Women's Groups are Outraged at FDA response on Silicone Breast Implants

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
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

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www.BreastImplantAwareness.org