New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

January 5, 2011. A closer examination of the data regarding the FDA-approved breast implants made by Mentor and Allergan, however, indicates numerous errors and missing information in the FDA’s most recent research summary (published online in June 2011), as well as in the information the agency provided to their Advisory Panel that met to discuss breast implants in August 2011. 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