FDA Warns of Dangers of Breast Implants

     WASHINGTON, DC -- More than 190,000 problems from breast implants have been officially reported to the Food and Drug Administration (FDA), according to a new consumer booklet that the FDA has published on its website. The reports included 123 deaths.

    For the first time, the FDA also has made photographs of adverse implant outcomes available on its website. The photos include breasts that are disfigured from having implants that were removed and not replaced. A little known risk of implants is that the breast tissue stretches out of shape, and that implants cause permanent damage that will be obvious if they are removed. This is depicted in one of the photographs. Other photos depict capsular contracture (a hard and misshappened breast) and deflation.

    "The number of reported adverse reactions is amazingly high, since most medical problems are not reported to the FDA" according to Dr. Diana Zuckerman, President of the National Center for Policy Research for Women & Families, a nonprofit research think tank. "It is especially shocking that more than one-third of the reports are for saline implants, most of which have been sold in the last few years. The photographs help illustrate how disfiguring augmentation can be. A cosmetic product should not cause disfigurement to so many women."

    Experts estimate that the FDA receives one complaint for every 10 or more problems, but 190,000 complaints would potentially represent more than 10 percent of the estimated 1.5 million women with breast implants.

    The FDA approved saline breast implants in May, but has never approved silicone gel implants as safe or effective. FDA officials have expressed concern that potential patients needed to be warned of the risks. The new consumer booklet provides much clearer warnings to reconstruction and augmentation patients than previous FDA efforts.

    The FDA booklet also warns women about some lesser-known problems:

Inability to obtain health insurance coverage is a risk; some women are unable to get any insurance, others have no coverage for breast-related or implant-related problems;

Toxic Shock Syndrome is described as a potentially life-threatening result of implant surgery and infection.

Additional surgeries can be expensive, pose health risks, and do not guarantee a good cosmetic outcome.

Implants interfere with mammography; mammograms cost more for implant patients, but are less likely to be accurate.

    This online information is an important first step in informing consumers" stated Dr. Zuckerman. We urge the FDA to publicize these efforts widely as soon as possible, rather than just putting it up quietly during the last week of August."

    The FDA booklet and photographs are listed separately at www.fda.gov/cdrh/breastimplants. The National Research Center website has additional information at www.center4research.org.

     The National Research Center is a nonprofit, nonpartisan organization dedicated to improving the lives of women and families by using objective, research-based information to encourage new, more effective programs and policies.

 

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