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Aims Prompted by increased reports of complications with the use of mesh for pelvic organ prolapse (POP) surgery, the FDA issued an initial public health notification (PHN) in 2008. We proposed to determine if the numbers of POP cases augmented with surgical mesh performed in U.S. Medicare beneficiaries changed relative to this PHN. Methods Using administrative healthcare claims for beneficiaries enrolled in the U.S. Medicare program from 2008 to 2009, we identified women who underwent POP surgery with and without surgical mesh by procedural and diagnosis coding. In addition to comparing cases with and without mesh, we also calculated rates (number of cases per 100,000 female beneficiaries) and compared these relative to the timing of the PHN. Results We identified 104,185 POP procedures, of which 27,839 (26.7%) included mesh material and 76,346 (73.3%) did not. Between the last three quarters of 2008 and the first three of 2009, the rates of mesh cases increased (40.3–42.1, P

Prompted by increased reports of complications with the use of mesh for pelvic organ prolapse (POP) surgery, the FDA issued an initial public health notification (PHN) in 2008. We proposed to determine if the numbers of POP cases augmented with surgical mesh performed in U.S. Medicare beneficiaries changed relative to this PHN.Using administrative healthcare claims for beneficiaries enrolled in the U.S. Medicare program from 2008 to 2009, we identified women who underwent POP surgery with and without surgical mesh by procedural and diagnosis coding. In addition to comparing cases with and without mesh, we also calculated rates (number of cases per 100,000 female beneficiaries) and compared these relative to the timing of the PHN.We identified 104,185 POP procedures, of which 27,839 (26.7%) included mesh material and 76,346 (73.3%) did not. Between the last three quarters of 2008 and the first three of 2009, the rates of mesh cases increased (40.3-42.1, P 0.001) and those without mesh decreased (115.5-111.4, P 0.001). Inpatient procedures decreased and outpatient procedures increased for both those with and without mesh augmentation. For inpatient procedures, the relative use of biologic graft and synthetic mesh material did not vary over the study period.A substantial number of Medicare beneficiaries underwent mesh POP procedures in 2008-2009. However, despite the PHN cautioning about potential mesh complications, the numbers of mesh cases continued to rise in the immediate period after the PHN.

This study evaluates potential risk factors for mesh exposure following transvaginal placement of polypropylene mesh for pelvic organ prolapse requiring reoperation. We performed a case-control study. Cases had mesh exposure requiring surgical revision; controls had no mesh exposures and were chosen for similar surgical date and type of mesh. We identified 48 cases and 48 controls. The adjusted odds ratio of having a bleeding complication at the time of mesh implantation was 7.25 [95% confidence interval (CI) 1.47–35.66], smokers versus nonsmokers was 3.17 (95% CI 0.59–17.12), and being 1 year older was 0.96 (95% CI 0.92–1.0), among women with mesh exposure. We identified bleeding complications at the time of mesh implantation as a risk factor for mesh exposure requiring reoperation. Despite being one of the largest studies on this topic, our data were inconclusive regarding the impact of other possible factors on mesh exposure.