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In This Newsletter
Dr. Lucila Pavan
Consultant, Gynecology, Urogynecology and Pelvic Reconstructive Surgery
Hospital Italiano de Buenos Aires,
Argentina
The use of transvaginal mesh (TVM) in vaginal prolapse surgery remains a relevant option in many countries worldwide. However, its ban in certain regions arose from indiscriminate use, often by surgeons lacking adequate training and the skills to manage its specific complications. This shift, from the success of TVM to viewing it as risky or dangerous, led some to revert to older, less advanced surgical techniques. Even so, the experience with these devices has taught us valuable lessons.
One of the greatest advantages of TVM is that it can be effectively used in vaginal surgery. It reduces operative times compared to traditional procedures and allows for uterus preservation through hysteropexy. Additionally, it facilitates the simultaneous treatment of multiple compartments without the need for switching surgical approaches, enabling faster recovery and immediate ambulation for patients.
Nevertheless, as any surgeon knows, no procedure is without complications, and TVM is no exception. TVM carries the same risks as any vaginal surgery, with the exception of mesh exposure, which is specific to its use. The key lies in understanding how to prevent complications, minimize their occurrence, and manage them effectively if they happen. This requires a multidisciplinary approach and a commitment to guiding and supporting patients through any unexpected situations.
The use of TVM has underscored the importance of patient selection. Not every patient is suited for every procedure. Surgeons must be adequately trained and focus on procedures they perform regularly, becoming high-volume specialists. This expertise not only improves outcomes but also enables surgeons to have a clear understanding of their own practice, complication rates, and effectiveness. These statistics are not merely for publication but are essential for self-evaluation and improvement.
Patient education is another critical lesson. Informed consent is essential. Patients must understand the potential risks and benefits of any procedure, particularly in the hands of their surgeon. Today, it is our duty as physicians to present all available options, provide comprehensive information, and empower patients to make informed decisions about their care.
Finally, we must be prepared to address complications, whether intraoperatively or postoperatively, either through our expertise or by referring patients to specialists equipped to handle complex situations. Listening to patients, understanding their needs, and ensuring their well-being—whether by resolving issues ourselves or through appropriate referrals—is at the core of good urogynecology practice.
As a urogynecologist and pelvic floor surgeon, I believe TVM is still a good option for many patients when used properly. The lessons learned from its use have reinforced the importance of skill, patient-centered care, and the ongoing improvement. By keeping these priorities in mind, we can continue to offer safe and effective solutions for pelvic floor disorders while respecting the autonomy and preferences of the women we treat.
Dr Natharnia Young,
Monash Health Victoria Australia
Sacral colpopexy is considered the gold standard for vaginal vault prolapse however multiple regulatory bodies such as FDA, TGA and European Commission have placed warnings on the use of mesh in urogynaecology and increasingly women want mesh alternatives due to potential mesh complications.
Fascia Lata can be used as an alternative to Mesh for sacral colpopexy. This graft can be obtained from cadaver or autologous and harvested from the upper thigh. Biomechanical properties have been studied and found that cadaveric fascia lost 60-89% in strength and stiffness but there was minimal change with Autologous fascia.1
Human fascia is an ideal biological graft with favourable tissue integration, large collagen content, improved tensile strength and angiogenesis.2
The Cochrane looked at 2 studies; sacral colpepexy: mesh compared to alternative graft. The risk of prolapse on examination (Stage 2 or above) was lower with mesh compared to fascia lata with a risk ratio 0.46 (0.19, 1.13).3 Culligan reported a higher anatomical failure rate that was predominantly in the anterior wall but there were no vault failures with use of cadaveric fascia.4 At 5 years follow up when re-analysed using clinical success – POP>0 and subjective awareness of bulge there was no difference between the groups.5
A prospective non-randomized study with autologous fascia lata versus mesh demonstrated no difference in success with a mean follow-up of 12 months (94.8 versus 97.8%). There was one anterior and apical failure in the fascia lata group with longer operating times.6
Harvest site complications are an additional risk to fascia lata sacral colpopexy. 14% had thigh bulge, 14% seroma, 53% parasthesia, 1 wound dehiscence, 1 infection and 1 difficulty with ambulation.7
In conclusion fascia lata is an alternative to mesh with a small risk of persistent leg complications.8
1 Dora CD, Dimarco DS, Zobitz ME, Elliott DS. Time dependent variations in biomechanical properties of cadaveric fascia, porcine dermis, porcine small intestine submucosa, polypropylene mesh and autologous fascia in the rabbit model: implications for sling surgery. J Urol. 2004 May;171(5):1970-3. doi: 10.1097/01.ju.0000121377.61788.
