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# Studies Confirm Boston Scientific’s Mesh Withdrawal
- URL: https://www.fdaweb.com/studies-confirm-boston-scientifics-mesh-withdrawal/
- Published: 2021-08-16T12:00:00.000Z
- Updated: 2026-09-14T17:10:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149942

Two Boston Scientific post-market surveillance studies ([522 studies](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?ref=fdaweb.com)) confirm the unfavorable benefit-risk profile of now-withdrawn **Boston Scientific’s transvaginal mesh for pelvic organ prolapse (POP). FDA 4/2019 ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of POP to immediately stop selling and distributing the products in the U.S. At the time, an agency** [**statement**](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM636114.htm?utm%5Fcampaign=04162019%5FPR%5FFDA%20takes%20action%20on%20tranvaginal%20mesh%20for%20POP%20repair&utm%5Fmedium=email&utm%5Fsource=Eloqua) **said it had determined that the products’ manufacturers — Boston Scientific and Coloplast — had not demonstrated a reasonable assurance of safety and effectiveness for the devices, which was the premarket review standard applied to them after their 2016 reclassification to Class 3.**  

The [final reports](https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh?utm%5Fmedium=email&utm%5Fsource=govdelivery) (36-month follow-up data) were reviewed by FDA. The results showed that Boston Scientific’s mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. “However, patients with transvaginal POP mesh repair are exposed to additional risks, including mesh exposure and erosion, compared to patients who underwent native tissue repair,” the agency says. “Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile.”