Government Accountability Project (GAP) • National Research Center for Women & Families •
National Women’s Health Network • Our Bodies Ourselves
October 25, 2006
Dear Congressman/woman :
In mid-October 2006, new allegations by a chemist who had worked at Mentor Corp. for 15 years accused the company of withholding unfavorable safety data about silicone gel breast implants from the FDA, which is currently deciding whether to approve these implants. The chemist reported that the implants are more likely to break than the company reported, that the silicone is more likely to leak even when the implants are not broken, and that platinum used in the implants is more dangerous than reported.
How did the FDA respond? They apparently said the safety data weren’t required by the FDA and therefore aren’t relevant.
If you’re as outraged as we are by FDA’s response, please let the FDA Acting Commissioner, Dr. Andrew von Eschenbach, know that you expect the FDA to thoroughly examine any evidence that a medical product is not as safe as its manufacturer says it is.
Silicone gel breast implants have never been approved by the FDA because they have not been proven safe and effective. However, the FDA permits Mentor and Allergan Inc. (maker of Inamed implants) to sell silicone gel breast implants to women who lose breasts to cancer or have breast deformities. And, 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.”
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 implant shell weakens more than they reported and becomes more dangerous over time.
In newspaper interviews, FDA officials stated that the safety issues were not criminal matters because the data involved had not been required by the FDA.
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.
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, the health and safety of women are 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 with no financial ties to the company, rather than by Mentor or its hired consultants or researchers.
Moreover, it is time for the FDA to take allegations from industry whistleblowers more seriously. They may not always be completely accurate, but they always deserve a thorough investigation, including replicating the research involved.
Although introduced before these allegations were made public, a bill introduced by Rep. Rosa DeLauro, the FDA Scientific Fairness for Women Act, would help ensure that the FDA does not approve silicone gel breast implants until they are proven safe for long-term use. We urge you to co-sponsor this legislation.
We’re glad to report that Senators Snowe and Feinstein, two of the Senate’s key experts on women’s health, wrote to the FDA Commissioner last Friday, urging him to have the FDA carefully examine these allegations and all data relevant to the safety of silicone breast implants. We ask that you also write to Dr. von Eschenbach, specifically asking that the FDA conduct its own independent research to determine whether the allegations made by the Mentor chemist are accurate, and to determine whether the risks of leakage and rupture are as worrisome as these allegations indicate.
Sincerely,
Breast Cancer Action
Center for Medical Consumers
Consumers Union
Government Accountability Project (GAP)
National Research Center for Women & Families
National Women’s Health Network
Our Bodies Ourselves