2 Hennes D. Biomechanical and immunobiological properties of human fascial ata vs TiMesh: implictions for pelvic reconstructive surgery. DOI: https//doi.org/10.33235/anzcj.29.4.110
3 Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database of Systematic Reviews 2023, Issue 7. Art. No.: CD012376. DOI: 10.1002/14651858.CD012376.pub2.
4 Culligan PJ, Blackwell L, Goldsmith LJ, Graham CA, Rogers A, Heit MH. A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy. Obstet Gynecol. 2005 Jul;106(1):29-37. doi: 10.1097/01.AOG.0000165824.62167.c1
5 Tate SB, Blackwell L, Lorenz DJ, Steptoe MM, Culligan PJ. Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up. Int Urogynecol J. 2011 Feb;22(2):137-43. doi: 10.1007/s00192-010-1249-3. Epub 2010 Aug 27.
6 Bock ME, Nagle R, Soyster M, Song L, Tachibana I, Hathaway JK, Powell CR. Robotic Sacral Colpopexy Using Autologous Fascia Lata Compared with Mesh. J Endourol. 2021 Jun;35(6):801-807. doi: 10.1089/end.2020.0537. Epub 2020 Nov 26.
7 Delu AA, Terrani KF, Funk JT, Twiss CO. Harvest of large fascia lata autograft: Outcomes in 108 patients. Neurourol Urodyn. 2024 Jun;43(5):1179-1184. doi: 10.1002/nau.25464. Epub 2024 Apr 8.
Prof.Dr. Tamer Erel
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Department of Obstetrics and Gynecology
Istanbul, Turkey
European Menopause and Andropause Society, General Secretary
Dr. Ipek Betul Ozcivit Erkan
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Department of Obstetrics and Gynecology
Istanbul, Turkey
The next step after a failed sling surgery is a matter of debate, posing a challenge both for patients experiencing persistent, life-debilitating symptoms and for urogynecologists who have already offered reasonable alternative treatment options.
Stress urinary incontinence (SUI) refers to the involuntary loss of urine during activities like coughing or exercising, often caused by damage to the pelvic floor muscles or nerve supply during childbirth. When pelvic floor muscle training and other conservative measures fail, surgery using a midurethral sling (MUS) is typically recommended. MUS involves the passage of a narrow tape through either the retropubic or obturator areas accessing from lower abdomen or groin. These procedures, commonly known as tension-free vaginal tape (TVT) and transobturator tape (TOT), remain the most frequently used surgical treatments for SUI, despite some warnings from institutions and societies about potential complications with synthetic materials.
Although many women experience successful outcomes from sling surgery, not all are cured. The long-term success rates for TOT/TVT procedures in treating SUI symptoms vary significantly, with failure rates reported to be as high as 16% after five to ten years of follow-up, overactive bladder symptoms are frequently encountered after these procedures. Additionally, we showed that mean ICIQ-SF scores were significantly higher, indicating more severe SUI symptoms, in patients who had previously undergone a failed TVT/TOT procedure compared to those without prior surgery1. The failure of sling surgery can be defined in several ways: (a) Failure to cure the symptom of stress incontinence, (b) Stress incontinence cured, but de novo overactive bladder (OAB) symptoms ± voiding symptoms, (c) Stress incontinence not cured, and emergence of de novo OAB symptoms ± voiding symptoms, and (d) Other new symptoms or complications, e.g. pain, erosion2.
