FDA Panel Okays Unsafe Silicone Breast Implants

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October 24, 2003

by Jan Erickson, NOW Foundation Government Relations Director

An advisory panel to the U.S. Food and Drug Administration (FDA) voted 9 to 6 on Oct. 15 to allow Inamed Corp. to proceed with sales of its silicone gel-filled breast implant, despite an abundance of data showing high rates of complications and potentially devastating long-term consequences.

The panel, composed of plastic surgeons, medical specialists and a non-voting consumer representative, initially appeared reluctant to recommend the company's marketing application after testimony and the company's own findings indicated that the silicone devices posed serious health risks to patients—the chair of the panel said he couldn't sleep that night because he was so upset at the testimony.

But when Inamed representatives promised that they would require implant patients to undergo frequent Magnetic Resonance Imaging (MRI) tests and extensive surveillance to detect implant ruptures and other complications, the panel voted 9 to 6 to recommend to the FDA that the Inamed application be approved. The FDA does not have to accept the panel's recommendation in making the final decision, but it usually agrees with its panels.

NOW and other women's organizations, along with dozens of women who testified about their experiences with silicone breast implants, were disappointed with the panel's apparent reversal.

NOW President Kim Gandy called it "astounding” that the panel accepted Inamed's plan after they provided the FDA with less than three years of data, considering that most serious problems with silicone breast implants develop, on average, about 7 to 10 years after implantation. She noted that scientific evidence indicates that silicone is associated with strong immune reactions in the body and that Inamed, itself, has stated in a U.S. patent document that silicone is not biocompatible with human tissue.

“In plain English, that means that silicone should not be placed in women's bodies,” Gandy said. “Safer saline-filled implants are available and no woman should be expected to take on the serious potential health risks of silicone gel.”

A number of the researchers and clinicians who discussed their research at NOW's May 8 symposium on silicone breast implant safety also presented testimony at the FDA hearings, including Dr. Edward Melmed, a Dallas plastic surgeon who showed what implants look like after rupture or calcification; Dr. Paul H. Wooley, a immunology professor with Wayne State University Medical School who discussed the results of studies on immune reactions associated with silicone; and Dr. Ernest Lykissa, with ExperTox, Inc., who discussed the findings of studies that show the presence of the toxic compounds of silicone in implant patients; all three were sponsored by NOW to participate in the FDA hearings.

Inamed's core study of 221 breast cancer reconstruction patients and 494 augmentation patients results showed alarmingly high complication rates. For example, 45% of reconstruction patients underwent at least one re-operation within three years and 21% of augmentation patients required re-operation within 3 years.

In 1991, after the FDA mandated long-term surveillance of women with silicone implants, a larger study of 15,465 reconstruction patients and 9,882 women who replaced their previous breast implants with new Inamed gel implants was conducted, but barely half of the breast cancer patients who received implants stayed in the study for one year, and only 27% stayed in the study for three years. Breast enhancement patients were even less likely to remain in the follow-up study: Only one in five remained for three years.

In the FDA review of the company's findings, agency scientists noted that muscle pain, joint pain, hair loss, rashes and fatigue all increased within two years of getting implants and every measure of emotional and physical health, including social interactions and self-esteem, declined within two years after getting implants. Sexual attractiveness was the only improvement patients reported.

Dr. Diana Zuckerman, president of the National Center for Policy Research for Women & Families and an expert on breast implants, said the large study was basically worthless as the company did not study the women long enough to determine the risks. A critical failure noted by many panelists was that no valid long-term data was available for the hearings.

Many observers who criticized the panel's recommendation noted that the FDA does not have the regulatory authority to assist in the monitoring of all patients with silicone gel-filled breast implants. Others questioned whether women would be able to afford regular MRI tests at a cost of approximately $700 for each test. Though insurance companies cover some costs associated with reconstruction for mastectomy patients, they may not cover subsequent procedures to remove implants and treat complications, and most do not cover procedures connected with cosmetic surgery, even removal of implants from women who are already ill.

Silicone breast implants were removed from general use in 1992 when women complained about rupture, local infections, autoimmune diseases like lupus, rheumatoid arthritis, scleroderma, fibromyalgia and other conditions. Other symptoms that have been commonly reported by implant patients include rashes, hair loss, open sores, aching muscles and joints, mental confusion and memory loss. Notably, most women who have silicone implants removed report feeling much better and seeing many of their painful symptoms recede.

Research shows that nearly all implants rupture and disintegrate within 15 to 20 years, and silicone gel begins to leak through the implant's porous shell from the moment of implantation. Silicone has been found in the major organs, the lymph glands and brains of women who have had silicone implants. About 150,000 reports of rupture, complications and illnesses have reported to the FDA as of 2002. Additionally, studies by the FDA and the National Cancer Institute show significantly higher rates of brain and lung cancer and suicide among women with implants.

Mastectomy patients and other women who agreed to participate in a clinical trial have been able to get silicone implants since 1992. Saline, or salt water-filled, implants remain available to anyone who wants these devices. About 240,000 augmentation (breast enhancement) surgeries are performed, a six-fold increase over the previous ten years. Saline implants are recognized as being safer than silicone gel-filled implants, but even those are associated with painful and disfiguring local complications as well. A procedure for breast reconstruction which appears to be much safer is the "tram flap," which uses the patient's own tissues from the abdomen to re-create the breasts.

For more information on breast implants and NOW's work on the safety of silicone breast implants, visit http://www.breastimplantinfo.org and http://www.now.org/symposium.

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