PROLENE SPMLIRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031050488), received between Jan 15, 2019 and Jan 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, UPPER AND LOWER BACK PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 24228678 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, UPPER AND LOWER BACK PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 24228665 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017 AND A COMPETITOR MESH WAS IMPLANTED. THERE WAS INCARCERATED OMENTUM. ADENOLYSIS WAS PERFORMED TAKING DOWN ALL ADHESIONS. MULTIPLE HERNIA DEFECTS SUPERIOR AND INFERIOR. HERNIA SACS WERE ALL OPENED AND EXCISED. PATIENT HAD MESH THAT HAD MULTIPLE SUTURE CONCERNING FOR INFECTION. SEROMA WAS REDUCED. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Seroma; Unspecified Infection

  MAUDE report 20477977 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16704604 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD NBII IT WAS REPORTED BY ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND PROLENE SOFT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 AND (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 16701168 ↗
• InjuryNov 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 12777076 ↗
• InjuryNov 1, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12729148 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Incontinence; Injury; Unspecified Infection

  MAUDE report 10211904 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT HAD HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 8250912 ↗