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Related Experiment Video

Updated: Mar 7, 2026

Transvaginal Mesh Insertion in the Ovine Model
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Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis.

Valerie Leiter1, Shelley K White1, Abigail Walters2

  • 1Department of Sociology, Simmons College, Boston, Massachusetts.

Women'S Health Issues : Official Publication of the Jacobs Institute of Women'S Health
|February 25, 2017
PubMed
Summary

Vaginal mesh manufacturer announcements, not FDA statements, significantly increased adverse event reports. This highlights issues with how the FDA handles postmarket surveillance for medical devices.

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Area of Science:

  • Medical device safety
  • Regulatory affairs
  • Public health

Background:

  • Vaginal mesh is a common surgical treatment for female urinary incontinence.
  • Concerns regarding the safety and efficacy of vaginal mesh devices have grown over the last decade.

Purpose of the Study:

  • To analyze trends in adverse event reports linked to vaginal mesh.
  • To investigate if Food and Drug Administration (FDA) announcements impact adverse event report numbers.

Main Methods:

  • Utilized interrupted time series regression models.
  • Analyzed adverse event report data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
  • Data spanned from 1998 to 2015.

Main Results:

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Last Updated: Mar 7, 2026

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  • FDA announcements showed minimal impact on the volume of adverse event reports.
  • A significant surge in adverse event reports occurred following a mesh manufacturer's announcement of market withdrawal.
  • This suggests manufacturer communications are more influential than regulatory announcements.

Conclusions:

  • Findings indicate potential issues with risk communication dissemination.
  • Raises questions about the FDA's reliance on adverse event reports for postmarket surveillance.
  • Highlights concerns regarding the FDA's clearance process for vaginal mesh, particularly the lack of rigorous safety and efficacy testing.