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.