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.