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

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

By Michael D. Towle

WebMD Feature

Saline Implants: FDA Hearing

March 27, 2000 (Chantilly, Va.) -- First, there was silicone.

In the 30 years after their introduction in 1962, silicone implants became the centerpiece of a legal and medical firestorm, culminating last November in a massive $3.2 billion settlement against the nation's leading maker of silicone implants, Dow Corning Corp.

Now the spotlight is on saline.

Saline, or saltwater-filled, implants currently are sold by the grace of a government loophole: They hit the market before the Food and Drug Administration's (FDA) began regulating medical devices in 1976.

They have been the only breast-enhancement option since the FDA removed silicone implants from the market in 1992, with the exception of a small number of women in limited clinical trials.

The FDA has been under pressure for years to address saline implants. In early March, an FDA advisory panel held three days of hearings to consider whether two types of implants should be allowed to stay on the market.

The panel stopped short of declaring that saline implants were safe and effective -- legal and regulatory language that women's groups and lawyers have been eager to hear.

But according to a source close to the panel, it did recommend that the FDA do more to make sure women know about implant risks, including:

  • Review the consent forms now given to women, usually by plastic surgeons prior to surgery, and recommend ways to improve them.
  • Require implant makers to come up with a "protocol" that would ensure that women get complete and accurate information on health risks.
  • Require implant makers to include more information about the number of women who require "revisions" after implant surgery -- essentially, second or even third operations to repair or replace damaged implants.

The panel also recommended more long-term studies on women who have received implants, as well as more testing to determine how and why implants rupture or leak.

To be sure, consumer demand for implants remains strong. In 1999, about 130,000 women received saline breast implants -- 80% of them for cosmetic purposes, not including reconstruction following cancer surgery or severe injury.

That makes breast augmentation the second-most popular cosmetic surgery in the United States, following liposuction. Twice as many women get cosmetic breast surgery as facelifts.

Ironically, the FDA has no plans at present to review silicone implants for safety and efficacy, despite a study published earlier this month in the New England Journal of Medicine that found no links between silicone implants and reports of autoimmune diseases such as arthritis and lupus.

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