PROLENE SPMHRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031050464), received between Nov 24, 2017 and Apr 24, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Adverse 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 SURGERY ON (B)(6) 2006 AND A MESH WAS IMPLANTED DUE TO ADHESION, OBSTRUCTION AND SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO PAIN, INFLAMMATION, DENSE ADHESIONS TO SMALL INTESTINE AND BOWEL OBSTRUCTION. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2022 AND A MESH WAS IMPLANTED DUE TO HERNIA RECURRENCE. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE.

  Patient problems: Hernia

  MAUDE report 21906079 ↗
• InjuryApr 24, 2025Adverse 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 SURGERY ON (B)(6) 2006 AND A MESH WAS IMPLANTED DUE TO ADHESION, OBSTRUCTION AND SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON 12/4/2018 DUE TO PAIN, INFLAMMATION, DENSE ADHESIONS TO SMALL INTESTINE AND BOWEL OBSTRUCTION. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2022 AND A MESH WAS IMPLANTED DUE TO HERNIA RECURRENCE. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE.

  Patient problems: Adhesion(s); Inflammation; Obstruction/Occlusion; Pain

  MAUDE report 21906075 ↗
• InjuryApr 24, 2025Adverse 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 SURGERY ON (B)(6) 2006 AND A MESH WAS IMPLANTED DUE TO ADHESION, OBSTRUCTION AND SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO PAIN, INFLAMMATION, DENSE ADHESIONS TO SMALL INTESTINE AND BOWEL OBSTRUCTION. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2022 AND A MESH WAS IMPLANTED DUE TO HERNIA RECURRENCE. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE.

  Patient problems: Insufficient Information

  MAUDE report 21906060 ↗
• InjuryJan 19, 2025Adverse 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 REVISION SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, DISTENTION AND SMALL-BOWEL OBSTRUCTION. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UNDERWENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Distention; Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 21188220 ↗
• InjuryNov 14, 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20680505 ↗
• InjuryNov 1, 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 REPAIR OF VENTRAL HERNIA OF ANTERIOR ABDOMINAL WALL WITH MESH IMPLANTED. IT WAS REPORTED PATIENT EXPERIENCED PAIN.

  Patient problems: Pain

  MAUDE report 20593744 ↗
• InjuryJun 18, 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 A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19564018 ↗
• InjuryMar 27, 2023Appropriate 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) 2018 AND MESH AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16625208 ↗
• InjuryNov 24, 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) 2010 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISIONARY PROCEDURE ON (B)(6) 2014 DUE TO SUI AND TVT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Incontinence

  MAUDE report 12867512 ↗
• InjuryNov 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12817861 ↗
• InjuryNov 8, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND TWO MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISIONS ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12769013 ↗
• InjuryOct 27, 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) 2007 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 12708830 ↗
• InjuryOct 22, 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) 2008 AND MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC SACROCOLPOPERINEOPEXY WITH GRAFT EXTENSION, LAPAROSCOPIC RIGHT SALPINGO-OOPHORECTOMY, LAPAROSCOPIC ENTEROCELE REPAIR, RECTOCELE REPAIR WITH PELVICOL GRAFT, PERINEOPLASTY AND CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERIES ON (B)(6) 2016, (B)(6) 2017, (B)(6) 2018 AND ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12680355 ↗
• InjuryNov 5, 2020Adverse 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 A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2017 DUE TO HERNIA RECURRENCE, CHRONIC ABDOMINAL PAIN AND BOWEL PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Hernia; Not Applicable

  MAUDE report 10791997 ↗
• InjuryDec 23, 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 UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND RECURRENCE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Inflammation; Nausea; Pain

  MAUDE report 9510801 ↗
• InjurySep 19, 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 UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERIES ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9085846 ↗
• InjurySep 19, 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 UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERIES ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9085839 ↗
• InjurySep 19, 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 UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERIES ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9085837 ↗
• InjuryDec 3, 2018Adverse 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 A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 8125599 ↗
• InjuryDec 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND THE MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUE AND UNDERWENT REVISIONARY PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Fistula; Incontinence; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7118498 ↗
• InjuryNov 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND HAD TO UNDERGO ADDITIONAL MEDICAL TREATMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7057521 ↗