Update on the Essure System for Permanent Birth Control

Transcription

1 Update on the Essure System for Permanent Birth Control Heidi Collins Fantasia IIn 2002, the U.S. Food and Drug Administration (FDA) approved Essure (Bayer, Whippany, NJ), a minimally invasive procedure that provides a form of permanent female contraception. Unlike tubal ligation, which involves general anesthesia and small abdominal incisions, the Essure procedure is accomplished by a trained physician in an outpatient setting. Completed in an average of 10 to 15 minutes, this hysteroscopic procedure involves the placement of hormone-free, flexible metallic inserts into the fallopian tubes without incisions. The approval of Essure provided women with a noninvasive option for permanent birth control that did not require significant recovery time or discomfort. The availability of another permanent contraceptive option for women was important, Photo bowdenimages / istockphoto.com Abstract In 2002, the U.S. Food and Drug Administration approved the Essure system for permanent birth control. Implantation with this device offers a minimally invasive option for permanent female contraception that is placed during a brief office visit. Unlike laparoscopic tubal sterilization, the Essure procedure requires no hospitalization or general anesthesia, resulting in minimal recovery time. After a decade of stability in the report of adverse effects, the U.S. Food and Drug Administration noted a sharp increase in patient-reported adverse events, including chronic pelvic pain, irregular bleeding, allergic reactions, and autoimmune-like reactions. In response to this increase in complaints, the U.S. Food and Drug Administration issued updated guidelines for patient education and counseling. This article discusses those updates, as well as implications for nurses who provide health care to women seeking permanent contraception. nwh Keywords adverse events contraception Essure permanent birth control sterilization nwhjournal.org 2017, AWHONN 401

2 Heidi Collins Fantasia, PhD, RN, WHNP-BC, is an associate professor in the Zuckerberg College of Health Sciences, Susan and Alan Solomont School of Nursing, at the University of Massachusetts, Lowell in Lowell, MA, and she is a women s health nurse practitioner at Health Quarters in Beverly, MA. The author reports no conflicts of interest or relevant financial relationships. Address correspondence to: Heidi_Fantasia@uml.edu. especially for women who were interested in sterilization but had risk factors for anesthesia or surgery, such as obesity, pelvic adhesions, and cardiovascular disease (American Association of Gynecologic Laparoscopists, 2016; Basinski & Bradley, 2016; Walter, Ghobadi, Hayman, & Xu, 2017). In the first 10 years after the FDA s approval of Essure, the number of providerreported and voluntary patient-reported complaints about the device remained stable, with approximately 100 to 200 complaints per year; however, in 2013 voluntary complaints from women increased 400% from the previous year. As of 2015, more than 5,000 complaints had been received about the Essure device. Most complaints (>4,600) were related to possible patient injury and a much smaller amount (474) were related to device malfunctions (Walter et al., 2017). The sharp rise in injury complaints included pain, irregular menstrual bleeding, allergic reactions, and autoimmune-type symptoms (e.g., fatigue, joint pain; FDA, 2016). In response to these complaints, the FDA re-evaluated the research data on Essure. Overview of Essure The Essure system consists of soft, flexible inserts that contain stainless steel coils that are wrapped in polyethylene terephthalate (i.e., PET) fibers. The fibers are covered in an outer layer of nickel titanium alloy (Bayer, 2002). The inserts are 4 cm in length, and when placed into the fallopian tubes via hysteroscopy the outer coil expands to conform to the shape of the fallopian tube. Once expanded after deployment, the insert anchors to the wall of the fallopian tube. The PET fibers facilitate tissue growth into and around the inserts. This assists with retention of the insert in the fallopian tube and eventually results in tubal occlusion. A confirmation test of insert retention, correct placement, and tubal occlusion should be performed by transvaginal ultrasound or modified hysterosalpingogram 3 months after the procedure (Bayer, 2002). Box 1. How to File a Concern With the FDA Adverse Effects Essure is associated with adverse effects. Varying levels of discomfort are commonly reported and include pain during and immediately after the procedure (sharp or cramping), chronic pelvic pain, dyspareunia, dysmenorrhea, and low back pain. In addition to pain, dizziness, nausea/vomiting, and a vasovagal response have been documented during the placement procedure. Reports of change in menstrual pattern, including irregular bleeding/spotting and heavier menstrual periods, have also been reported, as well as immediate and delayed allergic reactions to components of the device, especially nickel (Bayer, 2002). These reactions have manifested as pruritus, nausea, fatigue, and maculopapular and urticarial rashes (Siemons, Vleugels, & van Eijndhoven, 2017). In response to a sharp rise in voluntary, patient-provided complaints after a decade of stability in reports of adverse effects, the FDA worked with its Obstetrics and Gynecology Advisory Committee to re-examine the original clinical trial data for when Essure was initially evaluated for safety (Walter et al., 2017). Although no methodologic issues related to the research were discovered, the FDA acknowledged that some of the data were limited, and it made recommendations for improved patient selection, education, and follow-up. Summary of New Guidance From the FDA First, Essure was required to carry a black box warning, the highest level of warning issued when there is the possibility of a serious event associated with a medication or device. This warning highlights reported adverse events such as perforation of the uterus or fallopian tubes during placement, migration of the inserts into the pelvic or abdominal cavity, persistent pain, and suspected allergic and/or hypersensitivity reactions. It also carries a recommendation Reports of negative side effects or concerns about the Essure device can be submitted to the FDA at or by calling FDA Nursing for Women s Health Volume 21 Issue 5

