Fw: Helman's letter to the editor of the Vero Beach Press Journal

[Guest guest]

----- Original Message ----- From: Zuckerman

Undisclosed-Recipient:;@...

Sent: Tuesday, November 04, 2003 7:59 PM

Subject: Helman's letter to the editor of the Vero Beach Press Journal

Congrats to Helman, whose letter to the editor was published today in her local newspaper, the Vero Beach, FL Pree Journal.

As you know, we are helping women shape their testimony and personal stories into opinion articles. We'd prefer to have them published as articles, but some newspapers will publish them as letters to the editor instead. It all helps to educate other women, and to educate the editors, reporters, and Congressmen who read their local papers.

Let us know if you'd like our help.

Best wishes,

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families

FDA fails public on silicone implants

On Oct. 15 and 16, a Food and Drug Administration advisory panel met to consider the approval of silicone breast implants.

In a sharply divided 9-6 vote, the panel recommended approval of silicone breast implants, despite inadequate data to support even short-term safety — and lack of information on long-term safety.

I gave my testimony regarding my experience with implants. Unless they can be proven safe beyond a reasonable doubt, they should not be available. The first statement in the Hippocratic Oath is: "First, do no harm."

The FDA has failed the public by not requiring manufacturers to conduct longer-term clinical trials of these devices during the decade these devices were on the market in a restricted capacity.

The panel unanimously voiced concern that there was not sufficient data to support safety, questions regarding rupture, association with connective tissue disease and lack of information on long-term safety.

In the end, the panel, anchored by four plastic surgeons, voted to approve — but only swayed by the promise of unfeasible post-approval conditions by the manufacturer. Representatives of the FDA at the panel meeting acknowledged that the agency doesn't have the regulatory authority to enforce post-approval conditions.

It is clear that there is not sufficient safety information to approve these devices. I am concerned how the FDA will respond.

Close to 1 million women are expected to seek implants over the next three years and will probably choose silicone breast implants. I strongly urge the FDA, which has the responsibility for ensuring safe medical devices, not to approve silicone breast implants until their safety can be established.

A. Pope Helman Vero Beach