently enter what is known as "surgical menopause" (as opposed to normal menopause, which occurs naturally in women as part of the aging process). "Surgical menopause" differs from naturally occurring menopause in several respects: Surgical menopause is the result of surgery, while menopause is a natural event. A menopausal woman has intact functional female organs, a woman with surgical menopause does not. In natural menopause the ovaries generally continue to produce low levels of hormones, while in surgical menopause the ovaries and their hormones are absent, which can explain why surgical menopause is generally accompanied by a more sudden and severe onset of symptoms than natural menopause, symptoms which may continue until natural age of menopause arrives. These symptoms are commonly addressed through hormone therapy, utilizing various forms of estrogen, testosterone, progesterone or a combination of them. Cardiovascular risk When the ovaries are removed a woman is at a seven times greater risk of cardiovascular disease, but the mechanisms are not precisely known. The hormone production of the ovaries currently cannot be sufficiently mimicked by drug therapy. The ovaries produce hormones a woman needs throughout her entire life, in the quantity they are needed, at the time they are needed in response to and as part of the complex endocrine system. Osteoporosis Oophorectomy is associated with an increased risk of osteoporosis and bone fractures. However, the risk is limited to oophorectomy performed before menopause or during the early perimenopause. Reduced levels of testosterone in women is predictive of height loss, which may occur as a result of reduced bone density. In women under the age of 50 who have undergone oophorectomy, hormone replacement therapy (HRT) is often used to offset the negative effects of sudden hormonal loss (e.g., early-onset osteoporosis) as well as menopausal problems like hot flushes (also called "hot flashes") that are usually more severe than those experienced by women undergoing natural menopause.

12 Adverse effect on sexuality Oophorectomy does substantially impair sexuality. Substantially more women who had both an oophorectomy and a hysterectomy reported libido loss, difficulty with sexual arousal, and vaginal dryness than those who had a less invasive procedure (either hysterectomy alone or an alternative procedure), and hormone replacement therapy was not found to improve these symptoms. In addition, testosterone levels in women are associated with a greater sense of sexual desire, and oophorectomy greatly reduces testosterone levels. Managing side effects of prophylactic oophorectomy Non-hormonal treatments Hormonal treatments The side effects of oophorectomy may be alleviated by medicines other than hormonal replacement. Non-hormonal biphosphonates (such as Fosamax and Actonel) increase bone strength and are available as once-a-week pills. Low-dose Selective Serotonin Reuptake Inhibitors (e.g. Paxil, Prozac) alleviate vasomotor menopausal symptoms, i.e. "hot flashes". In general, hormone replacement therapy is somewhat controversial due to the known carcinogenic and thrombogenic properties of estrogen; however, many physicians and patients feel the benefits outweigh the risks in women who may face serious health and quality of life issues as a consequence of early surgical menopause. The ovarian hormones estrogen, progesterone, and testosterone are involved in the regulation of hundreds of bodily functions; it is believed by some doctors that hormone therapy programs mitigate surgical menopause side effects such as increased risk of cardiovascular disease, and female sexual dysfunction. Short-term hormone replacement with estrogen has negligible effect on overall mortality for high-risk BRCA mutation carriers. Based on computer simulations overall mortality appears to be marginaly higher for short term HRT after oophorectomy or marginally lower for short term HRT after oophorectomy in combination with mastectomy. This result can probably be generalized to other women at high risk in whom short term (i.e., one- or two-year) treatment with estrogen for hot flashes, may be acceptable.

13 Chapter 3 Salpingectomy and Tubal Ligation Salpingectomy Intervention: Salpingectomy Schematic frontal view of female anatomy ICD-10 code: ICD-9 code: Other codes: Salpingectomy refers to the surgical removal of a Fallopian tube. Indications The procedure was first performed by Lawson Tait in patients with a bleeding ectopic pregnancy; this procedure has since saved the lives of countless women. Other indications for a salpingectomy include infected tubes, (as in a hydrosalpinx) or as part of the surgical procedure for tubal cancer.

14 A bilateral salpingectomy will lead to sterility, and was used for that purpose, however less invasive procedures have become available as tubal occlusion procedures. Process Salpingectomy has traditionally been done via a laparotomy; more recently however, laparoscopic salpingectomies have become more common as part of minimally invasive surgery. The tube is severed at the point where it enters the uterus and along its mesenteric edge with hemostatic control. Related procedures Salpingo-oophorectomy Salpingectomy is commonly done as part of a procedure called a salpingooophorectomy, where one or both ovaries, as well as one or both Fallopian tubes, are removed in one operation (a Bilateral Salpingo-Oophorectomy (BSO) if both ovaries and Fallopian tubes are removed). If a BSO is combined with a hysterectomy, the procedure is commonly called a TAH-BSO: Total Abdominal Hysterectomy with a Bilateral Salpingo-Oophorectomy. Salpingostomy / Salpingotomy Salpingectomy is different from a salpingostomy and salpingotomy. The latter two terms are often used interchangeably and refer to creating an opening into the tube (e.g. to remove an ectopic pregnancy), but the tube itself is not removed. Technically, the creation of a new tubal opening (os) by surgery would be a salpingostomy, while the incision into the tube to remove an ectopic is a salpingotomy. History Salpingectomies were performed in the United States in the 20th century in accordance with eugenics legislation. From Buck v. Bell: The Virginia statute providing for the sexual sterilization of inmates of institutions supported by the State who shall be found to be afflicted with an hereditary form of insanity or imbecility, is within the power of the State under the Fourteenth Amendment.

15 Tubal ligation Tubal ligation Right Fallopian tube prior to ligation Background Birth control type Sterilization First use 1930 Perfect use 0.5% Typical use 0.5% Duration effect Reversibility User reminders Failure rates (first year) Permanent Sometimes None Usage Clinic review None Advantages and disadvantages STD protection No Risks Operative and postoperative complications. Tubal ligation or tubectomy (informally known as getting one's "tubes tied") is a form of female sterilization, in which the fallopian tubes are severed and sealed or "pinched shut", in order to prevent fertilization. Procedure There are mainly four occlusion methods for tubal ligation, typically carried out on the isthmic portion of the fallopian tube, that is, the thin portion of the tube closest to the uterus.

16 Partial salpingectomy, being the most common occlusion method. The fallopian tubes are cut and realigned by suture in a way not allowing free passage. The Pomeroy technique, is a widely used version of partial salpingectomy, involving tying a small loop of the tube by suture and cutting off the top segment of the loop. It can easily be applied via laparoscopy. Partial salpingectomy is considered safe, effective and easy to learn. It does not require any special equipment to perform; it can be done with only scissors and suture. Partial salpingectomy is not generally used with laparoscopy. Clips: Clips clamp the tubes and inhibits blood flow to the portion, causing a small amount of scarring or fibrosis, in turn, preventing fertilization. The most commonly used clips are the Filshie clip, made of titanium, and the Wolf clip (or "Hulka clip"), made of plastic. Clips are simple to insert, but require a special tool to put in place. Interval tubal ligation is not done after a recent delivery., in contrast to postpartum tubal Silicone rings: Tubal rings, similarly to clips, block the tubes mechanically. It encircles a small loop of the fallopian tube, blocking blood supply to that small loop, resulting in scarring that blocks passage of the sperm or egg. A commonly used type of ring is the Yoon Ring, made of silicone. Electrocoagulation or cauterization: Electric current coagulates or burns a small portion of each fallopian tube. It mostly uses bipolar coagulation, where electric current enters and leaves through two ends of a forceps applied to the tubes. Bipolar coagulation is safer, but slightly less effective than unipolar coagulation, which involves the current leaving through an electrode placed under the thigh. It is usually done via laparoscopy. ligation. In addition, a bilateral salpingectomy is effective as a tubal ligation procedure. A tubal ligation can be performed as a secondary procedure when a laparotomy is done; i.e. a cesarean section. Any of these procedures may be referred to as having one's "tubes tied." Tubal ligation can be performed under either general anesthesia or local anesthesia (spinal or epidural, often supplemented with a tranquilizer to calm the patient during the procedure). The default in tubal ligations following on from cesarean birth is usually spinal/epidural, while the default in non-childbirth related situations may be general anesthesia as a matter of doctor preference. However, tubal ligations under local anesthesia, either inpatient or outpatient, may be performed under patient request. Entry to the site of tubal ligation can be done in many forms; through a vaginal approach, through laparoscopy, a minilaparotomy ("minilap"), or through regular laparotomy.

17 Effectiveness A tubal ligation is approximately 99% effective in the first year following the procedure. In the following years the effectiveness may be reduced slightly since the fallopian tubes can, in some cases, reform or reconnect which can cause unwanted pregnancy. Method failure is difficult to detect, except by subsequent pregnancy, unlike with vasectomy or IUD. If pregnancy does occur it carries a 33% chance of being an ectopic pregnancy. Two economic studies suggest that laparoscopic bilateral tubal ligation could be less cost-effective than the Essure procedure, which uses a special type of fiber to induce a benign fibrotic reaction. Reversal Generally tubal ligation procedures are done with the intention to be permanent. Tubal reversal is microsurgery to repair the fallopian tube after a tubal ligation procedure. Usually there are two remaining fallopian tube segments the proximal tubal segment that emerges from the uterus and the distal tubal segment that ends with the fimbria next to the ovary. The procedure that connects these separateds of the fallopian tube is called tubal reversal or microsurgical tubotubal anastomosis. In a small percentage of cases, a tubal ligation procedure leaves only the distal portion of the fallopian tube and no proximal tubal opening into the uterus. This may occur when monopolar tubal coagulation has been applied to the isthmic segment of the fallopian tube as it emerges from the uterus. In this situation, a new opening can be created through the uterine muscle and the remaining tubal segment inserted into the uterine cavity. This microsurgical procedure is called tubal implantation, tubouterine implantation, or uterotubal implantation. Tubal reversal, if done by a specialist microsurgeon, has a high success rate and few complications. Successful repair of the fallopian tubes is now possible in 98% of women who have had a tubal ligation, regardless of the type of sterilization procedure. In vitro fertilization may overcome fertility problems in patients not suited to a tubal reversal. Prevalence Worldwide, female sterilization is used by 33% of married women using contraception, making it the most common contraceptive method. As of June 2010, there is a recent decline of tubal ligation procedures in the United States after two decades of stable rates, possibly explained by an improved access to a wide range of highly effective reversible contraceptives.

18 Access In developing countries, tubal ligation is generally a popular form of birth control, and is widely available, although some Muslim countries (e.g. Egypt and Indonesia) do not permit it. Faith-based medical institutions in developed countries will sometimes refuse to perform tubal ligations, and where long waiting times persist, there is a worrying risk of pregnancy or complications due to alternative contraception. Because of the permanent nature of the operation, physicians are often uncomfortable performing tubal ligation on women under 30 without children, from concern they may one day change their minds. Advantages and disadvantages Tubal ligation is a more major surgery than vasectomy. One study found that postoperative complications from tubal ligation are more likely than with vasectomy and more costly. However, this study did not consider post-vasectomy pain syndrome. In industrialized nations, mortality is 4 per 100,000 tubal ligations, versus 0.1 per 100,000 vasectomies. Tubal ligation may reduce the risk of ovarian cancer, with some studies estimating the Tubal ligation has a larger initial cost than other contraceptive methods. Typically vasectomies are more cost-effective than tubal ligation because they are less expensive. It may take more than a decade of use for tubal ligation to become as cost-effective as other highly effective, long term methods like IUD or implant. Continued method costs or costs from unintended pregnancies make many other methods as or more costly than tubal ligation if used for several years. The cost of tubal ligation is reduced if it is performed during a cesarean section since the tubes are already exposed during the laparotomy. relative risk at 0.66 for epithelial types, 0.40 for endometrioid types and 0.73 for serous types.

19 Chapter 4 Essure and Tubal Reversal Essure Birth control type Sterilization Essure Background First use 2002 Failure rates (first year, after occlusion) Perfect use 0.2% Typical use 0.2% Usage Duration effect Permanent Reversibility No Additional methods until 3 month check by User reminders hysterosalpingogram Clinic review None Advantages and disadvantages STD protection No Benefits Permanent contraception Essure is a permanent transcervical sterilization procedure for women developed by Conceptus Inc. It was approved for use in the United States on November 4, 2002.

20 Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic bilateral tubal ligation. Procedure Inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The insert contains inner polyethylene terephthalate fibers to induce benign fibrotic reaction and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil (1). Once in place, the device is designed to elicit tissue growth in and around the insert to form over a period of three months an occlusion or blockage in the fallopian tubes; the tissue barrier formed prevents sperm from reaching an egg. Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required. Follow-up Similar to some other methods of birth control, initially additional forms of birth control must be continued for 3 months to prevent pregnancy until the method's effectiveness can be confirmed. For the Essure method, three months after insertion a physician performs an x-ray test called a hysterosalpingogram, also known as an Essure Confirmation Test to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control. A contrast agent (dye) is injected through the cervix, and an X- Ray technician take photos of the Essure coils to ensure that they are in place. Efficacy Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up, with zero pregnancies reported in clinical trials. The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)".Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months. Cautions and warnings The inserts do not prevent the transmission of sexually transmitted diseases. The procedure takes about 10 minutes for a trained physician to perform and can be performed in a physician's office. General anesthesia is not required. Unlike many temporary methods of birth control, the Essure inserts do not contain or release hormones.

21 The inserts are made from polyester fibers, nickel-titanium and stainless steel and are safe to use with MRI equipment. The Essure procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed. Additional birth control must be used for three months after procedure. Risks Perforation, expulsion, or other unsatisfactory location of the insert Pregnancy and increased risk of ectopic pregnancy Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6 8 weeks due to changing birth control methods to a non-hormonal solution Nausea/vomiting Vasovagal response (fainting) Allergic reaction to the materials Tubal reversal Tubal reversal, also called tubal sterilization reversal or tubal ligation reversal, is a surgical procedure that attempts to restore fertility to women after a tubal ligation. By rejoining the separated segments of fallopian tube, tubal reversal may give women the chance to become pregnant again. Tubal anatomy The fallopian tube is a muscular organ extending from the uterus and ending next to the ovary. The tube is attached to the ovary by a small ligament. The inner tubal lining is rich in cilia. These are microscopic hair-like projections that beat in waves that help move the egg or ovum to the uterus in conjunction with muscular contractions of the tube.

22 Fallopian Tube Anatomy Tubal reversal procedures The fallopian tube is normally about 10 cm (4 inches) long and consists of several segments. Starting from the uterus and proceeding outward, these are the: Interstitial segment - extends from the uterine cavity through the uterine muscle Isthmic segment - narrow muscular portion adjacent to the uterus Ampullary segment - wider and longer middle part of the tube Infundibular segment - funnel shaped segment next to the fimbrial end Fimbrial segment - wide opening at the end of the tube facing the ovary Tubal ligation reversal utilizes the techniques of microsurgery to open and reconnect the fallopian tube segments that remain after a tubal sterilization procedure. Microsurgery minimizes tissue damage and bleeding during surgery. Essential elements of microsurgical technique include gentle tissue handling, magnifying the operating field, keeping body tissues in their normal state with warmed irrigation fluids, and using the smallest sutures with the thinnest needles capable of holding the tubal ends together to promote proper healing of the rejoined tubal segments. Tubotubal anastomosis Following a tubal ligation, there are usually two remaining fallopian tube segments - the proximal tubal segment that emerges from the uterus and the distal tubal segment that ends with the fimbria next to the ovary. After opening the blocked ends of the remaining tubal segments, a narrow flexible stent is gently threaded through their inner cavities or lumens and into the uterine cavity. This ensures that the fallopian tube is open from the uterine cavity to its fimbrial end. The newly created tubal openings are then drawn next to each other by placing a retention suture in the connective tissue that lies beneath the fallopian tubes (mesosalpinx). The retention suture avoids the likelihood of the tubal segments subsequently pulling apart. Microsurgical sutures are used to precisely align the muscular portion (muscularis externa) and outer layer (serosa), while avoiding the inner

23 layer (mucosa) of the fallopian tube. The tubal stent is then gently withdrawn from the fimbrial end of the tube. Tubouterine implantation In a small percentage of cases, a tubal ligation procedure leaves only the distal portion of the fallopian tube and no proximal tubal segment. This may occur when monopolar tubal coagulation has been applied to the isthmic segment of the fallopian tube as it emerges from the uterus. In this situation, a new opening can be created through the uterine muscle and the remaining tubal segment inserted into the uterine cavity. This microsurgical procedure is called tubouterine implantation, uterotubal implantation, or, simply, tubal implantation. Tubal implantation is performed when tubal anastomosis is not possible due to the absence of a proximal tubal segment and interstitial tubal lumen. Ampullary salpingostomy Fimbriectomy is an uncommon type of tubal ligation that is performed by removing the fimbrial portion of the fallopian tube next to the ovary, leaving the tubal segment attached to the uterus. After fimbriectomy, the remaining tubal segment can be opened by the technique ampullary salpingostomy. A microsurgical electrode is used to open the tubal end and expose the internal lining. When the opening has been enlarged sufficiently and the internal lining or endothelium has extruded from the tubal end, sutures are placed to keep the endothelium folded outward over the edge and to prevent the tube from closing again. Mini-laparotomy tubal reversal Mini-laparotomy for tubal reversal surgery involves making a small incision in the abdominal wall just above the pubic bone after shaving the hair with a sterile hair clipper. The size and location of the incision as well as the plastic surgery techniques used to close it make the hair-line scar invisible when it has healed. Atraumatic surgical techniques involve the use of local anesthesia at the incision site and other tissues operated upon. This makes the surgery comfortable and minimizes post-operative pain. As opposed to standard operative methods, avoiding the use of surgical retractors and packs, constantly irrigating tissues to keep them moist and at body temperature, and operating under magnification throughout the procedure results in very rapid patient recovery. Operating with microsurgical instruments allows precision in suturing of the tubal segments than is possible with longer needle holders and other instruments such as are used in laparoscopic surgery. After the mini-laparotomy approach, patients may attempt to become pregnant as soon as they are fully recovered from their surgery. Laparoscopic tubal reversal Laparoscopic Tubal Reversal is a minimally-invasive surgical procedure (laparoscopy), using small, specially-designed instruments to repair and reconnect the fallopian tubes.

