SURGICAL INFORMATION

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1 SURGICAL INFORMATION FOR PATIENTS WISHING TO HAVE BREAST IMPLANT SURGERY USING SILICONE IMPLANTS Dutch Association of Plastic Surgery (NVPC Nederlandse Vereniging voor Plastische Chirurgie) - November This information pamphlet has been created to provide you with the necessary information you need in order to make a well informed decision about whether or not to have silicone implants used for your breast surgery. This leaflet provides information on the use of silicone breast implants for your operation. It is important that you realise that breast implants are used in different types of surgical procedures and that these operations are all associated with their own specific advantages and disadvantages and with complications and risks that have nothing to do with the implants themselves. This information is provided separately by your plastic surgeon It is important that you read the information in this leaflet completely and thoroughly. You are requested to put your initials on every page to indicate that you have read the page and to indicate that you understand the information that it contains. Your initials will also indicate that you understand that there are limitations to potential uses of silicone breast implants, and that there are risks and alternative treatment options. Finally, you sign the informed consent form that is needed for you to give informed consent to your plastic surgeon to perform the operation. Not all operations involving silicone breast implants are used for medical indications. This means that there is no medical reason for the procedure. In those cases, it is the patient s choice to undergo the operation. To make such a choice, it is even more crucial for you to make an informed decision about whether or not to undergo the procedure. If you have any questions after studying this information brochure, or if you are not completely clear about any of its contents, the NVPC recommends that you contact your plastic surgeon, before making any decisions about whether or not to undergo the operation. No guarantees can be provided in advance about the eventual outcome. Even after carefully performed surgery it is possible that you are not happy with the end result. It is important to take this fact into account in your decision making about whether or not to undergo the operation. GENERAL INFORMATION Silicone breast implants are used to change breast contours to match desired changes, such as in breast enlargements, and in reconstruction surgery in which partial or total loss of one or both breasts is restored; so-called breast reconstruction. The most common reasons for insertion of breast implants are: reconstruction of the breast after complete or partial removal of breast tissue due to breast cancer; reconstruction of the breast after preventative amputation due to increased breast cancer risk; 1 of 11

2 reconstruction of the breast following disfigurement due to earlier operations, serious infections or serious damage; improvement of body contours, when the patient personally finds the size or shape of the breasts for example to be unacceptable; correction of loss of breast volume after pregnancy; improvement of breast size balance when the breast differ in size; removal of existing breast implants for cosmetic or reconstructive reasons. Silicone implants cannot be inserted in patients with untreated breast cancer or early stages of this condition. There are breast implants of different shapes and sizes, and with a smooth or roughened (textured) surface. The choice of a particular implant depends on your preference, on your anatomy and on the advice of your plastic surgeon. The shape and size of the breast (s) prior before surgery will affect both the recommended treatment as well as the actual result. A completely symmetrical result can never be guaranteed, especially when the breasts are not the same size or shape before surgery. Patients undergoing silicone breast implant surgery need to consider the following: The insertion of implants is associated with risks. This may include risks that are not yet known at the time of your operation. You can read more about this further on in this leaflet. Insertion of silicone breast implants will not always be a single or one-off operation. No single type of breast implant guarantees a life-long outcome. All prostheses can sweat, leak or rupture. You can read more about this later on in this leaflet. Changes that occur after implant surgery are not always reversible. If, for whatever reason, you choose to have your implants removed, this can adversely and permanently affect your appearance. Patients who have an increased risk of complications and a less favourable outcome are those patients who: have a diagnosed immune system disease; have conditions that affect blood clotting or wound healing; have reduced tissue perfusion/blood flow due to prior surgery, radiation or smoking; are grossly obese. COSTS OF PROSTHETIC BREAST SURGERY Reimbursement of breast prostheses surgery is subject to approval by your insurance company. Cosmetic surgery costs are not usually covered. Insurance cover that currently applies may change in the future. Please note that if you choose to have breast prostheses, you may incur extra costs in the future for possible further operations. ALTERNATIVE TREATMENT OPTIONS As an alternative to the use of silicone breast implants, you can choose to: avoid plastic surgery and use external breast prostheses or padding in your bra; 2 of 11