3 Photo 6okean / istockphoto.com that all women considering the Essure procedure individually evaluate the risks and benefits of Essure, including alternatives to hysteroscopic sterilization (American Association of Gynecologic Laparoscopists, 2016; Bayer, 2002; Walter et al., 2017). Second, informational materials for health care providers and consumers were updated. The updated patient education booklet includes clear information on contraindications, warnings, and precautions. Health care provider information was enhanced to highlight the importance of patient counseling, including a thorough discussion of risks and benefits. Additionally, health care providers were provided with guidance about when to consider removal and what the removal procedure would entail (Bayer, 2017a). Third, a discussion checklist was developed to standardize information that should be reviewed before the Essure procedure. This Patient Doctor Discussion Checklist is included with all devices and is broken into sections, including who is an appropriate candidate for Essure, potential immediate and long-term risks, other options to consider, pregnancy risks, and what to expect during the procedure. The checklist also includes a place for women to sign that they have read all the items and understand the information (Bayer, In the first 10 years after the FDA s approval of Essure, the number of providerreported and voluntary patientreported complaints about the device remained stable, with approximately 100 to 200 complaints per year; however, in 2013 voluntary complaints from women increased 400% from the previous year 2017b). The entire checklist, which is included in the patient brochure, can be found at -Information-Booklet.pdf. Lastly, the FDA ordered the device manufacturer to complete an additional postmarketing study. This research, known as a 522 study, is conducted after a device is approved but when patient-reported data suggest there may be a high risk of failure or serious injury (Walter et al., 2017). Voluntary patient complaints of persistent pelvic pain were inconsistent with earlier research data from Phase II and Phase III approval trials. This prompted the FDA to October November 2017 Nursing for Women s Health 403