24 After general anesthesia has been administered, a 10mm (less than ½-inch) tube (trocar) is inserted just at the lower edge of the navel, and a special gas is pumped into the abdomen to create enough space to perform the operation safely and precisely. The laparoscope (a telescope), attached to a camera, is brought into the abdomen through the same tube, and the pelvis and abdomen are thoroughly inspected. The fallopian tubes are evaluated and the obstruction (ligation, burn, ring, or clip) is examined. Three small instruments (5mm each, less than ¼-inch) are used to remove the occlusion and prepare the two segments of the tube to be reconnected. Once the connection (anastomosis) is completed, a blue dye is injected through the cervix, traveling through the uterus and tubes, all the way to the abdomen. This is to make sure the tubes have been aligned properly and that the connection is working well. Patients are seen between 5 7 days after the operation to look at the small incisions and remove any stitches if necessary. Most of the time, the few stitches that were placed will be under the skin and will be absorbed by the body, without need for removal. Robotic assisted tubal reversal Patients should wait two to three months prior to attempting pregnancy in order to give the tubes a chance to heal completely. Trying to conceive before could result in an increased risk of ectopic pregnancy (pregnancy inside the fallopian tube instead of in the uterus). When performed by a trained laparoscopic tubal reversal surgeon, laparoscopic tubal reversal combines the success rates of micro-surgical techniques with the advantages of minimally-invasive surgery namely faster recovery, better healing, less pain, fewer complications, and no large disfiguring scars. Robotic assisted tubal reversal surgery is a surgical procedure in which the fallopian tubes are repaired by a surgeon using a remotely controlled, robotic surgical system. The robotic system involves two components: a patient side-cart (also referred to as the robot) and a surgeon's console. The robot is placed adjacent to the patient and has several attached arms. Each arm has a unique surgical instrument and performs a specialized surgical function. The surgeon sits near the patient at the surgeon's console and visualizes the surgery through a monitor. The surgeon performs the entire reversal surgery using controllers located inside the surgeon's console. Robotic surgery experts have suggested robotic tubal ligation reversal offers the advantage of smaller incisions when compared to traditional laparotomy tubal reversal surgery. These smaller incisions have been reported to result in less pain and quicker return to work after robotic tubal reversal when compared to traditional tubal ligation reversal using larger abdominal incisions. Robotic experts have also suggested the robotic system offers a greater range of motion and more surgical dexterity than a surgeon can

25 obtain during laparoscopic tubal ligation reversal. The potential disadvantages to robotic surgery are longer operating times and higher costs. A retrospective, Cleveland Clinic study compared 26 patients who underwent robotic assisted tubal reversal to 41 patients who underwent outpatient mini-laparotomy (abdominal incision) tubal reversal. Robotic tubal reversal patients, when compared to abdominal tubal reversal surgery patients, had longer times under anesthesia (283 minutes vs 205 minutes) and longer times in surgery (229 minutes vs 181 minutes). On average, robotic tubal reversal patients returned to work one week sooner than abdominal tubal reversal patients and the robotic tubal reversal surgeries were also more expensive than abdominal tubal reversal surgeries. An Ohio State University study evaluating robotic tubal reversal vs abdominal tubal reversal discovered similar findings but also evaluated pregnancy outcomes. Robotic tubal reversal surgery, when compared to abdominal tubal reversal surgery, had longer operative times (201 minutes vs 155 minutes), shorter hospital stays (4 hours compared to 34 hours), and quicker return to activities of daily living. Pregnancy outcomes of robotic tubal reversal surgery patients were also compared to pregnancy outcome of abdominal incision tubal reversal patients. Approximately 65% of the robotic tubal reversal surgery patients became pregnant compared with 50% of the abdominal incision patients. Of the pregnancies, 6 abnormal pregnancies were in the robotic tubal reversal patients (4 ectopic and 2 miscarriage) and 2 were in the abdominal incision patients (1 ectopic and 1 miscarriage). Both surgeries were expensive and were found to cost in excess of $92,000. Robotic tubal reversal surgery was slightly more costly than the abdominal incision tubal reversal. Essure sterilization reversal Essure sterilization is a hysteroscopic tubal occlusion procedure and was approved by the FDA in Essure sterilization can be done as a simple, outpatient procedure. The Essure procedure requires a small camera (hysteroscope) be inserted through the cervix and into the uterine cavity. Two small, metallic coils are then inserted into each tubal ostia and into the isthmic portion of the fallopian tube. The coils cause the isthmic portion of the fallopian tube to scar (or heal) closed. To confirm tubal closure, a HSG x-ray should be performed three months after the Essure procedure. If either fallopian tube is open after the Essure procedure, then the Essure procedure should be repeated or another type of tubal occlusion method should be performed. Essure sterilization can be reversed and does not have to be permanent. Reversal of Essure sterilization requires the blocked isthmic portion of the tube be bypassed. The procedure to bypass the blocked portion of the tube is called a tubouterine implantation. Tubouterine implantation requires the reversal surgeon to make an incision into the uterus and reinsert the healthy portion of the tube through the uterine muscle and into the uterine cavity. Experts who specialize in tubal reversal surgery and tubouterine implantation are

26 able to perform this type of reversal as an outpatient procedure and provide success rates comparable, if not better, than IVF pregnancy success rates. Adiana sterilization reversal Adiana sterilization was approved by the FDA in Adiana sterilization is a hysteroscopic tubal occlusion procedure, which is very similar to Essure sterilization. The Adiana procedure is a outpatient procedure performed by inserting a small camera (hysteroscope) through the cervix and into the uterine cavity. A smaller catheter is inserted into the tubal ostia. The catheter emits radiowaves (microwaves). The radiowaves cause injury to the tubal lining and will result in the tube gradually closing. Prior to removal of the catheter a small silicone stent is left inside the isthmic portion of the tube and this promotes tubal closure by the acceleration of the tubal scarring. To confirm tubal closure, a HSG x-ray should be performed three months after the Adiana procedure. If either fallopian tube is open, then the Adiana procedure should be redone or another type of tubal occlusion method should be performed. Sterilization regret Adiana sterilization can be reversed and does not have to be permanent. Reversal of Adiana is similar to reversal of Essure sterilization and requires the blocked isthmic portion of the tube be bypassed. The procedure to bypass the blocked portion of the tube is called a tubouterine implantation. Tubouterine implantation requires the reversal surgeon to make an incision into the uterus and reinsert the healthy portion of the tube through the uterine muscle and into the uterine cavity. Experts who specialize in tubal reversal surgery and tubouterine implantation are able to perform this type of reversal as an outpatient procedure and provide success rates comparable, if not better, than IVF pregnancy success rates. The first successful Adiana reversal has recently been described. In a study called the U.S. Collaborative Review of Sterilization (CREST), women who had tubal ligations were asked "Do you still think tubal sterilization as a permanent method of birth control was a good choice for you?" Overall, 13% of women said they did not think that the tubal ligation was a good choice. The percentage expressing regret was 20% for women aged 30 years or younger at the time of sterilization, compared with 6% for women older than 30 years at the time of tubal ligation. For women under age 25, the rate was 40%. Despite the high percentage of women who subsequently regret having had a tubal ligation, only 0.2% of women in the CREST study underwent tubal reversal. Reasons for this discrepancy may include lack of information about tubal reversal, cost of the procedure, and lack of insurance coverage for this procedure. Women often receive inaccurate information about tubal reversal - such as tubal ligation cannot be reversed, or the only treatment option is in vitro fertilization (IVF), or tubal reversal is available only as a high cost operation requiring hospitalization.

27 Tubal Reversal Success Rates Tubal reversal success rates vary widely depending upon many factors. These include the patient population (women's ages, methods of tubal ligation that they had performed, experience of the surgeon and techniques for repairing the tubes, length of follow-up after reversal surgery and other factors). The following data are from the Tubal Reversal Pregnancy Report 2009, the largest study ever conducted. The study included 5,046 patients over an 8 year period following tubal reversal surgery performed at Chapel Hill Tubal Reversal Center, Chapel Hill, NC. Pregnancy Rates By Age As expected, younger women had higher pregnancy rates than older women. The pregnancy rate after surgery ranged from 80% for women under 30 to 31% for women 40 years of age and older. Table 1. Pregnancy Rates by Age Age Total Cases Pregnant (No.) Pregnant (%) < % % % % Pregnancy Rates By Tubal Ligation Method Reversal of tubal clip procedures had the highest pregnancy rate (75%), followed by tubal rings (72%), coagulation (66%) and ligation/resection (63%)as shown in Table 2. Table 2. Pregnancy Rates by Tubal Ligation Method Method Total Cases Pregnant (No.) Pregnant (%) Clip % Ring % Coagulation % Ligation/Resection %

28 Pregnancy Rates By Age And Method Pregnancy rates taking into account both age and tubal ligation method are shown in Table 3. The highest pregnancy rate (90%) was reported by women under 30 years of age who had reversal of a previous clip method of sterilization. Of the two variables, age is more predictive than tubal ligation method regarding the likelihood of becoming pregnant after reversal surgery. Table 3. Pregnancy Rates by Age and Tubal Ligation Method Age Clip Ring Coagulation Ligation/Resection <30 69/77 (90%) 137/163 (84%) 190/244 (78%) 192/248 (77%) /139 (82%) 227/299 (76%) 461/620 (74%) 517/744 (70%) /151 (73%) 210/303 (69%) 353/554 (64%) 421/681 (62%) /42 (31%) 40/88 (46%) 49/187 (26%) 77/250 (31%) Pregnancy Outcomes By Age Table 4 shows the relationship between age and pregnancy outcome following tubal ligation reversal at Chapel Hill Tubal Reversal Center. With increasing age, the percentage of pregnancies resulting in births declined due to an increasing percentage of miscarriages. Among women under age 35, over half of pregnancies resulted in birth or ongoing pregnancy while one third miscarried. The birth rate declined and the miscarriage rate increased significantly for women ages 40 and older. The overall ectopic pregnancy rate for all patients (14%) was higher than that found in the general population of women who have not had a tubal ligation, which is approximately 2.5%. The ectopic pregnancy rate after tubal reversal surgery may be overestimated, since some early pregnancy losses were reported as ectopic pregnancies when serum HCG levels did not rise normally but without confirmation of the diagnosis by ultrasound or laparoscopy. In the case of very early pregnancy loss, the actual site of the pregnancy (uterine or ectopic) is unknown. Whether there is an increased risk of miscarriage associated with tubal reversal is unclear. The miscarriage rate reported in the general population ranges from approximately 20% to 50% depending on a woman's age and how early pregnancy testing is performed. Table 4. Pregnancy Outcomes by Age Age Pregnant Birth/Ongoing Miscarriage Ectopic < (55%) 207 (34%) 67 (11%) (50%) 495 (36%) 204 (15%)

29 (44%) 466 (41%) 177 (15%) (33%) 110 (59%) 17 (9%) Pregnancy Outcomes By Tubal Ligation Method Table 5 shows the relationship between the tubal ligation method and pregnancy outcomes. Tubal ligation reversal after tubal clips (Hulka clip, Filshie clip) has the best outcome of all tubal ligation methods, with the highest birth rate (69%) and lowest miscarriage rate (25%) and ectopic pregnancy rate (6%). Reversal of tubal rings (Falope ring, Yoon ring) has the second best outcome, followed in order by ligation/resection and coagulation. These findings are almost certainly related to the minimal damage to the fallopian tube caused by tubal clips and rings. Table 5. Pregnancy Outcomes by Tubal Ligation Method Method Pregnant Birth/Ongoing Miscarriage Ectopic Clip (69%) 77 (26%) 19 (6%) Ring (52%) 232 (38%) 67 (11%) Ligation/resection (44%) 483 (40%) 188 (16%) Coagulation (44%) 429 (41%) 164 (16%)

30 Chapter 5 Hysterectomy Intervention: Hysterectomy ICD-10 code: ICD-9 code: 68.9 MeSH D Other codes: A hysterectomy (from Greek ὑστέρα hystera "womb" and εκτομία ektomia "a cutting out of") is the surgical removal of the uterus, usually performed by a gynecologist. Hysterectomy may be total (removing the body, fundus, and cervix of the uterus; often called "complete") or partial (removal of the uterine body while leaving the cervix intact; also called "supracervical"). It is the most commonly performed gynecological surgical procedure. In 2003, over 600,000 hysterectomies were performed in the United States alone, of which over 90% were performed for benign conditions. Such rates being highest in the industrialized world has led to the major controversy that hysterectomies are being largely performed for unwarranted and unnecessary reasons. Removal of the uterus renders the patient unable to bear children (as does removal of ovaries and fallopian tubes), and changes the hormonal levels of the female considerably, so the surgery is normally recommended for only a few specific circumstances: Certain types of reproductive system cancers (uterine, cervical, ovarian) or tumors Severe and intractable endometriosis (growth of the uterine lining outside the uterine cavity) and/or adenomyosis (a form of endometriosis, where the uterine lining has grown into and sometimes through the uterine wall musculature) after pharmaceutical or other surgical options have been exhausted Postpartum to remove either a severe case of placenta praevia (a placenta that has either formed over or inside the birth canal) or placenta percreta (a placenta that has grown into and through the wall of the uterus to attach itself to other organs), as well as a last resort in case of excessive postpartum bleeding For trans men, as part of their gender transition

31 For severe developmental disabilities Although hysterectomy is frequently performed for fibroids (benign tumor-like growths inside the uterus itself made up of muscle and connective tissue), conservative options in treatment are available by doctors who are trained and skilled at alternatives. It is well documented in medical literature that myomectomy, surgical removal of fibroids with reconstruction of the uterus, has been performed for over a century. The uterus is a hormone-responsive reproductive sex organ, and the ovaries produce the majority of estrogen and progesterone that is available in genetic females of reproductive age. Some women's health education groups such as the Hysterectomy Educational Resources and Services (HERS) Foundation seek to inform the public about the many consequences and alternatives to hysterectomy, and the important functions that the female organs have all throughout a woman's life. Incidence Canada In Canada, the number of hysterectomies between 2008 and 2009 was almost 47,000. The national rate in for the same timeline was 338 per 100,000 population, down from 484 per 100,000 in The reasons for hysterectomies differed depending on whether the woman was living in an urban or rural location. Urban women most common reason was due to uterine fibroids and rural women had hysterectomies mostly for menstrual disorders. United States According to the National Center for Health Statistics, of the 617,000 hysterectomies performed in 2004, 73% also involved the surgical removal of the ovaries. In the United States, 1/3 of women can be expected to have a hysterectomy by age 60. There are currently an estimated 22 million people in the United States who have undergone this procedure. An average of 622,000 hysterectomies a year have been performed for the past decade. United Kingdom In the UK, one in 5 women is likely to have a hysterectomy by age 60, and ovaries are removed in about 20% of hysterectomies.

