Mesh use in gynaecology for incontinence and/or prolapse has become highly contentious. Many practitioners may have been faced by women and their families with a high degree of anxiety about their options for treatment, either that which has been proposed, or potentially already undertaken.
It is my feeling that in the last 2 years in particular, women have become a lot ‘warier’ of surgical approaches such as the retropubic or transobturator mid-urethral slings, even though they are some of the most studied and well-validated surgical techniques available. So, what is the current situation around mesh use for incontinence, and what are the other options?
Stress incontinence (SUI) is the most common cause of urinary leakage in younger women and is primarily due to damage to the continence mechanism during childbirth.
Childbirth can damage the pelvic floor, as well as the delicate support tissues that surround the mid-urethra and attach it to fascia behind the pubic bone. It is worth noting that pelvic floor exercises when taught by a specialist pelvic floor physiotherapist, and practised regularly, can lead to improvement or cure in more than 70%1. It is also evident that up to one in four women are doing something OTHER than contracting their pelvic floor muscles effectively when they demonstrate a pelvic floor contraction, so never take their word for it! First line management should always include a visit to a good pelvic floor physio, as well as lifestyle advice and medication review. However, a long-term cure is difficult to sustain, so surgical options are also worth discussing.
Broadly speaking there are three main techniques: the fascial sling, the Burch colposuspension, and the synthetic mid-urethral sling (MUS). The first report of the use of MUS was published in 19962 and built on an expanded theory of pelvic floor support termed the ‘Integral Theory’. The aim was to recreate the dynamic fascial support of the urethra, without causing the voiding dysfunction inherent to the other techniques. The TVT was also designed to be an ambulatory procedure and to be done under local anaesthesia to allow a ‘cough test’ during the operation, aiming to avoid over-tightening the mesh. The first RCT was published in 19983 and follow-up data are available to 17 years from this original cohort4. Early reports did note complications such as retropubic haematoma, bladder perforation, and bowel injury, so in 2001 a different approach was reported, taking the mesh out through the obturator foramen rather than into the retropubic space5. In many places during my training in the 2000s, this was the procedure of choice for gynaecologists.
In both cases, it can be a day-stay procedure with a quick return to usual function and low morbidity.
The 2000s saw an explosion in innovation in mesh procedures in gynaecology, particularly transvaginal mesh placement for prolapse. With MUS the developments were to try to reduce the amount of mesh needed, refine the weave and ‘weight’ of the material, devise new mesh delivery systems, and introduction of ‘mini-slings’ which were placed through a single sub-urethral incision and anchored into the obturator internus fascia, avoiding mesh passage into the groin. However, the brakes were firmly applied in 2011 when the FDA released a second warning about mesh use6. In the years following, a number of jurisdictions (NZ included) have undertaken government-level reviews of mesh use, including MUS. In New Zealand, a Health Select Committee reported in 20167, while the Australian Senate Inquiry released their findings in 20188. Consistent recommendations include:
- Improving informed consent processes
- Credentialling and training of surgeons for mesh placement and removal
- Creation of registries to facilitate mandatory reporting of all mesh use and complications.
In Scotland, the process went further, with mesh use halted while their review took place. After an extensive review, the Scottish Inquiry9 recommended the use of retropubic slings over transobturator, citing a slight performance advantage over time, but also noting a significantly lower rate of pain complications.
In New Zealand, further developments followed the Australian Therapeutic Goods Authority10 ruling on the sale of mesh products in gynaecology surgery in December 2017. This required re-labelling of MUS products and removed ‘mini-slings’ and vaginallyplaced mesh for prolapse; MedSafe quickly followed. This led to a lot of confusion, with many media outlets reporting that mesh had been ‘banned’, and a lot of practitioners and patients were left confused.
We now have several products available which all meet the new requirements
There were a number of recommendations from the Australian Senate Inquiry, and one was to improve patient information and consent, which led the Australian Commission on Safety and Quality in Healthcare( ACSQHC) to develop patient centred guidelines. These* are excellent resources for patients, and I direct all women contemplating surgery for SUI or prolapse to them. They also developed credentialling guidelines and the New Zealand Ministry of Health has directed all private and public hospitals to implement these for surgeons who wish to continue to place MUS. How this will affect women in those smaller centres (and caseload in the bigger centres) remains to be seen.
