Sorry to bring bad news ... No irregularities found in FDA breast implant decision

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http://www.chron.com/disp/story.mpl/nation/4079221.html

July 28, 2006, 1:20PM

No irregularities found in FDA breast implant decision

By ANDREW BRIDGESAssociated Press

WASHINGTON — Allegations of improprieties surrounding the government's conditional approval of silicone gel-filled breast implants were largely unsubstantiated, according to the results of a Senate investigation released today.

The investigation by the panel's Republican staff did uncover concerns but nothing that suggested the Food and Drug Administration's 2005 decisions should be reversed, according to a seven-page summary of the investigation. The full report was not released.

The report by the Senate Health, Education, Labor and Pensions Committee does not address the safety of the implants.

More than two dozen women's and other groups had alleged conflicts of interest, undue influence on the FDA commissioner and the use of incomplete or biased data. They asked Congress to investigate.

" They missed the boat, " said Zuckerman, president of the National Research Center for Women & Families, who was among those who sought the investigation. " They didn't respond to the questions precisely as they were asked. It's that lack of precision that means they answered the wrong questions. "

In July and September of last year, the FDA first told Mentor Corp. and then Inamed Corp. — now part of Allergan Inc. — that it would let them begin selling silicone implants once the companies met certain unspecified conditions. The FDA has yet to grant final marketing approval to either California company.

Many of those seeking the congressional investigation found the case of Inamed especially egregious, since the company previously had failed to win the endorsement of an outside panel of experts convened by the FDA.

Investigators said they focused on 10 allegations but found only one that was substantiated: a member of a 2005 FDA advisory panel on plastic surgery devices did solicit money from a company owned by Inamed to produce educational materials on the silicone implants.

That relationship was disclosed to the FDA and did not violate any laws or regulations, but did present the appearance of a conflict of interest, the report said

.. That could lead to a change in the law.

" We will build on the findings of this investigation by including provisions to address the problem of potential conflicts of interest among advisory committee members in the drug safety bill Sen. () Kennedy and I are preparing for introduction, " said Sen. Mike Enzi, R-Wyo. Enzi is chairman of the committee that conducted the investigation, while Kennedy, D-Mass., is its top Democrat.

Senate investigators also found no reason to reopen a criminal investigation into whether Mentor falsified data on its implants. The investigation was closed in 2002 with the U.S. attorney declining to prosecute, the report said.

The report found some of the data used to support the two companies' applications was weak, one of the allegations made by the groups seeking the congressional investigation. That data either did not include information on women who had dropped out of a long-term study or included only limited information on the health consequences for women whose implants had ruptured, according to the report.

Silicone-gel breast implants were first sold in 1962, before the FDA required proof that all medical devices be safe and effective. In 1992, they were banned amid safety concerns. At the time, women worried they caused a variety of diseases, including cancer and lupus. Alarming cases of ruptures only added to the concern. Silicone implants now are available to women only as part of research studies.

The implants do not last a lifetime, and eventually must be removed or replaced, the FDA says.

" This report is hardly an exoneration of this device in terms of its serious safety problems, " said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, which opposes the reintroduction of the implants

..

Thousands of lawsuits forced Dow Corning Corp., which had manufactured silicone breast and other implants, into Chapter 11 in 1995. The company emerged in 2004, after setting aside $2.35 billion to settle claims.

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www.BreastImplantAwareness.org