32 Indications Hysterectomy is usually performed for problems with the uterus itself or problems with the entire female reproductive complex. Some of the conditions treated by hysterectomy include uterine fibroids (myomas), endometriosis (growth of tissue resembling the uterine lining tissue outside of the uterine cavity), adenomyosis (a more severe form of endometriosis, where the uterine lining has grown into and sometimes through the uterine wall), several forms of vaginal prolapse, heavy or abnormal menstrual bleeding, and at least three forms of cancer (uterine, advanced cervical, ovarian). Hysterectomy is also a surgical last resort in uncontrollable postpartum obstetrical haemorrhage. Uterine fibroids, although a benign disease, may cause heavy menstrual flow and discomfort to some of those with the condition. Many alternative treatments are available: pharmaceutical options (the use of NSAIDs or opiates for the pain and hormones to suppress the menstrual cycle); myomectomy (removal of uterine fibroids while leaving the uterus intact); uterine artery embolization, high intensity focused ultrasound or watchful waiting. In mild cases, no treatment is necessary. If the fibroids are inside the lining of the uterus (submucosal), and are smaller than 4 cm, hysteroscopic removal is an option. A submucosal fibroid larger than 4 cm, and fibroids located in other parts of the uterus, can be removed with a laparotomic myomectomy, where a horizontal incision is made above the pubic bone for better access to the uterus. performing a hysterectomy as part of prophylaxis treatment for BRCA mutations. Hysterectomy is sometimes performed as a prophylactic treatment for those with either a strong family history of reproductive system cancers (especially breast cancer in conjunction with BRCA1 or BRCA2 mutation) or as part of their recovery from such cancers. With the availability of new medications such as raloxifene, aromatase inhibitors, and more recent prophylactic strategies for high risk BRCA mutations, there are now alternatives available to either reduce or eliminate altogether the necessity of

33 Types of hysterectomy Schematic drawing of types of hysterectomy Hysterectomy in the literal sense of the word means merely removal of the uterus, however other organs such as ovaries, fallopian tubes and the cervix are very frequently removed as part of the surgery. Radical hysterectomy : complete removal of the uterus, cervix, upper vagina, and parametrium. Indicated for cancer. Lymph nodes, ovaries and fallopian tubes are also usually removed in this situation. Total hysterectomy : Complete removal of the uterus and cervix. Subtotal hysterectomy : removal of the uterus, leaving the cervix in situ. Many women want to retain the cervix believing that it may affect sexual satisfaction after hysterectomy. It has been postulated that removing the cervix causes excessive neurologic and anatomic disruption, thus leading to vaginal shortening, vaginal vault prolapse, and vaginal cuff granulations. These issues were addressed in a systematic review of total versus supracervical hysterectomy for benign gynecological conditions, which reported the following findings:

34 There was no difference in the rates of incontinence, constipation or measures of sexual function. Length of surgery and amount of blood lost during surgery were significantly reduced during supracervical hysterectomy compared to total hysterectomy, but there was no difference in post-operative transfusion rates. Febrile morbidity was less likely and ongoing cyclic vaginal bleeding one year after surgery was more likely after supracervical hysterectomy. There was no difference in the rates of other complications, recovery from surgery, or readmission rates. In the short-term, randomized trials have shown that cervical preservation or removal does not affect the rate of subsequent pelvic organ prolapse. However, no trials to date have addressed the risk of pelvic organ prolapse many years after surgery, which may differ after total versus supracervical hysterectomy. It is obvious that supracervical hysterectomy does not eliminate the possibility of having cervical cancer since the cervix itself is left intact. Those who have undergone this procedure must still have regular Pap smears to check for cervical dysplasia or cancer. Technique Hysterectomy can be performed in different ways. The oldest known technique is abdominal incision. Subsequently the vaginal (performing the hysterectomy through the vaginal canal) and later laparoscopic vaginal (with additional instruments inserted through a small hole, frequently close to the navel) techniques were developed. Most hysterectomies in the United States are done via laparotomy (abdominal incision, not to be confused with laparoscopy). A transverse (Pfannenstiel) incision is made through the abdominal wall, usually above the pubic bone, as close to the upper hair line of the individual's lower pelvis as possible, similar to the incision made for a caesarean section. This technique allows doctors the greatest access to the reproductive structures and is normally done for removal of the entire reproductive complex. The recovery time for an open hysterectomy is 4 6 weeks and sometimes longer due to the need to cut through the abdominal wall. Historically, the biggest problem with this technique were infections, but infection rates are well-controlled and not a major concern in modern medical practice. An open hysterectomy provides the most effective way to explore the abdominal cavity and perform complicated surgeries. Before the refinement of the vaginal and laparoscopic vaginal techniques it was also the only possibility to achieve subtotal hysterectomy, meanwhile any of the techniques can be used for subtotal hysterectomy. Vaginal hysterectomy is performed entirely through the vaginal canal and has clear advantages over abdominal surgery such as less complications, shorter hospital stays and shorter healing time. Abdominal hysterectomy, the most common method, is used in cases such as after caesarean delivery, when the indication is cancer, when complications are expected or surgical exploration is required. The average vaginal-to-abdominal hysterectomy quotient (VAQ) in US residency programs is 0.50.

35 With the development of the laparoscopic techniques in the s, the "laparoscopic-assisted vaginal hysterectomy" (LAVH) has gained great popularity among gynecologists because compared with the abdominal procedure it is less invasive and the post-operative recovery is much faster. It also allows better exploration and slightly more complicated surgeries then the vaginal procedure. LAVH begins with laparoscopy and is completed such that the final removal of the uterus (with or without removal of the ovaries) is via the vaginal canal. Thus, LAVH is also a total hysterectomy, the cervix must be removed with the uterus. Total laparoscopic hysterectomy (TLH) is more advanced than an LAVH and does not require a double-setup, laparoscopic and vaginal. In OBGYN residency programs, the average laparoscopy-to-laparotomy quotient (LPQ) is The "laparoscopic-assisted supracervical hysterectomy" (LASH) was later developed to remove the uterus without removing the cervix using a morcellator which cuts the uterus into small pieces that can be removed from the abdominal cavity via the laparoscopic ports. Total laparoscopic hysterectomy (TLH) is performed solely through the laparoscopes in the abdomen, starting at the top of the uterus. The entire uterus is disconnected from its attachments using long thin instruments through the "ports". Then all tissue to be removed is passed through the small abdominal incisions. Supracervical (subtotal) laparoscopic hysterectomy (LSH) is performed similar to the total laparoscopic surgery but the uterus is amputated between the cervix and fundus. "Robotic hysterectomy" is a variant of laparoscopic surgery using special remotely controlled instruments that allow the surgeon finer control as well as three-dimensional magnified vision.

36 uterus before hysterectomy

37 laparoscopical hysterectomy

38 transvaginal extraction of the uterus in total laparoscopical hysterectomy

39 cervical stump (white) after removement of the uterine corpus at laparoscopic supracervical hysterectomy

40 end of an laparoscopical hysterectomy Comparison of techniques The abdominal technique is very often applied in difficult circumstances or when complications are expected. Given this circumstances the complication rate and time required for surgery compares very favorably with other techniques, however time required for healing is much longer. Vaginal hysterectomy was shown to be superior to LAVH and some types of laparoscopic surgery (sufficient data was not available for all types of laparoscopic surgery), causing fewer short- and long-term complications, more favorable effect on sexual experience with shorter recovery times and fewer costs. It is however not possible or very difficult to perform some more complicated surgeries using this technique. A recent Cochrane review recommends vaginal hysterectomy over other variants where possible. Laparoscopic surgery offers certain advantages when vaginal surgery is not possible but has also the disadvantage of significantly longer time required for the surgery.

41 In direct comparison of abdominal (laparotomic) and laparoscopic techniques laparoscopic surgery causes longer operation time and substantially higher rate of major complications while offering much quicker healing. Vaginal hysterectomy is the only available option that is feasible without total anaesthesia or in outpatient settings (although so far recommended only in exceptional cases). Time required for completion of surgery in the eval trial is reported as following: abdominal 55.2 minutes average, range vaginal 46.6 minutes average, range laproscopic (all variants) 82.5 minutes average, range (combined data from both trial arms) The other techniques are not long enough in use to allow a general assessment, it appears Large multifibroid uteri and subtotal hysterectomies did previously require abdominal incision but with the use of in situ morcellation they can be sometimes also performed using laparoscopic or vaginal techniques. Even impacted fibroid uteri with severe adhesions, oblitered cul-de-sac and no motion whatsoever on pelvic exam can be removed laparoscopically by experienced laparoscopic surgeons. An advanced laparoscopist can replace the majority of inpatient total abdominal hysterectomies performed for benign indications with outpatient total laparoscopic hysterectomy. Non-robotic laparoscopic hysterectomy has a higher likelihood a requiring a large incision and conversion to open technique than robotic hysterectomy. In addition blood loss and duration of hospital stay were lower when using robotic technique when compared to non-robotic laparoscopic hysterectomy. that laparoscopic subtotal hysterectomy(lsh) is a promising technique. Benefits Hysterectomy is usually performed for serious conditions and is highly effective in curing those conditions. The Maine Women Health Study of 1994 followed for 12 months time approximately 800 women with similar gynecological problems (pelvic pain, urinary incontinence due to uterine prolapse, severe endometriosis, excessive menstrual bleeding, large fibroids, painful intercourse), around half of whom had a hysterectomy and half of whom did not. The study found that a substantial number of those who had a hysterectomy had marked improvement in their symptoms following hysterectomy, as well as significant improvement in their overall physical and mental health one year out from their surgery. The study concluded that for those who have intractable gynecological problems that had not responded to non-surgical intervention, hysterectomy may be beneficial to their

42 overall health and wellness. Somewhat surprisingly, ovarian cancer risk after hysterectomy appears to be substantially lowered even when the ovaries are preserved. Risks and side effects Hysterectomy has like any other surgery certain risks and side effects. Mortality and surgical risks Short term mortality (within 40 days of surgery) is usually reported in the range of 1-6 cases per 1000 when performed for benign causes. Risks for surgical complications are presence of fibroids, younger age (vascular pelvis with higher bleeding risk and larger uterus), dysfunctional uterine bleeding and parity. Reconvalescence The mortality rate is several times higher when performed in patients that are pregnant, have cancer or other complications. Long term effect on all case mortality is relatively small. Women under the age of 45 years have a significantly increased long term mortality that is believed to be caused by the hormonal side effects of hysterectomy and prophylactic oophorectomy. Approximately 35% of women after hysterectomy undergo another related surgery within 2 years. Hospital stay is 3 to 5 days or more for the abdominal procedure and between 2 to 3 days for vaginal or laparoscopically assisted vaginal procedures. Time for full recovery is very long and independent on the procedure that was used. Depending on the definition of "full recovery" 6 to 12 months have been reported. Serious limitations in everyday activities are expected for a minimum of 4 months. Unintended oophorectomy and premature ovarian failure Removal of one or both ovaries is performed in a substantial number of hysterectomies that were intended to be ovariesparing. The average onset age of menopause in those who underwent hysterectomy is 3.7 years earlier than average even when the ovaries are preserved. This has been suggested to be due to the disruption of blood supply to the ovaries after a hysterectomy or due to missing endocrine feedback of the uterus. The function of the remaining ovaries is significantly affected in about 40% women, some of them even require hormone replacement treatment. Surprisingly, a similar and only slightly weaker effect has been also observed for endometrial ablation which is often considered as an alternative to hysterectomy.

43 Substantial number of women develop benign ovarian cysts after hysterectomy. Premature menopause and its effects Estrogen levels fall sharply when the ovaries are removed, removing the protective effects of estrogen on the cardiovascular and skeletal systems. This condition is often referred to as "surgical menopause", although it is substantially different from a naturally occurring menopausal state; the former is a sudden hormonal shock to the body that causes rapid onset of menopausal symptoms such as hot flashes, while the latter is a gradually occurring decrease of hormonal levels over a period of years with uterus intact and ovaries able to produce hormones even after the cessation of menstrual periods. When only the uterus is removed there is a three times greater risk of cardiovascular disease. If the ovaries are removed the risk is seven times greater. Several studies have found that osteoporosis (decrease in bone density) and increased risk of bone fractures are associated with hysterectomies. This has been attributed to the modulatory effect of estrogen on calcium metabolism and the drop in serum estrogen levels after menopause can cause excessive loss of calcium leading to bone wasting. Urinary incontinence and vaginal prolapse Hysterectomies have also been linked with higher rates of heart disease and weakened bones. Those who have undergone a hysterectomy with both ovaries removed typically have reduced testosterone levels as compared to those left intact. Reduced levels of testosterone in women is predictive of height loss, which may occur as a result of reduced bone density, while increased testosterone levels in women are associated with a greater sense of sexual desire. Oophorectomy before the age of 45 is associated with a fivefold mortality from neurologic and mental disorders. Urinary incontinence and vaginal prolapse are well known adverse effects that develop with high frequency very long time after the surgery. Typically those complications develop years after the surgery. For this reason exact numbers are not known and risk factors poorly understood, it is also unknown if the choice surgical technique has any effect. It has been assessed that the risk for urinary incontinence is approximately doubled within 20 years after hysterectomy. One long term study found a 2.4 fold increased risk for surgery to correct urinary stress incontinence following hysterectomy The risk for vaginal prolapse depends on factors such as number of vaginal deliveries, the difficulty of those deliveries, and the type of labor the individual does. Effects on social life and sexuality Some women find their natural lubrication during sexual arousal is also reduced or eliminated. Those who experience uterine orgasm will not experience it if the uterus is

44 removed. The vagina is shortened and made into a closed pocket and there is a loss of support to the bladder and bowel. Other rare problems Hysterectomy may cause an increased risk of the relatively rare renal cell carcinoma. Hormonal effects or injury of the ureter were considered as possible explanations. Removal of the uterus without removing the ovaries can produce a situation that on rare occasions can result in ectopic pregnancy due to an undetected fertilization that had yet to descend into the uterus before surgery. Two cases have been identified and profiled in an issue of the Blackwell Journal of Obstetrics and Gynecology; over 20 other cases have been discussed in additional medical literature. Alternatives Myomectomy

45 Sutured uterus wound after myomectomy Depending on the problem there are alternatives to hysterectomy : Heavy bleeding Dysfunctional uterine bleeding (DUB) may be treated with endometrial ablation, which is an outpatient procedure in which the lining of the uterus is destroyed with heat, mechanically or by radio frequency ablation. Endometrial ablation will greatly reduce or entirely eliminate monthly bleeding in ninety percent of patients with DUB. It is not effective for patients with very thick uterine lining or uterine fibroids. Menorrhagia (heavy or abnormal menstrual bleeding) may also be treated with the less invasive endometrial ablation.

46 Uterine fibroids Uterine fibroids may be removed and the uterus reconstructed in a procedure called "myomectomy." A myomectomy may be performed through an open incision, laparoscopically or through the vagina (hysterescopy). Uterine artery embolization is a minimally invasive procedure for treatment of uterine fibroids. Under local anesthesia a catheter is introduced into the femoral artery at the groin and advanced under radiographic control into the uterine arterty. A mass of microspheres or polyvinyl alcohol (PVA) material (an embolus) is injected into the uterine arteries in order to block the flow of blood through those vessels. The restriction in blood supply usually results in in significant reduction of fibroids and improvement of heavy bleeding tendency. The 2006 Cochrane review comparing hysterectomy and UAE did not find any major advantage for either procedure. The subsequently finished HOPEFUL study found substantially fewer serious adverse effects for UAE with lesser overall cost and comparable satisfaction. In this study 86% UAE treated women and 70% hysterectomy treated women recommend their treatment to a friend. Prolapse may also be corrected surgically without removal of the uterus. Uterine fibroids can be treated also with a non-invasive procedure called Magnetic Resonance guided Focused Ultrasound (MRgFUS). This procedure involves no cutting or general anesthesia and the uterus remains intact. Prolapse As part of transitioning from female-to-male Hysterectomies with bilateral salpingo-oophorectomy are often performed either prior to or as a part of sex reassignment surgery for trans men. Some in the FTM community prefer to have this operation along with hormone replacement therapy in the early stages of their gender transition to avoid complications from heavy testosterone use while still having female-hormone-producing organs in place (e.g. uterine cancer and hormonally induced coronary artery disease) or to remove as many sources of female sex hormones as possible in order to better "pass" during the real life experience portion of their transition. Just as many, however, prefer to wait until they have full "bottom surgery" (removal of female sexual organs and construction of male-appearing external anatomy) to avoid undergoing multiple separate operations.

