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Posted on 10/08/2003 2:33:06 PM PDT by RJCogburn
Dozens of women on Wednesday protested the possible return of silicone gel-filled breast implants to the U.S. market, saying longer studies were needed before safety risks can be adequately known.
In 1992, the United States banned breast implants filled with silicone gel for most women after allegations they caused a variety of serious health problems. Now, U.S. regulators are reviewing an application to return them to the market.
Carrying graphic pictures of women whose implants had ruptured or been removed, the protesters urged the Food and Drug Administration to delay consideration of the application from California-based implant maker Inamed Corp. .
An FDA advisory panel meets next Tuesday and Wednesday to consider whether to recommend approval for Inamed's implants. The FDA usually follows the advice of its panels.
Inamed will present its research involving about 940 women who were followed for up to three years after getting the implants, Jo Ann Kuhne, the company's senior director for regulatory and clinical affairs, said in an interview.
"We believe our data definitely show they are safe and effective," Kuhne said.
She declined to give details on the study results, but added that two years was a typical length of time required by the FDA for studying implanted devices.
The women and a few men who protested in front of the Department of Health and Human Services headquarters said the FDA should require studies of implants in place for at least seven years to accurately gauge long-term effects.
"Women deserve to know the facts about implants, and they deserve to have a safe implant," said Mary McDonough, an actress who played Erin on the television series "The Waltons."
Three female senators also have written to the FDA asking the agency to reconsider whether it should rule on Inamed's application without additional safety information.
FDA spokeswoman Kathleen Quinn said a large portion of next week's meeting was set aside for women to speak about their implant experiences.
"FDA will carefully review this information, along with the most up-to-date scientific evidence and the recommendations from the advisory committee," Quinn said.
Many women in the early 1990s alleged silicone implants led to serious health problems. A 1999 Institute of Medicine study found the implants did not cause cancer, lupus or other chronic disorders, although they can rupture and cause other problems.
Saline-filled implants have remained on the market throughout the controversy. But plastic surgeons say many women prefer the look and feel of silicone gel-filled implants, which now are accessible only through clinical trials.
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Where's a good headline writer when you need one? This should read:
Enlarge Silicone Breast Implant Study.
I prefer peanut butter...
But it tends to stick to the roof of your mouth.
Three female senators also have written to the FDA asking the agency to reconsider whether it should rule on Inamed's application without additional safety information.
Does anybody else see the contradiction here? As if these people were legitimately interested in ensuring women's health? If you believe that one, just substitute the word "abortion" for the word "implant" and watch their heads spin around. Are there comparative statistics of complications from breast implants vs. complications from abortions (from the perspective of the woman - ignoring the obvious complications from the perspective of the fetus).
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