| Ilena Rose 2005-07-29, 5:56 pm |
| FDA Move on Breast Implants Draws Swift Reactions
http://www.rednova.com/news/health/...wift_reactions/
FRIDAY, July 29 (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."
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.
SOURCES: Richard A. D'Amico, M.D., chairman, breast implant task
force, American Society of Plastic Surgeons and American Society of
Aesthetic Plastic Surgery; Diana Zuckerman, Ph.D., president, National
Research Center for Women and Families, Washington, D.C.; Associated
Press; CNN~IMPL~~WMEN~
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