Breast Implant Safety

History of Breast Implants in the U.S.

Silicone gel implants were approved by the U.S. Food and Drug Administration for both cosmetic and reconstructive breast surgery in November 2006. The decision ended a 14-year period during which silicone gel implants were available in the U.S. only for breast reconstruction, for replacement implants and for use in studies. Extensive research that has been conducted on the safety and effectiveness of breast implants has failed to link breast implants with breast cancer, connective tissue disorders, neurological disorders or other health problems.

The history of breast implants in the U.S. dates back to 1962, when silicone gel filled implants were introduced to the market, followed by saline filled implants in 1965. Breast implants were not regulated by any government body until 1976, when a new law gave the U.S. Food and Drug Administration the authority to require proof of the safety and effectiveness of medical devices.

By 1988, reports of cancers, connective tissue disorders and other illnesses in women with breast implants led to concerns that the illnesses were caused by silicone gel that leaked from ruptured implants. (The saltwater solution used in saline implants is known to be harmlessly absorbed by the body.) The FDA asked makers of silicone gel implants to submit Premarket Approval Applications complete with scientific data proving that their implants were both safe and effective.

In 1992, the FDA took silicone gel implants off the cosmetic surgery market and restricted their use to clinical trials or for reasons of medical necessity. The FDA determined that there was not enough data, and the data that was available did not prove that the implants were safe. Saline filled breast implants were not affected by the restrictions and become the only option for cosmetic breast augmentation.

In 2000, the FDA formally approved the saline breast implants made by Mentor Corp. and McGhan Medical, but said that the companies must inform women about the risks involved.

In November 2006, the FDA approved silicone breast implants made by Mentor Corp. and Inamed Aesthetics for cosmetic breast augmentation after a 14-year moratorium. Restrictions on the implants in Canada were lifted less than a month earlier. Conditions of their approval include ongoing studies and follow-up of 40,000 patients over the next 10 years.

In March 2012, the portfolio of silicone gel breast implants made by Sientra, Inc. was approved by the FDA.

Breast Implant Studies

Decades of extensive research have been conducted on the safety and effectiveness of breast implants. Studies have largely exonerated implants as a cause of health problems, and both saline and silicone gel implants are approved for both cosmetic and reconstructive use in the U.S. and Canada.

Implant manufacturers are conducting ongoing clinical trials to continue to study the safety of breast implants. Mentor Corp. has sponsored a study of more than 70,000 women with silicone gel implants and investigated almost 5,000 patients with saline implants. In another study, Mentor has enrolled 1,000 women to evaluate the safety and effectiveness of its silicone gel implants. The study includes breast augmentation, breast reconstruction and revisionary surgery patients who will be followed for 10 years. Mentor is also studying patients implanted with contoured silicone gel implants and breast reconstruction patients.

Two ongoing studies are being conducted to evaluate the safety of INAMED silicone-filled breast implants. The Allergan Core Clinical Study is a 10-year study involving 940 women who had breast augmentation, reconstruction or revision of a previous surgery between 1999 and 2000. The Allergan Adjuct Clinical Study is collecting safety data from reconstruction and revision surgery patients at one, three and five years.

In 2006, the results of three long-term studies found that silicone breast implants did not increase the risk of breast cancer. In one study, Canadian researchers followed more than 24,000 women who had breast augmentation in the 1970s and 1980s and found that these women actually had a 43% lower rate of breast cancer than the general population. The other studies followed 3,500 Swedish women with breast implants for as long as 37 years, and almost 2,800 Danish women for up to 30 years.

In 2001, findings released by the National Cancer Institute further exonerated silicone gel breast implants as a cause of illness. The study was one of the longest and largest studies to date on the health effects of silicone implants, beginning in 1992 and involving 13,500 women who had cosmetic breast augmentation in both breasts using silicone gel implants prior to 1989. The research found no association between breast implants and the risk of developing breast cancer, dying from the breast cancer and developing connective tissue disorders.

In 1999, a landmark report issued by the National Academy Institute of Medicine found women with silicone gel breast implants were no more likely than women without implants to develop connective tissue diseases, cancer, neurological diseases or other systematic conditions. However, the report found that the implants commonly lead to complications and many patients require surgery to replace or remove the implants. The most serious complications were contraction of the tissue around implants, rupturing of implants and infection.

In 1998, the Rule 706 National Science Panel, which was established by the coordinating judge for federal breast implant litigation, released findings that concluded that there are no identifiable associations between silicone gel breast implants and connective tissue diseases or immune system disorders. The findings resulted from a review of more than 2,000 medical documents and testimony from legal, medical and scientific experts.

The 1995 Harvard Nurses Epidemiologic Study found no association between silicone gel breast implants and connective tissue diseases. The study used research information from 87,501 nurses over a 14-year period, including 1,183 with breast implants.

In 1994, a study conducted by the Mayo Clinic found that women with silicone gel breast implants were at no increased risk of connective tissue diseases and other disorders. The study compared 749 women with breast implants to a similar group of women without implants.

Risks and Possible Complications

All surgeries include some degree of risk, including infection, discomfort and adverse reaction to anesthesia. In addition, there are specific risks associated with surgery using breast implants, including capsular contracture and deflation/rupture. In general, the more serious occur rarely, and most complications involve an extension of the recovery period rather than any permanent effect on your final result. For more information, see our section on the risks and possible complications of breast augmentation surgery.