Women and Medical Devices: the Dangerous Reality

Women are understudied and underserved when it comes to the testing and development of medical devices.  

Dr. Nancy Lynch, MD writes:

Women are less frequently asked to participate in clinical trials than men. Furthermore, when asked, we opt out of participation in those same trials at higher rates than men. As such, trial results (among other things) may not accurately reflect treatment effects and/or safety issues in women. That’s left up to the real world to discover after the product is on the market.

Many people are stunned to find out that women were historically excluded from Phase 1 clinical trials, rendering many gender-specific risks unknown. Though the FDA changed this policy in 1993, women remain consistently underrepresented in medical device evaluations 

As a result, women suffer disproportionately from the effects of dangerous and defective medical devices.  A shocking recent example of this is the metal on metal hips, which are believed to have a more devastating effect on women’s health. 

Dr. Lynch suggests these first steps to improving medical devices for women:

The FDA is committed to an ongoing, interactive, multidisciplinary dialogue on this serious and complex topic. You can contribute by broadening your awareness of these issues (Gendered Innovations is an intriguing place to start), putting a gender lens in front of your gaze to see the opportunities, and then interjecting this subject as a recurring theme in your personal and professional conversations. Create a ripple effect by frequently engaging others. That’s the source of change. And who better to bring about that change than the 51%

Gender-specific devices, such vaginal mesh, are a multi-billion dollar industry and often plagued by corporate neglect and serious health risks.  For decades, manufacturers have put thoughts of health concerns to the side as they marketed their products.

Another outrageous reality both women and men face after being injured by a defective product is that they may not be able to hold the manufacturer legally accountable because of a 2008 U.S. Supreme Court decision, Riegel v. Medtronic

Not only did this decision limit access to justice for Americans who are injured or even killed by some defective products, it also reduced the incentive for medical devices corporations to fully consider the safety implications of their products before marketing them to consumers.