Last week, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA held public hearings the use of transvaginal surgical mesh for the repair of Pelvic Organ Prolapse (POP). As lawyers representing women adversely impacted by vaginal mesh and its use for POP, we want you to know the outcome of the first day of hearings. We will post separately on the second day of hearings that covered the use of vaginal mesh for stress urinary incontinence (SUI).
One the first day of the hearings, the views presented ranged from an outright ban on the use of mesh for this procedure, to the continued use of mesh, despite the adverse events that have occurred with its use. We have posted in recent weeks about these adverse events and complications women have suffered with the use of surgical mesh for these conditions.
The mesh manufacturers presented their point of view essentially stating (in summary) that the benefits of the use of mesh outweighs the complications. This group of presenters supported premarket clinical studies for new mesh products and postmarket studies to evaluate the long-term safety and effectiveness of mesh for POP repair. However, the manufacturers were not supportive of reclassification of the mesh to Class III which would also require premarket approval. One presenter that manufactures a porcine product for POP repair stated that their product does not have the vaginal erosion rates that synthetic surgical mesh has caused.