Vaginal Mesh Warnings
Vaginal mesh warnings were distributed to healthcare providers across the U.S. by the FDA in July 2011, and in September, the FDA held an advisory panel to further explore the risks and complications of vaginal mesh. The outcome of the advisory panel does not support the safety of vaginal mesh products.
Vaginal mesh is used as a surgical treatment for pelvic organ prolapse (POP) in which one or more internal organs have prolapsed (dropped) downward from their normal position. Vaginal mesh may also be used to treat stress urinary incontinence (SUI). Tens of thousands of women undergo vaginal mesh implant surgery each year in the U.S.
Vaginal mesh was approved as a surgical POP treatment in 2002, as a Class II device, which meant that preclinical trials were not required to test the safety of the the various brands and types of vaginal mesh. Now, the use of vaginal mesh is associated with thousands of reports of injuries and complications, described in the FDA's July Safety Communication. The complications include:
- Infection, including recurrent urinary tract infections
- vaginal mesh erosion (protrusion) into the vagina, bladder or rectum
- organ perforation and bleeding
- pelvic pain
- dyspareunia (painful sex for a patient or her partner)
- the need for additional corrective surgeries
- urinary problems; e.g., difficulty urinating
- vaginal scarring or shrinkage
- recurrent prolapse
- neuromuscular problems
Class III Reclassification Is Being Considered for Vaginal Mesh
The FDA advisory panel that convened in September 2011 called for additional clinical studies and tighter regulations for vaginal mesh. The panel's report suggested that preclinical use, premarket approval studies for new vaginal mesh products should be required, as opposed to the less stringent FDA device-clearance process that is now used for vaginal mesh. The panel also supports the reclassification of vaginal mesh products as Class III devices.
Learn More about the Risks of Vaginal Mesh
Whether you're a healthcare provider or a patient, if you have concerns about the complications and injuries linked to vaginal mesh, schedule a free consultation with a transvaginal mesh lawyer. Our lawyers represent women nationwide.