Feinstein voices breast implant concerns
Senator Dianne Feinstein
By Elizabeth Daley, Bay City News Service
November 19, 2006
Sen. Dianne Feinstein, D-Calif., is voicing her concerns to the
Food and Drug Administration about its recently lifted ban on
silicone breast implants.
Feinstein said Friday that while "the FDA announced this
afternoon that it has ended its 14-year ban on silicone gel breast
implants and approved products by Allergan and Mentor Corporation,"
she feels "serious questions remain about the long term safety
of these products. The FDA has a responsibility to carefully monitor
the health and safety of women who use these implants."
In 1992, the FDA restricted the use of silicone breast implants
amid heightened concern about their safety. In a speech, then
FDA commissioner Dr. David Kessler highlighted potential risks
posed by silicone implants, issued a moratorium on their use,
"There remain troubling questions about the safety of the
implants. We owe it to the American public to see to it that these
questions are thoroughly investigated."
Last month, Feinstein and Olympia Snowe, R-Maine, addressed a
letter to FDA acting commissioner Andrew von Eschenbach, calling
for a full review of product testing data before final approval
of the Mentor brand implant was granted, citing reports they felt
indicated Mentor may have inaccurately reported data regarding
potentially dangerous implant leakage.
"The whistleblower has made two key allegations against
Mentor. The first is that Mentor's implants used in surgery leak
more than the ones used in demonstrations to doctors and patients.
If this allegation proves true, women and their doctors will have
been intentionally mislead," wrote the senators.
"The second allegation is that there is a design flaw in
Mentor's implants which has resulted in a higher rupture rate
and that higher rupture rate has not been accurately reported
to the FDA."
Feinstien's office reported Friday the senators had not yet received
a response to their letter.
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