TRENDS AND FAILURE RATES IN THE MEDICAL TREATMENT OF PELVIC ORGAN PROLAPSE FOR MEDICARE PATIENTS

INTRODUCTION AND OBJECTIVES: The efficacy of transvaginal mesh for anterior colporrhaphy is well established (Nguyen 2008); however, complications related to use of transvaginal mesh led to the release of FDA safety communications in 2008 and 2011. This led to a significant decrease in the use of transvaginal mesh for pelvic organ prolapse (POP) since 2011 (Clemens 2013). We hypothesized that the decrease in transvaginal mesh use was partly driven by increased patient awareness of complications. We tested this using Google Trends , a public tool that provides data on temporal patterns of search terms and correlated this data with the timing of the FDA communications. METHODS: Weekly relative search volume (RSV) was obtained from Google Trends using the search term 00transvaginal mesh00, with higher RSV indicating an increase in search volume. These were divided into three groups: 2005 to July 13th 2011 (the date of the second FDA communication), a six-month period following the update, and thereafter until June 6th 2015. The distribution of the weekly RSV over the three periods was tested using one-way analysis of variance. We also tested the difference between total number of web pages containing 00transvaginal mesh00 (reported annually by Google) between 2006-2010 versus 2011-2015 using a paired t-test. RESULTS: The mean RSV prior to the 2011 FDA communication was 0.73 [standard deviation (SD)1⁄46.6], compared to 29.9 (SD1⁄417.0) in the six months after the update and 18.8 (SD1⁄47.7) thereafter (pu003c0.001), with no increase in RSV seen with the 2008 safety communication. The mean number of web pages on Google containing 00transvaginal mesh00 between 2006-2010 was 2,484 (SD1⁄41,388) vs. 38,680 (SD1⁄412,859) between 2011-2015 (pu003c0.001); the largest increase in search terms was seen between 2010 (4,390 webpages) to 2011 (25,500 webpages), reflecting the effect of the 2011 update. CONCLUSIONS: The FDA communication regarding transvaginal mesh for POP in 2011 was associated with significant increases in both Google search activity and total number of webpages about transvaginal mesh. This suggests the rise in lawsuits and decreased use of transvaginal mesh for POP may be partially driven by increased patient awareness of complications.