California Injury Attorney Blog

Last week, we posted on the recent FDA Obstetrics & Gynecology Devices Panel Advisory Committee hearings that centered on the use of transvaginal surgical mesh to correct Pelvic Organ Prolapse (POP). The second day of the advisory committee hearings focused on the use of surgical mesh for the surgical management of female Stress Urinary Incontinence (SUI), with differing recommendations from those regarding POP.

At the open public hearings, presenters ranged from patients to advocacy groups to clinicians. The presentations themselves also ranged widely from adverse event reporting to a broader review of clinical data.

Surgical mesh manufacturers also presented at the second day of hearings. The industry association AdvaMed advocated on the safety and effectiveness of what are known as suburethral slings to correct SUI. They do not believe that mandatory clinical studies are needed for the products currently being marketed. There are studies underway for products that have new features and they argued that this is sufficient. They also took the position that Class II special controls are adequate.

The FDA's review team also provided findings that were gleaned from their database that included data on both the safety and effectiveness on mesh suburethral slings used for SUI. Adverse events were described as well as a general summary of the device's risk-benefit profile. It was their conclusion that a reclassification is not necessary for the SUI mesh product. However, the FDA sought comment by the panel on the long-term safety and the effectiveness of a particular device called single-incision mini-slings.

The panel consensus with regard to the use of mesh for the correction of SUI (using retropubic and transobturator suburethral slings) was that the safety and effectiveness of these devices is well-established in that context. They did not believe that premarket clinical studies are necessary at this time. This view might change if there were significant changes in the material used or in the surgical procedure itself.

The panel did reach consensus that collection of adverse event information with regard to SUI correction should be coordinated and suggested that industry and health databases be used for this purpose. It was the opinion of the panel that post market studies for the SUI procedures using slings, are not necessary.

However, the panel did believe that premarket clinical studies are warranted with regard to the use of the single incision mini-sling in correcting SUI and that post market studies should also be performed with the mini-slings currently being marketed and that these should be compared in safety and effectiveness with conventional corrections.

Hersh & Hersh is a San Francisco, California consumer rights law firm that has been at the forefront of litigation involving women's health for four decades. We have litigated many landmark and historic cases, some of which involve 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.

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.