47 Chapter 6 Pelvic Exenteration and Uterine Artery Embolization Pelvic exenteration Intervention: Pelvic exenteration ICD-10 code: ICD-9 code: 68.8 MeSH D Other codes: Pelvic exenteration (or pelvic evisceration) is a radical surgical treatment that removes all organs from a person's pelvic cavity. The urinary bladder, urethra, rectum, and anus are removed. The procedure leaves the person with a permanent colostomy and vesicostomy. In women, the vagina, cervix, uterus, fallopian tubes, ovaries, and in some cases the vulva are removed. In men, the prostate is removed. Indications Pelvic exenteration is most commonly used in cases of very advanced or recurrent cancer, in which less radical surgical options are not technically possible or would not be sufficient to remove all the tumor. This procedure is performed for many types of cancer including genitourinary and colorectal cancers.

48 Complications After pelvic exenteration, many patients will have perineal hernia, often without symptoms, but only 3 10% will have perineal hernia requiring surgical repair. History The procedure was first described by Alexander Brunschwig in Uterine artery embolization Arteries of the female reproductive tract (posterior view): uterine artery, ovarian artery and vaginal arteries. Uterine artery embolization (UAE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the uterine body.

49 If the procedure is done for the treatment of uterine fibroids it is also called uterine fibroid embolization (UFE). Procedure and indications Under local anesthesia a catheter is introduced into the femoral artery at the groin and advanced under radiographic control into the uterine arterty. There microparticules (spheres or beads) are released which will block the vessel. Due to collateral circulation the uterus will not necrose even if both arteries are occluded. The procedure is not a surgical intervention and allows the uterus to be kept in place. This intervention can be used to relieve the main symptoms related to uterine fibromata (including excessive vaginal bleeding, pelvic pain and compression). This intervention can be proposed as an alternative to surgery in case of symptoms related to uterine fibroids. It is performed by interventional radiologists. UAE can also be used to control heavy uterine bleeding for other reasons than fibroids, i.e. in cases of postpartum obstetrical hemorrhage. Adverse effects Significant adverse effects resulting from uterine artery embolization have been reported, serious adverse effects are approximately four times less frequent than for hysterectomy. Adverse effects that have been reported include death from embolism, or septicemia (the presence of pus-forming or other pathogenic organisms, or their toxins, in the blood or tissues) resulting in multiple organ failure. Infection from tissue death of fibroids, leading to endometritis (infection of the uterus) resulting in lengthy hospitalization for administration of intravenous antibiotics. Misembolization from microspheres or polyvinyl alcohol (PVA) particles flowing or drifting into organs or tissues where they were not intended to be, causing damage to other organs or other parts of the body. Ovarian damage resulting from embolic material migrating to the ovaries. Loss of ovarian function, infertility, and loss of orgasm. Failure of embolization surgerycontinued fibroid growth, regrowth within four months. Menopause - iatrogenic, abnormal, cessation of menstruation and follicle stimulating hormones elevated to menopausal levels. Post-Embolization Syndrome (PES) - characterized by acute and/or chronic pain, temperatures of up to 102 degrees, malaise, nausea, vomiting and severe night sweats. Foul vaginal odor coming from infected, necrotic tissue which remains inside the uterus. Hysterectomy due to infection, pain or failure of embolization. Severe, persistent pain, resulting in the need for morphine or synthetic narcotics. Hematoma, blood clot at the incision site. Vaginal discharge containing pus and blood, bleeding from incision site, bleeding from vagina, fibroid expulsion (fibroids pushing out through the vagina), unsuccessful fibroid expulsion (fibroids trapped in the cervix causing infection and requiring surgical removal), life threatening allergic reaction to the contrast material, and uterine adhesions.

50 Chapter 7 Hysterosalpingography and Hysteroscopy Hysterosalpingography A normal hysterosalpingogram. Note the catheter entering at the bottom of the screen, and the contrast medium filling the uterine cavity (small triangle in the center).

51 Hysterosalpingography (HSG) is a radiologic procedure to investigate the shape of the uterine cavity and the shape and patency of the fallopian tubes. It entails the injection of a radio-opaque material into the cervical canal and usually fluoroscopy with image intensification. A normal result shows the filling of the uterine cavity and the bilateral filling of the fallopian tube with the injection material. To demonstrate tubal rupture spillage of the material into the peritoneal cavity needs to be observed. Procedure The procedure involves ionizating x-rays. It should be done in the follicular phase of the cycle. It is contraindicated in pregnancy. It is useful to diagnose uterine malformations, Asherman's syndrome, tubal occlusion and used extensively in the work-up of infertile women. It has been claimed that pregnancy rates are increased in a cycle when an HSG has been performed. Using catheters, an interventional radiologist can open tubes that are proximally occluded. Complications The test is usually done with radiographic contrast medium (dye) injected into the uterine cavity through the vagina and cervix. If the fallopian tubes are open the contrast medium will fill the tubes and spill out into the abdominal cavity. It can be determined whether the fallopian tubes are open or blocked and whether the blockage is located at the junction of the tube and the uterus (proximal) or whether it is at the end of the fallopian tube (distal). Complications of the procedure include infection, allergic reactions to the materials used, intravasation of the material, and, if oil-based material is used, embolisation. Air can also be accidentally instilled in to the uterine cavity by the operator, thus limiting the exam due to iatrogenically induced filling defects. This can be overcome by administering the Tenzer Tilt which will demonstrate movement of the air bubbles to the non-dependant portion of the uterine cavity. History For the first HSG Carey used collergol in Lipiodol was introduced by Sicard and Forestier in 1924 and remained a popular contrast medium for many decades. Later, water-soluble contrast material was generally preferred as it avoided the possible complication of oil embolism. Follow Up If the HSG indicates further investigations are warranted, a laparoscopy, assisted by hysteroscopy, may be advised to visualise the area in three dimensions, with the potential to resolve minor issues within the same procedure.

52 Hysteroscopy Intervention: Hysteroscopy Hysteroscopy 1898 ICD-10 code: ICD-9 code: MeSH Other codes: D Hysteroscopy is the inspection of the uterine cavity by endoscopy with access through the cervix. It allows for the diagnosis of intrauterine pathology and serves as a method for surgical intervention (operative hysteroscopy). Method A hysteroscope is an endoscope that carries optical and light channels or fibers. It is introduced in a sheath that provides an inflow and outflow channel for insufflation of the uterine cavity. In addition, an operative channel may be present to introduce scissors, graspers or biopsy instruments. A hysteroscopic resectoscope is similar to a transurethral resectoscope and allows entry of an electric loop to shave off tisse, for instance to eliminate a fibroid. A contact hysteroscope is a hysteroscope that does not use distention media. Insufflation media The uterine cavity is a potential cavity and needs to be distended to allow for inspection. Thus during hysteroscopy either fluids or CO 2 gas is introduced to expand the cavity. The choice is dependent on the procedure, the patient s condition, and the physician's preference. Fluids can be used for both diagnostic and operative procedures. However, CO 2 gas does not allow the clearing of blood and endometrial debris during the procedure, which could make the imaging visualization difficult. Gas embolism may also arise as a complication. Since the success of the procedure is totally depending on the quality of the high-resolution video images in front of surgeon's eyes, CO 2 gas is not commonly used as the distention medium.

53 Electrolytic solutions include normal saline and lactated Ringer s solution. Current recommendation is to use the electrolytic fluids in diagnostic cases, and in operative cases in which mechanical, laser, or bipolar energy is used. Since they are conducting electricity, these fluids should not be used with monopolar electrosurgical devices. Nonelectrolytic fluids eliminate problems with electrical conductivity, but can increase the risk of hyponatremia. These solutions include glucose, glycine, dextran (Hyskon), mannitol, sorbitol and a mannitol/sorbital mixture (Purisol). Water was once used routinely, however, problems with water intoxication and hemolysis discontinued its use by Each of these distention fluids is associated with unique physiological changes that should be considered when selecting a distention fluid. Glucose is contraindicated in patients with glucose intolerance. Sorbitol metabolizes to fructose in the liver and is contraindicated if a patient has fructose malabsorption. High-viscous Dextran also has potential complications which can be physiological and mechanical. It may crystallize on instruments and obstruct the valves and channels. Coagulation abnormalities and adult respiratory distress syndrome (ARDS) have been reported. Glycine metabolizes into ammonia and can cross the blood brain barrier, causing agitation, vomiting and coma. Mannitol 5% should be used instead of glycine or sorbitol when using monopolar electrosurgical devices. Mannitol 5% has a diuretic effect and can also cause hypotension and circulatory collapse. The mannitol/sorbitol mixture (Purisol) should be avoided in patients with fructose malabsorption. Procedure Hysteroscopy has been done in the hospital, surigal centers and the office. It is best done when the endometrium is relatively thin, that is after a menstruation. Diagnostic can easily be done in an office or clinic setting. Local anesthesia can be used. Simple operative hysteroscopy can also be done in an office or clinic setting. Hysteroscopic intervention can also be done under general endotracheal anesthesia or Monitored Anesthesia Care (MAC), but a short diagnostic procedure can be performed with just a paracervical block using the Lidocaine injection in the upper part of the cervix. The patient is in a lithotomy position. After cervical dilation, the hysteroscope with its sheath is guided into the uterine cavity, the cavity insufflated, and an inspection is performed. If abnormalities are found, an operative hysteroscope with a channel to allow specialized instruments to enter the cavity is used to perform the surgery. Typical procedures include endometrial ablation, submucosal fibroid resection, and endometrial polypectomy. Hysteroscopy has also been used to apply the Nd:YAG laser treatment to the inside of the uterus. When fluids are used to distend the cavity, care should be taken to record its use (inflow and outflow) to prevent fluid overload and intoxication of the patient.

54 Indications View of a submucous fibroid by hysteroscopy Hysteroscopy is useful in a number of uterine conditions: Asherman's syndrome (i.e. intrauterine adhesions). Hysteroscopic adhesiolysis is the technique of lysing adhesions in the uterus using either microscissors (recommended) or thermal energy modalities. Hysteroscopy can be used in conjunction with laparascopy or other methods to reduce the risk of perforation during the procedure. Endometrial polyp. Polypectomy. Gynecologic bleeding Endometrial ablation (Some newer systems specifically developed for endometrial ablation such as the Novasure do not require hysteroscopy) Myomectomy for uterine fibroids. Congenital Uterine malformations (also known as Mullerian malformations). Eg.septum, Evacuation of retained products of conception in selected cases. Removal of embedded IUDs.

55 The use of hysteroscopy in endometrial cancer is not established as there is concern that cancer cells could be spread into the peritoneal cavity. Hysteroscopy has the benefit of allowing direct visualization of the uterus, thereby avoiding or reducing iatrogenic trauma to delicate reproductive tissue which may result in Asherman's syndrome. Hysteroscopy allows access to the utero-tubal junction for entry into the fallopian tube; this is useful for tubal occlusion procedures for sterilization and for falloposcopy. Complications A possible problem is uterine perforation when either the hysteroscope itself or one of its operative instruments breaches the wall of the uterus. This can lead to bleeding and damage to other organs. If other organs such as bowel are injured during a perforation, the resulting peritonitis can be fatal. Furthermore, cervical laceration, intrauterine infection (especially in prolonged procedures), electrical and laser injuries, and complications caused by the distention media can be encountered. The use of insufflation media can lead to serious and even fatal complications due to embolism or fluid overload with electrolyte imbalances. The overall complication rate for diagnostic and operative hysteroscopy is 2% with serious complications occurring in less than 1% of cases.

56 Chapter 8 Vacuum Aspiration Abortion type First use Vacuum aspiration Background Surgical China 1958 and UK 1967 Gestation 3-12 weeks Usage Figures are combined usage of MVA and EVA. Sweden 42.7% (2005) UK: Eng. & Wales United States 64% (2006) 88.3% (2003) Vacuum or suction aspiration uses aspiration to remove uterine contents through the cervix. It may be used as a method of induced abortion, a therapeutic procedure used after miscarriage, or a procedure to obtain a sample for endometrial biopsy. The rate of infection is lower than any other surgical abortion procedure at 0.5%. Some sources may use the terms dilation and evacuation or "suction" dilation and curettage to refer to vacuum aspiration, although those terms are normally used to refer to distinct procedures. History Vacuuming as a means of removing the uterine contents, rather than the previous use of a hard metal curette, was pioneered in 1958 by Drs Wu Yuantai and Wu Xianzhen in China, but their paper was only translated into English on the fiftieth anniversary of the study that "ultimately led to the technique becoming the world s commonest and safest obstetric procedure". Dorothea Kerslake introduced the method into the United Kingdom in 1967 and published a study in the United States that further spread the technique. Harvey Karnen in the United States refined the technique the early 1970s with the

57 development of the Karman cannula, a soft, flexible cannula that avoided the need for initial cervical dilatation and so reduced the risks of puncturing the uterus. Clinical uses Vacuum aspiration may be used as a method of induced abortion, as a therapeutic procedure after miscarriage, to aid in menstrual regulation, and to obtain a sample for endometrial biopsy. It is also used to terminate molar pregnancy. When used as a miscarriage treatment or an abortion method, vacuum aspiration may be used alone or with cervical dilation anytime in the first trimester (up to 12 weeks gestational age). For more advanced pregnancies, vacuum aspiration may be used as one step in a dilation and evacuation procedure. Vacuum aspiration is the procedure used for almost all first-trimester abortions in many countries.

58 Procedure A diagram of a vacuum aspiration abortion procedure at 8 weeks gestation. 1: Amniotic sac 2: Embryo 3: Uterine lining 4: Speculum 5: Vacurette 6: Attached to a suction pump Vacuum aspiration is an outpatient procedure that generally involves a clinic visit of several hours. The procedure itself typically takes less than 15 minutes. Suction is created

59 with either an electric pump (electric vacuum aspiration or EVA) or a manual pump (manual vacuum aspiration or MVA). Both methods use the same level of suction, and so can be considered equivalent in terms of effectiveness and safety. The clinician may first use a local anesthetic to numb the cervix. Then, the clinician may use instruments called "dilators" to open the cervix, or sometimes medically induce dilation with drugs. Finally, a sterile cannula is inserted into the uterus and attached via tubing to the pump. The pump creates a vacuum which empties uterine contents. After a procedure for abortion or miscarriage treatment, the tissue removed from the uterus is examined for completeness. Expected contents include the embryo or fetus as well as the decidua, chorionic villi, amniotic fluid, amniotic membrane and other tissue. Post-treatment care includes brief observation in a recovery area and a follow-up appointment approximately two weeks later. Advantages over dilation and curettage Dilation and curettage (D&C), also known as sharp curettage, was once the standard of care in situations requiring uterine evacuation. However, vacuum aspiration has a number of advantages over D&C and has largely replaced D&C in many settings. Vacuum aspiration may be used earlier in pregnancy than dilation and curettage (D&C). Manual vacuum aspiration is the only surgical abortion procedure available earlier than the 6th week of pregnancy. Vacuum aspiration has lower rates of complications when compared to D&C. Vacuum aspiration - especially manual vacuum aspiration - is significantly cheaper than D&C. The equipment needed for vacuum aspiration costs less than a curette set. Unlike D&C, vacuum aspiration does not require general anesthesia and so can be performed as an outpatient procedure at a clinic rather than in a hospital surgical setting. While D&C is generally provided only by physicians, vacuum aspiration may be performed by midlevel health care providers such as physician's assistants and midwives. Manual vacuum aspiration does not require electricity and so can be provided in locations that have unreliable electrical service or none at all. Manual vacuum aspiration also has the advantage of being quiet, without the noise of an electric vacuum pump. Complications When used for uterine evacuation, vacuum aspiration is 98% effective in removing all uterine contents. Retained products of conception require a second aspiration procedure. This is more common when the procedure is performed very early in pregnancy, before 6 weeks gestational age.

60 Other complications occur at a rate of less than 1 per 100 procedures and include excessive blood loss, infection, injury to the cervix or uterus,, including perforation, and uterine adhesions.