4 order more in-depth research on the risk/benefit profile of Essure (Walter et al., 2017). The 522 investigation is a nonrandomized, prospective cohort study that will enroll 2,800 women between the ages of 21 and 45 in two cohorts: 1,400 who will undergo sterilization with Essure and 1,400 in the comparison group who will undergo laparoscopic tubal ligation (FDA, 2017). The major safety endpoints that will be evaluated are chronic lower abdominal/pelvic pain, abnormal uterine bleeding, hypersensitivity, allergic, and/or autoimmune-like reactions, One of the most important points to emphasize during health education and counseling is that Essure is a permanent method; there is no reversal procedure and even if the Essure implants are removed, there are no data on tubal patency and fertility rates after removal and device removal requiring surgery. The efficacy endpoint is pregnancy. Women enrolled in the study will be followed up for 3 years after sterilization, regardless of which procedure they choose. Implications for Nursing Practice Nurses can be an important resource for women who are making decisions about all forms of contraception, including permanent methods. This requires nurses to stay up to date on available methods and any changes that are associated with these methods. Women who have concerns about contraception must be provided with the most current, evidence-based information to make an informed decision. Although manufacturer recommendations, device labeling, patient information, and FDA updates state that physicians who are trained in hysteroscopy should insert Essure, it is possible that advance practice nurses with specific training in hysteroscopy and device insertion may also place Essure. All nurses who are involved in contraceptive counseling should be aware of the placement procedure, even if they do not personally insert Essure. Observing device placement will enable nurses to provide more comprehensive teaching and to answer questions more effectively. If watching a live placement is not possible, training videos that detail the steps of the procedure are another option. A manufacturer-produced training video is available at Currently there are no plans to remove Essure from the market while the 522 study is ongoing. Most complaints about Essure have been voluntarily provided from women and do not represent mandatory reporting of adverse effects required of physicians. Patient concerns have gained public attention, in part because of social media campaigns and exposure from television reports (Walter et al., 2017). Women may be relying on information provided by friends, work colleagues, and a variety of Internet sources (blogs, discussion boards, etc.) that might present personal stories instead of a more balanced perspective of evidence-based risks and benefits. Nurses who work with women considering Essure should address any concerns and clarify misconceptions. If a woman still expresses serious concerns about the device after counseling and teaching, consideration should be given to a different form of contraception. Women who have Essure should be encouraged to speak with their health care provider if they believe they are experiencing an adverse effect that is related to the device. Additionally, women can independently file a complaint with the FDA about Essure (see Box 1). One of the most important points to emphasize during health education and counseling is that Essure is a permanent method; there is no reversal procedure and even if the Essure implants are removed, there are no data on tubal patency and fertility rates after removal (Bayer, 2002). Therefore, women should be certain about their desire to end fertility. To avoid regret, those who express interest in the procedure but are not sure about a permanent method should be counseled to consider other highly effective but reversible methods, such as longacting reversible contraception. Conclusion Essure is a less invasive method of permanent female contraception that can be an important option for women who do not want surgery or are poor surgical candidates. The 522 study currently underway will provide additional 404 Nursing for Women s Health Volume 21 Issue 5

5 information about safety and efficacy. Until study data are available, women should be thoroughly counseled per updated guidelines, which include a standardized discussion checklist and a candid discussion of individualized risks and benefits, including those contained in the black box warning. Dispelling misconceptions and addressing concerns will allow women to make informed decisions about whether Essure is an appropriate contraceptive method they should consider. NWH References American Association of Gynecologic Laparoscopists. (2016). AAGL advisory statement: Essure hysteroscopic sterilization. Journal of Minimally Invasive Gynecology, 23(5), doi: /j.jmig Basinski, C. M., & Bradley, L. D. (2016). Essure: Patient education, identification, and counseling. OBG Management, 1, S1 S12. Bayer. (2002). Essure: Permanent birth control. Retrieved from Bayer. (2017a). Essure: Permanent birth control. Retrieved from home Bayer. (2017b). Your complete guide to the Essure procedure. Retrieved from Booklet.pdf Siemons, S., Vleugels, M., & van Eijndhoven, H. (2017). Evaluation of nickel allergic reactions to the Essure micro insert: Theoretical risk or daily practice? Journal of Minimally Invasive Gynecology, 24(1), doi: /j. jmig U.S. Food and Drug Administration. (2016). What women should know about Essure permanent birth control. Retrieved from ucm htm U.S. Food and Drug Administration. (2017). 522 postmarket surveillance studies. Retrieved from cfdocs/cfpma/pss.cfm?t_id=356&c_id=3854 Walter, J. R., Ghobadi, C. W., Hayman, E., & Xu, S. (2017). Hysteroscopic sterilization with Essure: Summary of the U.S. Food and Drug Administration actions and policy implications for postmarketing surveillance. Obstetrics & Gynecology, 129(1), doi: / AOG Rx It seems that barely a day goes by without a new drug being released or perhaps recalled. How can you stay on top of it all? Read Rx, a clinical practice column appearing three times a year in Nursing for Women s Health. It covers the latest developments in prescription and over-the-counter pharmacotherapeutics everything from the HPV vaccine to over-the-counter weight loss drugs, all to help you provide optimum care to your patients and to answer their questions. October November 2017 Nursing for Women s Health 405