WASHINGTON — The Food and Drug Administration's (FDA's) November re-approval of silicone breast implants has prompted Rep. Rosa L. DeLauro, D-Conn., to begin efforts to call Congressional hearings to determine whether the implants are indeed safe. "I have very serious concerns about FDA's decision to approve the use of silicone breast implants given the unproven safety record of these devices and recent allegations that one of the manufacturers failed to submit important safety data to the FDA," Rep. DeLauro tells Cosmetic Surgery Times . "This appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests."
HIGH-PROFILE HISTORY First available in the united states in the 1960s, silicone implants did not undergo rigorous studies until 1991, when the fda called for more stringent research in the wake of leakage and health complaints. This led to the fda pulling the implants from the mainstream market in 1992, allowing them only for patients having reconstructive surgery or pre-existing implant replacement. In 1999, results of an institute of medicine report suggested that silicone implants did not boost the risk of connective tissue disease, cancer or immune disorders, and in 2000, a study published in the new england journal of medicine concluded that the implants did not cause systemic disease. These studies and others reportedly influenced the FDA's decision to lift the ban on silicone implants late last year.
MARKET RUSH Rep. DeLauro says she thinks the FDA's lifting of that ban was far too precipitous — hence her effort to convene hearings. "A number of questions remain regarding the long-term safety of breast implants," she says. "This is evidenced by the additional conditions the FDA placed on the manufacturers."Rep. DeLauro says hearings would go a long way toward making sure silicone implants are indeed safe, and, on a larger scale, may shed light on what many perceive to be FDA decisions based more on corporate influence than on science. "Scientific data should trump the rush to the market," she says. "The manufacturers still need to do more long-term studies and provide additional information. And questions about the integrity of company safety data that came from within the company still remain. That is why I think Congress needs to look into the agency's approval process and ensure that the FDA makes decisions based on science and not on corporate and political considerations." Rep. DeLauro says hearings on the FDA's decision to lift the ban on silicone breast implants would shed more light on the approval process to ensure science is the determining factor in the future, and that hearings "would offer guidance on the next steps." An aide to Rep. DeLauro states that no date has been set for the proposed hearings.