What to do next, however, remains a topic of debate. Despite the lack of consensus and high-quality data on the best approach to recurrent or persistent stress urinary incontinence, as highlighted by a recent Cochrane review, several options are available 3. Surgeons may choose to leave the original tape in place, remove it, or insert a second sling. A different route, such as switching from retropubic to transobturator, can also be considered. Re-operation with a different type of synthetic mid-urethral sling is a common recommendation, with a re-operation rate of about 6%. Before selecting an appropriate management strategy, assessing urethral support is a critical component in evaluating a patient whose previous surgery for stress urinary incontinence has failed2. The presence of vaginal mesh erosion must be ruled out before considering further surgery, even with the aid of cystoscopy2. Urodynamic studies are essential for evaluating patients with failed slings, as they help determine if intrinsic sphincter deficiency (ISD) is present. In such cases, the retropubic approach yields better outcomes compared to the obturator approach4,5. Additionally, it is important to identify patients with voiding dysfunction following previous surgery, which may indicate obstruction or impaired detrusor contractility. A thorough assessment of urethral support is essential, as the management of patients with a hypermobile urethra differs from that of those with a well-supported urethra2.
If symptoms are mild, a conservative approach may be attempted, including physiotherapy, the use of incontinence pessaries, or medications such as duloxetine6. Alternative surgical procedures may also be considered:
- Burch colposuspension: This may be an option for women with failed sling surgery7, but it is not recommended for those with intrinsic sphincter deficiency (ISD).
- Repeat retropubic or obturator tape: Women with ISD generally experience better outcomes with the retropubic route5.
- Autologous fascial sling: Although no studies directly compare the efficacy of TVT (tension-free vaginal tape) and rectus sheath slings in cases where primary mid-urethral tape has failed, repeating the same operation may not be feasible when TVT has already failed.
- Bulking agents: These provide short-term improvement and can reduce procedure time in recurrent stress urinary incontinence (SUI) or even in mixed urinary incontinence (MUI)8,9, though they have a lower success rate compared to repeat surgeries9.
- Artificial urethral sphincter: The artificial urinary sphincter is increasingly used in female patients with complex SUI, particularly after multiple failed anti-incontinence surgeries and in cases with detrusor underactivity, but further research and long-term follow-up are required to refine its role and timing in the treatment pathway3,10.
Behavioral modification, oral anticholinergics, neuromodulation techniques, like sacral neuromodulation or percutaneous tibial nerve stimulation, may also be considered for women who emerged de novo detrusor overactivity11.
Our center has experience using Er-yag laser for treating patients with urinary incontinence, particularly SUI1,12,13. It works by heating the vaginal tissue, causing immediate collagen fiber shrinkage, followed by the stimulation of new collagen, elastin, and blood vessel formation14. This process strengthens the vaginal support structures, particularly in cases of urethral hypermobility, helping to prevent SUI.
We assessed the effectiveness of Er-yag laser treatment in women with SUI, comparing those with failed TOT/TVT surgeries to those without, in a retrospective multi-center study1. Our findings revealed that Er-yag laser significantly improved SUI symptoms in both groups. Younger women and those with fewer years in menopause showed a better response, with longer-lasting effects. The Er-yag laser is a promising alternative for patients with failed TOT/TVT procedures, particularly in younger and early postmenopausal women. Good responders experienced improvement lasting approximately 16 months. Patients should be informed about the potential need for additional sessions to maintain effectiveness. Furthermore, using vaginal estrogen cream or tablets for 2 to 3 weeks prior to Er-yag laser treatment may enhance its effectiveness by hydrating the vaginal epithelium for better laser absorption.
