Plastic Surgery Articles

FDA Lifts Silicone Implant Ban

November 20, 2006 -

More than a decade has passed since the Food and Drug Administration placed a ban on the use of silicone breast implants. On Friday, the ban came to an end as the FDA announced the return of silicone implants to the U.S. market.

The FDA approved the implants for use in revision and reconstruction surgeries as well as for use in breast augmentation procedures in women over the age of 22. Approval was based on a number of conditions, including mandatory follow-up studies and surgeon training.

“I think this is a huge victory for women, not just for those seeking cosmetic surgery but also for many reconstructive patients after breast cancer surgery,” said plastic surgeon Dr. David Song.

Silicone Implants Banned

In 1992, the FDA banned the use of silicone breast implants, citing that more studies needed to be conducted to determine their safety. Critics of the implants claimed that silicone leaks caused various autoimmune diseases and other health problems.

Since that time, several studies - including two published in the New England Journal of Medicine - have shown that there is no correlation between ruptured implants and adverse health effects.

“It’s sort of a vindication because we all knew there was no scientific evidence back in 1992 that necessitated the moratorium,” said Dr. Song.

Softer Than Saline

For the last 14 years, saline implants have been the norm for augmentation procedures. Many plastic surgeons are expecting that to change, especially because silicone implants are softer and more natural feeling than saline.

Breast augmentation is the second most popular cosmetic procedure currently performed in the U.S. According to the American Society for Aesthetic Plastic Surgery, approximately 365,000 women underwent the procedure in 2005.

Interested in breast augmentation? Please click here to locate a board certified plastic surgeon near you.

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