MS MAGAZINE: FDA Issues 'Approvable' Letter for Silicone Breast Implants

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> Note: forwarded message attached.

> > Date: Wed, 03 Aug 2005 13:08:01 -0600

> From: Ilena Rose <ilena03@...>

> Subject: MS MAGAZINE: FDA Issues 'Approvable' Letter

> for Silicone Breast Implant

> <Undisclosed-Recipient:;>

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> August 3, 2005

> FDA Issues 'Approvable' Letter for Silicone

> Breast Implants

> Despite safety concerns, the Food and Drug

> Administration (FDA) has preliminarily approved the

> sale of silicone breast implants made by Mentor

> Corporation. Due to widespread reports of women

> experiencing illnesses and pain from ruptured and

> leaky implants, in 1992 the FDA banned the use of

> silicone implants except in cases of reconstructive

> surgery. According to Sybil Goldrich, Executive

> Director of the Command Trust Network: National

> Breast Implant Information Clearinghouse, nearly all

> silicone breast implants eventually rupture and

> spread to other parts of the body, with half of

> implants failing in 10 years and three-quarters in

> 20 years.

>

> The FDA’s approvable letter to Mentor

> Corporation calls for the company to meet certain

> conditions, including the stipulation that the

> company continue long-term studies on the implants’

> safety and the requirement that the company undergo

> an independent annual review of its safety data.

> However, as women’s health organizations point out,

> the FDA not only lacks the power to ensure

> compliance with these conditions but studies

> conducted after approval will provide little in the

> way of assurance or protection to women who get the

> implants upon FDA approval.

>

> Last Thursday, Senators Dianne Feinstein

> (D-CA) and Olympia Snowe (R-ME), along with seven

> other women Senators sent a letter to newly

> confirmed FDA Commissioner Lester Crawford

> expressing serious concerns about the implants’

> safety. The joint letter urges the FDA to put

> women’s health first and argues that “post-marketing

> conditions” are not enough to protect women’s health

> – “such conditions have proven to be ineffective or

> unenforceable and thus cannot serve as a substitute

> for long-term clinical data.”

>

> The Senate Health, Education, Labor and

> Pensions committee is conducting an investigation

> into whether a conflict of interest influenced the

> panel’s decision, as a plastic surgeon who voted on

> Mentor’s application was found to have accepted

> money from one of the companies seeking silicone

> implant approval and an FDA expert on implants was

> not given the opportunity to testify, reports the

> Boston Globe

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