PROLENE SPMIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031050471), received between Dec 30, 2014 and May 14, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. IT WAS REPORTED TO THE SALES REP THAT FOLLOWING AN UNSPECIFIED PROCEDURE, A MESH THAT HAD BEEN IMPLANTED IN THE PATIENT WAS REPORTED TO HAVE TORN. THE MESH WAS DESCRIBED AS DEFECTIVE. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172616 ↗
• InjuryJan 16, 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 ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, DISTENTION AND SMALL-BOWEL OBSTRUCTION.

  Patient problems: Abdominal Distention; Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 21167661 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS BY AN ATTORNEY REPORTED THAT THE PATIENT UNDERWENT REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT LEFT INGUINAL HERNIA ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21033605 ↗
• InjuryOct 19, 2023Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 17971635 ↗
• MalfunctionAug 16, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE MESH WAS USED. IT WAS REPORTED THAT THE PRODUCT RECEIVED WITHOUT IFU. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230836 ↗
• InjuryApr 25, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND TWO (2) MESH PRODUCTS WERE IMPLANTED, DUE TO PELVIC ORGAN PROLAPSE AND URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT URINARY INCONTINENCE, VAGINAL BLEEDING, INFLAMED CERVIX, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, CHRONIC PAIN, FOUL SMELLING DISCHARGE, EROSION OF THE MESH INTO HER VAGINAL WALL, AND EROSION OF THE OTHER MESH INTO HER CERVIX AND ADHERENCE TO HER BOWEL. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(6) 2019 AND (B)(6) 2020 TO REMOVE THE PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Inflammation; Pain; Purulent Discharge; Urinary Tract Infection

  MAUDE report 14199086 ↗
• InjuryApr 25, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND TWO (2) MESH PRODUCTS WERE IMPLANTED, DUE TO PELVIC ORGAN PROLAPSE AND URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT URINARY INCONTINENCE, VAGINAL BLEEDING, INFLAMED CERVIX, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, CHRONIC PAIN, FOUL SMELLING DISCHARGE, EROSION OF THE MESH INTO HER VAGINAL WALL, AND EROSION OF THE OTHER MESH INTO HER CERVIX AND ADHERENCE TO HER BOWEL. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(6) 2019 AND (B)(6) 2020 TO REMOVE THE PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Inflammation; Pain; Purulent Discharge; Urinary Tract Infection

  MAUDE report 14199085 ↗
• InjuryApr 11, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Erosion; Incontinence; Pain

  MAUDE report 14079789 ↗
• InjuryNov 17, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12833727 ↗
• InjuryNov 17, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12833628 ↗
• InjuryNov 10, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6)2006 AND PROLENE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH ON (B)(6) 2006 DUE TO EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12785501 ↗
• InjuryOct 30, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Pain; Unspecified Infection

  MAUDE report 12724938 ↗
• InjuryOct 28, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED ABDOMINAL PAIN, PELVIC PAIN, INFECTIONS, BOWEL PROBLEMS, RECURRENCE OF PELVIC ORGAN PROLAPSE, RECURRENCE OF STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12716489 ↗
• MalfunctionJul 28, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND THE MESH WAS USED. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE FOIL PACKAGING OF THE DEVICE WAS UNFOLDED AND OPENED. THE FOIL PACKAGING WAS NOT SEALED PROPERLY SO THE DEVICE APPEARED TO BE UNSTERILE. THE MESH WAS NOT USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243066 ↗
• InjuryJan 28, 2020Adverse 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 A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN AND UNDISCLOSED INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2006 WHICH IS CAPTURED IN SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 9637421 ↗
• InjuryMay 30, 2019Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE MESH IN (B)(6) OF 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Not Applicable; Pain

  MAUDE report 8656434 ↗
• InjuryJan 17, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) AND THE MESH WAS IMPLANTED. THE PATIENT HAD A SUBSEQUENT SURGERY ON (B)(6) FOR MIGRATION. SECOND MESH IMPLANTED WAS BARD MESH. THIRD PROCEDURE FOR SAME ISSUE IS NEEDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 8259608 ↗
• InjuryNov 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR IN 2005 AND THE MESH WAS IMPLANTED. THE PATIENT IS EXPERIENCING BULGING IN THE AREA OF THE INITIAL HERNIA REPAIR, POTENTIAL HERNIATION RECURRENCE AT THE SITE AND PAIN. THE PATIENT IS GOING TO NEED A HERNIA REPAIR REPEATED AT THE SAME SITE. THE PATIENT HAS NOT BEEN TO HIS DOCTOR YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hernia; Not Applicable; Pain

  MAUDE report 8036286 ↗
• InjuryDec 30, 2014Material Erosion

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Extrusion; Foreign body, removal of; Other (for use when an appropriate patient code cannot be identified); Pain; Scar Tissue; Surgical procedure; Unspecified Infection

  MAUDE report 4370180 ↗