3 consider surgery for which your own body tissue is used; select implants that are filled with another substance (such as water) although these are associated with similar consequences and risks as silicone breast implants. These alternatives also have their disadvantages, risks and possible complications. Your plastic surgeon can provide further information about the risks associated with these alternative treatment options. RISKS AND COMPLICATIONS Any surgical procedure carries risks. Before you decide if you wish to undergo breast implant surgery, it is important that you are well informed about any associated complications and risks. The most common general complications are described below. This list may not be complete. Some specific operations have additional complications and risks about which your plastic surgeon will inform you separately. Aesthetic Local anaesthesia and general anaesthesia are associated with risks. For all types of anaesthesia there is a risk of complications or injury and in extremely rare cases, even death. Complications to the heart and lungs are a risk associated with any surgery and anaesthesia, even in patients without symptoms. Should any of these complications occur, then hospitalisation and additional treatment may be required. If you experience shortness of breath, chest pain or an unusual heartbeat after your operation, you should immediately consult a doctor. Deep surgical trauma There is an extremely small risk of physical injury to deeper body structures such as nerves, blood vessels, and lungs (collapsed lung or pneumothorax) during the surgical procedure. Injury may be temporary or permanent. In rare cases the surgical procedure may cause serious injury, especially when multiple or extended procedures are performed at the same time. Allergic reactions In rare cases, local allergies may occur to things such as disinfectants, tape, sutures, bandages, skin glue and blood products. Systemic reactions (spread throughout the body), including anaphylactic shock, may also occur in response to drugs used during surgery and prescription medications. All of these reactions may need additional treatment. If you are aware of having any allergies, please inform your plastic surgeon of these during your appointment. Pain You will experience pain after your surgery. Pain of varying intensity and duration may occur and persist after the insertion of breast implants. This pain may be due to the surgical technique, the place of the prosthesis against the chest muscle, strain on the tissues around the implant and/or implant size. Pain may also indicate a complication. If the pain increases in the first weeks after surgery, you should contact your plastic surgeon. In the longer term pain may be caused by scar tissue capsule formation. Very rarely chronic pain develops due to nerve compression or nerve injury. 3 of 11

4 Blood clots During and after surgery it is possible for blood clots to form in the legs (thrombosis) that may even travel into the lungs (pulmonary embolism). Inactivity increases the chance of blood clots travelling into the lungs. Pulmonary emboli are rare but can be life-threatening. It is therefore important to discuss with your plastic surgeon if you have ever had a leg or arm thrombosis and if you are being treated for a coagulation disorder. Sometimes after breast surgery veins may clot in the area around the breast. These veins have a cord/string-like appearance and are often very painful for a while. They usually resolve by themselves without medical or surgical treatment. Effective pain relief can initially reduce the pain considerably. Bleeding and haemorrhages It is possible for bleeding to occur either during or after surgery. If post-operative bleeding occurs, emergency treatment may be required to remove the accumulated blood. Very rarely a blood transfusion may be needed. The risks and complications of a blood transfusion are beyond the scope of this leaflet. Loss of blood (a hematoma) can appear at any time after surgery and can contribute to capsular scar tissue formation, infection or tissue breakdown. Some medications, herbs and dietary supplements can increase the risk of haemorrhaging. Discuss their use with your plastic surgeon. You may need to temporarily stop or modify these products. Serous ooze Immediately after surgery, injury or powerful movement, serous fluid (seroma) may accumulate around the implant. This swelling increases the incidence of complications, such as an infection or capsular scar tissue formation. Additional treatment may be needed to drain this fluid. Infection A superficial wound infection after the operation causes a painful red scar with irritation or even pus around the suture line/stitches. A deeper wound infection in the surgical site around the prosthesis will cause complaints right across the chest, with fever and a general feeling of being unwell. Should an infection occur after surgery, antibiotics and possible implant removal or additional surgery may be required. Infections near a breast implant are more difficult to treat than infections in general body tissues. Although very serious infections (toxic shock syndrome) are rare, they can cause serious illness and even lead to death. Low grade or chronic infections are also difficult to diagnose. Should it be necessary to remove the prosthesis in order to be able to treat the infection, then a new implant can usually be inserted at a later stage. It is extremely rare that an infection around an implant occurs due to a bacterial infection elsewhere in the body. Tissue necrosis Tissue death (tissue necrosis) can lead to loss of the implant and may be due to: disrupted wound healing due to post-operative complications; poor tissue coverage across the implant; inadequate tissue cover over the implant (due to very little or no existing breast tissue). Tissue death is more common in patients who smoke, who take certain hormones (steroids), after irradiation of breast tissue involved, after microwave diathermy use and excessive heat or cold therapy. An implant may become visible at the surface of the breast if it pushes itself through the various layers of surrounding skin. In some cases, surgical wounds do not heal normally after an operation and split open again (wound dehiscence). 4 of 11

