Synthetic mid-urethral sling (MUS) remains a common surgical option for women with stress urinary incontinence (SUI). There are two main types of MUS: tension-free vaginal tape (TVT) and transobturator tape (TOT).

However, severe complications, including disabling pain, have prompted concern.

A new French study analysing nearly all women who underwent these procedures between 2011 and 2018 reveals unexpectedly high rates of MUS removal or section, providing rare long-term, real-world evidence on the risks for these implants.

Speaking to Medscape French edition, Cyrille Guillot-Tantay, PhD, urologist at Hôpital Foch in Suresnes, France, and first author of the study, said: “Reinterventions (sling removal or division) could occur even more than 5 years after implantation.”

The study confirmed the significance of these complications after MUS insertion for SUI and showed that adverse events can occur long after surgery.

Controversy Over Complications

For SUI caused by urethral hypermobility, MUS placement via the TVT or TOT is commonly proposed in France, with approximately 90% efficacy at the 3-month follow-up.

Investigations, such as the US-based Implant Files and a French enquiry in 2018, revealed previously under-recognised adverse events, sparking public and medicolegal scrutiny. Representatives of the Association of Victims of Vaginal Implant Devices (DIVA) pursued recognition and legal action.

Since 2020, over 100 women in France have filed complaints for “deception” and “unintentional injuries” following complications from vaginal prostheses used for SUI and prolapse surgery.

Registry and comparative studies have quantified serious complications and reoperations after MUS procedures, informing guidelines and regulatory measures.

The VIGI-MESH national registry, which prospectively tracked serious complications in 2682 participants across 27 French centres, estimated the 2-year cumulative rate of serious complications to be 2.9% (95% CI, 1.9-4.3) in the TOT group and 5.8% (95% CI, 4.8-7.0) in the TVT group.

These findings, published in 2021, led the French National Authority for Health to publish best practice recommendations in 2023, in partnership with the French Association of Urology, to improve the management of complications.

TOT vs TVT: Methods and Outcomes

Using the French National Health Data System, investigators simulated a target randomised trial comparing TOT and TVT approaches in 215,141 women receiving MUSs between 2011 and 2018, with long-term observational follow-up.

“The choice of 2011 reflects the coding distinctions between the TOT and TVT. The SNDS does not allow identification of specific brands, models, or TOT techniques (‘inside-out’ vs ‘outside-in’),” said Guillot-Tantay.

At 5 and 7 years post-operation, the TVT group had a higher cumulative rate of reoperation for sling removal or division (4.13% at 5 years and 4.63% at 7 years) than the TOT group (3.25% at 5 years and 3.59% at 7 years).

Other complications, including hospitalisation for urinary retention, erosion, or infection, were more common with TVT.

The risk for urinary tract infection increased by 14% during the first year among patients with at least one infection and by 4% after 12 months compared with the TOT group.

“However, second MUS implantation was more frequent in the TOT than TVT group, which may suggest better effectiveness of the TVT approach. This result should be interpreted with caution because it relies on only SUI leading to reoperation (small proportion of recurrence or persistent SUI), and this was a secondary outcome,” wrote the authors.

Second MUS implantation was more frequent in the TOT group, which could suggest greater TVT efficacy, but this was a secondary outcome capturing only recurrence-driven reinterventions.

Literature from seven randomised trials shows 5-year reintervention rates of 2%-3% for TOT and 2%-7% for TVT.

“These rates are of the same order of magnitude as those we report,” said Guillot-Tantay, and are consistent with those of the VIGI-MESH registry.

Practice Implications

“In 2020, a ministerial order regulated sling implantation, requiring multidisciplinary review before any procedure and a learning curve for surgeons,” said Guillot-Tantay. It would be interesting to conduct a study since these measures were implemented, as he noted.

Furthermore, a 2025 decree redefined the framework for MUS implantation for the surgical treatment of SUI.

“It specifies that management of complications must occur in an expert centre and requires a minimum annual number of interventions per centre to ensure sufficient experience and quality of care,” said Guillot-Tantay.

While DIVA has called for a ban on TOT slings, Guillot-Tantay emphasised transparent counselling and long-term follow-up, noting that complications can emerge up to 5 years after implantation. “We must be transparent and monitor women over the long term after implantation,” Guillot-Tantay said.

Guillot-Tantay disclosed having relationships with Schlesinger Group France, IQVIA Inc., QualWorld, Teleflex Medical, Pfizer, and IBSA Pharma SAS.

This story was translated from Medscape’s French edition.