You may already know about the 1992 FDA-imposed moratorium on the use of silicone breast implants for cosmetic breast augmentation, which was enacted after the news media publicized the stories of some women who claimed that silicone implants had made them ill. The ruling was made because the FDA determined that there was not enough data available to prove that the implants were safe. The moratorium meant that during that time, silicone gel implants were available in the U.S. only for use in clinical trials and for breast reconstruction procedures performed on women who already had these implants and needed a replacement for medical reasons.
As you may have heard by now, the results of those clinical trials showed no increased risk of breast cancer, connective tissue diseases, neurological diseases or other illnesses in women with silicone breast implants. As a result, the 14-year moratorium on silicone implants ended in November 2006 when the FDA approved the silicone gel breast implants made by two companies -- Mentor and Allergan (formerly Inamed) -- for cosmetic breast augmentation surgery.
As per the FDA’s mandate, studies involving thousands of women are still ongoing to evaluate the long-term safety of silicone gel breast implants. There are also pre-approval clinical trials in process for a newer type of silicone implant made from a more highly cohesive gel (sometimes referred to as “gummy bear” implants).
Silicone Implants Still Carry Risk
It is important to understand that approval by the FDA does not mean that silicone implants are risk-free. There are risks inherent with any breast implant surgery, and special risks associated with silicone implants. For this reason, the FDA has a higher minimum age (22 for silicone, compared to 18 for saline) for women to receive silicone implants for cosmetic purposes. These risks include undetected rupture of the implant (known as a silent rupture), which may lead to the silicone migrating to other parts of the body and the formation of granulomas.
You might be thinking at this point, “Why get silicone implants if they are riskier?” Though silicone implants do carry some additional risk, satisfaction rates are high. If you are considering breast augmentation, you should definitely take the time to talk with your doctor and weigh the advantages and disadvantages of silicone vs. saline implants.
Want to Learn More About Silicone?
For more information about the many uses of silicone in plastic surgery, including safety information, read The Truth About Silicone.
Sources:
FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation, FDA News Release, November, 2006
Interview with Robert Kotler, MD, FACS, facial cosmetic surgeon in private practice, author of Secrets of a Beverly Hills Cosmetic Surgeon; Beverly Hills, CA, conducted on August 31, 2009
Silicone Implants, Consumer Information Presented by the Breast Implant Task Force (a joint effort of the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery)
