The FDA gave approval to two companies, Allergan Inc., of Irvine Calif., and Mentor Corp, of Santa Barbara, Calif., to market the implants to all women aged 22 and older. Until now, women have only been allowed access to the implants as part of research studies.
"In 1992 the FDA required manufacturers to stop selling silicone gel-filled breast implants because of lack of data to support marketing approval," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said during a late afternoon news conference.
"What is different today is the amount of clinical and non-clinical data now available on these devices," Schultz said. Based on this new data, the FDA believes the implants are safe and effective, he added.
Allergan and Mentor have gathered the information the FDA required, Schultz said. "FDA's decision was based on a thorough review of the companies' core studies," he said. In addition, the FDA inspected their manufacturing facilities, and "these implants will be manufactured according to FDA's quality system regulations," he added.
To ensure that the products continue to be safe, the FDA has required the manufacturers to continue studies for 10 years, and to have the risks clearly stated on the products' labeling, Schultz said.
"Women should know that breast implants are not lifetime devices," Schultz said. "A woman will likely need additional surgeries on her breasts, at least once over her lifetime."
In reaching the decision, the FDA considered the risks and benefits of silicone implants," Dr. Donna Bea-Tillman, FDA's director of the Office of Device Evaluation, said during the news conference.
"Although there were a number of complications reported in the core studies, including breast hardening, breast pain, breast implant rupture, and the need for additional surgery, most of the women in the core studies reported being satisfied with their results," she said.
In addition, the FDA looked at a report by the Institute of Medicine, which found no cases of connective tissue disease or cancer associated with silicon implants, Bea-Tillman said.
The watchdog group Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988. At that time, they petitioned the FDA to ban them after receiving numerous documents from FDA scientists concerned about their safety.
"The moratorium has been on for 14 years, and there is a lot of pressure from various places, from companies and plastic surgeons, to approve them," Public Citizen's Dr. Sidney Wolfe said. "It doesn't make any sense to approve them now."
Wolfe noted that saline implants are safer and a viable alternative to silicone.
"Saline implants have been approved for a long time," Wolfe said. "We never opposed the approval of those. When a saline implant ruptures, salt water, which is what we are made of, leaks out. When silicone implants rupture, a third of a quart of sticky, highly reactive, silicone gel goes out. It's just a black -and-white difference in terms of the dangers."
According to Public Citizen, the dangers of silicone implants, such as high rates of rupture, the need for repeat surgery and clear evidence of lymph node infiltration and damage by leaked silicone, were known when the devices were approved.
"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,' " Public Citizen said in a prepared statement.
source - HealthDay