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Ethicon Media Monitoring 09/15/2015
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Vaginal Mesh Revision Rates Low
Sep 14, 2015 | Medscape Medical News
By Beth Skwarecki
The rate of revision or removal was low, about 1 in 30 after 10 years, among women who received a synthetic vaginal mesh sling as part of surgery for stress urinary incontinence, according to a population-based retrospective cohort study. -
Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence.
Sep 15, 2015 | Uro Today
Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the US Food and Drug Administration has released warnings that question the safety of vaginal mesh.
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Vaginal Mesh Revision Rates Low
Sep 14, 2015 | Medscape Medical News
By Beth Skwarecki
The rate of revision or removal was low, about 1 in 30 after 10 years, among women who received a synthetic vaginal mesh sling as part of surgery for stress urinary incontinence, according to a population-based retrospective cohort study. The study also showed that patients of lower-volume surgeons were 37% more likely to require revision than those treated by high-volume surgeons.
"This population-based study addresses multiple key questions from the [US Food and Drug Administration] and Health Canada and substantiates their recommendation that surgeons should obtain training and experience in the use of vaginal mesh implants for [stress urinary incontinence]," Blayne Welk, MD, from the Department of Surgery, Western University, St. Joseph's Health Care, London, Ontario, Canada, and colleagues write in an article published online September 9 inJAMA Surgery.
The study included 59,887 women who received the surgery from 2002 to 2012 in Ontario, Canada, with a mean follow-up time of 4.4 years. The rate of removal or revision surgery was 2.2%, occurring a median of 0.94 years (interquartile range, 0.35 - 2.49) after the initial surgery. Of women who had more than one mesh-based procedure for stress urinary incontinence, the rate of revision or removal was higher, at 4.87% (95% CI, 3.86% - 6.06%).
Patients of surgeons who were considered high-volume, defined as those performing more procedures than 75% of their peers, were less likely to require revision surgery. The lower-volume surgeons had a 37% higher relative risk (95% CI, 17% - 49%; P < .01) for removal or revision. The investigators compared outcomes from urologists and gynecologists, but there was no significant difference between the specialties.
The investigators suggest that the importance of surgeons' experience is somewhat unusual in this type of surgery: "Although surgeon volume has been shown to be important for complex operations, such as oncologic and cardiac surgery, its role in less demanding procedures is not well defined," the authors write.
This type of surgery, however, is a "commonly performed, same-day procedure with a low baseline risk for complications," Christian Meyer, MD, from the Center for Surgery and Public Health and Quoc-Dien Trinh, MD, from the Division of Urologic Surgery, both at Brigham and Women's Hospital, Boston, Massachusetts, write in an accompanying invited commentary. Therefore, recommendations that it should be performed by high-volume surgeons are somewhat impractical, they say. "Should patients be expected to travel hundreds of miles for surgery by a designated high-volume surgeon?... A more reasonable approach to achieve quality surgical care for common procedures may come from structured proctoring and/or coaching models and from mandatory outcomes reporting. Although physicians may not openly welcome these initiatives, they ultimately will help to establish surgical audits and improve outcomes."
The study authors note several limitations, including an inability to distinguish which type of sling was used or the degree of incontinence a woman was experiencing before surgery. Also, the study did not consider complications that were treated without surgery or that were not treated.
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Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence.
Sep 15, 2015 | Uro Today
Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the US Food and Drug Administration has released warnings that question the safety of vaginal mesh.
To measure the incidence of mesh removal or revision after SUI procedures and to determine whether significant surgeon and patient risk factors exist.
Population-based retrospective cohort study that included all adult women undergoing an incident procedure for SUI with synthetic mesh in Ontario, Canada, from April 1, 2002, through December 31, 2012 (N = 59 887). The end of potential follow-up was March 31, 2013. Data were analyzed from November 1, 2014, through February 28, 2015.
Yearly volume of mesh-based procedures for SUI performed by the treating surgeons and their surgical specialty.
The primary outcome was a composite of surgical procedures related to removal or revision of mesh slings (owing to erosion, fistula, pain, or retention). We hypothesized a priori that surgeon volume would be inversely correlated with complications.
Among the identified 59 887 women who underwent a mesh-based procedure for SUI, the median age was 52 (interquartile range [IQR], 45-63) years. High-volume surgeons (≥75th percentile of yearly mesh-based procedures) were less likely to perform a simultaneous hysterectomy (performed in 11. 5% vs 16. 5% of patients; standardized difference, 0. 14), were more likely to work in an academic center (28. 9% vs 16. 3% of patients; standardized difference, 0. 30), and saw the patient less frequently in the year before the procedure (median, 2 [IQR, 1-3] vs 3 [IQR, 2-4] visits; standardized difference, 0. 26). Complications were treated in 1307 women (2. 2%), and the 10-year cumulative incidence rate was 3. 29 (95% CI, 3. 05-3. 53). In our multivariable survival model, patients of high-volume surgeons had a significantly lower risk (95% CI) for experiencing our composite outcome (hazard ratio [HR], 0. 73 [0. 65-0. 83]; absolute risk reduction, 0. 63% [0. 36%-0. 92%]; P < . 01). Gynecologists were not significantly associated with more complications compared with urologists (HR, 0. 94 [95% CI." class="hasTip1">95% CI, 0. 83-1. 08]; P = . 38). Among our secondary exposures of interest, multiple mesh-based SUI procedures increased the risk for complications (HR, 4. 73 [95% CI." class="hasTip1">95% CI, 3. 62-6. 17]; P < . 01). However, traditional high-risk patient features did not increase the risk (HR, 0. 58 [95% CI." class="hasTip1">95% CI, 0. 08-4. 13]; P = . 59).
Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication. These findings support the recommendations of the US Food and Drug Administration related to the use of vaginal mesh for treatment of SUI.
JAMA surgery. 2015 Sep 09 [Epub ahead of print]
Blayne Welk, Hana'a Al-Hothi, Jennifer Winick-Ng
Department of Surgery, Western University, St Joseph's Health Care, London, Ontario, Canada2Department of Epidemiology and Biostatistics, Western University, St Joseph's Health Care, London, Ontario, Canada3Institute for Clinical Evaluative Sciences, Lond. , Department of Surgery, Hamad Medical Corporation, Doha, Qatar. , Institute for Clinical Evaluative Sciences, London, Ontario, Canada.
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