FDA Re-Approves Silicone Breast Implants in U.S.

November 22, 2006
After a 14-year prohibition period, silicone breast implants make a comeback in the U.S. Now women over the age of 22 who are undergoing reconstruction surgery, cosmetic enhancement, or revision surgery will have the option to choose silicone implants.

“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 Dr. David Song, chief of plastic surgery at the University of Chicago.

Ban of Silicone

In 1992, silicone breast implants were temporarily banned as a result of safety concerns and were only allowed to be used in FDA-approved clinical studies. Many believed that a ruptured or leaking implant could cause serious health complications including a number of autoimmune diseases. However, recent studies show that these claims are unfounded.

“It's sort of a vindication because we knew there was no scientific evidence back in 1992 that necessitated the moratorium. Since 1992, there have been several landmark studies, two of which were in the New England Journal of Medicine, that showed there was no correlation between silicone leakage and all the health conditions that were being described,” said Dr. Song.

With the new silicone breast implant approval comes several conditions outlined by the FDA, including follow-up studies of 40,000 female patients over the next decade to ensure safety. Furthermore, plastic surgeons must complete proper training before performing surgeries with silicone implants.

Silicone: The Implant of Choice

Silicone implants are filled with a natural-feeling gel and are softer than their alternative saline implant. Because of this, plastic surgeons predict the number of silicone breast implant surgeries will significantly rise in the coming years.

Breast augmentation surgery remains one of the most performed plastic surgery procedures in the U.S. Last year, over 300,000 women underwent the procedure.

Considering breast augmentation? Please click here to set up a consultation with a qualified board certified plastic surgeon near you.

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