Regulatory Reticence and Medical Devices

The Milbank Quarterly, March 6, 2014. Our analysis of the recent history of device regulation in the United States, however, leads to a less optimistic conclusion: that these changes in regulatory policy fail to adequately address the central shortcoming in the regulation of medical devices in the United States and Europe.

Read More »

Comment on ‘Statement on Combined Hormonal Contraceptives Containing Third- or Fourth-Generation Progestogens or Cyproterone Acetate, and the Associated Risk of Thromboembolism’

Journal of Family Planning and Reproductive Health Care, July 8, 2013. 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 ‘Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism’ raises such concerns.

Read More »

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

Reproductive Health Matters, December 2012. 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 »