FDA: Breast Implant Safety Studies Will Continue

Web MD, August 31, 2011. After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue. Public health research director of the National Research Center for Women & Families, Dana Casciotti, said the 27 page questionaires that are currently being used in the studies are too long and ineffective. In order for the studies to be successful, the questionaires need to be shortened.

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FDA Affirms Safety of Breast Implants

The New York Times, August 31, 2011. Dr. Diana Zuckerman, president of National Research Center for Women & Families, told an FDA advisory panel that Allergan and Mentor did a poor job studying patients that got silicone implants.

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Experts Say Medical Device Review System Flawed

The Miami Herald, July 29, 2011. NRC President Diana Zuckerman expresses concern over the vast majority of medical devices being cleared through the 510(k) process—a process which has been described as “flawed” by Institute of Medicine panelists in a new report.

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