Case distribution and complications of mid-urethral sling surgery in a Canadian city before and after the Health Canada advisory on pelvic floor mesh.

INTRODUCTION AND HYPOTHESIS

Increased incidences of complications related to the use of mid-urethral slings (MUS) for the treatment of stress urinary incontinence resulted in both the Food and Drug Administration (FDA) and Health Canada issuing advisories in 2008 and 2010 respectively. The purpose of this study was to assess the effect these advisories had on the number of surgeons performing MUS surgery and post-surgical complications in Calgary, Canada.

METHODS

In this study, we conducted a retrospective analysis of administrative data between 2006 and 2011. Post-surgical complications were identified using diagnostic codes. All rates were adjusted for the increase in the female population in Calgary during the study period. An interrupted time series model was used to evaluate any changes in the number of surgeons performing MUS surgery and any post-surgical changes from the period before and that after the advisories.

RESULTS

The number of surgeons performing MUS surgery and the number of surgeries performed decreased over the study period, although neither of these was significantly related to the advisories. In terms of complications, we did not observe a significant change in the rate of repeat MUS surgeries, inpatient admissions, emergency department visits, or ambulatory care visits within 2 years of initial surgery.

CONCLUSION

The FDA and Health Canada advisories had no effect on the use of MUS in Calgary. This suggests either that they bear little influence on local surgeons' practices, or that safety was already at such a high level that improvements were not possible.