PROLENE PHSERecalls & reported problems
Ethicon Inc. · Polyproplylene Nonabsorbable Synthetic Surgical Mesh · Class 2 · Implant
Quick summary
This Ethicon Prolene surgical mesh is a synthetic mesh used to reinforce hernia repairs. Many of the 292 reports describe ongoing pain, adhesions where the mesh sticks to tissue, and returning hernias, and some describe repeat surgery to remove the mesh. The number of reports fell from 37 in the prior 12 months to 16 in the last 12 months. The reports include no deaths and 290 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 291
- Deaths reported
- 0
- Injuries reported
- 289
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 291 adverse event reports that list this exact device (DI 10705031048935), received between Mar 23, 2018 and Feb 25, 2026 — classified as 289 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem272
- Appropriate Device Problem Term/Code Not Available9
- Migration9
- Device Markings/Labelling Problem2
Patient problems
- Pain174
- Adhesion(s)105
- Hernia87
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available49
- Inflammation46
- Not Applicable40
- Insufficient Information36
- Scar Tissue35
Recent adverse event reports
The 25 most recent of 291 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A PATIENT THAT THEY UNDERWENT A DOUBLE INGUINAL HERNIA OPERATION ON (B)(6) 2024 AND MESH WAS USED. THE PATIENT EXPERIENCED SEVERE PAIN IN THE PUBIS AND LEFT GROIN CONTINUOUSLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pain
MAUDE report 24443969 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A PATIENT THAT THEY UNDERWENT A DOUBLE INGUINAL HERNIA OPERATION ON (B)(6) 2024 AND MESH WAS USED. THE PATIENT EXPERIENCED SEVERE PAIN IN THE PUBIS AND LEFT GROIN CONTINUOUSLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pain
MAUDE report 24443968 ↗MalfunctionFeb 6, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED DURING AN OPEN HERNIA REPAIR, THE PRODUCT DESCRIPTION WAS DIFFERENT FROM THE LABEL. THE CUSTOMER WANTING AN EXTENDED SIZE. THE PHYSICAL BOX PHSE THE MEASUREMENTS ARE DIFFERENT FROM WHAT THEY SAW ONLINE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280545 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIAS REPAIR WITH MESH ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE SCARRING AND CHRONIC RIGHT GROIN PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain; Scar Tissue
MAUDE report 24260300 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIAS REPAIR WITH MESH ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE SCARRING AND CHRONIC RIGHT GROIN PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain; Scar Tissue
MAUDE report 24260285 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL WALL HERNIA REPAIR ON (B)(6) 2004 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENTS UNDERWENT REMOVAL OF THE MESH ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH EROSION OF SMALL BOWEL, PAIN, BULGING AND ADHESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Erosion; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24228479 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL WALL HERNIA REPAIR ON (B)(6) 2004 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENTS UNDERWENT REMOVAL OF THE MESH ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH EROSION OF SMALL BOWEL, PAIN, BULGING AND ADHESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Erosion; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24228455 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2021 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTENSIVE SCARING OF THE PREVIOUS MESH. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Scar Tissue
MAUDE report 24202781 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA PROCEDURE ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED INGUINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. IT WAS REPORTED THE PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Adhesion(s); Pain
MAUDE report 24162434 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2021 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC RIGHT GROIN PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Pain
MAUDE report 24154206 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT INGUINAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Pain
MAUDE report 24100238 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR AND TWO (2) MESHES WERE IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Obstruction/Occlusion; Pain
MAUDE report 24083332 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR AND TWO (2) MESHES WERE IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Obstruction/Occlusion; Pain
MAUDE report 24083328 ↗InjuryNov 27, 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 INGUINAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 23663458 ↗InjuryNov 27, 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 INGUINAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 23663435 ↗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 THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22710791 ↗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) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SCARRING. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Pain; Scar Tissue
MAUDE report 22710761 ↗InjuryAug 1, 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 REPAIR OF RIGHT INGUINAL HERNIA AND A MESH WAS IMPLANTED ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22687250 ↗InjuryJun 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 REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22312938 ↗InjuryMay 25, 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) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain
MAUDE report 22082929 ↗InjuryMay 25, 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) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain
MAUDE report 22082928 ↗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 PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2020 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22060282 ↗InjuryMay 14, 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 REPAIR OF RIGHT INGUINAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22017985 ↗InjuryMay 12, 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) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22002057 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21948245 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.