FDA needs to provide breast implant patients and physicians with unreported industry data about quality of life, connective tissue symptoms, rupture rates per patient, and other complications

January 5, 2012 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective … Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, regarding maintaining and strengthening conflict of interest policies for advisory committees

August 3, 2011. In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases. Continue reading

Report: Medical Devices Lack Evidence of Safety and Effectiveness

July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe. Continue reading

Study on Medical Device Recalls Released Today

February 14, 2011. Our new study 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 on February 14 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

Statement of Diana Zuckerman, Ph.D. President National Research Center for Women & Families Regarding Senate Bill 1449 Bisphenol A-Free Children and Babies Act

FEBRUARY 1, 2010 Thank you for the opportunity to testify about Senate Bill 1449 on behalf of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund. Our Center is dedicated to improving the health … Continue reading

Circulatory System Devices Panel Meeting: Slide Presentation- Diana Zuckerman, Ph.D President, National Research Center for Women & Families

January 25, 2011. Researchers have reported that more than 20 percent of the almost one million AEDs in circulation were recalled by the FDA. Hundreds of people have died due to AED malfunctions. Innovation in design isn’t worth anything if the product doesn’t work when needed. Continue reading