PROLENE SPM3XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031238824), received between Sep 25, 2018 and Mar 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2021 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCARRING AND INFECTION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Scar Tissue; Unspecified Infection

  MAUDE report 24724240 ↗
• 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 LEFT LOWER QUADRANT VENTRAL HERNIA REPAIR SURGERY (B)(6) 2010 AND MESH AND 2 (TWO) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY AND MULTIPLE REVISIONARY SURGERIES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22312926 ↗
• InjuryJan 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TAR IN 2019 AND MESH WAS PLACED IN THE RETRO MUSCULAR LAYER. AFTER AN UNKNOWN NUMBER OF YEARS, THE PATIENT EXPERIENCED 5X6CM MIDLINE RECURRENCE DUE TO CENTRAL MESH FAILURE. THE SURGEON PREFORMED ANOTHER REPAIR AND THERE ARE NO COMPLICATIONS AT THIS POINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant; Hernia

  MAUDE report 18572712 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: POSTERIOR COMPONENT SEPARATION WITH TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR REPAIR OF COMPLEX INCISIONAL HERNIAS AFTER ORTHOTOPIC LIVER TRANSPLANTATION. THIS STUDY REPORTS THE EXPERIENCE OF TWO HIGH-VOLUME CENTERS USING TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR THE REPAIR OF INCISIONAL HERNIAS (IH) AFTER ORTHOTOPIC LIVER TRANSPLANT (OLT). A TOTAL OF 44 IMMUNOSUPPRESSED PATIENTS WHO HAD UNDERGONE IH REPAIR AFTER OLT UTILIZING A TAR TECHNIQUE AND HAD A MINIMUM OF A 1-YEAR FOLLOW-UP WERE INCLUDED IN THE STUDY. THERE WERE 33 MALES AND 11 FEMALES WITH A MEAN AGE OF 60 YEARS AND MEAN BMI OF 30.7 KG/M2. DURING THE INCISIONAL HERNIA REPAIR PROCEDURE, A PROLENE SOFT POLYPROPYLENE MESH RECTANGULAR SHAPED 50 CM × 50 CM (ETHICON), PROLENE POLYPROPYLENE MESH SQUARE SHAPED 30 × 30 CM (ETHICON), AND 3 OTHER NON-ETHICON MESH DEVICES WERE USED. AT THE CENTER OF THE MESH, 4¿5 CM FROM ITS MOST SUPERIOR EDGE, THE MESH IS FIXATED AROUND THE XIPHOID A FULL-THICKNESS TRANSFASCIAL SUTURE. MESH IS FURTHER FIXATED TO EACH OF THE COSTAL MARGINS, AT THE LEVEL OF THE HEMICLAVICULAR LINE WITH A MONOFILAMENT ABSORBABLE SUTURE. MESH IS FURTHER FIXATED CIRCUMFERENTIAL

  Patient problems: Cellulitis; Hematoma; Hemorrhage/Blood Loss/Bleeding; Seroma; Unspecified Infection

  MAUDE report 11738557 ↗
• InjurySep 25, 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 HERNIA SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCE ADHESIONS AND SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Blood Loss; Scarring

  MAUDE report 7904971 ↗