Inherent Risks of Silicone Gel-Filled Breast Implants
1. Implants – Breast implants, similar to other medical devices, can fail. When a silicone gel-filled implant ruptures, the gel material is usually contained within the scar tissue surrounding the implant (intracapsular rupture). In some cases, the gel may escape beyond the capsule layer and go into the breast tissue itself (extracapsular rupture and gel migration). Rupture of a breast implant may or may not produce local firmness in the breast. Rupture can occur as a result of an injury, from no apparent cause (silent rupture), or during mammography. It is also possible to damage an implant at the time of surgery. Damaged or broken implants cannot be repaired. Ruptured or damaged implants require replacement or removal. Breast implants can wear out, they are not guaranteed to last a lifetime and future surgery may be required to replace one or both implants. A Magnetic Resonance Imaging (MRI) study may be necessary to evaluate the possibility of implant rupture, yet it may not be 100% accurate in diagnosing implant integrity.
2. Capsular Contracture – Scar tissue, which forms internally around the breast implant, can tighten and make the breast round, firm, and possibly painful. Excessive firmness of the breasts can occur soon after surgery or years later. The occurrence of symptomatic capsular contracture is not predictable. The incidence of symptomatic capsular contracture can be expected to increase over time. Capsular contracture may occur on one side, both sides or not at all. It is more common with implant placement in front of the chest muscle layer. Treating capsular contracture may require surgery, implant replacement, or implant removal. Capsular contracture may reoccur after surgical procedures to treat this condition.
3. Implant Extrusion/Tissue Necrosis – Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant through the skin. Tissue breakdown (necrosis) has been reported with the use of steroid drugs, after chemotherapy/radiation to breast tissue, due to smoking, microwave diathermy, and excessive heat or cold therapy. In some cases, incision sites fail to heal normally. An implant may become visible at the surface of the breast as a result of the device pushing through layers of skin. If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary. Permanent scar deformity may occur.
4. Skin Wrinkling and Rippling – Visible and palpable wrinkling of implants and breast skin can occur. Some wrinkling is normal and expected with silicone gel-filled breast implants. This may be more pronounced and/or folds may be confused with palpable tumours and questionable cases must be investigated.
5. Calcification – Calcium deposits can form in the scar tissue surrounding the implant and may cause pain, firmness, and be visible on mammography. These deposits must be identified as different from calcium deposits that are a sign of breast cancer. Should this occur, additional surgery may be necessary to remove and examine calcifications.
6. Chest Wall Irregularities – Chest wall irregularities have been reported secondary to the use of tissue expanders and breast implants. Residual skin irregularities at the ends of the incisions or "dog ears" are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.
7. Implant Displacement and Tissue Stretching – Displacement, rotation, or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/or distortion in breast shape (visible rippling of the skin). Unusual techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to attempt to correct this problem. It may not be possible to resolve this problem once it has occurred.
8. Surface Contamination of Implants – Skin oil, lint from surgical drapes, or talc may become deposited on the surface of the implant at the time of insertion. The consequences of this are unknown.
9. Unusual Activities and Occupations – Activities and occupations that have the potential for trauma to the breast could potentially break or damage breast implants or cause bleeding/seroma.
10. Silicone Gel Bleed – Over time, small amounts of silicone gel material can pass through the shell layer of the implant and coat the outside of the implant. This may contribute to capsular contracture.
Inherent Surgical Risks of Breast Implant Surgery
11. Bleeding – It is possible, though unusual, to experience bleeding during or after surgery. If postoperative bleeding occurs, it may require emergency treatment to drain accumulated blood (haematoma). Blood transfusion is rarely required. Increased activity too soon after surgery can increase the risk of bleeding. It is important to follow all postoperative instructions and avoid strenuous activity for the advised period. I have stopped taking aspirin, anti-inflammatory medications, and any herbal or dietary supplements that may increase the risk of bleeding, as advised by my Consultant.
12. Seroma – Fluid may accumulate around the implant following surgery, trauma or vigorous exercise. Additional treatment may be necessary to drain fluid accumulation around breast implants. This may contribute to infection, capsular contracture, or other problems.
13. Infection – Although infection is unusual after this type of surgery, it may appear in the immediate postoperative period or at any time following the insertion of a breast implant. Subacute or chronic infections may be difficult to diagnose. Should an infection occur, treatment including antibiotics, possible removal of the implant, or additional surgery may be necessary. Infections with the presence of a breast implant are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the breast implant may have to be removed. After the infection is treated, a new breast implant can usually be reinserted. It is extremely rare that an infection would occur around an implant from a bacterial infection elsewhere in the body, however, prophylactic antibiotics may be considered for subsequent dental or other surgical procedures. In extremely rare instances, life threatening infections, including toxic shock syndrome have been noted after breast implant surgery. Individuals with an active infection in their body or weakened immune system should not undergo breast enlargement.
14. Scarring – All surgery results in scars. Although good wound healing is expected, scars may be wider, thicker, or more prominent than anticipated. Scar colour and texture may differ from surrounding skin, and scars may appear different on each side of the body. Hypertrophic or keloid scarring may occur, particularly in patients of Asian or Afro-Caribbean descent. Visible suture marks are possible. In some cases, further treatment such as steroid injections, silicone products, or surgical scar revision may be required. If the areola is very large or poorly defined, there is a risk that some areola will be left behind on the lower half of the lifted breast.
