California-Based Firm Gets FDA Approval to Widen Sales of Breast Implants

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California-Based Firm Gets FDA Approval to Widen Sales

of Breast Implants

Sep. 22--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 U.S. 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 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

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.

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Source: The Boston Globe