5 In cases of tissue necrosis or wound dehiscence causing exposure of the implant, the prosthesis may need to be removed. Delayed wound healing Disrupted or delayed wound healing may also occur. Sometimes areas of the breast skin and/or the nipple do not heal as is to be expected and healing may take a long time. It is even possible that the skin or the nipple dies due to poor blood flow. However this is rare. Wounds that heal more slowly can require frequent dressing, or further surgery to remove non-healing tissue. Women with reduced blood flow due to previous surgery or radiation therapy are at an increased risk of poor wound healing. Smokers also have a greater risk of skin loss and complications related to wound healing. Sutures Most surgical techniques use deep suturing materials that dissolve in the body. Sutures may push through the skin, become visible or cause irritation that necessitates their removal. Scar formation Every operation leaves scars, some more obvious than others. Excessive scarring can result but is uncommon. Although proper wound healing is expected, scarring may occur in the skin and deeper tissues. Scars can be unattractive and have a different colour to the surrounding skin. Their appearance can also vary within the same scar. Scars can also be asymmetric in relation to scars on the other side of the body. It is also possible for traces of the sutures to be visible in the skin. In some cases, scarring will require revision surgery or other treatment. Skin discolouration/swelling A certain degree of bruising and swelling is normal after breast surgery using implants. The skin in and around the incisions can become lighter or darker than the surrounding skin. Although this is unusual, the skin may remain swollen and discoloured over a prolonged period, and in rare cases even permanently. Asymmetry In most women, asymmetry is natural. Differences in breast and nipple shape, size, and/or symmetry may also occur after surgery. Additional surgery may be necessary to try to improve symmetry. Altered sensation It is possible that you experience changes (or loss of) sensitivity of the nipples and the skin of your breasts. This may be temporary or sometimes permanent (especially after post mastectomy reconstructions). These changes can affect your sexual experiences. SPECIFIC RISKS RELATED TO SILICONE BREAST IMPLANTS It is important for you to be aware of the fact that during your operation a silicone breast implant is being inserted. Silicone implants are products that are foreign to the body. Implantation of foreign objects always involves risks. This also applies when operations are performed with due care. Furthermore, it is important that you bear in mind that future risks may also occur, that were not yet known at the time of your operation, despite the fact that much relevant scientific research has been done. You need to take these factors into account when making your decision about whether or not to undergo surgery. 5 of 11

