PROLENE SPMXXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031050518), received between Dec 3, 2018 and Apr 24, 2025 — classified as 5 injuries.

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

• 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 UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2017 AND A MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21897132 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REVISION SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.

  Patient problems: Discomfort; Insufficient Information; Nausea; Pain; Swelling/ Edema; Vomiting

  MAUDE report 19959940 ↗
• InjuryNov 10, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2002 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2014 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12785502 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECURRENT UMBILICAL INCISIONAL HERNIA REPAIR WITH MESH PLACED PRE-PERITONEAL ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT DEVELOPED ERYTHEMA ON 7 SEPT WITH NO ACTION; ERYTHEMA RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. THE PATIENT DEVELOPED TACHYCARDIA ON 5 SEPT AND STOP 10 SEPT WITH NO ACTION INDICATED. TACHYCARDIA RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. PATIENT DEVELOPED TACHYPNEA 6 SEPT AND STOP 7 SEPT WITH CXR REVEALING ATELECTASIS. TACHYPNEA RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL WALL INFECTION REQUIRING ADMISSION TO AN OUTSIDE FACILITY FOR TREATMENT. THE PATIENT'S POST DISCHARGE COURSE WAS COMPLICATED BY THE ABDOMINAL WALL INFECTION WHICH REQUIRED A HOSPITALIZATION. THE PATIENT WAS ADMITTED TO THE LOCAL HOSPITAL FOR 10 DAYS FOR IV ANTIBIOTICS AND LOCAL WOUND CARE. THE PATIENT HAS RECENTLY FINISHED HER DISCHARGE COURSE OF ANTIBIOTICS AND IS HEALING APPROPRIATELY. THE PATIENT CONTINUES TO RECEIVE EVERY OTHER DAY WOUND CARE BY A WOUND CARE SPECIALIST. THE INFECTION BEGAN ON (B)(6) 2014 AND ENDED ON (B)(6) 2014. THIS ADVERSE EVENT IS POSS

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9154426 ↗
• 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 PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 8125255 ↗