It is no secret that there has been some majors concerns of using surgical mesh to repair Pelvic Organ Prolapse (POP) (Check out our recent articles on the vaginal mesh dangers here, here and here). Now the Food and Drug Administration (FDA) identified serious safety and effectiveness concerns over the use of the for the transvaginal repair of POP based on a review of adverse events reported to the FDA and an assessment of the scientific literature.
Surprisingly, the FDA is on top of this issue. Recent history shows the FDA is genuinely trying to sort out whether or not the mesh is actually safe to use.
As a result of the large number of adverse events received in October 2008, the FDA issued a Public Health Notification (PHN) informing clinicians and their patients of these findings, with recommendations on how to mitigate risks and how to counsel patients.
In January 2011 the FDA completed another search of the Manufacturer and User Device Experience (MAUDE) database for the 2008-2010 timeframe. This new search identified an additional 2874 Medical Device Reportings (MDR’s) for urogynecologic surgical mesh, with slightly more than half associated with POP repairs.
On July 13, 2011, based on the 2008-2010 MAUDE database search and the FDA scientific literature review, the FDA issued “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” to inform the medical community and patients that: serious complications associated with vaginal surgical mesh for repair of POP are not rare (contrary to what was stated in the 2008 PHN). The safety update also stated that it is not clear that transvaginal POP repair with vaginal mesh is more effective than traditional non-mesh repair.
The Safety Communication also provided a list of recommendations for health care providers and patients to consider for before and after transvaginal POP repair with mesh.
In addition to providing an updated FDA Safety Communication to promote understanding of the risks associated with transvaginal POP repair using surgical mesh and to encourage informed decision-making by patients and health care providers about the use of vaginal mesh, the FDA decided it would convene an Advisory Panel of outside experts to consider clinical studies that may improve our understanding of the safety and effectiveness of vaginal mesh.
And, on September 8-9, 2011, it did just that. The FDA convened the Obstetrics & Gynecology Devices Advisory Committee to discuss the use of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
The panel was asked to provide input on the risks and benefits of surgical mesh used for POP repair based on the published literature and adverse event data from the FDA’s (MAUDE) database. The panel also weighed in on the FDA’s proposed premarket and postmarket regulatory strategies for surgical mesh indicated for POP repair, including reclassification into Class III (premarket approval) and postmarket surveillance studies.
The panel considered the risks and benefits of vaginal mesh to treat SUI. The FDA sought the panel’s input on the need for additional clinical studies (premarket and/or postmarket) on all or a subset of surgical mesh indicated to treat SUI based on data from the published literature and the MAUDE database.
The panel was also asked to consider whether 522 studies are needed for cleared mini-slings, all cleared surgical mesh indicated for SUI, or not needed for these devices. If the panel believes 522 studies are needed for all or just a subset of these products, the panel will be asked to discuss the type of clinical study that should be required, with consideration to patient selection, controls, randomization, outcome measures, concomitant surgeries, follow up duration, etc.
Updated information from this panel should be expected from the FDA soon.