6 Additional information related to breast implants is available from the manufacturers of the implants. If you still have questions after reading this brochure, or if you have any doubts, your plastic surgeon can provide you with the manufacturer's product information brochure for the implant that is being considered for you. This product information may help you in making an informed decision about having breast augmentation or reconstruction surgery using breast implants. Ruptures Breast implants can break down, just like other medical devices. When a silicone breast implant splits, the gel spreads out around the implant (intracapsular rupture). In some cases (less than 10 percent of cases) the gel can escape and invade surrounding tissues or nearby lymph nodes (extracapsular rupture with gel migration). Microscopic silicon particles can also travel to other areas of the body. If an implant ruptures, it can cause local inflammatory reactions, but it is not clearly shown that this has an effect on general health. A rupture may occur as a result of injury, due to no apparent cause (a 'silent' tear), or (rarely) during mammography. Research shows that after 8-10 years, 10-14% of breast enlargement patients and 14-27% of breast reconstruction patients have a ruptured prosthesis. Damaged or ruptured implants cannot be repaired. Breast implants can wear out, and are not guaranteed to last a lifetime. Therefore, future surgery to replace the device may be needed. In case of complaints related to the breast, an MRI scan or ultrasound will be needed to determine whether an implant is ruptured or not, but these investigations can never confirm with 100 percent certainty that an implant is still intact. Sweating associated with silicone Over time small amounts of silicone gel implant material may pass through the outer layer of the prosthesis (sweating). This material will remain in the capsule, which is the membrane created by the body around the implant. This possibly contributes to more capsule development. Capsule formation Capsule formation means that the body forms scar tissue around the implant. In most patients this is an unnoticeable flexible scar tissue layer. In some patients this capsule is firmer and tighter. This can lead to a hardening of the breast and sometimes even pain. Excessive capsular development of the breasts can occur soon after surgery, but also years later. The occurrence of excessive capsular development is not predictable, but the chance of occurrence increases over time. It can occur on one or both sides. It is more common in placement of the implant in front of the chest muscle and the incidence of excessive capsule formations can vary per type of prosthesis. Research shows that after 8-10 years 11-20% of breast enlargement patients and 15-25% of breast reconstruction patients suffer from capsule formation problems. Treatment options are surgery to remove or replace the implant. Capsule formation problems may however, recur repeatedly but pose no general health risks. Many women will need additional operations to replace, remove or correct their implants. 6 of 11

7 Wrinkles and folds The implants themselves and the skin of the breast can develop palpable or visible wrinkles and folds. Some wrinkling is normal and to be expected with silicone breast implants. Palpable folds can be confused with other palpable abnormalities of the breast (such as a tumour) and in case of doubt, should always be investigated. Calcification Calcification can develop in the scar tissues around the implant, causing pain and rigidity of the breast. These deposits are visible on mammograms and should be differentiated from calcium deposits that may also occur in breast cancer. If calcium deposits occur, treatment intervention may be necessary to remove and investigate it. Chest wall irregularities When using tissue expanders during surgery, irregularities of the chest wall may occur. These are generally without consequences. Displacement Displacement or rotation of a breast implant may be associated with discomfort and/or distortion of the breast. To fix this, additional corrective surgery may be required. However, displacement or rotation can recur repeatedly. Unusual activities and professions There is no scientific evidence, but certain activities and professions with a risk of direct and heavy strain on the implants could possibly cause earlier damage or displacement of implants. So far unknown complications Over time, other complications may also occur that were unknown at the time of the surgery and could not have been known. In the future, knowledge about the behaviour of implants in the body and reactions of the body to implants can also change. ADDITIONAL INFORMATION ABOUT BREAST IMPLANTS Breast cancer Current medical science shows no increased risk of breast cancer for women with breast implants for both cosmetic and reconstructive purposes. All women are advised to periodically self-examine their breasts, get involved in national breast cancer screening programs and seek professional help if they detect a lump. In the presence of breast implants, caution is advised in breast biopsies because of the risk of damaging the breast implant. Mammography in patients with breast enlargement X-rays are not transmitted through breast implants. As a result, after breast augmentation breast implants interfere with mammography, making breast cancer detection difficult. This depends on the size and location of the breast implant, but is independent of the type of implant. There is also a chance of rupturing an implant by pressure on the breast during mammography. Therefore, always inform mammography technicians of the presence of implants so that they can be taken into account. If there is capsule formation, a mammogram is particularly painful and it will be increasingly difficult to get a good image of the breast as capsule formation is worse. 7 of 11

