NRC In the News

Statement of Dr. Diana Zuckerman on FDA Approval of new Silicone-Gel Breast Implant Natrelle 410

February 21, 2013. Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc. Unfortunately, Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market. Read More >

Metal Hip Implants Face Tighter Controls

Wall Street Journal. January 18, 2013. Diana Zuckerman, president of the National Research Center for Women & Families, said: “There are so many shortcuts at the FDA device center that they often take a shortcut and approve a product with minimal safety testing.” Read More >

Interview with Dr. Diana Zuckerman on the Dangers of Anti-psychotic Drug Overuse in Nursing Homes

Healthcare Policy Podcast, December 21, 2012. During this 30 minute interview, Dr. Zuckerman discusses the long-standing and widespread overuse or misuse of anti-psychotics in medicating nursing home residents. Read More >

Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t

Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. Read More >

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Tens of thousands of defective silicone breast implants were recalled in Europe in 2011–12 soon after the FDA’s unrelated announcement that a rare cancer of the immune system was associated with all saline and silicone gel breast implants. These developments raised questions about whether U.S. and European regulations were protecting patients from unsafe medical implants. Read More >

No Need for Skin Preps to Be Sterile, FDA Told

December 13, 2012. MedPage Today. Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday. “We need to have better communication that a product is not sterile,” Dr. Jennifer Yttri said, adding that could come from product labeling. Read More >

J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?

December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Read More >