On this holiday cheer time ... there are untold thousands of us who
feel that the FDA caved in to the silicone industry, by granting
questionable 'safety approval' for an unproven product. We believe
this will endanger the lives of millions of women, who oft are denied
health insurance because of their implants.

The Humantics Foundation message mirrors that of Dr. Sidney Wolfe's of
Public Citizen. Bravo to his strong stance on the dangers of breast
implants. 

http://www.citizen.org/hot_issues/issue.cfm?ID=1477

Nov. 17 - Silicone gel breast implants most defective medical device
ever approved by the FDA

Statement of Dr. Sidney Wolfe, Director of Public Citizen’s Health
Research Group

Public Citizen has opposed the use of silicone gel breast implants
since the fall of 1988, when we petitioned the Food and Drug
Administration (FDA) to ban them after receiving numerous documents
from FDA scientists concerned about their safety.

In terms of adverse safety and health information known at the time of
approval – such as high rates of rupture, the need for repeat surgery
and clear evidence of lymph node infiltration and damage by leaked
silicone – silicone gel breast implants are the most defective medical
device ever approved by the FDA. The approval makes a mockery of the
legal standard that requires “reasonable assurance of safety.”

It is a terrible reminder of the double standard for women versus men
that the FDA has not approved silicone gel testicular implants because
of the inadequacy of clinical trials on these devices. (Saline breast
implants and testicular implants have been approved by the FDA.)

This approval of such a defective medical device raises again the
larger issue of the poor leadership and dangerously poor performance
of the FDA’s Center for Devices and Radiological Health (CDRH). Recent
examples of this include the large number of defibrillator and
pacemaker recalls, primarily the fault of manufacturers such as
Guidant but abetted by the lack of FDA promptness, and the approval of
the vagus nerve stimulator for depression despite the opposition of
dozens of FDA staffers because it lacked evidence of effectiveness.

We will certainly be urging thorough congressional investigations and
hearings on this lack of assertion of regulatory authority by the
FDA’s CDRH.

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