Medical devices and women's health: Are loopholes putting women at risk?

The public health community and Congress have become increasingly concerned about the FDA's safety record regarding prescription drug approvals. Some of the FDA's most controversial decisions and failures, however, have involved medical devices rather than drugs. The FDA did not regulate medical devices until 1976; a law was passed after widely-sold IUDs were found to cause infections leading to infertility and even death. In the more than 30 years since then, many medical devices, including permanent implants, have been approved by the FDA without proof of either safety or efficacy. Stents, defibrillators, and contact lens solution (ReNu with MoistureLoc) are just three recent examples of products regulated as medical devices that have been found to be more dangerous than expected. This presentation will explain the FDA process of approval for medical devices and the loopholes that have resulted in the widespread use of medical devices that may not be proven safe or effective. These issues will be described using specific examples of medical devices that are used disproportionately by women.