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

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. Continue reading