Silicone Breast Implants Gain FDA Approval

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The U.S. Food and Drug Administration lifted a 14-year ban on silicone breast implants last Friday. The implants will be available for breast reconstruction and revision procedures, as well as for augmentation in women age 22 and older.

“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.

The Silicone Ban

Silicone breast implants were banned in 1992 over safety concerns and were subsequently only used in FDA-approved clinical trials. The primary concern was that ruptured implants caused a number of health conditions, including various autoimmune diseases. However, several recent studies have shown that these concerns were unsubstantiated.

“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,” Dr. Song said.

As part of the approval, the FDA outlined a number of conditions that silicone implant manufacturers and plastic surgeons must meet. One condition requires plastic surgeons to participate in training before they can begin to receive shipments of the implants. Another requires the implant makers to conduct follow-up studies over the next decade.

The Future of Silicone Implants

Implants made of silicone gel tend to have a softer, more natural feel than saline implants. For this reason, many plastic surgeons expect the number of breast augmentations done with silicone implants to soar in coming years.

Breast augmentation is one of the most popular cosmetic procedures performed in the U.S., second only to liposuction. Last year alone, more than 300,000 women had the procedure.

Considering breast augmentation? Please contact us today to schedule a consultation with a board certified plastic surgeon near you.


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