Wisdom gleaned from the international clamor around the use of mesh in prolapse surgery

It may seem like yesterday, but it was 2011 when the US FDA posted a warning regarding the risks of surgical mesh placed transvaginally. Continued vaginal mesh use eventually resulted in an order to manufacturers to stop selling transvaginal mesh surgical devices in 2019. Other national governmental agencies in the UK, Australia and other countries also analyzed available data and held public enquiries into vaginal mesh safety, which resulted in further national bans on mesh use. In addition, plaintiffs’ attorneys in the US promptly recognized the opportunity to represent potential mesh use victims. Advertisements in the media to help identify patients who had undergone mesh surgery (whether they had complications, or not) further expanded public awareness about the reported negative aspects of vaginal mesh use. This resulted in multi-million dollar class action law suit settlements by mesh manufacturers which further de-incentivized any company from producing or marketing vaginal mesh products for pelvic organ prolapse (POP). Use of mesh via an abdominal approach (i.e. for sacrocolpopexy) continues to be approved for marketing and use.

At the beginning of the controversy regarding vaginal mesh use, IUGA convened 2 Roundtables of international experts to review data to date (2005 and 2011). The first was to review the biology of available grafts/mesh and the 2011 roundtable to generate recommendations for the safe use of vaginal mesh.(1-4) Unfortunately, this series of IUGA publications, along with other professional society statements did not significantly alter the popularity of mesh use by surgeons or its marketing by manufacturers.

What lessons have we learned from this “mesh fiasco”?

Regulatory process: Vaginal mesh was approved for sale by the FDA via a 510(k) process which bases the approval on the existence of a substantially similar (predicate device) previously approved product. Prior to mesh use for POP, only incontinence slings were approved via the vaginal approach, and served as the predicate device for the 510(k) process. The 510(k) process has since been revised and any new vaginal mesh product would need to go through a more stringent Pre-Market Approval (PMA) process.

Lesson 1: Any novel products for POP associated with a permanent implant should undergo appropriate scientific and clinical scrutiny and validation prior to marketing and widespread use. Once marketing has begun, outcomes should be prospectively monitored via registries or like processes.

Patient selection: Appropriate selection of patients who may be candidates for a novel procedure is key to successful outcomes being achieved. Specific criteria for vaginal mesh use were not developed prior to marketing of mesh devices. Degree of prolapse, site of prolapse, primary vs. recurrent prolapse and specific patient comorbidities, among others, were subsequently identified as important considerations for vaginal mesh use. Mesh use should be limited to specific clinical criteria.

Lesson 2: Identification of specific patient criteria should be pursued and evaluated prior to recommending a novel device for POP.

Surgeon training: Vaginal mesh products achieved widespread use due to aggressive marketing by manufacturers, frequently competing for market share. As such, many surgeons who were not skilled at vaginal surgery procedures were compelled to implant vaginal mesh products. This was associated with an increased complication rate. In addition, many early outcome reports and training materials made mesh surgeries look rather simple and minimized negative outcomes.

Lesson 3: Surgeons who can appropriately and safely utilize novel POP products should be identified and receive training prior to marketing new POP products.

Dealing with complications: Soon after vaginal mesh products were initially marketed mesh-related complication began to be identified and reported. Although complication rates and risk factors were identified, appropriate management of complications was not evaluated scientifically. Thus, complications may have persisted, worsened or led to additional complications. Specific specialized centers with expertise in management of complications were not identified.

Lesson 4: Since no procedure is complication-free, once associated complications are identified, methods for prevention and management as well as identification of referral centers with expertise in managing said complications should be proactively pursued.(5) Consideration should be given to a use “halt” in order to gain a better understanding of the pathophysiology, prevention and management of complications.

What about countries where mesh use was not banned?

There are countries where mesh use for POP has continued and even persist as standard of care. In these countries, low complication rates are reported, there are no medico-legal implications or patient advocacy groups speaking up. This is likely due to vaginal mesh use being restricted to referral specialized urogynecology centers and by high volume surgeons.(6) Additionally, as mesh technology has evolved, lower weight monofilament meshes are exclusively used, which are associated with lower complication rates.

Where does mesh use stand now?

The results of 2 FDA-ordered post-market surveillance (522) studies were recently published. Both the Coloplast (2022) and Boston Scientific (2021) vaginal mesh kits for POP repair were compared to native tissue repair with 36 month follow-up. Both showed similar effectiveness and safety outcomes to native tissue repairs. However, the FDA continues to believe that mesh devices of this type continue to be associated with risks not associated with native tissue repairs, including mesh exposure and erosion.(7) No vaginal mesh POP products are marketed in the US.

Urogynecologic surgeons were recently involved in a highly controversial and painful process questioning the safety and effectiveness of vaginal mesh use for POP. The above noted lessons are certainly not the only lessons learned from this process. Innovation in patient care can allow us to better care for our patients – as long as we proceed methodically with caution and incorporate previously-learned lessons in the process.

References:

1. Davila GW. Introduction to the 2005 IUGA Grafts Roundtable. Int Urogynecol J 2006;17(suppl):S4-S5.
2. Davila GW, Drutz H, Deprest J. Clinical implications of the biology of grafts: Conclusions of the 2005 IUGA Grafts Roundtable. Int Urogynecol J 2006;17(suppl):S51-55.
3. Davila GW. Optimizing safety and appropriateness of graft use in pelvic reconstructive surgery: Introduction to the 2nd IUGA Grafts Roundtable. Int Urogynecol J. 2012 Apr;23 Suppl 1:S3-6. doi: 10.1007/s00192-012-1676-4.
4. Davila GW, Baessler K, Cosson M, Cardozo L. Selection of patients in whom vaginal graft use may be appropriate. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J. 2012 Apr;23 Suppl 1:S7-14. doi:10.1007/s00192-012-1677-3.
5. Joint Writing Group of the American Urogynecologic Society and the International Urogynecological Association. Joint position statement on the management of mesh-related complications for the FPMRS specialist. Int Urogynecol J. 2020;31:679–94. https://doi.org/10.1007/s00192-020-04248-x.
6. Zhang Z, Guo J, Tian W, et al. Efficacy and safety of transvaginal mesh repair in a cohort with a minimum of 10-year follow-up. Sci China Life Sci. 2024 May;67(5):1061-1068. Doi:10.1007/s11427-023-2508-x. Epub 2024 Feb 26.
7. US Food and Drug Administration. FDA's Activities: Urogynecologic Surgical Mesh. Content current as of 04/11/2024