FDA Panel Issues Regrettable Decision on Silicone Gel-Filled Breast Implants

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FDA Panel Issues Regrettable Decision on Silicone Gel-Filled Breast

Implants

http://www.now.org/press/04-05/04-13.html

April 13, 2005

" The Food and Drug Administration (FDA) advisory panel's decision is

deplorable, " said NOW President Kim Gandy. " In light of dramatically

insufficient data and overwhelming reports from women who believe

they suffered injury and illness from silicone gel-filled breast

implants, they favored corporate greed over women's health. "

Despite the FDA's request 15 months ago for long-term studies that

might indicate safety and effectiveness, the FDA panel approved 7-

to- 2, with conditions, a Mentor Corp. application to bring silicone

breast implants back onto the general market. These implants were

removed from general use in 1992.

The conditions attached to the approval included requirements for

more detailed studies relating to rupture and illness as well as

training for physicians and independent data monitoring.

" Implant manufacturers and plastic surgeons have utterly failed to

monitor and evaluate women with implants over a longer period of

time, " said Gandy. " The data with regard to health consequences when

silicone implants leak or rupture are still lacking. "

Most serious problems become manifest at 10 to 12 years after

implementation. This means that current studies fall short of

providing women with a complete set of data to advise them of the

implants full medical risks and options.

Today's action backtracks on the agency's stated intent — to

strengthen the scientific basis through longer-term studies and use

this information to base their final decision about allowing

silicone implants back on the general market.

" Manufacturers had 12 years to conduct detailed studies on

reconstruction and other patients who have received silicone gel-

filled breast implants in clinical trials, yet this has not

happened, " said Gandy.

In a 5-to-4 vote Tuesday, the FDA panel rejected a similar

application from Inamed Corp. based on reasons of insufficient data.

NOW urges FDA interim commissioner Lester Crawford and other top FDA

officials - who will review the advisory panel recommendations - to

issue their final decision in the best interest of women's health

and not corporate profits.