Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading

Comment on ‘Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism’

Mishka Terplan and Diana Zuckerman From the Journal of Family Planning & Reproductive Health Care Despite the increased interest in evidence-based medicine, many medical guidelines and statements of medical professionals are based primarily on opinion rather than scientific facts. The … Continue reading

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. Continue reading