Senator Feinstein voices continued concerns on silicone gel implants

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http://www.fogcityjournal.com/news_in_brief/bcn_feinstein_breast_implants_061119.shtml

By 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. Kessler highlighted potential risks posed by

silicone implants, issued a moratorium on their use, and said;

" 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 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.