According to the American Society of Plastic Surgeons, breast augmentation is the most frequently performed cosmetic surgical procedure as reported in 2008. Although the exact number is not known, it is mostly likely in the range of 6 million women who have had this procedure.
Because of moratorium on silicone implants, most implants are currently filled with saline. Saline implants are not superior, but are inferior in many ways to silicone implants. Saline implants are found to be firmer and rounder than silicone implants and the implant shell can be more easily palpated.
Silicone implants are now being used more frequently but there continues to be controversy about the safety of these implants. Much of the controversy is due to insufficient public knowledge about the history of the implants and misinformation about the scientific studies.
The first silicone breast implants were developed in the 1960s by Drs. Frank Gerow and Thomas Cronin in Houston and were rapidly introduced into their clinical practice. At that time there was no requirement for scientific studies by the Food and Drug Administration (FDA). In 1976, the FDA enacted the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act, which would require clinical safety trials prior to their approval.
Since silicone implants had been on the market for almost 15 years prior to the amendment, the implants were "grandfathered" in and no special studies were retroactively required for federal approval. However in 1988, the FDA began requiring safety updates and regulations for implants.
Although there had been anecdotal reports of safety concerns regarding silicone implants, the issue did not achieve national concern until Connie Chung reported the safety concerns of silicone implants on her television show in December 1990. Congressional hearings and public scrutiny soon followed.
This culminated in the voluntary moratorium on the implantation of silicone breast implants in January 1992 by the FDA commissioner David Kessler. At that time the panel recommended that the further use of implants be limited for reconstruction only and women receiving the implant participate in scientific protocols and studies.
In 1999, the Institute of Medicine (IOM), a private non-profit organization, released a comprehensive report prepared by an independent committee of scientists. This study concluded that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any systemic diseases such as lupus or rheumatoid arthritis.
If the Medical Device Act were enacted prior to the use of the silicone breast implants, extensive scientific studies would have been done. This would have avoided the hysteria related to the implants. No evidence has been found that silicone causes any autoimmune diseases or that silicone is found in human breast milk in women with silicone breast implants.
On Nov. 17, 2006, the FDA approved the scientific studies of Allergan and Mentor Manufacturers silicone breast implants and placed the implants back on the U.S. market. Of note, the United States was the only country that had banned the implants. South America and Europe, both major consumers of the implants, had free unrestricted use. Saline implants were not restricted during the silicone moratorium.
Armed with this information, women considering this procedure should realize that there are safe choices for breast augmentation. Women should also realize that like almost all medical devices, breast implants can wear out and will need to be removed and probably replaced during a woman's lifetime.
Additional surgeries will be required either because of rupture of the implant or because of localized complications such as a capsular contracture. Breast implants will need to be monitored by a plastic surgeon and serial MRI scans may need to be completed for evaluation of possible rupture. Breast implants do not increase the risk of breast cancer and they do not alter the prognosis or treatment of breast cancer. Silicone gel breast implants have been approved for reconstruction for women of all ages and for augmentation for women only age 22 years and older.
A board certified plastic surgeon will explain the risks, benefits and alternatives of breast augmentation during patient consultation. This procedure should be performed in a certified operating room facility by an experienced plastic surgeon. Clear and concise patient education is essential for patients considering this surgery.
This procedure has a very high patient satisfaction rate but it also is associated with risks. Patients should always inquire about their potential surgeon's experience. A patient should receive information about their surgeon including the board certifications, hospital affiliations, and training experience.
Care should be taken when choosing a plastic surgeon. Plastic surgeons are specially trained to perform this surgery as well as other forms of cosmetic surgery. The American Board of Plastic Surgeons has a complete list of board certified plastic surgeons in San Antonio and the outlying areas. Their Web site is www.plasticsurgery.org.















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