3 novembre, 2006 18:34
Contact Congress, FDA About NEW Implant Safety Risks
FDA Ignores New Allegations
--This month new allegations by a scientist formerly employed by Mentor Corp. accused the company of withholding unfavorable safety data about silicone gel breast implants from the Food and Drug Administration (FDA), which is currently deciding whether to approve these implants for unrestricted use. NOW has concluded that silicone gel breast implants pose unacceptable health risks to women.
How did the FDA respond to these new allegations? The agency reportedly said that the safety data wasn't requested by the FDA and therefore isn't relevant, according to the watchdog consumer group, Public Citizen.
Action Needed:
If you're as outraged as we are by FDA's response, you should let Congress know. This is the time to write to your member of Congress, with a copy to the FDA Commissioner, to say that you expect the FDA to thoroughly examine any evidence that a medical product is not as safe as its manufacturer says it is.
Background:
Silicone gel breast implants have never been approved by the FDA because they have not been proven safe, and their general sale was banned in the early 1990's. However, the FDA permits Mentor and Allergan Inc. (maker of Inamed implants) to sell silicone gel breast implants to women who lose a breast to cancer or have breast deformities.
A year ago the FDA announced its intention to approve silicone gel breast implants made by these two companies, if certain conditions could be met. Until a final decision is announced, the alternative is saline breast implants, which are approved by the FDA as "reasonably safe." This situation is similar to a recent expose involving Bayer, a pharmaceutical company that failed to disclose new research data about the risks of Trasylol, a widely used drug. And, of course, it is similar to previous disclosures about companies failing to inform the FDA about the risk of suicide among children taking anti-depressants and the risk of heart damage from patients taking Vioxx.
More Evidence That Implants Leak
-Similar allegations were made by a Mentor engineer in December 2005, but the new allegations are more specific and are made by a chemist who himself conducted much of the research he has discussed in his allegations. According to Public Citizen, the chemist told the FDA in June 2006 that the company under-reported the amount of silicone gel seeping out of the implant into the body, and failed to inform the FDA that the platinum leaking from the implant is potentially dangerous, that the implant shell weakens more than they reported, and that the implant becomes more dangerous over time.
It is the responsibility of the FDA to make sure that information provided by industry about medical products is accurate, and that the products are safe, before an approval decision is made. This is not always possible, but when whistleblowers come forward, the allegations must be scrutinized immediately. Whether the specific issues involved with silicone implants are criminal in nature, it seems clear that the health and safety of women is at risk, and these issues must be thoroughly investigated. It would be outrageous for the FDA to approve silicone gel breast implants until these allegations are checked with new analyses made by independent researchers who have no financial ties to the company, rather than by Mentor or its hired consultants and researchers.
These allegations were not reported in Canada, and the Canadian health agency decided to approve silicone gel breast implants on October 20, a week after the allegations were published in the U.S. media. To avoid a similar, dangerous decision in the U.S., it is essential that you ask your member of Congress to let the FDA know that she or he expects the agency to take such allegations seriously and to follow them up with an appropriate investigation. A copy of your message to Congress will be sent to FDA Commissioner von Eschenbach so that he knows that Congress is watching.
