If Device Manufacturers are Not Accountable, Women’s Health is at Risk

Gender-specific devices 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 to women.

One of the most recent devastating examples is vaginal mesh, which the U.S. Food and Drug Administration (FDA) just recently took steps to reclassify as “high-risk.” The FDA took these steps after thousands of American women held manufactures of mesh accountable in court. 

Despite concealing more than 400 complaints from the FDA, Boston Scientific could not stop its mesh from being recalled in 1999 because of high rates of erosion, extrusion, and related infection and pain.

Another outrageous reality both women and men face after being injured by a defective medical 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. The Court ruled that manufacturers of medical devices approved by the FDA’s strict review process, known as premarket approval or PMA, are shielded from accountability in court even when the devices are known to be dangerous. 

The Court’s decision gave manufacturers a get-out-of-jail-free card for knowingly selling dangerous devices, and thousands of patients injured by corporate misconduct were left unable to seek justice.  

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 device corporations to fully consider the safety implications of their products before marketing them to consumers. 

Accountability is key when producing safe medical products for women.