61 Chapter 9 Endometrial Ablation and Myomectomy Endometrial ablation Endometrial ablation is a medical procedure that is used to remove (ablate) or destroy the endometrial lining of a woman's uterus. This technique is most often employed for women who suffer from excessive or prolonged bleeding during their menstrual cycle but can not or do not wish to undergo a hysterectomy. The procedure is most commonly done on an outpatient basis. Placenta accreta may occur if the patient becomes pregnant after endometrial ablation, so birth control is recommended. Procedure A number of competing procedures are available. The HTA System uses a small telescope-like device called a hysteroscope which is inserted into the uterus through the cervix, to help doctors safely confirm proper probe placement and to see the area they are treating. This device circulates heated saline which burns the lining of the uterus. This procedure will stop, or significantly decrease, menstrual bleeding. 68% of patients who have undergone this procedure reported a satisfactory decrease in menstrual flow. An alternative is the Thermachoice III balloon that is filled with heated fluid to destroy the uterine lining. The fluid is safely contained in a flexible and non-allergenic material that conforms to most uterine shapes and sizes with no reduction of efficacy. 81% of patients report returning to normal levels of menstrual bleeding or lower. With the Novasure system a mesh is introduced into the cavity and the lining is destroyed by applying electrical energy to the mesh that will thermally damage the adjacent endometrium. 78% of patients have a successful reduction in bleeding down to normal levels.

62 Older methods utilize hysteroscopy to insert instruments into the uterus to destroy the lining under vision using laser or electrical current in a small loop. Another system introduces a radiofrequency rod that emits energy to destroy the uterine lining. The procedure is done while the patient is either under local anesthesia, or, if necessary, general or spinal anesthesia. The recovery period can be from one day up to 2 weeks. After the procedure, the endometrium heals by scarring, reducing or removing the possibility of future uterine bleeding. The patient may develop amenorrhea, however hormonal functioning will remain unaffected. Effectiveness Approximately 90% of women who undergo this procedure will have reduced menstrual bleeding. Of those, approximately 45% will stop having periods altogether. However, a second procedure or a hysterectomy will be required in approximately 22% of cases. Although uncommon, the procedure can have serious complications including: Risks Perforation of the uterus Burns to the uterus (beyond the endometrial lining) Pulmonary edema or embolism Bowel Burn

63 Myomectomy A laparoscopic myomectomy: The uterus has been incised and the myoma is held and about to be shelled out Myomectomy, sometimes also fibroidectomy, refers to the surgical removal of uterine leiomyomas, also known as fibroids. In contrast to a hysterectomy the uterus remains preserved and the woman retains her reproductive potential. Indications The presence of a fibroid does not mean that it needs to be removed. Removal is called for when the fibroid causes pain or pressure, abnormal bleeding, or interferes with reproduction. Patients have many options in the management of uterine fibroids, including: observation, medical therapy (such a GNRH agonists), hysterectomy, uterine artery embolization, and high-intensity focused ultrasound ablation. Despite these many

64 options, the surgical approach of selected fibroid removal remains an important choice for those women who want or need to preserve the uterus for reproduction. Procedure A myomectomy can be performed in a number of ways, depending on the location and number of lesions and the experience and preference of the surgeon. Laparotomy Traditionally a myomectomy is performed via a laparotomy with a full abdominal incision, either vertically or horizontally. Once the peritoneal cavity is opened, the uterus is incised, and the lesion(s) removed. The open approach is often preferred for larger lesions. One or more incisions may be set into the uterine muscle and are repaired once the fibroid has been removed. Recovery after surgery takes four to six weeks. Laparoscopy Using the laparoscopic approach the uterus is visualized and its fibroids located and removed. Morcellators are available to shred larger fibroids so that they can be removed through the small portholes of laparoscopy.. Studies have suggested that laparoscopic myomectomy leads to lower morbidity rates and faster recovery than does laparotomic myomectomy. As with hysteroscopic myomectomy, laparoscopic myomectomy is not generally used on very large fibroids. A study of laparoscopic myomectomies conducted between January 1990 and October 1998 examined 106 cases of laparoscopic myomectomy, in which the fibroids were intramural or subserous and ranged in size from 3 to 10 cm. Robotic surgery Using the da Vinci Surgical System a limited numbers of myomectomies have been performed.it has not been proven that results are superior to laparoscopy. Hysteroscopy A fibroid that is located in a submucous position (that is, protruding into the endometrial cavity) may be accessible to hysteroscopic removal. This may apply primarily to smaller lesions as pointed out by a large study that collected results from 235 patients suffering from submucous myomas who were treated with hysteroscopic myomectomies; in none of these cases was the fibroid greater than 5 cm. However, also larger lesion have been treated by hysteroscopy. Recovery after hysteroscopic surgery is but a few days.

65 Complications and risks Complications of the surgery include the possibility of significant blood loss leading to a blood transfusion, the risk of adhesion or scar formation around the uterus or within its cavity, and the possible need later to deliver via cesarean section. It may not be possible to remove all lesions, nor will the operation prevent new lesions from growing. Development of new fibroids will be seen in 42-55% of patients undergoing a myomectomy. There is some suggestion that myomectomy surgery is associated with a higher risk of uterine rupture in later pregnancy. Myomectomy during pregnancy Leiomyomata tend to grow during pregnancy but rarely interfere with the growing pregnancy directly. Generally, surgeons tend to stay away from operative interventions during the pregnancy because of the risk of hemorrhage and the concern that the pregnancy may be interrupted. Also, after a pregnancy, myomas tend to shrink naturally. However, in selected cases myomectomy may become necessary during pregnancy, or also at the time of a cesarean section to gain access to the baby.

66 Chapter 10 Cervical Cerclage, Vaginectomy and Vulvectomy Cervical cerclage Cervical cerclage (tracheloplasty), also known as a cervical stitch, is used for the treatment of cervical incompetence (or insufficiency), a condition where the cervix has become slightly open and there is a risk of miscarriage because it may not remain closed throughout pregnancy. Usually this treatment would be done for a woman who had suffered one or more miscarriages in the past, in the second trimester of pregnancy. The treatment consists of a strong suture being inserted into and around the cervix early in the pregnancy, usually between weeks 12 to 14, and then removed towards the end of the pregnancy when the greatest risk of miscarriage has passed. Types There are three types of cerclage: A McDonald cerclage, described in 1957 is the most common, and is essentially a pursestring stitch used to cinch the cervix shut; the cervix stitching involves a band of suture at the upper part of the cervix while the lower part has already started to efface. This cerclage is usually placed between 12 weeks and 24 weeks of pregnancy. The stitch is generally removed around the 37th week of gestation. A Shirodkar cerclage is very similar, but the sutures pass through the walls of the cervix so they're not exposed. This type of cerclage is less common and technically more difficult than a McDonald, and is thought (though not proven) to reduce the risk of infection. The Shirodkar procedure sometimes involves a permanent stitch around the cervix which will not be removed and therefore a Caesarean section will be necessary to deliver the baby. The Shirodkar technique

67 was first described by Dr. V. N. Shirodkar in Bombay in In 1963, Dr. Shirodkar traveled to NYC to perform the procedure at the New York Hospital of Special Surgery; the procedure was successful, and the baby lived to adulthood. An abdominal cerclage, the least common type, is permanent and involves stitching inside the abdomen. This is usually only done if the cervix is too short to attempt a standard cerclage, or if a vaginal cerclage has failed or is not possible. However, a few doctors (namely Dr. Arthur Haney at the University of Chicago and Dr. George Davis at the University of Medicine and Dentistry of New Jersey) are pushing for the transabdominal cerclage to replace vaginal cerclages, due to perceived better outcomes and more pregnancies carried to term. Aftercare risks associated with regional or general anesthesia After the cerclage has been placed, the patient will be observed for at least several hours (sometimes overnight) to ensure that she does not go into premature labor. The patient will then be allowed to return home, but will be instructed to remain in bed or avoid physical activity for two to three days, or up to two weeks. Follow-up appointments will usually take place so that her doctor can monitor the cervix and stitch and watch for signs of premature labor. Risks While cerclage is generally a safe procedure, there are a number of potential complications that may arise during or after surgery. These include: premature labor premature rupture of membranes infection of the cervix infection of the amniotic sac (chorioamnionitis) cervical rupture (may occur if the stitch is not removed before onset of labor) injury to the cervix or bladder bleeding Cervical Dystocia with failure to dilate requiring Cesarean Section displacement of the cervix Normal results The success rate for cervical cerclage is approximately 80-90% for elective cerclages, and 40-60% for emergent cerclages. A cerclage is considered successful if labor and delivery is delayed to at least 37 weeks (full term).

68 Morbidity and mortality rates Approximately 1-9% of women will experience premature labor after cerclage. The risk of chorioamnionitis is 1-7%, but increases to 30% if the cervix is dilated greater than 1.2 in (3 cm). The risks associated with premature delivery, however, are far greater. Babies born between 22 and 25 weeks of pregnancy are at significant risk of moderate to severe disabilities (46-56%) or death (approximately 10-30% survive at 22 weeks, increasing to 50% at 24 weeks, and 95% by 26 weeks). Vaginectomy Intervention: Vaginectomy ICD-10 code: ICD-9 code: 70.4 Other codes: Vaginectomy is a medical procedure to remove all or part of the vagina. It is usually used as a treatment for vaginal cancer. Vaginectomy is also used as part of some types of female-to-male sex reassignment surgery. Cancer Vaginectomy can be divided into two kinds of operations. An operation under which the whole vagina is removed is called a radical vaginectomy. If only the upper part of the vagina is removed then the operation is called a partial vaginectomy. Which process is best depends upon the severity of the case and the affected areas. Usually after a radical vaginoplasty, a plastic surgeon will perform a vaginal reconstruction, using skin and muscle from other body parts, for aesthetic reasons. Vulvectomy Vulvectomy refers to a gynecological procedure in which the vulva is partly or completely removed. Usually performed as a last resort in certain cases of cancer, vulvar dysplasia, Human Papilloma Virus or FGM/C (genital Mutilation). Although there may be severe pain in the groin area after the procedure, for a number of weeks, sexual function is generally still possible but limited.

69 Types A simple vulvectomy means removal of all external tissue, while a radical vulvectomy is the same however, also includes the removal of the clitoris, lymph nodes and nearby tissue. A partial vulvectomy is the least severe, only removing the affected portion of the vulva. Skinning vulvectomy involves the removal of the top layer of vulvar skin (the external female genital organs, including the clitoris, vaginal lips and the opening of the vagina). In this case Skin grafts from other parts of the body may be needed to cover the area. There are two types of Skinning Vulvectomy, the partial skinning vulvectomy and the total skinning vulvectomy. The objective of the first one is the preservation of the cosmetic and functional integrity of the vulva in younger and sexually active patients, in whom a steady increase in the incidence of vulvar intraepithelial neoplasia has been observed in the last decade. Meanwhile, the objective of the total skinning vulvectomy is to remove the entire vulva with total skin graft replacement in patients with an entire vulvar cancer involvement. Modified radical vulvectomy involves the removal of vulva containing cancer and some of the normal tissue around it.

70 Chapter 11 Pap Test Micrograph of a Pap test showing a high-grade squamous intraepithelial lesion (HSIL). Atypical (abnormal) cells are seen in the lower left of the image. Pap stain. The Papanicolaou test (also called Pap smear, Pap test, cervical smear, or smear test) is a screening test used in gynecology to detect premalignant and malignant (cancerous)

71 processes in the ectocervix. Significant changes can be treated, thus preventing cervical cancer. The test was invented by and named after the prominent Greek doctor Georgios Papanikolaou. An anal Pap smear is an adaptation of the procedure to screen and detect anal cancers. In taking a Pap smear, a speculum is used to gather cells from the outer opening of the cervix (Latin for "neck") of the uterus and the endocervix. The cells are examined under a microscope to look for abnormalities. The test aims to detect potentially pre-cancerous changes (called cervical intraepithelial neoplasia (CIN) or cervical dysplasia), which are usually caused by sexually transmitted human papillomaviruses (HPVs). The test remains an effective, widely used method for early detection of pre-cancer and cervical cancer. The test may also detect infections and abnormalities in the endocervix and endometrium. In general, in countries where Pap smear screening is routine, it is recommended that females, age 18 to 65, who have had sex seek regular Pap smear testing. Guidelines on frequency vary, from annually to every five years. If results are abnormal, and depending on the nature of the abnormality, the test may need to be repeated in six to twelve months. If the abnormality requires closer scrutiny, the patient may be referred for detailed inspection of the cervix by colposcopy. The patient may also be referred for HPV DNA testing, which can serve as an adjunct to Pap testing. Indications Screening guidelines vary from country to country. In general, screening starts about age 20 or 25 and continues until about age 50 or 60. Women should wait a few years after they first have intercourse before they start screening. For example, United States Preventive Services Task Force (USPSTF) recommends waiting three years. American Congress of Obstetricians and Gynecologists (ACOG) recommends starting screening at age 21 (since that is a few years after initial sex for most American women). Many other countries wait until age 25 or later to start screening. For instance, Great Britain starts screening at age 25. Most women contract HPV soon after becoming sexually active. It takes an average of a year, but can take up to four years, for a woman's immune system to control the initial infection. Screening during this period may show this immune reaction and repair as mild abnormalities, which are usually not associated with cervical cancer, but could cause the woman stress and result in further tests and possible treatment. Cervical cancer usually takes time to develop, so delaying the start of screening a few years poses little risk of missing a potentially precancerous lesion. For instance, screening women under age 25 does not decrease cancer rates under age 30. There is little or no benefit to screening women who have not had sexual contact. HPV can be transmitted in sex between women, so women who have only had sex with other women should be screened, although they are at somewhat lower risk for cervical cancer.

72 Guidelines on frequency of screening vary typically every three to five years for those who have not had previous abnormal smears. Some older recommendations suggested screening as frequently as every one to two years, but acknowledge that most women can be screened less often. Some guidelines recommend more frequent screening for younger women, for instance in Great Britain, screening is recommended every 3 years for women under 50, and every 5 years for those over. Guidelines vary on when to stop screening. There is probably no benefit screening women aged 60 or over whose previous tests have been negative. If a woman's last three Pap results were normal, she can stop at age 65, according to the USPSTF, ACS says 70, ACOG says 65 or 70, England's NHS says 64. There is no need to continue screening after a complete hysterectomy for benign disease. Pap smear screening is still recommended for those who have been vaccinated against HPV, since the vaccines do not cover all of the HPV types that can cause cervical cancer. Also, the vaccine does not protect against HPV exposure before vaccination. More frequent Pap smears may be needed to follow-up after an abnormal Pap smear, or after treatment for abnormal Pap or biopsy results, or after treatment for cancer.

73 Procedure Cervix in relation to upper part of vagina and posterior portion of uterus. For best results, a Pap test should not occur when a woman is menstruating. However, Pap smears can be performed during a woman's menstrual period, especially if the physician is using a liquid-based test; if bleeding is extremely heavy, endometrial cells can obscure cervical cells, and it is therefore inadvisable to have a Pap smear if bleeding is excessive.

74 The patient's perception of the procedure ranges from no discomfort at all to severe discomfort (especially in women with cervical stenosis). Many women experience spotting or mild cramping afterward. The physician or operator collecting a sample for the test inserts a speculum into the patient's vagina, to allow access to the cervix. Samples are collected from the outer opening or os of the cervix using an Aylesbury spatula and an endocervical brush is rotated in the cavity of the cervix. The cells are placed on a glass slide and checked for abnormalities in the laboratory. A plastic-fronded broom is sometimes used in place of the spatula and brush. The broom is not as good a collection device, since it is much less effective at collecting endocervical material than the spatula and brush. The broom is used more frequently with the advent of liquid-based cytology, although either type of collection device may be used with either type of cytology. the abnormal sample which may require further investigation. The sample is stained using the Papanicolaou technique, in which tinctorial dyes and acids are selectively retained by cells. Unstained cells cannot be visualized with light microscopy. The stains chosen by Papanicolaou were selected to highlight cytoplasmic keratinization, which actually has almost nothing to do with the nuclear features used to make diagnoses now. In some cases, a computer system may pre-screen the slides, indicating some that do not need examination by a person, or highlighting areas for special attention. The sample is then usually screened by a specially trained and qualified cytotechnologist using a light microscope. The terminology for who screens the sample varies according to the country; in the UK, the personnel are known as Cytoscreeners, Biomedical scientists (BMS), Advanced Practitioners and Pathologists. The latter two take responsibility for reporting

75 Results Micrograph of a Pap test showing a low-grade intraepithelial lesion (LSIL) and benign endocervical mucosa. Pap stain.

