FDA endorses 2d firm on silicone implant sales
Inamed gave agency more safety data after its rejection in April
WASHINGTON -- The Food and Drug Administration yesterday told a second manufacturer it is willing to approve wider sales of its silicone gel-filled breast implants, which are expected to return to the US market by year's end.
Inamed Corp. received the same conditional FDA approval as its rival, Mentor Corp., did in July. The agency took a more lenient stance with Inamed than did federal advisers who in April rejected the company's application by a 5-4 vote.
''Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the FDA said in a statement. In addition, Inamed withdrew from consideration an implant responsible for the highest rupture rates. Federal advisers had worried about the long-term safety of the implants, since they can leak silicone gel with little warning.
After the FDA's action, Inamed stock climbed higher, closing at $77.42, up 8.9 percent. Mentor stock fell 3.5 percent, closing at $50.70.
Women say silicone gel implants look and feel more realistic than versions filled with saltwater. An analyst who follows both companies said silicone implants could be sold more widely in the United States by the end of the year. The market is worth about $300 million annually.
Manufacturers began selling silicone gel implants in 1962, before manufacturers had to prove safety and efficacy to earn FDA approval. The FDA imposed a near-total ban in 1992 due to safety concerns, and an avalanche of class action lawsuits followed. Since then, women who survived breast cancer have been among the few allowed to get silicone implants. The reconstructive market accounts for 25 percent of implant sales in the United States, said Amit Hazan, a SunTrust Robinson Humphrey analyst.
Silicone implants are expected to begin edging out saline implants quickly, with $75 million in sales expected in 2006, Hazan said. Already, the pricier silicone implants account for 90 percent of European sales, he said.
The prospect of relaxing one of the FDA's highest-profile bans resulted in often emotional testimony in April.
Women scarred by early-generation, defective implants cautioned the FDA to protect others from similar suffering. Poster-sized photographs of failed implants extruding from breasts lined the hallway of the hotel where federal advisers gathered.
A national association representing plastic surgeons went on a promised offensive to counter the expected opposition. It paid travel expenses for scores of healthy women and their doctors to testify before the federal advisers in favor of relaxing restrictions on implants.
The dispute continued yesterday, as women's advocates accused the FDA of signaling it will approve an application without sufficient safety data.
''Whether it's a breast implant or a heart valve or a pain medication, it has to be proven safe," said Diana Zuckerman, the president of the National Research Center for Women and Families.
Some attributed the April rejection to fewer plastic surgeons on the advisory panel than at an earlier session, when federal advisers voted 9-6 in favor of Inamed's application.
This week, the Senate approved legislation that would inform the public about possible conflicts of interest among such FDA advisory panels, in most cases, no fewer than 15 days before a meeting.
Diedtra Henderson can be reached at dhenderson@globe.com. 
