Press Releases
Coalition Partner Consumers Union’s Press Release on the De Novo Process and High-Risk Medical Devices
Consumers Union, one of our partners in the Patient, Consumer, and Public Health Coalition released a public news release on our recent letter to FDA Commissioner, Dr. Margaret Hamburg on the de novo approval process and high-risk medical devices. Read More
Study Suggests Women Have Higher Risk of Hip Implant Failure
A February 2013 study in JAMA shows that women have a higher risk of implant failure than men following total hip replacement. In a commentary, NRC President Diana Zuckerman stresses that long-term comparative effectiveness data would enable patients and their physicians to choose the hip devices and surgical techniques that are most likely to be successful for a longer period. Read More
The National Research Center for Women and Families Responds to the Silimed Breast Implant Scandal
Polyurethane foam-covered implants were banned in the U.S. over two decades ago, but versions were still sold in Europe for the last ten years exposing how lower safety standards for medical devices have hurt tens of thousands of men and women. Read More
A Stronger State of the Union: Safe Medical Devices
When the safety of medical devices is compared to toxic waste dumps and financial scandals, it reflects a sea change in awareness for the public and the White House. The President is right: patients are dying and being permanently injured … Read More
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. Read More
Congresswoman Rosa L. DeLauro Responds to Breast Implant Safety Report
June 22, 2011. In response to the FDA breast implant safety report, Congresswomen DeLauro asks the FDA to require and enforce more rigorous post-market studies of medical devices. Read More
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. Read More
NRC for Women & Families responds to FDA’s proposed changes to the review of medical devices
January 19, 2011. Reading the FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments. FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results. Read More
NRC for Women & Families responds to the announcement that Joshua Sharfstein is leaving his post of FDA Deputy Commissioner
January 4, 2011. His efforts have saved lives and those of us who care about patient safety and public health are very sorry to see him leave. Read More
NRC for Women & Families responds to FDA’s decision to ban Darvon
November 19, 2010. The FDA has been slow to require data ensuring its safety, and now finally has decided its risks outweigh its benefits. Read More