15. Allergic Reactions – In rare cases, local allergies to tape, suture material and glues, blood products, topical preparations or injected agents have been reported. Serious systemic reactions including shock (anaphylaxis) may occur in response to drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.
16. Thrombosed Veins – Thrombosed veins, which resemble cords, occasionally develop in the area of the breast and usually resolve without medical or surgical treatment.
17. Pain – Some degree of pain and discomfort is expected after surgery, which is usually well controlled with prescribed painkillers. In rare cases, chronic pain may develop due to nerves becoming trapped in scar tissue or tissue stretching. Small nerve endings may become overactive during healing, producing areas of tenderness or heightened sensitivity, which typically resolves with massage and time. If pain persists, I will inform my Consultant.
18. Skin Discolouration/Swelling – Some bruising and swelling normally occurs after breast enlargement. The skin in or near the surgical site can appear either lighter or darker than surrounding skin. Although uncommon, swelling and skin discolouration may persist for long periods of time and, in rare situations, may be permanent.
19. Sutures – Most surgical techniques use deep sutures. You may notice these sutures after your surgery. Sutures may spontaneously poke through the skin, become visible or produce irritation that requires suture removal.
20. Asymmetry – Some breast asymmetry naturally occurs in most women. Differences in terms of breast and nipple shape, size, or symmetry may also occur after surgery. Additional surgery may be necessary to attempt improvement of asymmetry after a breast enlargement.
21. Change in Nipple and Skin Sensation – You may experience a diminished (or loss) of sensitivity of the nipples and the skin of your breast. Partial or permanent loss of nipple and skin sensation may occur. Changes in sensation may affect sexual response or the ability to breast feed a baby.
22. Damage to Deeper Structures – There is the potential for injury to deeper structures including nerves, blood vessels, muscles and lungs (pneumothorax) during this surgical procedure. The potential for this to occur varies according to the type of procedure being performed. Injury to deeper structures may be temporary or permanent.
23. Delayed Healing – Wound disruption or delayed wound healing is possible. Some areas of the breast skin or nipple region may not heal normally and may take a long time to heal. Areas of skin or nipple tissue may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to breast tissue from past surgery or radiation therapy may be at increased risk for wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.
24. Shock – In rare circumstances, your surgical procedure can cause severe trauma, particularly when multiple or extensive procedures are performed. Although serious complications are infrequent, infections or excessive fluid loss can lead to severe illness and even death. If surgical shock occurs, hospitalisation and additional treatment would be necessary.
24a. Fat Necrosis – Fatty tissue found deep in the skin might die. This may produce areas of firmness within the skin. Additional surgery to remove areas of fat necrosis may be necessary. There is the possibility of contour irregularities in the skin that may result from fat necrosis.
25. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) – I understand that there is a small risk for me to develop Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery. Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiotherapy.
25a. Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) – I understand that there is an emerging risk of Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC), a rare but aggressive type of cancer that has been reported in association with both textured and smooth breast implants. BIA-SCC develops in the scar capsule surrounding the implant. Symptoms may include a lump, swelling, or skin changes around the implant. Treatment may include implant and capsule removal, mastectomy, chemotherapy, or radiotherapy. I understand that long-term follow-up and reporting of any changes to my Consultant is important.
26. Second Generation Effects – A review of the published medical literature regarding the potential damaging effect on children born of mothers with breast implants is insufficient to draw definitive conclusions that this represents a problem.
27. Long Term Results – Subsequent alterations in breast shape may occur as the result of aging, weight loss or gain, pregnancy, menopause, or other circumstances not related to your breast enlargement. Breast sagginess may normally occur.
28. Unsatisfactory Result – Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. You may be disappointed with the results of surgery. Asymmetry in implant placement, displacement, nipple location, unanticipated breast shape and size, loss of function, wound disruption, poor healing, and loss of sensation may occur after surgery. Breast size may be incorrect. Unsatisfactory surgical scar location may occur. In some situations, it may not be possible to achieve optimal results with a single surgical procedure. It may be necessary to perform additional surgery to improve your results, change implant size or remove and not replace implants.
29. Removal/Replacement of Breast Implants – Future revision, removal, or replacement of breast implants and the surrounding scar tissue envelope involves surgical procedures with risks and potential complications. There may be an unacceptable appearance of the breasts following removal of the implant. I understand that certain conditions may necessitate mandatory removal of breast implants, including but not limited to: persistent infection unresponsive to antibiotic treatment, confirmed implant rupture, diagnosis of BIA-ALCL or BIA-SCC, severe capsular contracture unresponsive to treatment, and implant extrusion through the skin.
30. Capsule Squeeze Procedures – Closed capsulotomy, the process of forcefully squeezing the fibrous capsule around a breast implant to break up scarring is not recommended. This may result in rupture of the breast implant, gel migration, bleeding, or other complications.
31. Breast Implant Technology – The technology of breast implant design, development and manufacture will continue to progress and improve. Newer or future generations of implants may be better in some way from those currently available.
31a. Implant Warranty – I understand that breast implant manufacturers may offer warranty programmes and that my Consultant will provide details of the warranty applicable to the implants used in my surgery.