There appears to be a new wave of public conversation about mesh used in pelvic floor surgery in recent months. AUGS has not changed its positions on the use of appropriately selected mesh placed by providers with the education, skills and volume to optimize outcomes; presenting and assessing all of the literature that supports this position is beyond the scope of this message. However, I felt it would be a service to our membership to provide an update and summary of international publications and statements. This year marks 10 years since the field changing first FDA Public Health Notification concerning risks of mesh use in pelvic floor surgery. The impact of the advisory continues to influence our patient counseling. I would point to an article by Dr Souders et al entitled, “The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics” in this month’s FPMRS Journal for greater detail.[i] Among other findings, the article demonstrates that the rate of claims is growing rapidly, and that there are nearly twice as many claims related to midurethral sling as transvaginal prolapse repairs. These statistics highlight the growing public awareness of mesh complications, and the deepening need for accurate information.
Since 2011, issues regarding mesh use have been investigated more thoroughly in the world literature. This, in conjunction with a public discourse by women suffering complications, has led to some recent international governmental expositions about the use of transvaginal mesh. While AUGS does not necessarily agree with or endorse any of the following statements from abroad, I felt our members should be aware of them.
The Scottish government released its Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse (POP) in Women. This report concludes that, in the case of prolapse, “current evidence does not indicate any additional benefit from the use of transvaginal implants (polypropylene mesh or biological graft) over native tissue repair. Transvaginal mesh procedures must not be offered routinely.” For the case of SUI, “When surgery involving polypropylene or other synthetic mesh tape is contemplated, a retropubic approach is recommended.”
The Scottish Review also expressed “serious concern that some women who had adverse events felt they were not believed, adding to their distress and increasing the time before any remedial intervention could take place. Improving awareness amongst clinical teams of the possible symptoms of mesh complications together with good communication skills, (including good listening and empathy) is an essential part of good clinical care.”
The UK’s National Institute for Health and Care Excellence published their Interventional Procedures Guidance (document 599) which concludes, “current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious but well-recognized safety concerns. Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.” This document, as well as the companion Information for the Public document, avoid discussion of mesh used to treat urinary incontinence.
The Australian Therapeutic Goods Administration (TGA), based on its review of the literature, states that “benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.” Transvaginal mesh for prolapse and single-incision mesh slings were removed from the list available therapeutic options; midurethral slings for SUI were left in place.
New Zealand’s Ministry of Health wrote letters to the manufacturers of mesh – including midurethral slings – requesting that they stop marketing their products in the country, unless they could produce evidence proving their safety and efficacy. This effectively results in a ban in all transvaginal mesh, including SUI treatments.
Moreover the past decade has seen manufacturers of mesh devices modify their Instructions for Use to reflect the array of potential adverse outcomes that we have come to appreciate. The legal principle of the “learned intermediary doctrine” states that a manufacturer’s obligations to educate the end user (patient) of the risks of using a product can be fulfilled by educating an intermediary – in this case, the surgeon. The message here is that surgeons should not expect the manufacturer to bear the burden of patient education. Surgeons should endeavor to educate their patients about the risks of a planned procedure including any implanted devices, as part of the informed consent process.
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.” 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), endorsed by ACOG, AAGL and NAFC, WHF, and SGS, is being reissued in partnership with IUGA, to reflect the support of the international community as well. We are in the final stages of reconfirming the ongoing support of all the original endorsing organizations.
- 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 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
An important aspect of providing important information to patients is supporting investigational work to define both benefits and risks associated with procedures that utilize mesh. This has been another priority for the AUGS Board, which has pursued multiple initiatives to inform providers and their patients.
- AUGS continues to promote the scientific approach to understanding the risks and benefits of implants. AUGS’ Pelvic Floor Disorders Registry (PFDR) is one of the largest and highest-quality research databases of prolapse treatment, with groups that include mesh-based repairs, native-tissue repairs, and pessary treatments.
- The AQUIRE registry’s SUI module is realizing its goal of being a real-world, surgeon- and patient-friendly vehicle to deliver quality and benchmarking information, as well as clinical and patient-based outcomes. The FDA has partnered with AUGS in this effort, underlining the importance in the coming years.
- AUGS published its Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” reflecting the opinion that balance of knowledge, surgical skill, and education, with appropriate ongoing surgical volume and monitoring of outcomes and adverse events” is required for such cases.
AUGS continues to feel that women are better served when their preferences and values are honored through a range of treatment options for SUI and POP, including the option for transvaginally placed polypropylene mesh when appropriate. However, in the spirit of “Reflection” (the theme for the 2018 PFD Week meeting) it is important that we acknowledge that complications related to mesh implants, sometimes severe complications that are difficult to correct, can and do occur, and those patients should be treated with respect and honesty. They should also benefit from evidence-based treatment options. Consequently, sustaining investigation into optimal treatment of mesh complications and providing a venue for knowledge translation is also a priority for AUGS:
- Our Journal, Female Pelvic Medicine and Reconstructive Surgery, currently offers 475 articles related to mesh, many of which relate to issues of mesh, ways to promote its safe selection and use, as well as potential complications and their optimal management.
- AUGS is developing a request for applications from the PFD Research Foundation specifically targeted at optimizing the treatment of women with mesh-related complications.
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.
Finally – AUGS will always strive to provide our membership with opportunities to learn where the state of the art of FPMRS stands. In addition to PFD Week, and the wide variety of in-person and web-based educational options presented to members by the AUGS Education Council, we invite interested clinicians to consider attending the AUGS course, “Urogyn Update 2018: Latest Techniques & Emerging Trends,” a new offering this year for providers to hear the latest and most practical information to inform the practice of caring for women with pelvic floor disorders.
[i] Souders,CP, Eilber KS, McClelland, Wood LN, Souders,AR, Steiner V, Anger JT. The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics. Female Pelvic Med Reconstr Surg 2018;24: 21–25