FDA Wants Transvaginal Mesh Classified as “High-Risk Device”
Medpage Today reports that the U.S. Food and Drug Administration (FDA) is pushing forward a proposal that would reclassify transvaginal mesh as a “high-risk device.”
FDA Actions Span Six Years
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapsed (POP) and is now proposing to address those risks for more safe and effective products.” – William Maisel, MD, with the FDA’s Center for Devices and Radiological Health as published by Medpage Today
Transvaginal placement of surgical mesh has long been associated with significant side effects with the FDA first issuing a Public Health Notification in 2008, concerning serious complications which include infection, scarring, pain and recurrence of prolapsed.
In 2011, the FDA released updated communications about potential complications and its Obsterics and Gynecology Devices Panel recommended reclassification of the mesh from class II to class III.
In January of 2012, the FDA ordered manufacturers of transvaginal mesh to conduct postmarket surveillance studies that would address specific safety and effectiveness concerns.
In their latest proposal, transvaginal mesh used in the repair of POP would be considered a “high-risk device.” If finalized, manufacturers would be required to provide premarket clinical trial data to demonstrate safety and effectiveness.
The FDA would then review the data before considering the devices for approval.
List of Transvaginal Mesh Adverse Events
- Mesh erosion
- Serious infection
- Chronic pain
- Pain during intercourse
- Urinary problems
- Bowel, bladder, and blood vessel perforation
- Recurrence of prolapsed
- Revision surgery