Today, the FDA issued a final reclassification order regarding Surgical Instrumentation for Use with Urogynecologic Surgical Mesh from Class I to Class II. Examples of the surgical instruments covered by the order include needle passers and trocars, needle guides, fixation tools, and tissue anchors for procedures including transvaginal POP repair, sacral colpopexy (transabdominal POP repair) and treatment of female SUI. This is not a surprise, nor should it result in an immediate change in the range of products currently available. We have been expecting this final order which was initially proposed in May 2014. It expands upon prior FDA decisions to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III devices and importantly, the instruments include those used for placement of midurethral slings. The aim of this blog is to provide a synopsis of the 22 page order that can be accessed at https://federalregister.gov/d/2016-31862.
The decision to “up classify” instruments specifically designed for use with urogynecology mesh reflects the consensus of the FDA and the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee which conducted updated analyses on adverse event (AE) information associated with stress urinary incontinence procedures (retropubic, transobturator, mini-sling) and POP procedures (transvaginal and transabdominal sacral colpopexy). Sources for the AEs included the medical literature, the MAUDE and Medical Device Reporting (MDR) databases. The nature of the AE reports presented difficulties in their discrete attribution to the surgical mesh or the instrumentation. As a result, the FDA considered it reasonable to assume that perioperative adverse events such as organ perforation, hemorrhage and bleeding, nerve injury and pain are “caused by or related to” the use of specialized surgical instrumentation to insert, place, fix or anchor the surgical mesh during the Urogynecologic procedure.
This order predominantly impacts the manufacturers of the Specialized Surgical Instruments For Use with Urogynecology Mesh by requiring that they demonstrate “reasonable assurance of the safety and effectiveness” of their device through evidence of biocompatibility, sterility or if reusable, capability for adequate reprocessing; shelf life (packaging integrity and device functionality). They are required to conduct and report non-clinical performance testing to demonstrate that the device meets all design specifications and performs as intended. Additionally, the order requires enhanced device labeling to include information on a) mesh design compatible with the device; b) summary of clinical evaluations pertinent to device use; c) expiration date; d) validated methods and instructions for sterilization and/or reprocessing of reusable components.
AUGS has actively supported FDA’s effort to evaluate and enhance the effectiveness and safety of mesh augmented procedures. For over five years, our members have served on the special panels of the Medical Devices Advisory Committee. We partnered with the FDA and industry to establish a dedicated registry within the PFD Research Registry to host industry-sponsored 522 studies of transvaginal mesh devices for pelvic organ prolapse. We are committed to, and capable of, hosting post-market surveillance studies within the AUGS structure.
We strongly believe that there is an important role for the selective use of mesh augmented repairs in prolapse and incontinence in women. We will continue to advocate for their availability to our patients by contributing to the ongoing acquisition of evidence to direct patient selection and the understanding of the anatomic, functional and quality of life outcomes for women after these procedures. Each member can join this effort through participation in one of our registries. Learn more about our registries on our website and in a future blog about the soon to launch AUGS Quality Improvement Registry known as AQUIRE.