Fw: FDA Guidance for Approval of Breast Implants Calls for Limited Long-Term Data

[Guest guest]

Hard to believe...what in the world are these people missing??? What can't

they see??? (Money is blinding their eyes, I guess....) It looks like the

nightmare may continue for unsuspecting women with the possible return of

silicone gel implants to the market in the near future. What a scam...

Patty

----- Original Message -----

From: " ilena rose " <ilena@...>

<Recipient List Suppressed:>

Sent: Sunday, August 19, 2001 11:59 AM

Subject: FDA Guidance for Approval of Breast Implants Calls for Limited

Long-Term Data

> (NOTE from EILEEN: I am sickened by this. Two years is no where

NEAR

> long enough to be considered long term...)

>

> WASHINGTON (Reuters Health) Aug 13 - Makers of breast implants will only

> need 2 years worth of safety data to earn approval >from the US Food and

> Drug Administration (FDA), according to an agency guidance document

issued

> on Monday.

> The guidance document comes at a time when the FDA is looking at the

> possible approval of at least one silicone gel-filled breast implant to

be

> manufactured by Mentor Corporation of Santa Barbara, California.

>

> In recent years, the distribution of silicone breast implants basically

> ceased after consumer groups raised several safety concerns, including the

> long-term risk of cancer. But because it has since been determined that

the

> greatest risk is posed by local complications rather than systemic

diseases

> such as cancer, the FDA said that it would now only expect additional

> follow-up if patients underwent a removal and replacement.

> According to the FDA, the greatest risks are the need for replacement,

> breast pain, wrinkling, pinching and leakage and deflation. These local

> complications are also in many ways unavoidable since all breast implants

> eventually will fail, the FDA previously has noted.

>

> In May 2000, the FDA also observed that while these risks are apparent, it

> actually was up to physicians and women to make the decision whether the

> breast implants are still warranted. The FDA observation was made in

> connection with its approval of two saline-filled breast implants made by

> Mentor Corp. and McGhan Medical Corp., also from Santa Barbara,

> California.

> Manufacturers now want to pursue the approval of silicone-filled breast

> implants because these products reportedly feel more natural.

> A full copy of the FDA's latest guidelines for the approval of breast

> implants is available on the agency's web site at

> http://www.fda.gov/cdrh/ode/guidance/1354.html.

>

>

>