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.
The FDA presented the findings it has gleaned from their databases and other sources, including an epidemiological review of the published literature and clinical data on the risk-benefit profile of mesh for POP repair. The FDA stated their conclusion that the use of vaginal mesh for POP repair in fact poses vaginal erosion risks and that the use of the mesh is questionable given the benefit of the alternative procedure, which involves surgical repair. They recommend that the risk-benefit analysis would be best evaluated through both premarket and postmarket clinical studies.
One of the most important results of these hearings is the FDA’s recommendation that vaginal mesh should be reclassified from Class II (Special Controls) to Class III (Premarket Approval) which would result in designed clinical trials. This is something that in our opinion should have been done in the first instance, prior to the fast track approval of the use of synthetic mesh when there are much safer surgical procedures that do not include mesh.
The Advisory Panel consensus is significant in several areas. The panel consensus is that vaginal mesh safety in POP repair has not been well-established, that it may not be more effective than traditional repair methods, that the risk-benefits of mesh have also not been well-established and that studies are needed to evaluate the use of vaginal mesh for POP repair. The panel also reached consensus that the vaginal mesh should be reclassified to Class III. Postmarket studies are also recommended.
In addition to all of this, the panel noted that patient information such as labeling and informed consent as well as mandatory registration of mesh devices used in procedures, surgical training, education, and credentialing are all important components. The panel also suggested that the FDA work on coordinating data and collection of data for post market clinical information.
Hersh & Hersh has been at the forefront of litigation involving women’s health for four decades. We have litigated landmark and historic cases involving medical procedures, defective devices and dangerous drugs that have adversely impacted women. If you have been injured by a procedure involving surgical mesh for POP or stress incontinence, please contact our law firm. We will consult with you free of charge to evaluate your situation.