What of the other options for SUI?
Since the MUS became popular, fascial slings have been less commonly performed. This is for a number of reasons, including it being a significantly larger procedure, requiring harvesting of fascia from either the thigh or the rectus sheath, and a Pfannenstiel-type incision to attach the sutures to the rectus sheath. Infection, length of stay and postoperative catheterisation rates are higher than MUS. De-novo urgency symptoms may arise in as many as 20% of women, but graft complications are much reduced. These have more commonly been used as a second (or even third) procedure where MUS has been unsuccessful or for women with intrinsic sphincter deficiency or neurogenic incontinence11. The other first-line procedure is the Burch colposuspension. This is a retropubic procedure to fix the paraurethral tissues to the iliopectineal line.
Traditionally an open operation, it can be performed laparoscopically, but care has to be exercised to avoid over-correction of bladder neck support. Postoperative voiding dysfunction is relatively more common than the MUS, as are complications related to the more significant surgery required, longer hospital stay, and denovo posterior compartment prolapse12. It is important to emphasise that neither of these procedures are complicated by some of the particular issues with transvaginal mesh, but equally a lot of the research is considerably older and pain outcomes, in particular, may not have been as rigorously recorded. Other options such as peri-urethral bulking agents are available and undergoing a resurgence of interest, especially in the UK. A durable and non-obstructive option remains the goal.
Despite the controversies and the occasional severe and life-changing complications (particularly pain-related) that can be seen with MUS, it remains the procedure of choice for most women in view of the long-term success and minimally invasive nature of the procedure. Due to the reduction in the potential for pain complications, I have opted to move to retropubic MUS. An alternative option is the laparoscopic Burch colposuspension, although women need to appreciate the differences in terms of postoperative effects and complications.
These are excellent resources for patients, and I direct all women contemplating surgery for SUI or prolapse to them.
Australian Commission on Safety and Quality in Healthcare (ACSQHC) resources – Treatment options for stress urinary incontinence (PDF)
1. Dumoulin, C., et al. (2018). Pelvic muscle training versus no treatment or inactive control treatments, for urinary incontinence treatments in women. Cochrane Database of Systematic Reviews, Oct 4; 10. CD005654. doi: 10.1002/14651858.CD005654.pub4
2. Ulmsten, U., Henriksson, L., Johnson, P., & Varhos, G. (1996). An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct, 7(2), 81-85; discussion 85–86
3. Ulmsten, U., Falconer, C., Johnson, P., Jooma, M., Lanner, L., Nilsson, CG., & Olsson, I. (1998). A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct, 9(4), 210–213
4. Nilsson, CG., Palva, K., Aarnio, R., Morcos, E., Falconer, C., (2013). Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J, 24(8), 1265–1269
5. Delorme, E. (2001). Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol, 11(6), 1306-1313
6. FDA. (2011). FDA Safety Communications: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Retrieved from http:// www.fda.gov/MedicalDevices/Safety/ AlertandNotices/ucm262435.htm.
7. NZ Health Select Committee. (2016). Retrieved from https://www parliament. nz/en/pb/sc/reports/document/51DBSCH _SCR69220_1/petition-20110102- of-carmel-berry-and-charlotte-korte accessed 4 Feb 2019
8. Australian Senate Inquiry. (2018). Retrieved from https://www.aph. gov.au/parliamentary_business/ committees/senate/community_ affairs/meshimplants/report accessed 4 Feb 2019
9. Scottish Independent Review. (2017). Retrieved from https://www.gov.scot/ publications/scottish-independentreview- use-safety-efficacy-transvaginal -mesh-implants-treatment-9781 786528711/ accessed 4 Feb 2019
10. Australian Therapeutic Goods Association statement. (2017). Retreived from https://www.tga.gov. au/alert/tga-actions-after-reviewurogynaecological- surgical-meshimplants# actions accessed 4 Feb 2019
11. Rehman, H., et al. (2017). Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev, Jul 26; 7. CD001754. doi: 10.1002/14651858. CD001754.pub4
12. Lapitan, M., et al. (2017). Open retropubic colposuspension for urinary incontinence in women. Cochrane Datbase Syst Rev, Jul 25; 7. CD002912. doi: 10.1002/14651858. CD002912.pub7