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Breast Implant Data Sought

Safety: A House panel asks the FDA to turn over documents about studies presented by two manufacturers.

July 13, 2002|From Bloomberg News

A House panel is investigating the safety and effectiveness of breast implants made by Mentor Corp. and Inamed Corp.

The committee asked the Food and Drug Administration to turn over documents about studies presented by the companies at a Tuesday meeting.

Both Mentor and Inamed are based in Santa Barbara.

The studies showed that more than 25% of women who receive saline implants to increase the size of their breasts will undergo another breast operation within five years, House Energy and Commerce Committee Chairman W. J. "Billy" Tauzin (R-La.) wrote in a letter to FDA Deputy Commissioner Lester Crawford.

Many of the women needed additional surgery to correct problems, including leaking, wrinkling and deflation of the implants, the letter said.

Tauzin also wants an update of the FDA's criminal investigation of Mentor's safety studies on the implants, which was first disclosed two years ago.

Tauzin asked for all FDA records relating to Mentor since Jan. 1, 2001. Lawmakers want the documents by July 25.

The legislators' letter cited a Washington Post article reporting that some members of the FDA advisory panel expressed serious concerns about the results and the nature of the studies presented at this week's meeting.

Peter Nicholson, a spokesman for Inamed, disputed the paper's account and said the advisory panel's members were "very complimentary" of the information Inamed presented.

"We would cooperate with any request from FDA or Congress," Nicholson said. "We have a strong commitment to conducting clinical work at the highest ethical level."

Mentor said the data presented by both companies Tuesday were consistent with data previously released and confirm the safety and efficacy of saline implants.

Chief Executive Christopher Conway also said Mentor has been cooperating with the FDA investigation that began several years ago, but the company has not been able to find out what the investigation is about.

On Nasdaq, Mentor fell $7.83 to $26.95 and Inamed fell $3.64 to $13.56.

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