Silicone Is Safe, FDA Says

Silicone Is Safe, FDA SaysFood and Drug Administration is essentially telling U.S. consumers worried about silicone breast implants: “Told you so.” But in releasing new research backing up its 2006 decision to allow the implants back onto the market, the agency also reminds women, in a way, that they have only two choices — silicone or saline.

So let’s take a look at those options.

Until 2006, silicone implants had been under a 14-year ban by the FDA because of concerns that leaks or ruptures could increase the risk of certain diseases, including breast cancer and connective tissue diseases.

So for many years, saline implants were the only approved choice of implantable padding. Saline implants are made of a silicone outer shell filled with saltwater solution, either pre-filled or filled during the operation. Should they leak, the released water is absorbed by the body.

But not everyone is enamored with the look or feel of such implants — saline having a far different consistency than human tissue.

Silicone implants have the same outer shell, but are filled with a sticky gel that resembles fat in consistency. Such implants are widely considered to be more natural feeling than saline implants, but when they rupture or leak … well, that’s been a key issue.

The FDA says in the executive summary to its new report:

“The most common complications and adverse outcomes include capsular contracture, reoperation, and implant removal. Other complications include implant rupture, wrinkling, asymmetry, scarring, pain and infection. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience local complications. As many as one in five primary augmentation patients and one in two primary reconstruction patients require device removal within 10 years of implantation.

The post-approval studies to date do not show evidence that silicone gel-filled breast implants cause connective tissue disease, reproductive problems, or breast cancer.”

The Mayo Clinic offers more details about rupture.

Even the FDA cautions that implants need follow-up, and that they aren’t lifetime devices. And of course the implants require surgery, which always carries a risk.

The FDA helpfully offers a page on what to expect and questions to ask — of the doctor and the person considering implants.

But for those who’d rather not bother with surgery worries or leaking silicone, there’s always another option — the natural look.

Writer: Marissa Cevallos, HealthKey

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Category: Breast

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