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 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.

Read More »

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.

Read More »