National NOW Times >> Winter 2003/2004 >> Article
Will FDA Ignore Danger of Silicone Breast Implants?
by Jan Erickson, Government Relations Director
The issue of breast implants is both a personal health question for hundreds of thousands of women, who need complete information in order to make informed choices about their health and safety, and a public health question arising from the substantial number of women with implants who become ill and depend on government health care systems for medical care.
Silicone breast implants were withdrawn from general use by the FDA in 1992 following numerous reports of illness following rupture and leakage. Hundreds of thousands of women with breast implants—both silicone and saline—filed lawsuits against implant manufacturers in the 1990s. Yet the implants remained available in clinical trials for the next 13 years so that the manufacturer could gather long-term safety data.
Not surprisingly, Inamed Corp., the manufacturer, presented only the most recent three years of that data to the FDA panel, and many of those patients had been implanted for less than a year. The company declined to present the long-term data, and the FDA did not require it, although most problems with silicone breast implants develop seven to ten years after implantation.
But even that limited 3-year data documented that complication rates were high for both breast reconstruction (post-breast cancer surgery) and augmentation patients. Despite that evidence, the advisory panel recommended (by a 9-6 vote) that the FDA approve the implants for general marketing, with some conditions. Notably, four members of the committee are cosmetic surgeons, and several derive their income from breast augmentation.
Dr. Thomas Whalen, a pediatrician and the non-voting chair of the advisory panel, sent a letter after the hearing to FDA Commissioner Mark McClellan expressing strong reservations about the advisory panel's recommendation to approve the return of silicone implants to the general market. Whalen also asked that Inamed be required to submit rigorous, long-term prospective studies to demonstrate safety before being given approval to market their implants.
Meanwhile, the U.S. Department of Health and Human Services is proceeding with its own lawsuit against several breast implant manufacturers, asking for tens and perhaps hundreds of millions of dollars to reimburse the agency for funds spent providing health care to women injured by breast implants.
NOW president Kim Gandy, who testified before the advisory committee, called their recommendation "astounding," considering that the manufacturer provided the FDA with less than three years of data.
A half dozen clinicians and researchers, sponsored by NOW and other organizations, came forward to describe the findings of their research into toxic components of silicone gel, immune reactions to the silicone gel, and illnesses experienced by breast implant patients which diminished once the implants were removed.
More than 100 people testified, the majority of them women who had silicone gel-filled breast implants and had experienced a range of illnesses, including rashes, open sores leaking silicone, hair loss, memory loss, mental confusion, muscle weakness, and local and regional infections. Some had suffered serious diseases like lupus, fibromylagia, scleroderma, rheumatoid arthritis and others.
The advisory panel recommendation included certain conditions, such as requiring long-term follow-up and frequent Magnetic Resonance Imaging (MRI) exams for breast implant patients. But the FDA does not have the authority to carry out such extensive and costly surveillance.
Additionally, breast implant patients would have to pay $700 to $1,100 out-of-pocket for each Magnetic Resonance Imaging procedureamounts that not all women can easily afford, and there was no provision to guarantee compliance with the review process.
If silicone breast implants are once again allowed on the market, the number of women who could become seriously ill from these devices will be considerably greater than before. In just the last five years, the number of women and girls undergoing breast augmentation has more than doubled to 249,000 plus. And that number is expected to increase by approximately 10 percent every year for the foreseeable future.
Says Gandy: "I was often asked by Inamed supporters whether I didn't think women should have the 'choice' of breast implantsI replied that it's impossible to make an informed choice when long-term safety data is being withheld from us."
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