- The Washington Times - Thursday, April 14, 2005

Wednesday’s approval by a Food and Drug Administration advisory panel of the sale of a silicone breast implant brand has improved the chances for more implants to re-enter the market after a 13-year ban, industry analysts said yesterday.

?This vote has absolutely opened the door for Inamed [Corp.] and other companies to mimic what Mentor [Corp.] did,? said Amit Hazan, a medical device analyst with SunTrust Robinson Humphrey Capital Markets, a division of Atlanta banking company SunTrust Banks Inc.

The FDA panel, which regulates the sale of medical devices, voted 7-2 in favor of allowing breast-implant manufacturer Mentor to sell its silicone-gel-filled breast implants, but imposed strict conditions.

The vote came one day after the same panel voted 5-4 to reject a similar request from breast-implant competitor Inamed Corp.

Mentor’s shares on the New York Stock Exchange jumped $2.58, or 7 percent, to close at $37.91 yesterday, while Inamed dropped $3.21 to $60.30 on the Nasdaq Stock Market.

The FDA in 1992 banned the use of silicone implants, except for specialized cases, because of health concerns that leakage could cause long-term defects or diseases.

Senior analyst Juan Noble, with New York investment bank Oppenheimer & Co. Inc., said the recent vote signaled the best chance so far for silicone implants to be sold again in the United States.

But the FDA could reject the panel’s vote. The agency has not said when it will rule.

The FDA last year turned down a similar silicone-implant bid from Inamed even though an advisory panel had said the product should be sold again.

Mr. Noble, who does not own Mentor or Inamed stock, lowered his rating for Inamed to ?neutral,? while keeping his ?buy? rating for Mentor. Oppenheimer has no banking relationship with either company, which are both headquartered in Santa Barbara, Calif.

Mr. Hazan, who yesterday raised his Mentor stock rating to ?buy,? said he expected to see more silicone implant manufacturers seek FDA approval in the next few years.

Long-term data on the rupture rate of silicone implants likely would be the determining factor for FDA approval, he said. Mr. Hazan does not own any stock, but SunTrust owns less than 1 percent of Mentor stock.

Dr. Donald Kress, a Frederick, Md., plastic surgeon who performs on average five breast-implant surgeries a week, said he looked forward to a chance to use silicone implants for his healthy patients.

?For young women who would like to have implants, the only thing we can offer them are saline implants, which are unbelievably unsatisfactory,? he said.

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