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Page 1 of 7 Breast augmentation, or augmentation mammoplasty, has become one of the most frequently requested plastic surgery procedures by women of all ages. It is most commonly performed to increase the size of small breasts, correct a difference in size between the breasts, and for breast reconstruction following mastectomy for breast cancer. A breast implant is inserted either behind the breast tissue of each breast or behind the pectoralis major muscle, the major muscle of the chest wall, thereby increasing the size of the breast. Breast augmentation has been around since 1962, and both saline and silicone implants were available to women between 1962 and 1992. At that point, the Federal Drug Administration (FDA) placed a moratorium on silicone gel implants, preventing the use of these implants for breast augmentation, because of possible evidence that they caused autoimmune illnesses in women who had received them. Currently, there are two companies in the United States making breast implants: Mentor and McGhan. Currently, both companies are associated with the FDA and have a formal study program to evaluate breast implants. In May 1995, Mentor provided a quick response information service in Santa Barbara, California. They offered information to the public about seventeen major United States and international studies that consistently found no link between implants and autoimmune disease. In addition, the British government has reviewed the research on implants and has found no evidence of increased risk of connective tissue disease in women with implants. Therefore, they did not change the policy and practice on implants in the United Kingdom. The French government recently lifted its ban on gel implants after reviewing this same research. Although silicone is used in a wide variety of lifesaving devices and technologies, lawsuits from silicone breast implant patients threaten its availability. The silicone implants currently on the market are more durable than the ones first developed in 1962. The actual capsule itself is thicker and made of solid silicone; the inside of the implant is empty and is usually filled, at the time of surgery, with saline or an antibiotic solution. Gel implants remain available to patients, but they must be part of an FDA or an FDA–Mentor study and must satisfy specific criteria. There is some speculation, based on recent, overwhelming scientific data, that the FDA may be lifting the moratorium on silicone implants. If so, they would be available to all patients for both reconstructive and cosmetic reasons. As a practicing plastic surgeon, my thoughts regarding already-placed implants are mixed. Should the breast implants be left in place or removed? Who knows? I have removed implants from patients with autoimmune disease, and their autoimmune disease improved. For others, there was no change. Currently, there have been over twenty-five scientific studies that show no connection between silicone implants and autoimmune disease. Many clinicians who are among the nation's top scientific academicians believe there is no connection between autoimmune disease and saline implants. I therefore believe the various implants are safe, based on current scientific research. Dr. Joan Campagna, a well-known rheumatologist, is conducting research in this area. The medical community is anxiously awaiting her findings. She currently recommends the placement of saline implants for those interested in breast augmentation. It is true that many medical devices such as heart valves, catheters, and cataract lenses contain Silastic/silicone and do not cause problems for these medical patients. VitaDocs Medical Reference from "The Plastic Surgery Sourcebook"
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