FDA Approves New Silicone Gel-Filled Breast Implants



For a long time, Allergan and Johnson & Johnson have been the only two companies allowed to distribute silicone gel-filled breast implants in the U.S.—but all that changed two weeks ago, when the FDA approved a third company, Sientra, for that same privilege.

The decision to green-light Sientra’s implants came after three years of gathering data from 1,788 participants. The FDA says that Sientra’s studies yielded the same results as typical breast implant studies; risks can in some cases involve capsular contraction, asymmetry, and infection, according to the clinical data, but no more so than the other implants on the market.

In a statement after the FDA’s decision was made public, Sientra CEO Hani Zeini said that with this approval, his company has “successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice.”

I’m not sure that Sientra’s intentions are as altruistic as that statement seems to try to make them sound; when it comes down to it, they’re a company selling a new product. However, there is a kernel of truth in what Zeini said—namely, that having another silicone-gel choice out there to choose from is a good thing from a doctor’s and from a patient’s perspective.

This is especially true because Sientra has said that it will be creating implants in multiple shapes and sizes; since I select the implants I use in breast augmentation based on each patient’s breast and body shape, having a greater variety to choose from will be extremely helpful. And, of course, increased competition is often followed by decreased costs—something to look out for in the future!