In a major victory for cosmetic surgeons and patients alike, the FDA has recently approved silicone breast implants.
Silicone gel implants first went on the market in 1962, before proof of safety and effectiveness was required by the FDA. Thirty years after their introduction, the implants were banned due to safety concerns. The implants have a history of dangerous silicone leakage, which they still retain with a rupture rate as high as 77% (according to an Institute of Medicine report from 2000). When the silicone implant leaks, the gel may migrate throughout the body and form irregular lumps among other problems. The implants must be replaced or removed during the patient’s lifetime in order to prevent rupture. They may also cause infection or form disfiguring scar tissue if the procedure does not heal properly.
Despite these drawbacks, the implants are still a blessing to many who long for a more natural looking breast augmentation. Since 1992, the implants have only been available as a part of research studies. There is still some stigma on the image of silicone implants due to concerns over relations to cancer, lupus and other diseases, although a connection has yet to be made between the implant and these issues. On the whole, it would seem that the increased availability of natural breast augmentation results to women outweighs the current possibility of damage.
The FDA does require that many steps be taken both to prevent and treat such concerns. Only patients who are aged 22 and older may receive the silicone implants. It is now required that all companies who manufacture silicone implants complete ten year studies on patients for safety purposes. The manufacturers are also required to begin new ten year studies on 40,000 women with silicone implants. Patients must now take regular MRI exams for the rest of their lives after the implant procedure to catch and treat “silent ruptures”, where the silicone implant leaks and the patient is not aware.
The end to the 14 year ban on silicone implants may mean renewed hope for many women.