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

[Guest guest]

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.

A little late isn't it?

I will never trust FDA approval again. As far as I am concerned, it is

meaningless.

> http://www.rednova.com/news/health/248014/

californiabased_firm_gets_fda_approval_to_widen_sales_of_breast/index.html?

source=r_health

>

> 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.

>

> -----

>

> To see more of The Boston Globe, or to subscribe to

> the newspaper, go to http://www.boston.com/globe.

>

> Copyright © 2005, The Boston Globe

>

> Distributed by Knight Ridder/Tribune Business News.

>

> For information on republishing this content, contact

> us at (800) 661-2511 (U.S.), (213) 237-4914

> (worldwide), fax (213) 237-6515, or e-mail

> reprints@k...

>

> IMDC, MNT, STI,

>

>

>

> Source: The Boston Globe