PROLENE PHSLRecalls & reported problems

Summary

The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 10705031048966), received between May 9, 2017 and Feb 13, 2026 — classified as 454 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (15 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 25 most recent of 458 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN ANTERIOR REPAIR OF UMBILICAL HERNIA ON (B)(6) 2019 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUPRAUMBILICAL ABSCESS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 24338014 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2019 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24218864 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2019 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24218862 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2017 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 24205008 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL AND LEFT GROIN PAIN AND BULGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24203298 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24180191 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2020 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24179361 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2019 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC LEFT INGUINAL PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 24162724 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT INGUINAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC POST HERNIORRHAPHY INGUINODYNIA AND A FOLDING DISPLACEMENT IN THE POSTERIOR ASPECT OF THE MESH WITH SIGNIFICANT ASSOCIATED INFLAMMATION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 24146031 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INGUINAL PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 24085802 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR WITH MESH ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SMALL ADHESION AND PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24061897 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL AND REVISION SURGERY ON (B)(6) 2022 AND A MESH WAS IMPLANTED. THERE WAS A SIZEABLE HYDROCELE WHICH WAS MARSUPIALIZED. THE MESH WAS THEN DISSECTED FREE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, HYDROCELE, SPERMATIC CORD ADHESIONS AND SCAR TISSUE AND SPLIT MESH. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2021 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Erosion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 23966619 ↗
• MalfunctionSep 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. SPECK OF FOREIGN MATERIAL OBSERVED IN PRODUCT PACKAGING. NO PATIENT OR END-USER INJURED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021061 ↗
• InjuryAug 20, 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 RIGHT INGUINAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22847779 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2004 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2007. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22696973 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2004 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2007. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22696971 ↗
• MalfunctionJul 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGE HAD A HAIR IN IT WHEN IT WAS OPEN, PICTURE'S WHERE NOT TAKEN. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438789 ↗
• InjuryJun 3, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2007 AND TWO(2) MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22129611 ↗
• InjuryMay 28, 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 LEFT AND RIGHT REPAIR OF BILATERAL INGUINAL HERNIA ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ALL MESH DURING WHICH THE SURGEON NOTED DEBRIDEMENT OF BILATERAL TISSUE, ABSCESS, EXTENSIVE LYSIS OF ADHESIONS, PLACEMENT OF PORCINE MESH UNDERLAY AND COMPONENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Adhesion(s)

  MAUDE report 22094854 ↗
• InjuryMay 28, 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 LEFT AND RIGHT REPAIR OF BILATERAL INGUINAL HERNIA ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ALL MESH DURING WHICH THE SURGEON NOTED DEBRIDEMENT OF BILATERAL TISSUE, ABSCESS, EXTENSIVE LYSIS OF ADHESIONS, PLACEMENT OF PORCINE MESH UNDERLAY AND COMPONENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Adhesion(s)

  MAUDE report 22094847 ↗
• InjuryMay 27, 2025Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH AND REPAIR OF LEFT RECURRENT BILATERAL INGUINAL HERNIA ON (B)(6) 2011. DURING WHICH THE SURGEON NOTED DISPLACED POSTERIOR SLEEVE OF THE MESH BALLED IN THE PREPERITONEAL SPACE INCORPORATING THE CORD STRUCTURE WITHIN FIBROSIS ASSOCIATE WITH THE DISPLACED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKS WITH SMALL AMOUNT OF SEROSANGUINEOUS DRAINAGE, ADHESION, PAIN, AND TENDERNESS LOWER QUADRANT LEFT GROIN. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22085657 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND TENDERNESS AT THE INCISION SITE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22071134 ↗
• InjuryMay 21, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22060073 ↗
• InjuryMay 21, 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 REPAIR ON (B)(6) 2019 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6) 2018 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22060036 ↗
• InjuryMay 21, 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 REPAIR SURGERY ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22058879 ↗