Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Officials Say More Information Is Needed on Safety of the Devices

WebMD Health News

FDA Nixes Silicone Breast Implants, for Now

Jan. 8, 2004 -- Silicone breast implants still aren't quite ready for reuse in women, according to the FDA.

Hours after the agency sent a "not approvable" letter to silicone implant manufacturer Inamed Corp., FDA officials today announced that they've revised their advice to manufacturers on what they should show in order to gain approval, citing a need to know more about the long-term safety of the devices.

"What is most important is to be able to understand what are the things that predict rupture and subsequent failure," says David W. Feigal, MD, director of the FDA's Center for Devices and Radiological Health. "Because rupture of these products is the most important problem relating to failure and frequently to surgical removal of the product."

Aside from needing more information about silicone breast implant rupture rates, Feigal says the FDA also needs to know more about what to do with so-called "silent ruptures," in which leaking silicone implants are only detectable by MRI (magnetic resonance imaging) scans.

The move is the latest in an ongoing saga between silicone breast implants and the FDA, which has generated considerable interest from public interest groups, politicians, and researchers.

By demanding better proof of the devices' safety, women's health advocates say the FDA's action will send a clear message to the medical device industry.

"This decision has the potential to convince implant makers to try to develop a safer breast implant, and that is good for consumers and good for the companies," says Diana Zuckerman, PhD, president of the National Center for Policy Research for Women & Families, in a statement released today.

Inamed says they plan to work with the FDA to meet their revised expectations.

"Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our PMA [premarket approval application] by the Food and Drug Administration," says Inamed Chairman Nick Teti in a news release.

Silicone Breast Implants and the FDA

Silicone gel-filled breast implants were introduced in the U.S. in the early 1960s, before medical devices became subject to FDA regulation in 1976.

By the early 1990s, concerns about potential health risks associated with silicone breast implants began to emerge, including leakage and rupture problems, reports of connective tissue disorders, and a possible cancer risk among women with the implants.

URAC: Accredited Health Web Site TRUSTe online privacy certification HONcode Seal AdChoices