AUGS recently became aware that, on Sunday, May 13th, “60 Minutes” will be airing a segment on mesh injuries. We know that some of the content will include interviews with patients; beyond that, we don’t know what to expect. We should be prepared, however, for a public reaction, and another layer of anxiety that our patients bring with them into our offices. I wrote recently to provide an update about international activity in the mesh arena, in an effort to provide some clarity to our members as to what is, and what is not, changing on the international stage. But even here at home, there continues to be new echoes of the anxieties surrounding mesh.
Many of you will be aware of the New York Times (NYT) article from April 15 entitled, “How Profiteers Coax Women into Surgery.” Although we have been aware of it for some time now, the NYT shone a spotlight onto the practice, by some physicians, of accepting payment directly from legal firms to perform surgery with the primary goal of bolstering a legal suit against the manufacturer, even in cases where clinical indications are not met. AUGS decries this practice, as such triangulation introduces significant bias, and corrupts the fiduciary responsibility we hold for our patients. However, this difficult story casts further confusion into the conversation about mesh for pelvic floor repairs.
As surgeons we should endeavor to educate our patients, as part of the informed consent process about the risks of a planned procedure including any implanted devices.
I feel it is important to reiterate that AUGS has not changed its positions about the appropriately selected use of mesh devices for reconstructive surgery. The “Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders,” published by the Board of Directors in 2013 offers the opinion that, “in some circumstances, the use of transvaginal mesh may be the most appropriate surgical option.” AUGS continues to hold this position. We feel that well-informed women are usually well served by having options, allowing them, with the guidance of their surgeon, to select an approach that balances benefits and risks for their individual circumstances. Towards that end, AUGS has sought to enhance our patients’ options and information about these options to inform their decisions. The following is a partial list of these efforts:
- The AUGS/SUFU joint statement in strong support of the midurethral sling (MUS) was reissued, with inclusion of international support, and endorsed by ACOG, AAGL, IUGA, SGS and NAFC.
- AUGS is developing an Informed Consent Toolkit for MUS, to supplement the Toolkit already available for placement of transvaginal mesh. AUGS seeks to serve its members and their patients by putting together a packet of materials that makes is easier for a surgeon to provide robust and evidence-based informed consent, and to document that process.
- The Public Education Committee has drafted a Fact Sheet for patients that addresses some of the issues and concerns that patients may have in light of the NYT “Profiteers” article
- AUGS is about to launch the SUI Surgery Registry module to the AQUIRE Registry. This user-friendly registry will provide new data to compare different surgical modalities for SUI. It includes quality measures, provider characteristics, and patient-reported outcomes, on a larger scale. The FDA is partnering with AUGS, as this model is expected to help improve the way that we learn about device performance.
Although AUGS does not hold any specific regulatory role for surgical devices, we can strive to provide a culture of practice where new technologies can be introduced, evaluated, and deployed, and continuously re-evaluated, in an evidence-based and systematic manner. Now more than ever, AUGS possesses an infrastructure of networks, registries, and scientific expertise that can be brought to bear on asking the important questions about new devices and technologies.