> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Late in Removing Mesh Products: Study
- URL: https://www.fdaweb.com/fda-late-in-removing-mesh-products-study/
- Published: 2020-02-20T12:00:00.000Z
- Updated: 2026-09-14T16:03:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146133

Researchers from three universities say that FDA was late in removing mesh implants for pelvic organ prolapse repairs “despite the numerous safety warnings and adverse events reported from patients’ narratives.” Writing in *Obstetrics and Gynecology*, the researchers [say](https://journals.lww.com/greenjournal/Abstract/publishahead/Long%5Fterm%5FDevice%5FOutcomes%5Fof%5FMesh%5FImplants%5Fin.97451.aspx?ref=fdaweb.com) that the factors that prevented timely response to an FDA warning first issued in 2008 might be related to patient-reported outcomes favoring mesh use in specific subgroups.

The purpose of the study was to evaluate the longer-term safety and reintervention of outcomes of mesh implants in pelvic organ prolapse. The researchers conclude that even though FDA ordered all mesh manufacturers to stop selling or distributing their products 4/1/19 for transvaginal repair of anterior prolapse, the risk of mesh complications has not diminished over time and the women who underwent such repairs warrant close follow-up.

The authors note that thousands of complications have been reported to FDA and more than 73,000 federal lawsuits have been filed against manufacturers of transvaginal mesh products. FDA has concluded that there was no “reasonable assurance of safety and effectiveness for these devices.”