BRAVO! SF CHRONICLE: Silicone implant politics

April 15, 2005

We all can write & call our local newspapers, magazines, TV

stations, radio stations with this message!

~~~~~~~~~

EDITORIAL

Silicone implant politics

Friday, April 15, 2005

FOR THOSE HOPING to get a new drug or medical device approved by the

Food and Drug Administration advisers, here's a tip: Less is more.

Just one day after an FDA panel rejected a bid by Inamed Corp. to be

allowed to sell its silicone-breast implants, panelists recommended

that Mentor Corp. be allowed to sell theirs.

Strange, considering that Mentor provided one year's less data than

Inamed.

" Yesterday, they wanted more data and today they accepted less, "

said Dan Cohen, an Inamed vice president.

Cohen's anger is understandable. If approved, sales of the implants

are expected to reach $1 billion. In addition, shares of Mentor

closed up 7.3 percent on Thursday, following the panel's vote.

Inamed, too, could be cashing in, had its data been more limited.

Mentor's study provided only 3 of the expected 10 years of data.

Because only 6 out of 420 patients had experienced implant ruptures

so far, the company argued that it must be safe.

The women's health over the next seven years is apparently not as

important as getting these money-makers on the market.

To assuage any fears, there are " conditions " on the approval,

including an educational program for doctors and monitoring of the

patients.

Maybe after 10 years, the FDA and the scores of women expected to

buy the new products will find out just how safe they really are --

or not.

Let's remember why the FDA banned the implants: Numerous reports

linked them to arthritis, vascular disease and a range of autoimmune

disorders.

Until there are more data, the FDA must reject the panel's vote and

keep the ban enforced.

If not, it will turn thousands of women into nothing more than

Mentor's guinea pigs.

Page B - 8

~~~~~~~~~~~

Recommended Posts