Does Vaginal Mesh Have a Future in the United Kingdom?

Prior to the pause on all vaginally implanted mesh, mid-urethral mesh tapes (MUTs) were considered the gold standard treatment for stress incontinence (Ford et al 2017) and accounted for the surgical treatment of over 98% of women within the NHS (NHS Digital 2018). As long-term complications of prolapse mesh came to light (Devices IM and M 2019), similar complications were found in those with MUTs, but at lower rates (Keltie et al 2017). These complications include chronic pain (the most common complication), vaginal mesh exposure, lower urinary tract perforation and mesh infection (Taithongchai et al 2019). It is important to highlight the significant burden these complications have on women. Surgery to excise mesh is complex, carries its own risks and does not always result in complete excision or resolution of symptoms. For a cohort of women, mesh is not the right choice. Many of the ongoing issues surrounding the use of mesh are related to a lack of information presented to women and pressure to select a mesh procedure without alternatives offered.

Mesh prolapse repairs were not found to be superior to native tissue repairs (Kahn et al 2022), so it is difficult to see a role for the use of mesh for prolapse. However, alternatives to MUTs which carry comparable efficacy rates, namely colposuspension and autologous fascial slings, also carry significant risks. The risks specific to permanent implants are not negated by colposuspension. Furthermore, alternative procedures require abdominal surgery and longer operative and recovery times. These are not small factors for women to consider. As stress incontinence has a major negative impact on quality of life, it is important to offer effective treatment. Reintroduction of MUTs would provide women with a shorter procedure, quicker recovery time, and an effective treatment option. However, there are several factors to consider ensuring safe reintroduction.

In the era of shared decision making coupled with the lessons learned through the Montgomery case*, our role as clinicians has shifted to facilitate the decision-making process by informing women of known risks of all procedures and allowing them to weigh what these risks mean to them. Reintroduction of MUTs will require ensuring women are appropriately counseled on risks.

MUTs placed by “high volume” surgeons are less likely to require surgical revision (Brennand & Quan 2019). The safe reintroduction of MUTs may be limited to these surgeons or specialist mesh centers which can manage complications.

To reduce the risk of complications further, we should aim to identify individual risk factors and assess if these are modifiable or if some women are predisposed to mesh complications. When complications develop, we should be able to provide effective treatment options. These are all necessary areas for further research to allow us to empower women to make safer, informed decisions regarding their choice of MUTs for stress incontinence.

The reintroduction of MUTs in the UK will always remain controversial, and women who have suffered from mesh complications often express that lessons have not been learned by the medical community. Some of the important lessons are of honesty regarding known risks, and the willingness to learn more about the unknown complications as women report these.

REFERENCES

Brennand EA, Quan H. Evaluation of the Effect of Surgeon’s Operative Volume and Specialty on Likelihood of Revision After Mesh Midurethral Sling Placement. Obstet Gynecol. 2019;133(6):1099. doi:10.1097/AOG.0000000000003275.

Devices IM and M. The Independent Medicines and Medical Devices Safety Review Written Evidence Patient Groups: Pelvic Mesh. 2019.

Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017;(7). doi:10.1002/14651858.CD006375.pub4.

Kahn B, Varner ER, Murphy M, et al. Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse. Obstet Gynecol. 2022;139(6):975-985. doi:10.1097/AOG.0000000000004794.

Keltie K, Elneil S, Monga A, et al. Complications following vaginal mesh procedures for stress urinary incontinence: An 8 year study of 92,246 women. Sci Rep. 2017;7(1). doi:10.1038/s41598-017-11821-w.

NHS Digital. Retrospective Review of Surgery for Urogynaecological Prolapse and Stress Urinary Incontinence Using Tape or Mesh Key Findings. 2018.

Taithongchai A, Sultan AH, Wieczorek PA, Thakar R. Clinical application of 2D and 3D pelvic floor ultrasound of mid-urethral slings and vaginal wall mesh. Int Urogynecol J. 2019;30(9):1401-1411. doi:10.1007/s00192-019-03973-2

*Montgomery v Lanarkshire Health Board [2015] UKSC 11 is a Scottish delict, medical negligence and English tort law case on doctors and pharmacists that outlines the rule on the disclosure of risks to satisfy the criteria of an informed consent.