Rate of sling removal 9 years after MUS for SUI over 3%

The long-term mesh removal rate in women with a midurethral mesh sling (MUS) insertion for treating stress urinary incontinence (SUI) was 3.3%, a British study found.

Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.

“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.

The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.

At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).

“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.

Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.

The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.

Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.

The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.

“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.

“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.

The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.

SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.

The long-term mesh removal rate in women with a midurethral mesh sling (MUS) insertion for treating stress urinary incontinence (SUI) was 3.3%, a British study found.

Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.

“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.

The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.

At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).

“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.

Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.

The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.

Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.

The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.

“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.

“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.

The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.

SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.

The long-term mesh removal rate in women with a midurethral mesh sling (MUS) insertion for treating stress urinary incontinence (SUI) was 3.3%, a British study found.

Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.

“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.

The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.

At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).

“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.

Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.

The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.

Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.

The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.

“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.

“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.

The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.

SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.