GYNECARE GYNEMESH GPSL (UDI 20705031037738)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20705031037738), received between Jan 18, 2018 and Aug 22, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K013718); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, MODERATE VAGINAL SCARRING WAS NOTED. EXCISION OF THE SCAR WAS PERFORMED AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2024. THIS WAS REPORTED AS NOT RELATED TO THE STUDY DEVICE, BUT POSSIBLY RELATED TO THE PRIMARY STUDY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 22874679 ↗
• InjuryAug 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR REPAIR PROCEDURE IN 2005 AND MESH WAS IMPLANTED ALONG WITH INSERTION OF TYCO IVS. PATIENT HAS EXPERIENCED A RIGID BAND OF TISSUE IN POSTERIOR DISTAL VAGINA SINCE SURGERY. IN 2023 PATIENT STARTED EXPERIENCING DYSPAREUNIA AND VAGINAL PAIN WITH VAGINAL STENOSIS. ALSO NOTED PV BLEEDING POST INTERCOURSE, WAS STRUGGLING TO PUT A FINGER IN HER VAGINA, URINARY FREQUENCY AND URGENCY, RECURRENT UTIS AND BOWELS ARE REGULAR. PATIENT AWAITING EUA, VAGINOSCOPY AND CYSTOSCOPY. NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Pain; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 22833822 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. AFTER SURGERY, THE PATIENT HAD CHRONIC PAIN IN THE PELVIS AND DOWN THE LEFT LEG. THE DOCTOR SAID PATIENT MUST HAVE HAD A PREVIOUS CONDITION, BUT PATIENT REPORTS ONLY HAVING SUFFERED FROM MIGRAINES NOTHING MORE. AFTER THAT, THE PATIENT WAS IN A WHEELCHAIR CHAIR FOR 2.5 YEARS - LIFE HAD DEPLETED TO NOTHING. PATIENT OUTCOME/CONSEQUENCES INCLUDE BASICALLY IN HOME AND SCARED TO LEAVE AS PATIENT MAY FALL. DATE OF EXPLANATION WAS REPORTED AS (B)(6) 2018. NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22188658 ↗
• InjuryJun 6, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE PROLAPSE SURGERY IN 2008-2009 AND MESH WAS USED. THE PATIENT RECENTLY VISITED THE HOSPITAL AND A PATIENT HAS URETERAL STONES. TRANSURETHRAL URETEROLITHOTRIPSY WAS PERFORMED, A FIBROUS MATERIAL THAT APPEARED TO BE MESH WAS FOUND IN THE URETER, AND STONES WERE ATTACHED AROUND THE MESH. THE MESH WAS PARTIALLY REMOVED AND RETRIEVED UNDER URETEROSCOPY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Calcium Deposits/Calcification; Erosion; Hematuria

  MAUDE report 22158251 ↗
• InjuryMar 4, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2018 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 18824813 ↗
• InjuryNov 9, 2022Appropriate 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 11/19/2003 AND MESH X2 WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLETE WALL PROLAPSE, URGENCY, LOW BACK PAIN, HIP PAIN, ABDOMINAL PAIN, COCCYGEAL PAIN, URINE TRACT INFECTIONS, ULCERATED CYSTOCELE, DYSPAREUNIA, STRESS INCONTINENCE, FREQUENCY, NOCTURIA, VAGINAL DISCOMFORT, GROIN PAIN, BUTTOCK PAIN, CONSTIPATION, DYSURIA, URINARY LEAKAGE AND PELVIC PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Dysuria; Incontinence; Micturition Urgency; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 15765274 ↗
• InjuryNov 2, 2021Adverse 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) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED ALONG WITH ANTERIOR COLPORRHAPHY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL INCONTINENCE AND PAIN IN HER BACK PASSAGE AND VAGINA. NO ADDITIONAL INFORMATION WAS PROVIDED. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Incontinence; Pain

