8 avril, 2005 20:52
Breast Implant Panel Leader Supported Silicone Ban (Update1)
April 8 (Bloomberg) -- The cancer surgeon chosen by U.S. regulators to lead a review of silicone breast implants opposed lifting a ban on them in 2003 because of safety concerns.
``I do not think that we have sufficient information to provide reasonable assurance of long-term safety,'' said Michael A. Choti, a professor at Johns Hopkins University in Baltimore, at an October 2003 advisory committee meeting convened by the Food and Drug Administration.
The agency overruled the panel's 9-6 vote that Inamed Corp. should be permitted to resume sales of the devices. Cosmetic use was banned in 1992 because of links to immune system diseases. Next week, the 47-year-old Choti will be chairman of a 13-member committee of doctors and scientists weighing a new petition by Inamed and Mentor Corp. to bring back silicone implants.
The panel will probably vote against the proposal, Lazard Freres & Co. analyst Alex Arrow said in a voice mail to clients and reporters yesterday. The FDA, under scrutiny over its monitoring of safety, asked Pfizer Inc. yesterday to withdraw its Bextra pain drug because of links to heart and skin diseases, rejecting the advice of an advisory committee.
``The crux of the panel discussion will center on rupture- rate data over the so-called long term, apparently defined as 10 years after each patient's surgery,'' Arrow said in the voice mail. He predicted a 6-5 decision to turn the companies down. Not all the panel members vote, including chairman Choti, except to break a tie.
Concern Over Ruptures
When ruptures occur, silicone gel can escape into the body and has been linked to connective-tissue disorders. The silicone can migrate to the armpit, chest wall and abdomen. Dow Corning Corp. agreed in 1998 to pay as much as $3.2 billion over 16 years to settle claims from more than 300,000 women who said they were harmed by its silicone breast implants.
Choti declined through an assistant to comment before the panel meeting. He was concerned at the 2003 hearing about diagnosing ruptures, according to the FDA's transcript.
``I don't think any physician, perhaps including myself, (would) be able to detect easily what rupture would look like,'' Choti said at the meeting.
Groups including the National Organization of Women are protesting the Mentor and Inamed bids to bring back silicone implants. Congress and consumer groups have pressured the FDA to take a tougher stand on the safety of medical treatments since Merck & Co. withdrew its Vioxx painkiller, which was similar to Bextra, because of a link to heart attacks and strokes.
Data's `Limited' Value
The FDA asked Choti's panel to consider the potential consequences of ruptured silicone implants. The agency said it rejected Inamed's first application largely on concerns about leakage of silicone gel.
In its review of the new Inamed application, the FDA staff found the data on implant ruptures of ``limited'' value. The FDA prepared its review to brief Choti and other panel members for the April 11-13 meeting in Gaithersburg, Maryland.
The FDA committee will include eight members of the 2003 group, including Choti. He wasn't chairman of the earlier panel.
Returning panelists who in 2003 voted for allowing a resumption of sales include three surgeons and a specialist in the study of failure of medical devices.
They are Stephen Li, president of Sarasota, Florida-based Medical Device Testing Innovations LLC, and surgeons Marilyn Leitch of University of Texas Southwestern Medical Center in Dallas, Michael Miller of University of Texas M.D. Anderson Cancer Center in Houston and Michael Olding of George Washington University School of Medicine in Washington.
Returning `No' Votes
Those who voted with Choti against the 2003 application include a statistician, a dermatologist and a psychiatrist. They are Brent Blumenstein of TriArc Consulting in Seattle; Amy Newberger of Scarsdale, New York-based Dermatology Consultants; and Louisiana State University psychiatry professor Barbara Manno.
The new members of the panel include Cheryl Ewing, an assistant professor of clinical surgery at the University of California-San Francisco's Carol Buck Breast Care Center, and Joseph Lo Cicero, chairman of the University of South Alabama's department of surgery.
Also on the panel is Leigh Callahan, an associate professor at the University of North Carolina at Chapel Hill, who studies how arthritis affects people, and Lee Doyle, an assistant dean for faculty development at the University of Arkansas, who will serve as the consumer representative.
``Net-net, the makeup seems pretty evenly balanced,'' said Amin Hazan, an analyst with SunTrust Robinson Humphrey in an April 7 note about the FDA panel.
To contact the reporter on this story:
Kerry Dooley Young in Washington at kdooley@bloomberg.net
To contact the editor responsible for this story:
Robert Simison at rsimison@bloomberg.net
Last Updated: April 8, 2005 14:33 EDT
