PROLENE PMIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10705031049024), received between Dec 5, 2017 and Sep 15, 2026 — classified as 96 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (9 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 111 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by an attorney that patient underwent hernia repair on an unknown date in 2009 and an unknown hernia mesh was implanted. It was reported that the patient underwent removal surgery on an unknown date. It was reported that the patient experienced fatigue and an autoimmune disorder. No additional information was reported.

  Patient problems: Autoimmune Disorder; Fatigue

  MAUDE report 50776283 ↗
• MalfunctionAug 25, 2026Device Markings/Labelling Problem

  It was reported from the analysis of the returned product that confirmed counterfeit was observed. It was reported that a Test Sample procured during market survey suspected to be counterfeit. There were no reported patient or user harm. There were no significant delays reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434368 ↗
• MalfunctionJul 1, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND MESH WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT CONFIRMED COUNTERFEIT PRODUCT WAS OBSERVED. DURING MARKET SURVEY, 2 SAMPLES OF PROLENE MESH WERE PROCURED WHICH ARE SUSPECTED TO BE COUNTERFEIT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681476 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25144639 ↗
• MalfunctionMay 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND MESH WAS USED. AT THE TIME OF SURGERY SURGEON OPEN MESH ITS BEHAVE LIKE SOFT MESH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142031 ↗
• MalfunctionNov 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. DURING THE SURGERY SURGEON OPENED A MESH, WHILE CUTTING THE MESH FOR APPLICATION SURGEON SAW A SHRINKAGE IN MESH AND NOTICED SOME CHANGE IN MESH MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487618 ↗
• MalfunctionMay 21, 2025Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR ON (B)(6) 2025 AND MESH WAS USED. THE CORNERS OF THE MESH WAS FRAYING AND CRUMPLE IN NATURE WHILE HANDLING IT DURING THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062832 ↗
• MalfunctionMay 21, 2025Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR ON (B)(6) 2025 AND MESH WAS USED. THE CORNERS OF THE MESH WAS FRAYING AND CRUMPLE IN NATURE WHILE HANDLING IT DURING THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062824 ↗
• InjuryApr 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 REVISION SURGERY ON (B)(6) 2021 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON UNSPECIFIED DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21916531 ↗
• InjuryFeb 26, 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) 2014 AND TWO(2) MESH, ONE(1) MESH AND ONE (1)MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21475469 ↗
• MalfunctionFeb 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND MESH WAS USED. IT WAS VERY THIN WITH THE ROLLED EDGES AND IT WAS VERY UNSATISFACTORY AND POOR-QUALITY MESH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381225 ↗
• InjuryFeb 10, 2025Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6)2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND REPAIR OF RIGHT INGUINAL HERNIA ON (B)(6) 2022 DURING WHICH THE SURGEON NOTE RECURRENT INGUINAL HERNIA WITH EXTENSIVE SCAR TISSUE, PREVIOUS INGUINAL HERNIA MESH NOTED STUCK TO THE VAS DEFERENS. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF RIGHT INGUINAL MESH ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED SCARRING IN THE RIGHT INGUINAL REGION FROM PREVIOUS HERNIA, MESH SCARRED INTO CORD CONTENTS IN THE FLOOR OF THE INGUINAL CANAL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, CONSTIPATION, UNABLE TO PERFORM HEAVY LIFTING, HERNIA RECURRENCE, DISCOMFORT, DEPRESSION, LIMITED MOBILITY, ADHESION, MESH MIGRATION, DEFORMATION, MESH SHRINKAGE, EXCESSIVE SCARIFICATION, FAILURE TO INCORPORATE AND CHRONIC INFLAMMATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Depression; Discomfort; Fatigue; Hernia; Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 21351337 ↗
• InjuryFeb 5, 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 RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND TWO MESHES WERE IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21318449 ↗
• MalfunctionJan 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ENFORCEMENT ACTION AGAINST A PHARMACY SHOP INVOLVED IN COUNTERFEIT PROLENE MESH. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060145 ↗
• MalfunctionJan 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ENFORCEMENT ACTION AGAINST A PHARMACY SHOP INVOLVED IN COUNTERFEIT PROLENE MESH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21059756 ↗
• InjuryDec 30, 2024Adverse 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21033933 ↗
• MalfunctionDec 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND MESH WAS USED. IT WAS VERY THIN WITH THE ROLLED EDGES AND IT WAS VERY UNSATISFACTORY AND POOR-QUALITY MESH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000806 ↗
• InjuryDec 7, 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 RIGHT GROIN EXPLORATION WITH REVISION OF RIGHT INGUINAL HERNIA REPAIR AND MESH REMOVAL SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20873500 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE IN 2024 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A POSSIBLE ALLERGIC REACTION, RASH AND ITCHING WITH SEVERAL DIFFERENT APPEARANCES OVER THE WHOLE BODY, COMES AND GOES FROM TIME TO TIME, DOES NOT REACT TO STEROID THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 20835670 ↗
• InjuryNov 30, 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 RECURRENT INGUINAL HERNIA WITH MESH ON (B)(6) 2002 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 20813606 ↗
• InjuryNov 27, 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 VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED AND REMOVAL SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NERVE DAMAGE AND CHRONIC AND INTRACTABLE ABDOMINAL PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Nerve Damage

  MAUDE report 20794784 ↗
• InjuryNov 27, 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 VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED AND REMOVAL SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NERVE DAMAGE AND CHRONIC AND INTRACTABLE ABDOMINAL PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Nerve Damage

  MAUDE report 20794382 ↗
• InjuryNov 19, 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 REVISION SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECTRORECTUS HERNIA REPAIR AND REMOVAL OF PRIOR MESH ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT, SWELLING, PAIN, VOMITING, NAUSEA, CONSTIPATION, AND RECURRENCE OF HERNIA. NO OTHER INFORMATION PROVIDED.

  Patient problems: Discomfort; Hernia; Nausea; Pain; Swelling/ Edema; Vomiting

  MAUDE report 20723238 ↗
• InjuryNov 6, 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 HERNIA PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20620003 ↗
• InjuryOct 31, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2008 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED MULTIPLE ADHESIONS BETWEEN THE PREVIOUS MESH AND THE BOWEL AND OMENTUM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA, EXCISION OF MESH AND LYSIS OF ADHESIONS ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE RECURRENT INCISIONAL HERNIA REPAIRS WITH WOUND INFECTION ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATION OF MIDLINE SURGICAL WOUND PULSED IRRIGATION AND PLACEMENT OF VAC DEVICE ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT OF ABDOMINAL WOUND AND WOUND VAC PLACEMENT ON (B)(6) 2010 DURING WHICH THE SURGEON NOTED MIDLINE SCAR HAD A GRANULATING AREA OF THE WOUND WAS EXCLUDED FROM THE SURGICAL FIELD, THERE WAS NONHEALING ABDOMINAL WOUND AND ABSCESS CAVITY WAS ENCOUNTERED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC ABDOMINAL PAIN, AND INTERMITTENT BOWEL OBSTRUCTION. OTHER PROCEDURE WA

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

  MAUDE report 20584829 ↗