76 Micrograph of a Pap test showing trichomoniasis. Trichomonas organism seen in the upper right. Pap stain.

77 Micrograph of a Pap test showing changes of herpes simplex virus. Pap stain. In screening a general or low-risk population, most Pap results are normal. In the United States, about 2-3 million abnormal Pap smear results are found each year. Most abnormal results are mildly abnormal (ASC-US (typically 2-5% of Pap results) or low-grade squamous intraepithelial lesion (LSIL) (about 2% of results)), indicating HPV infection. Although most low-grade cervical dysplasias spontaneously regress without ever leading to cervical cancer, dysplasia can serve as an indication that increased vigilance is needed. In a typical scenario, about 0.5% of Pap results are high-grade SIL (HSIL), and less than 0.5% of results indicate cancer; 0.2 to 0.8% of results indicate Atypical Glandular Cells of Undetermined Significance (AGC-NOS). As liquid based preparations (LBPs) become a common medium for testing, atypical result rates have increased. The median rate for all preparations with low-grade squamous intraepithelial lesions using LBPs was 2.9% compared with a 2003 median rate of 2.1%. Rates for high-grade squamous intraepithelial lesions (median, 0.5%) and atypical squamous cells have changed little.

78 Abnormal results are reported according to the Bethesda system. They include: Squamous cell abnormalities (SIL) o Atypical squamous cells of undetermined significance (ASC-US) o Low-grade squamous intraepithelial lesion (LGSIL or LSIL) o Atypical squamous cells - cannot exclude HSIL (ASC-H) o High-grade squamous intraepithelial lesion (HGSIL or HSIL) o Squamous cell carcinoma Glandular epithelial cell abnormalities o Atypical Glandular Cells not otherwise specified (AGC or AGC-NOS) Endocervical and endometrial abnormalities can also be detected, as can a number of infectious processes, including yeast, herpes simplex virus and trichomoniasis. However it is not very sensitive at detecting these infections, so absence of detection on a Pap does not mean absence of the infection. Effectiveness Prior to the introduction of the Pap test, carcinoma of the cervix was a leading cause of cancer death in women. Since the introduction of the Pap test, deaths caused by carcinoma of the cervix have been reduced by up to 99% in some populations wherein women are screened regularly. A regular program of pap smear screening, with appropriate follow-up, can reduce cervical cancer incidence by up to 80%. Failure of prevention of cancer by the Pap test can occur for many reasons, including not getting regular screening, lack of appropriate follow up of abnormal results, and sampling and interpretation errors. In the US, over half of all invasive cancers occur in women that have never had a Pap smear; an additional 10 to 20% of cancers occur in women that have not had a Pap smear in the preceding five years. About one-quarter of US cervical cancers were in women that had an abnormal Pap smear, but did not get appropriate follow-up (woman did not return for care, or clinician did not perform recommended tests or treatment). Adenocarcinoma of the cervix has not been shown to be prevented by Pap tests. In the UK, which has a Pap smear screening program, Adenocarcinoma accounts for about 15% of all cervical cancers Estimates of the effectiveness of the United Kingdom's call and recall system vary widely, but it may prevent about 700 deaths per year in the UK. A medical practitioner performing 200 tests each year would prevent a death once in 38 years, while seeing 152 women with abnormal results, referring 79 for investigation, obtaining 53 abnormal biopsy results, and seeing 17 persisting abnormalities lasting longer than two years. At least one woman during the 38 years would die from cervical cancer despite being screened.

79 Since the population of the UK is about 61 million, the maximum number of women who could be receiving Pap smears in the UK is around 15 million to 20 million (eliminating the percentage of the population under 20 and over 65). This would indicate that the use of Pap smear screening in the UK saves the life of 1 person for every approximately 20,000 people tested (assuming 15,000,000 are being tested yearly). If only 10,000,000 are actually tested each year, then it would save the life of 1 person for every approximately 15,000 people tested. Types of screening Conventional cytology In the conventional Pap smear, the physician collecting the cells smears them on a microscope slide and applies a fixative. In general, the slide is sent to a laboratory for evaluation. Studies of the accuracy of conventional cytology report: sensitivity 72% specificity 94% Liquid-based monolayer cytology Since the mid-1990s, techniques based on placing the sample into a vial containing a liquid medium that preserves the cells have been increasingly used. Two of the types are Sure-Path (TriPath Imaging) and Thin-Prep (Cytyc Corp). The media are primarily ethanol-based for Sure-Path and methanol for ThinPrep. Once placed into the vial, the sample is processed at the laboratory into a cell thin-layer, stained, and examined by light microscopy. The liquid sample has the advantage of being suitable for high-risk HPV testing and may reduce unsatisfactory specimens from 4.1% to 2.6%. Proper sample acquisition is crucial to the accuracy of the test, as a cell that is not in the sample cannot be evaluated. Studies of the accuracy of liquid based monolayer cytology report: sensitivity 61% to 66% specificity 82% to 91% Some, but not all studies, report increased sensitivity from the liquid-based smears. Human papillomavirus testing Most women will successfully clear HPV infections within 18 months. Those that have a prolonged infection with a high-risk type (e.g. types 16, 18, 31, 45) that are more likely to

80 develop Cervical Intraepithelial Neoplasia, due to the effects that HPV has on DNA. Studies of the accuracy of HPV testing report: sensitivity 88% to 91% (for detecting CIN 3 or higher) to 97% (for detecting CIN2+) specificity 73% to 79% (for detecting CIN 3 or higher) to 93% (for detecting CIN2+) By adding the more sensitive HPV Test, the specificity may decline. However, the drop in specificity is not definite. If the specificity does decline, the result is increased numbers of false positive tests and, for many women that did not have disease, an increased risk for colposcopy and treatment. A worthwhile screening test requires a balance between the sensitivity and specificity to ensure that those having a disease are correctly identified as having it and those without the disease are not identified as having it. HPV testing can reduce the incidence of grade 2 or 3 cervical intraepithelial neoplasia or Regarding the role of HPV testing, randomized controlled trials have compared HPV to colposcopy. HPV testing appears as sensitive as immediate colposcopy while reducing the number of colposcopies needed. Randomized controlled trial have suggested that HPV testing could follow abnormal cytology or could precede cervical cytology examination. A study published in April 2007 suggested that the act of performing a Pap smear produces an inflammatory cytokine response, which may initiate immunologic clearance of HPV, therefore reducing the risk of cervical cancer. Women that had even a single Pap smear in their history had a lower incidence of cancer. "A statistically significant decline in the HPV positivity rate correlated with the lifetime number of Pap smears received." cervical cancer detected by subsequent screening tests among women years old according to a randomized controlled trial. The relative risk reduction was 41.3%. For patients at similar risk to those in this study (63.0% had CIN 2-3 or cancer), this leads to an absolute risk reduction of 26%. 3.8 patients must be treated for one to benefit (number needed to treat = 3.8). Testing in resource-poor areas Many resource-poor areas cannot provide regular screening, and must rely on infrequent screening. A study of cervical cancer screening of 131,746 women in rural India found that a single DNA test reduced the number of advanced cervical cancers and deaths over 8 years, while a single acetic acid examination or a single Pap screening did not. However, the DNA test cost US $30 40, which was unaffordable in many regions, it is time-consuming, and requires a sophisticated laboratory infrastructure. A simple, affordable, and accurate test is being evaluated in China and other countries. The new test may become available on the market in 2010 at significantly lower cost than current tests.

81 With HPV testing, there was a 50 percent reduction in the number of deaths from cervical cancer compared to unscreened women. Compared to other methods, the research showed the HPV testing reported the fewest false negatives. Other options The Bill and Melinda Gates Foundation has funded an eight-year study of a DNA test for the virus that causes cervical cancer. The test manufactured by Qiagen for a low cost per test with results available in only a few hours may allow reduction in use of annual Pap smears. The test has been shown to work "acceptably well" on women who take the swabs themselves rather than allowing a physician to test. This may improve the chances of early diagnosis for women who are unwilling to be screened due to discomfort or modesty. Automated analysis In the last decade, there have been successful attempts to develop automated, computer image analysis systems for screening. Although, on the available evidence automated cervical screening could not be recommended for implementation into a national screening program, a recent NHS Health technology appraisal concluded that the 'general case for automated image analysis ha(d) probably been made'. Automation may improve sensitivity and reduce unsatisfactory specimens. Two systems have been approved by the FDA and function in high-volume reference laboratories, with human oversight. Practical aspects The endocervix may be partially sampled with the device used to obtain the ectocervical sample, but, due to the anatomy of this area, consistent and reliable sampling cannot be guaranteed. As abnormal endocervical cells may be sampled, those examining them are taught to recognize them. The endometrium is not directly sampled with the device used to sample the ectocervix. Cells may exfoliate onto the cervix and be collected from there, so as with endocervical cells, abnormal cells can be recognised if present but the Pap Test should not be used as a screening tool for endometrial malignancy. Experimental techniques Colposcopy is the "gold standard" tool in the developed world for diagnosing cervical abnormalities after an abnormal pap smear. The procedure requires a trained colposcopist and can be expensive to perform. Experimental visualization techniques use broad-band light (e.g., direct visualization, speculoscopy, cervicography, visual inspection with acetic acid or with Lugol's, and colposcopy) and electronic detection methods (e.g., Polarprobe and in-vivo

82 Spectroscopy). These techniques are less expensive and can be performed with significantly less training. They do not perform as well as Pap smear screening and colposcopy. At this point, these techniques have not been validated by large-scale trials and are not in general use. Visual inspection to detect pre-cancer or cancer In areas where Pap smear screening is not available or affordable, other methods of testing have been evaluated. Visual inspection of the cervix, using acetic acid (VIA) or Lugol s iodine (VILI) to highlight precancerous lesions so they can be viewed with the naked eye, shifts the identification of precancer from the laboratory to the clinic. Such procedures eliminate the need for laboratories and transport of specimens, require very little equipment and provide women with immediate test results. A range of medical professionals doctors, nurses, or professional midwives can effectively perform the procedure, provided they receive adequate training and supervision. As a screening test, VIA may perform as well as or better than cervical cytology in accurately identifying pre-cancerous lesions. This has been demonstrated in various studies where trained physicians and mid-level providers correctly identified between 45% and 79% of women at high risk of developing cervical cancer. By comparison, the sensitivity of cytology has been shown to be between 47 and 62%. Cytology provides higher specificity (fewer false positives) than VIA. Like cytology, one of the limitations of VIA is that results are highly dependent on the accuracy of an individual's interpretation. This means that initial training and on-going quality control are of paramount importance. Increased false positives are particularly important in a screen-and-treat setting, since over-treatment and resulting impairment of fertility is more likely. VIA can offer significant advantages over Pap in low-resource settings, particularly in terms of increased screening coverage, improved follow-up care and overall program quality. Due to the need for fewer specialized personnel and less infrastructure, training, and equipment, with VIA public health systems can offer cervical cancer screening in more remote (and less equipped) health care settings and can achieve higher coverage. Furthermore, providers can share the results of VIA with patients immediately, making it possible to screen and treat women during the same visit. This helps ensure that followup care can be provided on the spot and reduces the number of women who may miss out on treatment because they are not able to return to the clinic at another time. In a screen and treat project in Peru, for example, only 9% of women who screened positive failed to receive treatment in the single-visit approach, compared with 44% of women who were lost to treatment using a multi-visit model. VIA has successfully been paired with cryotherapy, a relatively simple and inexpensive method of treating cervical lesions that can be performed by primary care physicians and mid-level providers.

83 Endocervical adenocarcinoma on a pap test.

84 Candida organisms on a pap test.

85 Viral cytopathic effect consistent with herpes simplex virus on a pap test.

86 Normal squamous epithelial cells in premenopausal women

87 Atrophic squamous cells in postmenopausal women

88 Normal endocervical cells should be present into the slide, as a proof of a good quality sampling

89 the cytoplasms of squamous epithelial cells melted out; many Döderlein bacilli can be seen

90 Infestation by Trichomonas vaginalis

91 An obviously atypical cell can be seen

92 Chapter 12 Female Genital Cutting Campaigning against female genital mutilation - a road sign near Kapchorwa, Uganda Female genital cutting (FGC), also known as female genital mutilation (FGM), female circumcision, or female genital mutilation/cutting (FGM/C), is any procedure involving the partial or total removal of the external female genitalia or other injury to the female genital organs "whether for cultural, religious or other non-therapeutic reasons." The term is almost exclusively used to describe traditional or religious procedures on a minor, which requires the parents' consent because of the age of the girl.

93 When the procedure is performed on and with the consent of an adult, it is generally called clitoridectomy, or it may be part of labiaplasty or vaginoplasty. It also generally does not refer to procedures used in sex reassignment surgery, and the genital modification of intersexuals. FGC is predominantly practiced in Northeast Africa and parts of the Near East and Southeast Asia, although it has also been reported to occur in individual tribes in South America and Australia. Opposition is motivated by concerns regarding the consent (or lack thereof, in most cases) of the patient, and subsequently the safety and long-term consequences of the procedures. In the past several decades, there have been many concerted efforts by the World Health Organization (WHO) to end the practice of FGC. The United Nations has also declared February 6 as "International Day of Zero Tolerance to Female Genital Mutilation". Varying terminology Different terms are used to describe female genital surgery and other such procedures. The terms female genital mutilation (FGM) and female genital cutting (FGC) are now dominant in the international community. Practitioners commonly prefer the term female circumcision (FC). Groups that oppose the stigma of the word "mutilation" prefer to use the term female genital cutting. A few organizations have started using the combined term female genital mutilation/cutting (FGM/C). All terms are currently still actively used. Female genital mutilation Support for the term female genital mutilation grew in the late 1970s. The word "mutilation" not only established a clear linguistic distinction from male circumcision, but also emphasized the putative gravity of the act. In 1990 the term was adopted at the third conference of the Inter-African Committee on Traditional Practices Affecting the Health of Women and Children (IAC) in Addis Ababa. In 1991, the World Health Organization (WHO) recommended that the UN adopt this terminology, which it did. In this context, the term female genital mutilation has replaced the term female circumcision: The extensive literature on the subject, the support of international organizations, and the emergence of local groups working against the continuation practices appear to suggest that an international consensus has been reached. The terminology used to refer to these surgeries has changed, and the clearly disapproving and powerfully evocative expression of "female genital mutilation" has now all but replaced the possibly inaccurate, but less value-laden term of "female circumcision".

94 Female genital cutting Because the term female genital mutilation has been criticized for increasing the stigma associated with female genital surgery, some groups have proposed an alteration, substituting with the word "cutting" the one of "mutilation." According to a joint WHO/UNICEF/UNFPA statement, the use of the word "mutilation" reinforces the idea that this practice is a violation of the human rights of girls and women, and thereby helps promote national and international advocacy towards its abandonment. They state that, at the community level, however, the term can be problematic; and that local languages generally use the less judgmental "cutting" to describe the practice. They also state that parents resent the suggestion that they are "mutilating" their daughters. In 1999, the UN Special Rapporteur on Traditional Practices called for tact and patience regarding activities in this area and drew attention to the risk of "demonizing" certain cultures, religions, and communities. As a result, the term "cutting" has come to be used when trying to avoid alienating communities. In 1996, the Uganda-based initiative REACH (Reproductive, Educative, And Community Health) began using the term "FGC", observing that "FGM" may "imply excessive judgment by outsiders as well as insensitivity toward individuals who have undergone some form of genital excision." The UN uses "FGM" in official documents, while some of its agencies, such as the UN Population Fund, use both the terms "FGM" and "FGC". Female circumcision Several dictionaries, including medical dictionaries, define the word circumcision as applicable to some procedures performed on females. Cook states that historically, the term female circumcision was used, but that "this procedure in whatever form it is practiced is not at all analogous to male circumcision and so the term 'female circumcision' gave way to the term 'female genital mutilation'" Shell-Duncan states that the term female circumcision is a euphemism for a variety of procedures for altering the female genitalia. Toubia argued, in 1995, that the term female circumcision "implies a fallacious analogy to nonmutilating male circumcision, in which the foreskin is cut off from the tip of the penis without damaging the organ itself." However, in the 1999 book Male and Female Circumcision, Toubia states that she agrees that "circumcision that is, the genital mutilation of girls and boys is wrong despite its widespread practice." Procedures: World Health Organization categorization FGC consists of several distinct procedures. Their severity is often viewed as dependent on how much genital tissue is cut away. The WHO which uses the term Female Genital Mutilation (FGM) divides the procedure into four major types (see Diagram 1), although there is some debate as to whether all common forms of FGM fit into these four categories, as well as issues with the reliability of reported data.

