Activists Assail FDA on Safety of Silicone Breast Implants

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October 10, 2003

by NOW Staff

At an Oct. 8 rally and press conference at the U.S. Department of Health and Human Services, NOW activists and women's health advocates criticized the Food and Drug Administration (FDA) for rushing to approve silicone gel-filled breast implants without studying their long-term health effects.

Next week, the FDA will review an application from implant manufacturer Inamed Corp. to return silicone gel-filled breast implants back into the general market. The agency withdrew these devices 11 years ago in response to numerous reports of ruptures and illnesses.

Actress Mary McDonough said she had met hundreds of women who experienced problems with silicone breast implants. Photo by Lisa Bennett

"The FDA is examining less than three years of clinical trial data, yet the FDA's own researchers have previously noted in published studies that problems with breast implants dramatically increase at, on average, seven to ten years post-implantation," said NOW President Kim Gandy, pointing out that, despite its application to restore silicone breast implants to the general market, Inamed Corp. has on file with the U.S. Patent Office documents stating that silicone gel is not "biocompatible" with human tissue.

Also at the press conference were women who have experienced serious health problems after receiving silicone implants, including a number of actresses who are leading the effort to warn other women in the entertainment business about the dangers of implants.

NOW President Kim Gandy noted that studies by the FDA's own researchers have shown that problems with silicone breast implants increase after 7-10 years. Photo by Lisa Bennett

Mary McDonough, an actress who appeared on television's "The Waltons," said she had met hundreds of women who experienced problems with implants. "Since I went public with my breast implant problems six years ago, hundreds of women have contacted me, desperate for trustworthy information about breast implants," she said. "Like me, they underwent various operations that they were told were safe, and then had terrible problems."

"We do know that breast implants do not last a lifetime," McDonough continued. "They all fall apart in the body over time. When mine were removed, the outer lining was completely missing, and the gel was held in place by my own scar tissue."

Sybil Goldrich, a breast cancer survivor who founded the Command Trust Network, also spoke to the crowd, describing the five surgeries she underwent to correct problems with her silicone breast implants. The implants hardened, became misshapen and changed position. She suffered from infections and skin decay when a skin graft was performed to create a nipple area. Goldrich recalled, "I remember thinking, 'I've survived breast cancer; will I survive breast implants?'"

Activists urged the FDA not to approve silicone gel-filled breast implants without studying their long-term health effects. Photo by Lisa Bennett

During the rally, photographs of women who have been disfigured by breast implant surgeries were displayed on large signs, and some protestors wore tape over their mouths to symbolize how women's injuries from silicone breast implants have been downplayed.

National Council of Women's Organizations Chair Martha Burk called attention to the concerted efforts by implant manufacturers and plastic surgeons to keep research findings about problems with silicone implants out of the public eye, citing the enormous profits made on breast implants by both industries.

A week before the rally, U.S. Senators Dianne Feinstein, Barbara Boxer and Mary Landrieu sent a letter to Health and Human Services Secretary Tommy Thompson as well as FDA Commissioner Mark McClellan, urging them to reconsider approving silicone breast implants in the absence of more complete scientific information about long-term impact.

Activists gathered at the Oct. 8 rally at the Department of Health and Human Services in Washington D.C.

Photo by Lisa Bennett

The senators' letter pointed out that just this month the Eleventh Circuit has allowed a lawsuit by the U.S. government to go forward against former manufacturers of breast implants, including Baxter, Bristol-Meyers Squibb Company and 3M, on behalf of the federal government and tens of thousands of U.S. women with implant-related medical problems, and that the FDA's own epidemiologists have identified long-term potential health risks from silicone implants, such as fibromyalgia.

In May, NOW sponsored a scientific symposium on silicone breast implants, followed by a press conference and a congressional briefing in July to discuss findings that seriously questioned the long-term safety of silicone breast implants.

For more information:

StopSilicone.org

Research Indicates Long-Term Risk to Women's Health from Silicone Breast Implants Not Fully Addressed in FDA Clinical Trials

Health and Consumer Groups to Call On U.S. FDA to Slow Breast Implant Approval Process

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