Patients often experience frustration after a failed procedure, making it difficult to convince them to undergo another surgery. A thorough history and examination are essential, followed by a shared and well-informed decision-making process with the patient. Currently, there is insufficient data and a lack of randomized controlled trials comparing different surgical approaches for managing patients whose primary mid-urethral tape has failed. Consequently, the superiority of one approach over another in such cases remains undetermined, highlighting a critical area for further research.
1 Erel CT, Fernandez LDC, Inan D, Makul M. Er:YAG laser treatment of urinary incontinence after failed TOT/TVT procedures. European Journal of Obstetrics & Gynecology and Reproductive Biology 2020;252:399–403. https://doi.org/10.1016/j.ejogrb.2020.07.010.
2 Smith ARB, Artibani W, Drake MJ. Managing unsatisfactory outcome after mid‐urethral tape insertion. Neurourol Urodyn 2011;30:771–4. https://doi.org/10.1002/nau.21090.
3 Bakali E, Johnson E, Buckley BS, Hilton P, Walker B, Tincello DG. Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women. Cochrane Database of Systematic Reviews 2019;2019. https://doi.org/10.1002/14651858.CD009407.pub3.
4 Lee K-S, Doo CK, Han DH, Jung BJ, Han J-Y, Choo M-S. Outcomes Following Repeat Mid Urethral Synthetic Sling After Failure of the Initial Sling Procedure: Rediscovery of the Tension-Free Vaginal Tape Procedure. Journal of Urology 2007;178:1370–4. https://doi.org/10.1016/j.juro.2007.05.147.
5 Stav K, Dwyer PL, Rosamilia A, Schierlitz L, Lim YN, Chao F, et al. Repeat Synthetic Mid Urethral Sling Procedure for Women With Recurrent Stress Urinary Incontinence. Journal of Urology 2010;183:241–6. https://doi.org/10.1016/j.juro.2009.08.111.
6 Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, et al. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn 2016;35:15–20. https://doi.org/10.1002/nau.22677.
7 De Cuyper EM, Ismail R, Maher CF. Laparoscopic Burch colposuspension after failed sub-urethral tape procedures: a retrospective audit. Int Urogynecol J 2008;19:681–5. https://doi.org/10.1007/s00192-007-0506-6.
8 Dray E V., Hall M, Covalschi D, Cameron AP. Can Urethral Bulking Agents Salvage Failed Slings? Urology 2019;124:78–82. https://doi.org/10.1016/j.urology.2018.09.019.
9 Gaddi A, Guaderrama N, Bassiouni N, Bebchuk J, Whitcomb EL. Repeat Midurethral Sling Compared With Urethral Bulking for Recurrent Stress Urinary Incontinence. Obstetrics & Gynecology 2014;123:1207–12. https://doi.org/10.1097/AOG.0000000000000282.
10 Canagasingham A, Popa I, Chung A, Tse V. The Role of the Artificial Urinary Sphincter in Female Incontinence in 2023: A Literature Update. Curr Bladder Dysfunct Rep 2024;19:144–9. https://doi.org/10.1007/s11884-024-00756-4.
11 Sajadi KP, Vasavada SP. Overactive Bladder after Sling Surgery. Curr Urol Rep 2010;11:366–71. https://doi.org/10.1007/s11934-010-0136-2.
12 Erel CT, Inan D, Mut A. Predictive factors for the efficacy of Er:YAG laser treatment of urinary incontinence. Maturitas 2020;132:1–6. https://doi.org/10.1016/j.maturitas.2019.11.003.
13 Erel CT, Gambacciani M, Ozcivit Erkan IB, Gokmen Inan N, Hamzaoglu Canbolat K, Fidecicchi T. SUI in postmenopausal women: advantages of an intraurethral + intravaginal Er:YAG laser. Climacteric 2023;26:503–9. https://doi.org/10.1080/13697137.2023.2210282.
14 Tadir Y, Gaspar A, Lev‐Sagie A, Alexiades M, Alinsod R, Bader A, et al. Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies. Lasers Surg Med 2017;49:137–59. https://doi.org/10.1002/lsm.22637.