Q. How many women have breast implants?
A. It is estimated that up to two million women have silicone breast implants. About 25% of these are for breast reconstruction following cancer; 75% for aesthetic (cosmetic) breast enlargement.
Q. How long have breast implants been available?
A. Modern silicone breast implants were introduced in the US in the early 1960s. Plastic surgeons have had almost thirty years of experience with breast implants and, over that period of time, have observed that the devices have a good overall safety record.
Q. When did the FDA approve the manufacture and sale of breast implants?
A. The FDA regulates the manufacture and sale of medical devices in accordance with the Medical Devices Amendments passed by Congress in 1976. However, breast implants were available before the passage of these amendments. Therefore, along with many other devices that do not show a significant health risk, they were allowed to remain on the market until they could be classified and reviewed. In June 1988, the FDA did classify breast implants as Class III devices. Under this classification, manufacturers must demonstrate the safety and effectiveness of breast implant devices through scientific studies.
Q. What is the most common problem with breast implants?
A. Capsular contracture is by far the most common problem associated with breast implants. The body forms a scar envelope, or capsule, around any foreign material (the implant). For reasons that are not well understood, some patients may experience tightening of this scar around the implant severe enough to compress it and cause the breast to feel firm. (It should be noted that it is the membrane around the implant, rather than the implant itself, that hardens). Capsular contracture can occur at any time after your operation, even years later. A recent national survey of women who have undergone breast augmentation shows that only 5% have breast implants that they describe as "hard." Of those women who say that they have any degree of breast firmness, 74% find it "not at all" or "not very" bothersome.
Q. Can the body reject breast implants, pushing them through the skin?
A. It is unlikely that a properly inserted implant would pop through the skin. However, this can occur in rare cases, especially following breast reconstruction. If the skin covering the implant is too thin and tight, extrusion of the implant is possible. While this occurrence is unfortunate and emotionally painful of those few individuals affected, it should be remembered that this is a very uncommon problem, and most women have a highly satisfactory experience with breast implants. In fact, 80% of women who have undergone breast reconstruction with implants say they would do it again "without a doubt"; 16% say they "probably would"; and only 2% say they "definitely would not" make the same decision.
Q. What happens if an implant breaks?
A. An implant is made of a silicone rubber envelope filled with either silicone gel, salt water, or some combination of the two. While the envelope's silicone rubber is extremely tough, it is possible for an implant to break or leak due to injury or, occasionally, for no apparent reason. If the implant is filled with silicone gel, the scar capsule surrounding it will usually keep the gel contained. However, if the rupture is discovered, extraction of the gel and replacement with a new implant is recommended. If the implant suffers impact severe enough to tear the scar tissue, the gel may travel to areas away from the breast from which it may be difficult to remove. While apparently posing no health risk, the silicone may form unattractive lumps. A saline-filled implant poses no problem other than replacement of the implant following deflation, since the fluid is harmlessly absorbed by the body.
Q. Does silicone gel "bleed" through the implant's envelope?
A. Minute quantities of silicone do travel through the implants envelope and are picked up by the body's white blood cells. There is no evidence that this small amount of silicone is harmful. Silicone is the least reactive foreign material known and is used as the US Pharmacopoeia baseline standards for biocompatability. Everyone has tiny amounts of silicone in their body, since it is a major ingredient in many over-the-counter drugs and is present in our food, clothing, furniture, and cosmetics from which it may be absorbed. It is also used to coat every needle and syringe to make injections less painful.
Q. Do implants cause cancer?
A. There is no evidence of any relationship between breast implants and cancer in humans. Opponents of breast implants often refer to studies which show a form of rare cancer can develop when silicone is implanted in rats. It is well known in the scientific community that any smooth surfaced object implanted in laboratory rodents has initiated tumor growth. In the opinion of an ad hoc advisory group of scientists representing the FDA and the National Institute of Health (NIH), it is unlikely that this finding is relevant to humans.
Q. Do implants interfere with the detection of cancer?
A. Breast implants do complicate mammography, but research has shown that compensatory measures can be taken. Routine, two-view screening mammography may leave large portions of the breast unvisualized, resulting in an unsatisfactory exam. Studies show that mammographic accuracy can be improved when experienced radiologists use special techniques and extra views designed to maximize visualization of breast tissue ordinarily hidden by the implant. One such method (the Ecklund technique) involves positioning the breast so that the implant is pushed against the chest wall and the glandular tissue is pulled forward. Women who are over 35 years old should have an initial mammogram taken before breast augmentation. This can be valuable as a baseline for comparison of future mammographic x-rays. All women, including those with implants, should engage breast self-examination monthly and be examined by a physician once a year. They should follow the American Cancer Society's guidelines for periodic mammogram: women with implants should use a skilled radiologist recommended by their plastic surgeon.
Q. Do implants cause connective tissue disease?
A. Several studies have questioned a possible relationship between breast implants and scleroderma, a relatively rare disease of the connective tissue. None has substantiated any cause-and-effect relationship. Given the very small number of cases of this disease and its unknown causes, it is difficult to draw any statistically valid conclusions at this time. However, it appears that risk, if any existed, to the general population of women with breast implants would be minimal.
Q. Why should breast implants remain available to women?
A. The decision to have breast implant surgery is one that each woman must make for herself, weighing the risks and benefits with the advice and consultation of a qualified doctor. Breast implants have shown no significant health risk over the 30 years since their introduction. Furthermore, breast implants offer important benefits to women who seek to improve their self-image and self-esteem, with a fuller, better-proportioned breast contour. The overwhelming majority of women who have had breast implant surgery, either for breast enlargement or reconstruction, say that they are satisfied with the results and "without a doubt" would choose to have the surgery again.
Q. Where can a woman get accurate information about breast implants?
A. Anyone considering breast implant surgery should schedule a consultation with one or more qualified plastic surgeons. Before making an appointment, a prospective patient should check that the surgeon is certified by the American Board of Plastic Surgery or certified in plastic surgery by the Royal College of Physicians and Surgeons of Canada.
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