  MAUDE report 12741801 ↗
• InjuryJun 2, 2021Adverse 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) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11926053 ↗
• InjuryApr 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED.  IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, CYSTOCELE, INFECTION, URINARY PROBLEMS, DYSPAREUNIA AND VAGINAL SCARRING.  THE PATIENT UNDERWENT CYSTOSCOPY; ROBOTICALLY ASSISTED LAPAROSCOPIC RESECTION OF SACRAL COLON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT UNDERWENT CYSTOCELE REPAIR USING A CELL AND CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Not Applicable; Pain; Scarring; Unspecified Infection

  MAUDE report 7422756 ↗
• InjuryMar 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT REPORTED THAT THE DEVICE DID NOT WORK AND ANOTHER UNSPECIFIED DEVICE WAS IMPLANTED IN 2011. THE PATIENT REPORTED THAT SHE EXPERIENCED MESH EROSION IN THE VAGINA AND INTEGRATED MESH INTO THE BACK WALL OF THE BLADDER. THE PATIENT ALSO EXPERIENCED GROIN, HIP AND BACK PAIN, URINARY TRACT INFECTIONS, DYSPAREUNIA, STRESS INCONTINENCE, DISCOMFORT WHEN SITTING OR STANDING FOR LONG PERIODS AND EXACERBATION OF IMMUNE RESPONSE TO MESH. THE PATIENT HAS EXPERIENCED AN OVERALL DECREASE IN HEALTH, QUALITY OF LIFE AND MARRIAGE. THE PATIENT UNDERWENT PARTIAL MESH REMOVAL ON (B)(6) 2017. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Incontinence; Not Applicable; Pain; Urinary Tract Infection

  MAUDE report 7352884 ↗
• InjuryMar 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE MESH ERODED IN THE VAGINA ON THREE OCCASIONS WHICH REQUIRED ADDITIONAL SURGERY. THE PATIENT ALSO EXPERIENCED CHRONIC PAIN, SENSITIVITY TO PLASTERS AND IV COVERS, PUDENDAL NERVE DAMAGE, INCREASED NUMBER OF URINARY TRACT INFECTIONS, DYSPAREUNIA AND PAIN WHEN WALKING. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Erosion; Hypersensitivity/Allergic reaction; Nerve Damage; Not Applicable; Pain; Urinary Tract Infection

  MAUDE report 7337802 ↗
• InjuryFeb 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  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, URINARY/BOWEL PROBLEMS, BLEEDING, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blood Loss; Erosion; Incontinence; Neurological Deficit/Dysfunction; Not Applicable; Pain; Scarring

  MAUDE report 7289389 ↗
• InjuryJan 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE MESH DISTORTED OVER A NUMBER OF YEARS, AND CAUSED DAMAGE TO PUDENDAL NERVE SYSTEM, AFFECTING THE WHOLE INTERNAL PELVIC AREA, LOWER BUTTOCKS AND UPPER THIGHS. THE PATIENT UNDERWENT SURGICAL PROCEDURE FOR REMOVAL OF THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Nerve Damage; Not Applicable

  MAUDE report 7231090 ↗
• InjuryJan 18, 2018Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR REPAIR ON (B)(6) 2009 AND MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED MESH EROSION, NERVE DAMAGE, INFECTION, LOWER BACK PAIN, LOWER LEG PAIN. THE PATIENT CANNOT STAND ON LEGS MORE THAN 4 HOURS PER DAY. THE PATIENT REPORTED MESH WAS REMOVED. THE PATIENT WAS TAKING ANTI-DEPRESSANTS AND WAS PROVIDED ANTIBIOTICS FOR INFECTION(S) IN THE PELVIC AREA. THE PATIENT IS UNDERGOING PHYSICAL THERAPY TO GAIN SOME STRENGTH AND IS TAKING VAGFEM LOW PESSARIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Depression; Erosion; Nerve Damage; Pain; Unspecified Infection

  MAUDE report 7203363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013718. One submission often covers many models, so check the product and lot details in each record.

• Z-0795-2007 · Apr 20, 2007 · Terminated
  Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland