Related Experiment Video
Updated: Jul 19, 2025
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Lessons Learned from the MAUDE Database on Transvaginal Synthetic Mesh and Sling Reports
Annie Abraham1, Kristina Tzartzeva1, Alana Christie1
1UT Southwestern Medical Center, Dallas, Texas.
Introduction:
We investigated the volume and sources of MDRs (medical device reports) on transvaginal mesh and sling complications in the FDA (Food and Drug Administration) MAUDE (Manufacturer and User Facility Device Experience) database.
Methods:
We extracted and analyzed reports on transvaginal mesh and sling complications submitted to the MAUDE database from 2008 to 2014. We also examined reports for major mesh and sling brands as well as reporter occupation.
Results:
The number of reports on transvaginal mesh and sling implants increased slowly from 2008 to 2011, ending with 1,687 reports in 2011. In 2012 the volume increased nearly sevenfold, yielding 11,710 reports. The year 2013 witnessed an even greater surge, with a total of 43,680 complication reports. This trend quickly subsided in 2014 as the number of reports decreased to 5,467. Meanwhile, the number of attorney submitted reports greatly increased by a factor of 18.6 in 2012 and then by a smaller increment in 2013. Physician submitted reports increased threefold in 2012 and then by a factor of 5.6 in 2013. Unfortunately more than half of the 2013 reports list an unknown occupation for the reporter.
Conclusions:
The marked growth of transvaginal mesh and sling reports in the MAUDE database, as well as attorney submitted reports, correlated with the timing of the 2011 FDA issued notification warning the public about the risk of complications associated with transvaginal mesh placement. Despite some shortcomings, the MAUDE database offers an appropriate tool to measure overall trends of device complications and serves as a vehicle for the FDA to alert the public regarding potential dangers.
Insights
Medical device reports for transvaginal mesh complications surged after a 2011 FDA safety alert. The Manufacturer and User Facility Device Experience database effectively tracks these device complication trends.
Area of Science:
- Medical device safety and regulatory science.
- Urogynecology and pelvic reconstructive surgery.
- Health informatics and adverse event reporting systems.
Background:
- Investigated the volume and origins of medical device reports (MDRs) concerning transvaginal mesh and sling complications.
- Focused on data within the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
Purpose of the Study:
- To analyze trends in transvaginal mesh and sling complication reports.
- To identify changes in report volume and sources over time.
- To correlate report trends with FDA safety communications.
Main Methods:
- Extracted and analyzed MDRs submitted to the MAUDE database between 2008 and 2014.
- Examined reports for major transvaginal mesh and sling brands.
- Assessed reporter occupations, including physicians and attorneys.
Main Results:
- A significant sevenfold increase in reports occurred in 2012, followed by a further surge in 2013 (43,680 reports).
- Attorney-submitted reports increased dramatically (18.6-fold in 2012), alongside a threefold increase in physician reports.
- Report volume decreased in 2014, with over half of 2013 reports having an unknown reporter occupation.
Conclusions:
- The rise in transvaginal mesh complication reports correlates with the FDA's 2011 safety notification.
- The MAUDE database serves as a valuable tool for monitoring device complication trends and FDA public warnings.
- Despite limitations, MAUDE data effectively highlights potential dangers associated with medical devices.
