FDA backs decision to return silicone breast implants to market, despite frequent problems

Associated Press. June 22, 2011. President of the National Research Center for Women & Families, Diana Zuckerman, explains that missing data in the largest, most important studies on silicone gel breast implants weaken the quality of the studies and, therefore, the conclusions provide inadequate, useless information for consumers, health professionals, and the public. Continue reading

Most women with silicone breast implants need more surgery

MSNBC. June 22, 2011. Diana Zuckerman, president of the National Research Center for Women & Families, says the studies the FDA used to say silicone implants are safe are incomplete. In addition, Zuckerman claims women need to understand that when they get breast implants they may need removal or replacements for the rest of their lives. Continue reading

FDA seems to take light approach to Allergan and Lap-Band

LA Times. February 22, 2011. Dr. Diana Zuckerman, president of the National Research Center for Women & Families, criticizes the FDA’s recent approval of the lap-band surgery for the less obese; there is not sufficient evidence to ensure the safety of this procedure and the time to ask for better research is before you say yes. Continue reading

Medical Device Recalls and the FDA Approval Process

February 14, 2011. Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Continue reading

New Study Shows that Most Medical Devices Recalled for Life-Threatening Problems Were Not Tested on Patients

EMBARGOED FOR RELEASE: 4 P.M. (EST), MONDAY, FEBRUARY 14, 2011. A new study released today finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Continue reading