Medical Journal Articles

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 >

Hip Implant Failure for Men and Women: What and When We Need to Know

Invited Commentary by Diana Zuckerman, PhD in JAMA Internal Medicine, published online February 18, 2013 Total hip replacement is a popular procedure that is increasing as baby boomers age. A new study by Inacio et al in this issue … Read More >

Antibiotic Uses and Challenges — A Comprehensive Review From NRC

Medscape. June 16, 2010. Diana Zuckerman, president of the National Research Center for Women & Families co-writes a review of antibiotics. The goal of the review is to help primary care physicians prescribe the correct antibiotics for their patients. Read More >

Medical Device Recalls and the FDA Approval Process

Archives of Internal Medicine, February 14, 2011. Research done by Dr. Zuckerman, President of the National Research Center for Women & Families, et. al provides convincing evidence that the process used to clear medical devices for use on patients needs to be reformed to ensure safety. Read More >

Medical Device Recalls: Get it Right the First Time

Archives of Internal Medicine, February 14, 2011. Dr. Rita Redberg, Chief Editor of “The Archives of Internal Medicine”, agrees with Dr. Diana Zuckerman, President of the National Research Center for Woman & Families, that the public deserve better protection from unsafe medical devices. Read More >

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. Read More >

Medical Journal Articles

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

Hip Implant Failure for Men and Women: What and When We Need to Know

Antibiotic Uses and Challenges — A Comprehensive Review From NRC

Medical Device Recalls and the FDA Approval Process

Medical Device Recalls: Get it Right the First Time

Medical Device Recalls and the FDA Approval Process

Reasonably Safe? Breast Implants and Informed Consent

Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction

Reconstructive Breast Implantation After Mastectomy