Sens. Feinstein, Snowe Ask FDA for Safety Review of Silicone Breast Implant Manufacturer's Product Application

Daily Women's Health Policy

http://www.kaisernetwork.org/daily_r...fm?DR_ID=40617

Public Health & Education | Sens. Feinstein, Snowe Ask FDA for Safety
Review of Silicone Breast Implant Manufacturer's Product Application
[Oct 24, 2006]

Sens. Dianne Feinstein (D-Calif.) and Olympia Snowe (D-Maine) on
Friday sent a joint letter to acting FDA Commissioner Andrew von
Eschenbach asking the agency to launch a full review into whether
Santa Barbara, Calif.-based Mentor intentionally withheld safety data
on its silicone breast implant application, CQ HealthBeat reports (CQ
HealthBeat, 10/23). Most breast implants, which often are given to
women who have undergone a mastectomy to treat breast cancer, contain
saline solution.

Silicone breast implants were banned in 1992 because of safety
concerns. Mentor and Inamed, which now is part of Allergan, applied to
sell silicone implants, and FDA in July and September 2005 gave both
applications preliminary approval pending the meeting of certain
conditions.

A former employee of Mentor in June last year expressed concerns to
Mentor officials that staff had misrepresented, covered up or withheld
resilience, leakage and other data on the implants. The employee was
laid off by the company in May, and one month later he contacted FDA
with the allegations.

The consumer advocacy group Public Citizen earlier in the month sent
a letter to von Eschenbach asking the agency to conduct a criminal
investigation into Mentor's product-testing data. FDA spokesperson
Heidi Valetkevich said, "The agency conducted a thorough investigation
into these charges and found no evidence of wrongdoing and nothing
that would raise questions about the safety of the product under
review or the integrity of the data submitted to FDA" (Kaiser Daily
Women's Health Policy Report, 10/13). Feinstein and Snowe in their
letter cited allegations that Mentor might have withheld data and some
errors regarding leakages from the implants. The senators asked von
Eschenbach to "fully review all data collected by Mentor, whether or
not it was originally required.

If the FDA has already investigated these allegations, we request
that you share with us the nature and results of this investigation"
(CQ HealthBeat, 10/23).





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