November 21, 2006
Critics are assailing the U.S. Food and Drug Administration's decision to allow the marketing of silicone gel-filled breast implants made by two companies. Public Citizen labeled them the "most defective medical device ever approved by the FDA."
"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," said Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group.
The FDA approved implants manufactured by manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif., for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.
"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
The FDA will continue to monitor the devices by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants.
Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988, when it petitioned the Food and Drug Administration (FDA) to ban them after receiving what it said 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," Wolfe said.
"The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety,'" he said.
FDA said its decision was based on a thorough review of each company's clinical and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.
In addition, FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA's Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.
However, FDA said the majority of women in the studies reported being satisfied with their implants.
FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to: conduct a large postapproval study; continue its core study through 10 years; conduct a focus group study of the patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.
The postapproval studies will continue to gather information about the safety and effectiveness of the implants. Information will be collected about rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates.
Wolfe said Public Citizen will also remain interested. "We will certainly be urging thorough Congressional investigations and hearings on this lack of assertion of regulatory authority by (FDA)," he said.
