Bloomberg, October 20, 2011. President of the National Research Center for Women & Families Dr. Diana Zuckerman told Bloomberg that the 501(K) FDA approval process has become a gateway for high-risk medical devices such as joint implants and vaginal mesh that can claim a tie to older products.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
Left to Their Own Devices
The Economist, September 10, 2011. Scandals, recalls, stingy customers, anxious regulators—any one of these would traumatise a chief executive. America’s industry for medical devices is suffering from all of them. Omar Ishrak, the new boss of Medtronic, the world’s biggest medical-technology company, recently described the problem succinctly to analysts: “There is a lot of work ahead of us.”
Read More »FDA Advisers Urge Closer Scrutiny of Pelvic Mesh
Associated Press, September 8, 2011. Diana Zuckerman, president of the National Research Center for Women & Families tells the Associated Press about the necessity for studies on pelvic mesh.
Read More »FDA Eyes Registry for Breast Implants Problems
Reuters, August 31, 2011. U.S. health regulators said they would consider setting up a registry that tracks safety problems with breast implants, after too many patients dropped out of company-funded studies. NRC president Diana Zuckerman brings up the fact that Allergan has three times more patients participating than the other manufacturer of silicone breast implants Mentor, and that they needed to be held responsible.
Read More »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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