Faced with mounting adverse event reports, the FDA issued several safety communications regarding the risks associated with transvaginal mesh products, leading to a surge in related lawsuits.
FDA’s Public Health Notifications on Transvaginal Mesh Risks
The Food and Drug Administration (FDA) has actively monitored the safety of transvaginal mesh devices that repair pelvic organ prolapse (POP).
Here’s a timeline of the FDA’s actions regarding transvaginal mesh:
- In 2008, the FDA released a public health notification highlighting the complications related to transvaginal mesh after receiving over 1,000 adverse reports within three years.
- 2011 saw the FDA upgrading the previous alert, clarifying that mesh-related complications are not rare, which was a significant shift in stance from 2008.
- According to the press announcements on their website, the FDA brought Specialists and patient groups together in 2019 to discuss the safety and efficacy of these devices.
- The agency mandated the reclassification of transvaginal mesh for POP repair as Class III, which denotes high risk and required manufacturers to submit premarket approval applications.
Explosion of Transvaginal Mesh Lawsuits Following FDA Warnings
The increased transparency and severity of FDA warnings did not go unnoticed by the public or the legal community.
They triggered a sharp increase in transvaginal mesh lawsuits, reflecting patients’ growing concerns:
- In response to the FDA warnings, individuals who experienced severe complications from vaginal mesh implants began seeking legal retribution.
- Law firms nationwide started representing thousands of women complaining of mesh-related complications in mesh lawsuits.
- The influx of lawsuits increased awareness and scrutiny of medical devices, especially pelvic mesh products.
These FDA actions and subsequent legal battles highlight an ongoing concern regarding the safety of medical devices and the vigilance required to ensure patient well-being.