FRIDAY, July 29, 2005 (HealthDay News) -- After a 13-year moratorium, silicone gel-filled breast implants are making their way back to the U.S. market.
Thursday night, the U.S. Food and Drug Administration moved one step closer to this end by issuing an "approvable letter" for Mentor Corp.'s application to reintroduce the product.
Reaction was swift and urgent, with calls for caution coming even from a bipartisan group of female U.S. senators, including Dianne Feinstein (D-Calif.), Olympia Snowe (R-Maine) and Hillary Clinton (D-N.Y.).
The nine senators sent a letter to FDA Commissioner Lester Crawford urging the agency to consider women's health safety in its final decision on the implants.
Because of flaws in the basic research, CNN reported, the senators said they were "extremely concerned that the risks of this device are far disproportionate to the benefit that a woman undergoing breast augmentation would realize."
The letter also noted differences between saline and silicone implants, stating that silicone implants "bear greater risk." The FDA was urged to note the additional distinction between using implants for reconstruction following cancer surgery and implants for augmentation.
Post-marketing conditions meant to address safety concerns "have proven to be ineffective or unenforceable," the letter concluded.
The other senators signing the letter were Kay Bailey Hutchison (R-Texas), Barbara Boxer (D-Calif.), Mary Landrieu (D-La.), Debbie Stabenow (D-Mich.), Blanche Lincoln (D-Ark.) and Barbara Mikulski (D-Md.).
Other reactions were mixed.
Diane Zuckerman, president of the National Research Center for Women & Families, criticized the decision as "pathetic science" and "bad politics" while at the same time urging people "not too make a big deal of this."
"This is a step in a process, not a final decision," she said. "I would say a stumble in the wrong direction, because I think it's illogical and really undermines the credibility of the FDA at a time when their credibility is not too high to start with. I think it's politically an error for Dr. [Lester] Crawford [head of the FDA], who's just been confirmed, to proceed, I think, recklessly in this direction."
Zuckerman stressed that her organization is not against silicone implants or any other implants. "We're a critic of unsafe medical implants," she emphasized. "We just want some safe implants whatever they're made of."
Dr. Richard A. D'Amico, chairman of the breast implant task force of the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery, said, "The FDA decision really follows as a logical outcome of the science on these devices. They're the most studied medical device and the data supports their use."
D'Amico speculated that, depending on conditions requested of Mentor by the FDA, things could get going by the end of the year. "The plastic surgery societies are fully prepared to teach the educational component the FDA may require," he said. "There will probably be other conditions, including a breast implant registry and we're very supportive of that. That would really allow thorough postmarket surveillance. Plastic surgeons are ready to go now. We're just waiting for FDA conditions."
Dr. Nolan Karp, associate professor of plastic surgery at New York University School of Medicine, said, "I think it's about time. The companies, particularly Mentor, did what the FDA asked. What Mentor has is a more cohesive gel implant so if it ruptures, the gel is much less likely to come out."
The letter sent from the FDA to Mentor Corp. spells out certain conditions the company must meet to receive final FDA approval to market the implants in the United States. The agency said it was prohibited from disclosing the specific contents of that letter.
In April, the FDA's General and Plastic Surgery Devices Advisory Committee voted 7-2 that Santa Barbara, Calif.-based Mentor's application to bring back silicone-gel implants was "approvable with conditions."
The FDA stressed that Thursday's letter doesn't mean the devices have been approved for marketing in the United States.
During the review process in April, the advisory panel rejected a similar request by silicone-gel implant maker Inamed Corp.
Inamed officials testified that the new generation of implants were less prone to rupture and leakage. But the FDA advisers were skeptical, saying significant questions still persisted on how long the implants last inside a woman's body -- and the health consequences when they break.
Silicone gel implants went on sale in 1962 in the United States. Thirty years later, the FDA banned all but those used for breast cancer reconstruction, amid fears that leaks might be responsible for autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue.
By 1998, more than 170,000 lawsuits had been filed against implant manufacturers by women claiming their silicone implants had caused immune system disorders and chronic diseases such as rheumatoid arthritis and systemic lupus. Four companies paid out millions of dollars in settlements to the women, and one of them, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle its claims.
However, studies by the Mayo Clinic, Harvard Medical School and the Institute of Medicine (IOM) panel from the National Academy of Sciences subsequently found no evidence that leaked silicone from gel implants caused systemic disease.
More recent research has focused on the problems of scar tissue developing at the site of the implant and on the rate of rupture of the devices.
The rupture rate was a prime reason the FDA refused last January to allow the devices back on the market.
More information
The FDA has more on breast implants.