8 Women aged 50 to 75 years are invited to participate in community based breast cancer research every two years, with the aim of early breast cancer detection by mammograms. This is a nationwide screening program that is offered free of charge by the Government. Depending on the location and size of the breast implant in a small group of women it may be that there is not enough breast tissue visible on the mammogram. In these cases, general population breast cancer screening is no longer appropriate. Ultrasound, specialised mammography and an MRI can then be used to assess breast changes on the basis of (specific) complaints related to possible breast cancer. However, these are not standard screening methods offered by general population screening and may incur personal costs. At the time that women with (specific) complaints are referred to a hospital, more x-rays and/or special mammography techniques are often needed. Additional investigations for breast reconstruction patients after breast cancer Women who have had complete post-mastectomy breast reconstruction by breast implant do not need mammography of the reconstructed breast as there is no longer any remaining glandular breast tissue present. If there are specific concerns about this breast, it is more likely that an ultrasound or an MRI scan will be performed. Effect on children An overview of published medical literature on possible harmful effects in children born to mothers with breast implants is insufficient to draw conclusions. Breastfeeding Many women who have breast augmentations with silicone breast implants have successfully breast fed their babies. However, it is not known whether there are risks associated with breastfeeding by women with breast implants. A study on the Silicon element in breast milk showed no increased values in breastmilk of women with silicone implants when compared to women without such implants. Surgical techniques involving incisions near the nipple and areola can reduce the success of breastfeeding. Long-term results Changes in the shape of the breast may occur as a result of aging, weight loss, pregnancy, menopause, weight gain or other factors. Sagging of the breast is a natural phenomenon that occurs in all breasts over time. Dissatisfaction with the result Although the expected outcomes are good, there is no guarantee of a (lasting) good result. There is always a chance that the results of your surgery are disappointing. In some cases optimal results cannot be achieved by one single surgical procedure. Additional surgery may need to be performed to improve results, to change the size of the implant, or to remove or replace implants. Removal/replacement of breast implants Future revision, removal or replacement of breast implants and removal of surrounding scar tissue involves surgical procedures with risks and possible complications. After removal of implants your breast may appear less attractive to you. Capsulotomy 8 of 11

9 Closed capsulotomy is to be avoided. This is a process done by a surgeon forcefully manipulating the scar tissue capsule to break it down. This procedure can cause implant rupture, migration of silicone gel, bleeding and other complications. Conditions of the immune system and unknown risks A very small number of women with breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma and other arthritis-like syndromes. However, to date after several large epidemiological studies in women with and without implants, no scientific evidence that women with breast implants have an increased risk of these diseases has been defined. These diseases do not seem to be more common in women with implants than in women without implants. The appearance of symptoms associated with the immune system after implant insertion is known as ASIA (Autoimmune Syndrome Induced by Adjuvants). If you experience symptoms that may reflect diseases of the immune system, we advise you to discuss these with your plastic surgeon, physician or immunologist. ALCL Another very rare reported complication is ALCL (Anaplastic Large Cell Lymphoma), a rare form of Non- Hodgkin s Lymphoma (lymph node cancer) which may occur in the scar, scar capsule and fluid around the implant. Women with breast implants have a relatively increased risk of ALCL compared to women without breast implants. The chance of women with breast implants getting ALCL at some time in their lives however, remains extremely small and is estimated to be about 1 in 30,000. Pain, unexplained swelling of the entire breast (seroma) and relatively fast development of asymmetry in volume after the chest has healed from insertion of the implant, all need further diagnosis for which you need to contact your plastic surgeon. Breast and nipple piercings Women with breast implants who want to have breast piercings should be aware that this can cause infections. If an infection occurs, it is possible that this will spread to the area around the implant. Treatment such as antibiotics, implant removal, or additional surgery may become necessary. Infections around a breast implant are more difficult to treat than infections in normal body tissues. If the infection does not respond to antibiotics, implant removal may be necessary. Women who already have pierced breasts before surgery have a higher risk of getting infections than those without. Sentinel node procedure in patients after breast enlargement surgery During breast enlargement or breast reconstruction surgery, glandular lymph tissue is sometimes incised. This could possibly change the drainage pattern of lymphatic fluid from the breast and thus reduce reliability of diagnostic procedures such as a sentinel lymph node biopsy procedure for the staging of breast cancer. Women who do not want to take this risk, should consider a different surgical approach. Large volume Patients who want large volume breast implants must realise that this choice has an increased risk of suboptimal results, with all related consequences including revision surgery involving extra charges. Insertion of large breast implants makes the tissues irreversibly thinner and can cause visible wrinkles and folds. 9 of 11

