Groups Call for Delay in FDA Approval of Silicone Breast Implants
A coalition of advocacy groups on Tuesday asked FDA to delay approval of silicone breast implants manufactured by Mentor until the medical device company provides long-term safety data, USA Today reports (Rubin, USA Today, 8/10). FDA officials last month indicated that they likely will approve an application from Mentor to market the implants, provided that the company meets certain conditions.
Donna-Bea Tillman, director of the FDA Office of Device Evaluation, said that the agency sent Mentor an "approvable" letter, but she did not specify the conditions for approval. The letter followed an FDA advisory committee recommendation that the agency approve the implants under certain conditions (California Healthline, 7/29).
A number of advocacy groups have criticized the FDA advisory committee's recommendation. Ten groups, including the National Organization for Women, have issued complaints about how FDA has addressed the Mentor application. In addition, the Senate Health, Education, Labor and Pensions Committee has launched an investigation into whether conflicts of interest might have influenced the expected approval of the Mentor application (Henderson, Boston Globe, 8/3).
At a news conference on Tuesday, the advocacy groups alleged that Mentor manufactured "defective implants" and provided FDA with "fraudulent and misleading data," the Baltimore Sun reports. Cindy Pearson, executive director of the National Women's Health Network, said, "We can't risk another Dalkon Shield," a reference to a contraceptive intrauterine device removed from the market in 1974 after reports linked the device with pelvic inflammatory disease (Rockoff, Baltimore Sun, 8/10).
Kim Gandy, president of the National Organization for Women, said, "FDA Commissioner Lester Crawford is rewarding a company that has been accused by former employees of falsifying and withholding data about these implants and was the subject of a long criminal investigation by the very agency he heads" (CQ HealthBeat, 8/9). She added that NOW has submitted a Freedom of Information Act request to obtain details about the conditions for approval of the Mentor application, as well as documents related to an FDA investigation of allegations against the company.
Diane Zuckerman, head of the National Research Center for Women and Families, said, "We know that implants do break in the body. We need to know what happens to women when that silicone is leaking in their body" (USA Today, 8/10). She said that FDA should require "studies of a few thousand women and what happens to them over time" to ensure the safety of the implants (CQ HealthBeat, 8/9).
Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The dangerous doctrine of approve now and test later must be firmly rejected" (Kopecki, Dow Jones/Wall Street Journal, 8/10). Wolfe said that Public Citizen likely would file suit to block sales of the implants in the event FDA approves the Mentor application (CQ HealthBeat, 8/9). The groups also called for addition congressional investigation into the issue (Baltimore Sun, 8/10).
FDA spokesperson Julie Zawisza said the agency has reviewed data from long-term studies provided by Mentor that indicate the safety and efficacy of the implants. She added that objections from the advocacy groups will not affect the FDA review of the Mentor application. "It's not that we turn a blind eye to public concerns -- we absolutely don't. But at the end of the day, we still have to look at the scientific and technical data to make our decision," Zawisza said (Baltimore Sun, 8/10). Zawisza also said that "there was a very thorough investigation by FDA" of the allegations made by former employees and a former FDA inspector, adding, "There was not sufficient evidence to support prosecution" (CQ HealthBeat, 8/9). Zawisza said that FDA by law cannot release information about products currently under review (USA Today, 8/10).
Mentor CEO Josh Levine said the issues raised by the groups are "old news." He added, "These groups are once again raising unfounded allegations from a lawsuit that was dismissed after (the court involved) reviewed all the facts and evidence. FDA conducted an investigation that we believe included these allegations and closed the file with no action taken." Levine also said that FDA and the agency advisory committee "rigorously and objectively reviewed Mentor's data and related science," adding, "We remain confident this scientific process will not be complicated by old accusations from parties with agendas that go well beyond the safety and efficacy of these products" (CQ HealthBeat, 8/9).