News / 

FDA Denies Request to Return Silicone Breast Implants to Market



This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in its archived form does not constitute a republication of the story.

It's been eleven years since silicone breast implants were banned due to safety concerns.

In response to an application to re-introduce the implants, an advisory panel to the FDA met for two days last October. After heated arguments on both sides of the debate, the panel voted 9-6 in favor of lifting the ban.

Despite that recommendation, the FDA rejected the application as written, saying they need more information on long term safety.

Plastic and reconstructive surgeon Dr. Lauren Eskenazi says it's a double standard.

Dr. Lauren Eskenazi/ Plastic & Reconstructive Surgeon: "They've never been removed from the market for women with cancer. So there was a bit of a double standard in that decision, because if it's okay in this women's population, why isn't it ok for other women?"

She says saline implants are generally prefered because they're less likely to harden or form what's called a capsular contracture. While silicone implants may feel more natural to the touch, in most women you can't see a difference between a saline and a silicone implant.

But for a woman with cancer, the skin and fatty layer can be very, very thin, making a breast implant visible.

Dr. Lauren Eskenazi/ Plastic & Reconstructive Surgeon: "The reason it was okay for women with cancer is because women with cancer had more of a cosmetic deformity from the mastectomy that required silicone as a solution, so that they had a normal looking breast that wasn't rippling."

In this group of women the benefits of silicone are thought to outweigh the potential risks. Even so, Dr. Eskenazi says the safety issues apply to all women who have breast implants.

Critics of the FDA decision say there was relatively little science presented at the hearings held in October.... that 95% of the testimony covered moral, ethical and emotional issues, with 5% of testimony on scientific data.

SIGN UP FOR THE KSL.COM NEWSLETTER

Catch up on the top news and features from KSL.com, sent weekly.
By subscribing, you acknowledge and agree to KSL.com's Terms of Use and Privacy Policy.

KSL Weather Forecast