10 Psychological disturbances It is important that all patients who undergo a medically unnecessary procedure such as a breast augmentation or cosmetic breast enhancement, have realistic expectations aimed at improvement rather than perfection. Complications or less beautiful results are sometimes inevitable, sometimes require an extra operation and are often experienced as stressful. We therefore ask you to openly discuss any emotional or psychological problems with your plastic surgeon prior to any surgery. Although many people obtain psychological benefit from the results of cosmetic surgery, the effects on your mental health cannot be predicted accurately. Technology Technological developments in production and design related to breast implants will always involve progress. This means that newer or future generations of implants may be better in certain contexts than the implants that are currently available. Medications It is important to inform your plastic surgeon if you are taking birth control pills, oestrogen replacement medication or of a (suspected) pregnancy. Also inform him/her of any other medications (such as blood thinners and medications that affect blood clotting), whether or not they are prescription drugs, they can all cause side effects. Therefore, make sure that you tell your plastic surgeon whether or not and what medications you are taking. If you experience medication side effects, stop the medication and call your plastic surgeon for further directions. In case of a severe reaction, go straight to your nearest emergency department. The prescription painkillers that are prescribed after surgery may affect your thought- and coordination processes. Take the prescribed medication only as indicated, avoid driving and operating complex machinery, do not make important decisions and do not drink alcohol while taking this pain medication. Smoking and passive smoking Patients who are smoking tobacco products or using nicotine products (such as nicotine patches and chewing gum) at the time of surgery, have a greater risk of complications such as skin necrosis (skin death) and reduced wound healing. People who are exposed to second-hand smoke (passive smoking) may also run an increased risk of similar complications. Smoking can also have a negative effect on anaesthesia and recovery from this, with coughing and possibly an increased risk of bleeding as a result. People without exposure to tobacco smoke or nicotine containing products have a significantly lower risk of such complications. REVISION SURGERY NECESSITY There are several factors that affect long term outcomes. It is unknown how your tissues will respond to implants and how the wound will heal after surgery. Follow-up surgery may be necessary to replace your breast implants, or to enhance the result of the operation. You can choose to ask advice about having your breast implants removed and not replaced. Complications may also necessitate additional surgery or other treatments. The practices of medicine and surgery are not an exact science. And although good results are anticipated, there is no exact certainty or guarantee about the results of operations. In some situations it is possible that one single surgical procedure does not achieve the optimum result. 10 of 11

11 Treatment compliance Follow all of your doctor's instructions carefully. Treatment success depends on the operation itself as well as on aftercare. It is important that the surgically closed wounds are not exposed to strain/excessive force, friction/abrasion or movement while healing. Personal, sexual, sport and professional activities with any risk of exposure should be limited. In addition, physical activities that increase your heart rate can result in bruising, swelling, fluid accumulation around the implants and revision surgery. Please consider these factors until your doctor tells you that everything is safe again. 11 of 11

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