95 Diagram 1:This image shows the different types of FGM and how they differ to the uncircumcised female anatomy. Type I The WHO defines Type I FGM as the partial or total removal of the clitoris (clitoridectomy) and/or the prepuce (clitoral hood); see Diagram 1B. When it is important to distinguish between the variations of Type I cutting, the following subdivisions are proposed: Type Ia, removal of the clitoral hood or prepuce only (which some view as analogous to male circumcision and thus more acceptable); Type Ib, removal of the clitoris with the prepuce. In the context of women who seek out labiaplasty, there is disagreement among doctors as to whether to remove the clitoral hood in some cases to enhance sexuality or whether this is too likely to lead to scarring and other problems.

96 Type II The WHO's definition of Type II FGM is "partial or total removal of the clitoris and the labia minora, with or without excision of the labia majora. When it is important to distinguish between the major variations that have been documented, the following subdivisions are proposed: Type IIa, removal of the labia minora only; Type IIb, partial or total removal of the clitoris and the labia minora; Type IIc, partial or total removal of the clitoris, the labia minora and the labia majora. Type III: Infibulation with excision The WHO defines Type III FGM as narrowing of the vaginal orifice with creation of a covering seal by cutting and repositioning the labia minora and/or the labia majora, with or without excision of the clitoris (infibulation)." It is the most extensive form of FGM, and accounts for about 10% of all FGM procedures described from Africa. Infibulation is also known as "pharaonic circumcision". In a study of infibulation in the Horn of Africa, Pieters observed that the procedure involves extensive tissue removal of the external genitalia, including all of the labia minora and the inside of the labia majora. The labia majora are then held together using thorns or stitching. In some cases the girl's legs have been tied together for two to six weeks, to prevent her from moving and to allow the healing of the two sides of the vulva. Nothing remains but the walls of flesh from the pubis down to the anus, with the exception of an opening at the inferior portion of the vulva to allow urine and menstrual blood to pass through; see Diagram 1D. Generally, a practitioner recognized as having the necessary skill carries out this procedure, and a local anesthetic is used. However, when carried out "in the bush", infibulation is often performed by an elderly matron or midwife of the village, without sterile procedure or anesthesia. A reverse infibulation can be performed to allow for sexual intercourse or when undergoing labor, or by female relatives, whose responsibility it is to inspect the wound every few weeks and open it some more if necessary. During childbirth, the enlargement is too small to allow vaginal delivery, and so the infibulation is opened completely and may be restored after delivery. Again, the legs are sometimes tied together to allow the wound to heal. When childbirth takes place in a hospital, the surgeons may preserve the infibulation by enlarging the vagina with deep episiotomies. Afterwards, the patient may insist that her vulva be closed again. Women who have been infibulated face a lot of difficulty in delivering children, especially if the infibulation is not undone beforehand, which often results in severe tearing of the infibulated area, or fetal death if the birth canal is not cleared (Toubia, 1995). The risk of severe physical, and psychological complications is more highly associated with women who have undergone infibulations as opposed to one of the lesser forms of FGM. Although there is little research on the psychological side effects of FGM, many women feel great pressure to conform to the norms set out by their community, and

97 suffer from anxiety and depression as a result (Toubia, 1995). "There is also a higher rate of post-traumatic stress disorder in circumcised females" (Nicoletti, 2007, p. 2). A five-year study of 300 women and 100 men in Sudan found that "sexual desire, pleasure, and orgasm are experienced by the majority (nearly 90%) of women who have been subjected to this extreme sexual mutilation, in spite of their being culturally bound to hide these experiences." Type IV: Other types There are other forms of FGM, collectively referred to as Type IV, that may not involve tissue removal. The WHO defines Type IV FGM as "all other harmful procedures to the female genitalia for non-medical purposes, for example, pricking, piercing, incising, scraping and cauterization." This includes a diverse range of practices, such as pricking the clitoris with needles, burning or scarring the genitals as well as ripping or tearing of the vagina. Type IV is found primarily among isolated ethnic groups as well as in combination with other types. Reasons for Female Genital Mutilation Cultural, religious and social causes The causes of female genital mutilation include a mix of cultural, religious and social factors within families and communities. Where FGM is a social convention, the social pressure to conform to what others do and have been doing is a strong motivation to perpetuate the practice. FGM is often considered a necessary part of raising a girl properly, and a way to prepare her for adulthood and marriage. FGM is often motivated by beliefs about what is considered proper sexual behaviour, linking procedures to premarital virginity and marital fidelity. FGM is in many communities believed to reduce a woman's libido, and thereby is further believed to help her resist "illicit" sexual acts. When a vaginal opening is covered or narrowed (type 3 above), the fear of pain of opening it, and the fear that this will be found out, is expected to further discourage "illicit" sexual intercourse among women with this type of FGM. FGM is associated with cultural ideals of femininity and modesty, which include the notion that girls are clean and "beautiful" after removal of body parts that are considered "male" or "unclean". Though no religious scripts prescribe the practice, practitioners often believe the practice has religious support.

98 Religious leaders take varying positions with regard to FGM: some promote it, some consider it irrelevant to religion, and others contribute to its elimination. Local structures of power and authority, such as community leaders, religious leaders, circumcisers, and even some medical personnel can contribute to upholding the practice. In most societies, FGM is considered a cultural tradition, which is often used as an argument for its continuation. In some societies, recent adoption of the practice is linked to copying the traditions of neighbouring groups. Sometimes it has started as part of a wider religious or traditional revival movement. In some societies, FGM is being practised by new groups when they move into areas where the local population practice FGM. Reversal In recent years, surgical techniques to reverse FGM have been developed by gynecologists such as Dr. Pierre Foldes and Dr. Marci Bowers. Techniques can include ablating scar tissue, reconstructing the labia, and drawing the internal part of the clitoris outward to compensate for clitoral excision. FGC can now be partially reversed via a surgical technique, which gives back certain sensation to the genitalia. Clitoraid, a non-profit international organization, is in the process of building a hospital in Burkina Faso, West Africa, where women who have undergone FGC will be able to receive this procedure free of charge. The hospital will be staffed with volunteers, including surgeons who specialise in the technique. Cultural and religious aspects A Greek papyrus from 163 B.C. mentions both boys and girls in Egypt undergoing circumcision and it is widely accepted to have originated in Egypt and the Nile valley at the time of the Pharaohs. Evidence from mummies has shown both Type I and Type III FGC present. Al-Azhar Supreme Council of Islamic Research, the highest religious authority in Egypt, issued a statement saying FGM/C has no basis in core Islamic law or any of its partial provisions and that it is harmful and should not be practised." Coptic Pope Shenouda, the leader of Egypt's minority Christian community, said that neither the Qur'an nor the Bible demand or mention female circumcision.

99 Medical consequence Among practising cultures, FGC is most commonly performed between the ages of four and eight, but can take place at any age from infancy to adolescence. Prohibition has led to FGC going underground, at times with people who have had no medical training performing the cutting without anaesthetic, sterilisation, or the use of proper medical instruments. The procedure can lead to death through shock from excessive bleeding. The failure to use sterile medical instruments may lead to infections. Other serious long term health effects are also common. These include urinary and reproductive tract infections, caused by obstructed flow of urine and menstrual blood, various forms of scarring and infertility. Epidermal inclusion cysts may form and expand, particularly in procedures affecting the clitoris. These cysts can grow over time and can become infected, requiring medical attention such as drainage. The first episode of sexual intercourse will often be extremely painful for infibulated women, who will need the labia majora to be opened, to allow their partner access to the vagina. This second cut, sometimes performed by the partner with a knife, can cause other complications to arise. genital cutting. A June 2006 study by the WHO has cast doubt on the safety of genital cutting of any kind. This study was conducted on a cohort of 28,393 women attending delivery wards at 28 obstetric centers in areas of Burkina Faso, Ghana, Kenya, Senegal and The Sudan. A high proportion of these mothers had undergone FGC. According to the WHO criteria, all types of FGC were found to pose an increased risk of death to the baby (15% for Type I, 32% for Type II, and 55% for Type III). Mothers with FGC Type III were also found to be 30% more at risk for cesarean sections and had a 70% increase in postpartum haemorrhage compared to women without FGC. Estimating from these results, and doing a rough population estimate of mothers in Africa with FGC, an additional 10 to 20 per thousand babies in Africa die during delivery as a result of the mothers having undergone In cases of repairing the damage resulting from FGC, called de-infibulation when reversing Type III FGC, this is usually carried out by a gynecologist. A 12-year-old Egyptian girl, Badour Shaker, died in June 2007 during or soon after a circumcision, prompting the Egyptian Health Ministry to ban the practice. She died from an overdose of anaesthesia. The girl's mother, Zeinab Abdel Ghani, paid the equivalent of US$9.00 ( 4.60 pounds sterling, 6.82 euro) to a female doctor, in an illegal clinic in the southern town of Maghagh, for the operation. The mother stated that the doctor tried to give her $3,000 to withdraw a lawsuit, but she refused. HIV Relatively little research has been conducted on the effect female genital alteration may have on HIV prevalence. Some studies have found increased risk of HIV among women who had undergone FGC. Other studies have found no statistically significant

100 associations, or have identified more complex patterns. Two studies have reported that FGC is associated with decreased risk of HIV. Kanki et al. (1992) reported that, in Senegalese prostitutes, women who had undergone FGC had a significantly decreased risk of HIV-2 infection when compared to those who had not. Klouman et al. (2005), studying women in Tanzania, found that among women who had undergone FGC the odds of being HIV positive were roughly twice those among women who had not. However, both HIV and FGC were strongly associated with age; when controlling for age, the association was no longer statistically significant. Brewer et al. (2007) found that in virgins, FGC was associated with a higher prevalence of HIV infection (3.2% vs 1.4%), which the authors attributed to unsterile procedures. Among sexually experienced women, FGC was associated with lower HIV prevalence (5.5% vs 9.9%). The authors suggested two possible reasons: that an HIV-specific immunity might be acquired through FGC procedures, and mortality of those infected at the time of FGC would reduce HIV prevalence in surviving adults. Maslovskaya et al. (2009) found that FGC was associated with higher risk of HIV among women whose first-union partner was younger or the same-age, but it was associated with lower risk of HIV among women whose first-union partner was older than the women herself. Yount et al. reported that, although FGC and HIV were not directly related, FGC was indirectly related to HIV via a number of associations with other factors, including extra-union partners, early onset of sexual activity, being widowed or divorced, and having an older partner. The authors concluded that FGC "may be an early life-course event that indirectly alters women's odds of becoming infected with HIV through protective and harmful practices in adulthood". remained significant after adjusting for region, household wealth, age, lifetime partners, Stallings et al. (2009) reported that, in Tanzanian women, the risk of HIV among women who had undergone FGC was roughly half that of women who had not; the association union status, and recent ulcer. The authors, who expressed surprise at their finding, concluded that the association was due to confounding due to a further, unknown factor. Recent reviews have suggested that FGC may increase the risk of HIV. Several mechanisms have been proposed by which FGC would expose women to greater risk of HIV. These include: non-sterile procedures (Monjok notes that the same instrument is frequently used on girls); an increase in blood transfusions due to blood loss during the procedure itself, intercourse, or childbirth; increased anal intercourse due to difficult or painful vaginal intercourse; tearing of the vagina during intercourse; and increased susceptibility to infectious conditions that are recognised risk factors for HIV, such as genital ulcers. Sexual effects The effect of FGC on a woman's sexual experience varies depending on many factors. FGC does not eliminate all sexual pleasure for all women who undergo the procedure, but it does reduce the likelihood of orgasm. Stimulation of the clitoris is not solely

101 responsible for the sexual excitement and arousal of a woman during intercourse; this involves a complex series of nerve endings being activated and stimulated in and around her vagina, vulva (labia minora and majora), cervix, uterus and clitoris, with psychological response and mindset also playing a role. Lightfoot-Klein (1989) studied circumcised and infibulated females in Sudan, stating, "Contrary to expectations, nearly 90% of all women interviewed said that they experienced orgasm (climax) or had at various periods of their marriage experienced it. Frequency ranged from always to rarely." Lightfoot-Klein stated that the quality of orgasm varied from intense and prolonged, to weak or difficult to achieve. A study in 2006 found that in some infibulated women, some erectile tissue fundamental to producing pleasure had not been completely excised. Defibulation of subjects revealed that a part of or the whole of the clitoris was underneath the scar of infibulation. The study found that sexual pleasure and orgasm are still possible after infibulation, and that they rely heavily on cultural influences when mutilation is lived as a positive experience, orgasm is more likely. When FGC is experienced as traumatic, its frequency drops. The study suggested that FGC women who did not suffer from long-term health consequences and are in a good and fulfilling relationship may enjoy sex, and women who suffered from sexual dysfunction as a result of FGC have a right to sex therapy. Psychological and psychiatric consequences In February 2010, a study by Pharos, a Dutch group which gathers information on health care for refugees and migrants, found that many women who have undergone FGC suffer psychiatric problems. This was the first study into the psychiatric and social complaints associated with female circumcision. In the study 66 questioned Dutch African women, who had been subjected to the practice, were found to be "stressed, anxious and aggressive". It also found that they were more likely to have relational problems or in some cases had fears of establishing a relationship. According to the study, an estimated 50 women or girls are believed to be circumcised every year in the Netherlands. The report was published to mark the International day against female genital mutilation. A study by anthropologist Rogaia M. Abusharaf, found that "circumcision is seen as 'the machinery which liberates the female body from its masculine properties' and for the women she interviewed, it is a source of empowerment and strength". Attempts to end the practice Despite laws forbidding the practice, FGC remains an enduring tradition in many societies and cultural groups. Political leaders have found FGC difficult to eliminate on the local level because of its cultural and sometimes political importance. For instance, in Kenya, missionaries present in the 1920s and 1930s forbade their Christianised adherents to practice clitoridectomy. In response, FGC became instrumental to the ethnic independence movement among the Kikuyu, the most populous ethnic group of Kenya

102 indigenous people reacted against what they perceived as cultural imperialistic attacks by Europeans. Likewise, prohibition by the British of the procedure among tribes in Kenya significantly strengthened the tribes' resistance to British colonial rule in the 1950s and increased support for the Mau Mau guerrilla movement. Because the practice holds much cultural and marital significance, FGC opponents recognize that ending it requires that they work closely with local communities. To leave no individuals handicapped, as happened with the rapid abandonment of foot binding among the Chinese early in the 20th century, members of a marriage network must all give up the practice simultaneously. Despite the close tie between FGC and cultural and, sometimes, religious tradition, there are cases where attempts at ending FGC have been successful. One example is in Senegal, where initiative was taken by native women working at the local level in connection with the NGO Tostan. Since 1997, 4,203 communities in Senegal, 364 in Guinea, 23 in Burkina Faso, 24 in The Gambia, and 14 in Somalia have voluntarily given up FGC and are also working to end early and forced marriage. This has come about through the voluntary efforts of locals carrying the message out to other villages within their marriage networks in a self-replicating process. The expansion of community declarations, beginning in the village of Malicounda Bambara in 1997 and continuing to grow, "show the replicability of the Tostan program for large-scale abandonment of this practice". Molly Melching, founder of Tostan, and UNICEF believe that in Senegal the practice of female genital mutilation could be ended by She credits education, instead of cultural imperialism, for the rapid and significant changes in Senegal. practice entirely. However, with pressure from the WHO and other groups, laws are Some countries that prohibited FGC still experience the practice in secrecy. In many cases, enforcement of this prohibition is a low priority for governments. Other countries have tried to educate practitioners to make it easier and safer instead of outlawing the being passed in regards to FGC. On June 28, 2007 Egypt banned female genital cutting after the death of 12-year-old Badour Shaker during a genital circumcision. The Guardian of Britain reported that her death "sparked widespread condemnation" of the practice. However, Britain has had its own problem confronting cases of FGC, as immigrants from Africa have been known to send their daughters to their home nations to undergo the procedure before returning to Britain. In Mauritania, where "health campaigners estimate that more than 70% of Mauritanian girls undergo the partial or total removal of their external genitalia for non-medical reasons", 34 Islamic scholars signed a fatwa banning the practice in January Their aim was to prevent people from citing religion as a justification for genital mutilation. The United Nations Population Fund (UNFPA) has declared February 6 as the International Day Against Female Genital Mutilation. The UNFPA has stated that "[the] practice violates the basic rights of women and girls" and "female genital mutilation or cutting is not required by any religion."

103 There are two main anti-fgc frameworks: the health model and the human rights-based model. The health model campaign defines FGC as harmful to women's health (physical and psychological trauma, sterility, damage to the urethra and anus, tetanus, child and maternal mortality and more recently HPV and HIV infection). This approach has failed to bring about large scale behavioural change. Furthermore, although the health model is against FGC and the adverse effects associated, it often rejects methods to provide medical support to minimize FGC health risks (i.e. medicalization). The human rightsbased model has in more recent times replaced the health based model as the preferred approach in anti-fgc campaigns. The human rights model encompasses four important human rights discourses: violence against women, rights of the child, freedom from torture and rights to health and bodily integrity. Laws and prevalence Amnesty International estimates that 135 million women worldwide have experienced some form of Female genital cutting mutilation, with over 2 million girls estimated to undergo the procedure every year. Female gender mutilation is present in Africa and in the Near East. Map: Estimated Prevalence of Female Genital Cutting (FGC) in Africa. Data based on uncertain estimates. Whilst FGM is widely practised out in the open by many communities of varied faiths in its locus of concentration in Northeastern Africa, it is practised in different parts of the Middle East. In the Arabian peninsula, Types I and II FGM are usually performed, often referred to as Sunna circumcision. The practice occurs particularly in northern Saudi Arabia, southern Jordan, and northern Iraq (Kurdistan). In the Iraqi village of Hasira, a recent study found that 60% of the women and girls reported having undergone FGM.

104 Before the study, there had been no solid proof of the prevalence of the practice. There is also circumstantial evidence to suggest that Female genital cutting is practised in the Kurdish regions of Syria, Turkey and Iran. In Oman, a few communities still practice Female genital cutting; however, experts believe that the number of such cases is small and declining annually. In the United Arab Emirates and Saudi Arabia, it is practiced mainly among foreign workers from East Africa and the Nile Valley. A 2009 study suggested that FGM had virtually disappeared among the Negev Bedouin due to modernisation process under Israeli rule. Female genital Cutting mutilation is practiced in Palestinian territories Female genital Cutting is also present in Western Asia Region of Chechnya. The practice can also be found among a few ethnic groups in South America. In Indonesia, the practice is common in several districts; almost all are Type I or Type IV, the latter usually involving the pricking of blood release. Sometimes the procedures are merely symbolic, and no actual cutting is done. justified by Freedom of Religion because it is seen as a religious practice. As a result of immigration, the practice has also spread to Europe, Australia and the United States. Some tradition-minded families have their daughters undergo FGM whilst on vacation in their home countries. As Western governments become more aware of FGM, legislation has come into effect in many countries to make the practice a criminal offense. In 2006, Khalid Adem became the first man in the United States to be prosecuted for circumcising his daughter. A lot of sources exist for the practice, but all sources point into different directions. The practice can not be attributed to just one ethnic group and may not be trivialised in these regions. Even if a country officially forbids or denies the practice, it is often a traditional part in the sociological structure. It is hard to get such behaviour out of the line of generations because it belongs to the traditional practices or religion. FGM is often Africa In July, 2003 at its second summit, the African Union adopted the Maputo Protocol promoting women's rights including and to end female genital mutilation. Having been ratified by fifteen members, it went into force in November, By December 2008, 25 member countries had ratified and deposited the Maputo Protocol. The countries where FGC is commonly practised were identified by the US State Department. Other information in this section is from Skaine (2005), Appendix I. Algeria (no Data) Female genital cutting - mutilation is present in Algeria. Benin (17% prevalence, Type II) Female genital cutting mutilation is prevalent in Benin. Burkina Faso (71.6% prevalence, Type II)

105 A law prohibiting FGC was enacted in 1996 and went into effect in February Even before this law, however, a presidential decree had set up the National Committee against excision and imposed fines on people guilty of excising girls and women. The new law includes stricter punishment. Several women excising girls have been handed prison sentences. Burkina Faso ratified the Maputo Protocol in Cameroon (20% prevalence, Type I and II) Female genital cutting mutilation is prevalent in Cameroon. Central African Republic (43.4% prevalence, Type I and II) In 1996, the President issued an Ordinance prohibiting FGC throughout the country. It has the force of national law. Any violation of the Ordinance is punishable by imprisonment of from one month and one day to two years and a fine of 5,100 to 100,000 francs (approximately US$8 160). No arrests are known to have been made under the law. Chad (60% prevalence, Type II and III) In 2001 law was being drafted to specifically outlaw FGC. Prior to this it may have been prosecutable under existing laws protecting minors from involuntary physical assault. Comoros (no Data available) Female genital cutting mutilation is prevalent on Comoros. Côte d'ivoire (44.5% prevalence, Type II) A December 18, 1998 law provides that harm to the integrity of the genital organ of a woman by complete or partial removal, excision, desensitization or by any other procedure will, if harmful to a women's health, be punishable by imprisonment of one to five years and a fine of 360,000 to two million CFA Francs (approximately US$576 3,200). The penalty is five to twenty years incarceration if a death occurs during the procedure and up to five years' prohibition of medical practice, if this procedure is carried out by a doctor. Democratic Republic of the Congo (5% prevalence, Type II) Female genital cutting mutilation is practiced in the Congo. Djibouti (90 98% prevalence, Type II and III) FGC was outlawed in the country's revised Penal Code that went into effect in April Article 333 of the Penal Code provides that persons found guilty of this practice will face a five year prison term and a fine of one million Djibouti francs (approximately US$5,600). Djibouti ratified the Maputo Protocol in Egypt (78 97% prevalence, Type I, II and III) Egypt's Ministry of Health and Population has banned all forms of female genital cutting since The ministry's order declared it is 'prohibited for any doctors, nurses, or any other person to carry out any cut of, flattening or modification of any natural part of the female reproductive system'. Islamic authorities in the nation also stressed that Islam opposes female circumcision. The Grand Mufti of Egypt, Ali Gomaa, said that it is "Prohibited, prohibited, prohibited." The June 2007 Ministry ban eliminated a loophole that allowed girls to undergo the procedure for health reasons. There had previously been provisions under the Penal Code involving "wounding" and "intentional infliction of harm leading to death", as well as a ministerial decree prohibiting FGC. In December 1997, the

106 Court of Cassation (Egypt's highest appeals court) upheld a government banning of the practice providing that those who did not comply would be subjected to criminal and administrative punishments. This law had proved ineffective and in a survey in 2000, a study found that 97% of the country's population still practiced FGC. In light of the widespread practice of FGC, even after the ban in 1997, some Egyptian villages decided to voluntarily give up the practice, as was the case with Abou Shawareb, which vowed in July 2005 to end the practice. However, it remains a culturally accepted practice, and a 2005 study found that over 95% of Egyptian women have undergone some form of FGC. Eritrea (90% prevalence, Type I, II, and III) Eritrea has outlawed all forms of female genital cutting since Ethiopia (69.7% 94.5% prevalence, Type I, II, III, and IV) Ethiopia's Regional statistics of the prevalence from the survey are: Afar Region 94.5%; Harare Region 81.2%; Amhara Region 81.1%; Oromia Region 79.6%; Addis Ababa City 70.2%; Somali Region 69.7%; Beneshangul Gumuz Region 52.9%; Tigray Region 48.1%; Southern Region 46.3%. This practice is not specifically illegal in Ethiopia. Discussions with government officials and NGOs active in the eradication of these practices indicate that the legal provision for prohibiting harmful traditional practices and the policy statements against them are not, as a practical matter, enforced. There are no documented cases of women going to court over or seeking protection against this practice. We are unaware of any groups or organizations that provide protection to women or girls who wish to avoid it. Gambia (80 90% prevalence, Type I,II,III and IV) Female genital cutting mutilation is prevalent in Gambia. Ghana (40% prevalence, Type I,II and III) Female genital cutting - mutilation is prevalent in Ghana. In 1989, the head of the government of Ghana, President Rawlings, issued a formal declaration against FGC. Article 39 of Ghana's Constitution also provides in part that traditional practices that are injurious to a person's health and well being are abolished. Ghana ratified the Maputo Protocol in Guinea (98.6% prevalence, Type I, II and III) FGC is illegal in Guinea under Article 265 of the Penal Code. The punishment is hard labor for life and if death results within 40 days after the crime, the perpetrator will be sentenced to death. No cases regarding the practice under the law have ever been brought to trial. Article 6 of the Guinean Constitution, which outlaws cruel and inhumane treatment, could be interpreted to include these practices, should a case be brought to the Supreme Court. A member of the Guinean Supreme Court is working with a local NGO on inserting a clause into the Guinean Constitution specifically prohibiting these practices. Guinea signed the Maputo Protocol in 2003 but has not ratified it. Guinea-Bissau (50% prevalence, no Data) Female genital cutting mutilation is present in Guinea-Bissau. Kenya (50% prevalence, Type I,II and III) Female genital cutting mutilation is prevalent in Kenya. Liberia (60% prevalence, Type II)

107 Female genital cutting mutilation is prevalent in Liberia. Libya (No Data) Female genital cutting - mutilation is practiced in Libya. Malawi (No Data) Female genital cutting - mutilation is practiced in Malawi. Mali (92% prevalence, Type I,II and III) Female genital cutting mutilation is prevalent in Mali. Mauritania (71% prevalence, Type I and II) Female genital cutting mutilation is prevalent in Mauritania. Mozambique (No Data) Female genital cutting - mutilation is present in Mozambique. Niger (20% prevalence, Type II) Female genital cutting mutilation is prevalent in Niger. Nigeria (25.1% prevalence, Type I, II and III) There is no federal law banning the practice of FGC in Nigeria. Opponents of these practices rely on Section 34(1)(a) of the 1999 Constitution of the Federal Republic of Nigeria that states "no person shall be subjected to torture or inhuman or degrading treatment" as the basis for banning the practice nationwide. A member of the House of Representatives has drafted a bill, not yet in committee, to outlaw this practice. Nigeria ratified the Maputo Protocol in Republic of the Congo (5% prevalence, Type II) Female genital cutting mutilation is practiced in the Republic of the Congo. Senegal (20 30% prevalence, Type II and III) Female genital cutting mutilation is prevalent in Senegal. A law that was passed in January 1999 makes FGC illegal in Senegal. President Diouf had appealed for an end to this practice and for legislation outlawing it. The law modifies the Penal Code to make this practice a criminal act, punishable by a sentence of one to five years in prison. A spokesperson for the human rights group RADDHO (The African Assembly for the Defense of Human Rights) noted in the local press that "Adopting the law is not the end, as it will still need to be effectively enforced for women to benefit from it. Senegal ratified the Maputo Protocol in Sierra Leone (90% prevalence, Type II) Female genital cutting mutilation is practiced in Sierra Leone. Somalia (95 % prevalence, Type I and III) In 1999 Parliament approved legislation making FGM illegal although there is little evidence to support its enforcement. South Africa (No Data) Female genital cutting - mutilation is present in South Africa. Sudan (91% prevalence, Type I, II and III) Currently there is no law forbidding FGC, although Sudan was the first country to outlaw it in 1946, under the British. Type III was prohibited under the 1925 Penal Code, with less severe forms allowed. Outreach groups have been trying to eradicate the practice for 50 years, working with NGOs, religious groups, the government, the media and medical practitioners. Arrests have been made but no

108 further action seems to have taken place. Sudan signed the Maputo Protocol in June, 2008 but no ratification has yet been deposited with the African Union. Tanzania (17.6% prevalence, Type II and III) Section 169A of the Sexual Offences Special Provisions Act of 1998 prohibits FGC. Punishment is imprisonment of from five to fifteen years or a fine not exceeding 300,000 shillings (approximately US$250) or both. There have been some arrests under this legislation, but no reports of prosecutions yet. Tanzania ratified the Maputo Protocol in Togo (50% prevalence, Type II) Female genital cutting mutilation is practiced in Togo. On October 30, 1998, the National Assembly unanimously voted to outlaw the practice of FGC. Penalties under the law can include a prison term of two months to ten years and a fine of 100,000 francs to one million francs (approximately US$160 to 1,600). A person who had knowledge that the procedure was going to take place and failed to inform public authorities can be punished with one month to one year imprisonment or a fine of from 20,000 to 500,000 francs (approximately US$32 to 800). Togo ratified the Maputo Protocol in Uganda (<5% prevalence, Type I and II) Recently, a law was passed to outlaw genital mutilation. Under this law, anyone convicted of this practice is subject to 10 years in prison. If the life of the patient is lost during the operation a life sentence is recommended. In 1996, however, a court intervened to prevent the performance of this procedure under Section 8 of the Children Statute, enacted that year, that makes it unlawful to subject a child to social or customary practices that are harmful to the child's health. Uganda signed the Maputo Protocol in 2003 but has not ratified it, despite calls from women's rights advocates. In early July 2009, President Yoweri Museveni stated that a law would soon be passed prohibiting the practice, with alternative livelihoods found for its practitioners. Zaire (5% prevalence) Female genital cutting - mutilation is present in Zaire. Zimbabwe (No Data) Female genital cutting - mutilation is present in Zimbabwe. Central Asia Tajikistan (No Data avail.) Female genital cutting mutilation is present in Tajikistan. West Asia Chechnya (No national prevalence figures avail.) Female genital cutting mutilation is present in Chechnya, Caucasus region. Daghestan (No Data avail.) Female genital cutting mutilation is present in Daghestan, Caucasus region. Ingushetia (No Data avail.) Female genital cutting mutilation is present in Ingushetia, Caucasus region.

109 Southeast Asia Indonesia (No national prevalence figures avail., Type I and IV) In 2006 FGC was banned by the government. However, since the ban the practice has undergone a resurgence, primarily due to promotion by religious groups such as Indonesian Ulema Council. Malaysia (No national prevalence figures avail., Type IV) No laws exist in reference to FGC, although the practice is reported in certain regions. Near Middle East Afghanistan (no data available) Female genital cutting mutilation is present in Afghanistan. Iran (No national prevalence figures avail.) Female genital cutting mutilation exists in Western and Southern Iran, primarily in Iranian Kurdistan where it is reported to be widespread, but also in regions such as Khuzestan. Iraq, Iraqi Kurdistan (72.7% prevalence (excluding Dohuk), Type I and II) There is no law against FGM in Iraqi Kurdistan, but in 2007 a draft legislation condemning the practice was submitted to the Regional Parliament, but was not passed. Jordan (No national prevalence figures avail.) Female genital cutting mutilation is prevalent in Jordan. Oman (No national prevalence figures avail.) The practice is prevalent in Oman. Pakistan (No national prevalence figures avail.) The practice is prevalent in Pakistan. Palestinian territories (No national prevalence figures avail.) Female genital cutting mutilation is prevalent in Palestinian territories. Saudi-Arabia (No national prevalence figures avail.) Female gender cutting mutilation is prevalent in Northern Saudi-Arabia. Syria (No national prevalence figures avail.) Circumstantial evidence suggests Female genital cutting mutilation exists in Syria. Turkey (No national prevalence figures avail.) Circumstantial evidence suggests Female genital cutting mutilation exists in Turkey. United Arab Emirates(No national prevalence figures avail., Type I) The WHO mentions a study that documents Female genital cutting in United Arab Emirates, but does not provide data. A report at a conference in 2003 of the findings by the authors suggest that the practice is prevalent in rural and urban UAE, but is declining. Yemen (23% prevalence in women 15 to 49) In addition to the adult prevalence, UNICEF reports that 20% of women aged have a daughter who had the procedure.

110 Other regions Stone tools from Australia used for circumcision and clitoridectomy Several countries outside areas where FGC is traditionally performed have laws banning the practice. Australia In 1994 there were several anecdotal reports of FGC being practised amongst migrant communities in Australia. By 1997, all Australian states and territories had made FGC a criminal offence. It is also a criminal offence to take, or propose to take, a child outside Australia to have a FGC procedure performed. The incidence of FGC in Australia is unknown as it is unreported to authorities and is often only uncovered when women and girls are taken to hospital due to complications with the procedure. Canada FGC is considered child assault and prohibited under sections 267 (assault causing bodily harm) or 268 (aggravated assault, including wounding, maiming, disfiguring) of the Criminal Code. France FGC, like other forms of sexual mutilation, is a criminal offense punishable by up to 20 years in jail. In addition, the law requires anyone to report any case of