GYNECARE GYNEMESH GPSXL3Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031037748), received between Jan 23, 2018 and Apr 22, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Migration” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 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 SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. THE PATIENT REPORTS THAT: "SINCE THE OPERATION, I HAVE BEEN IN CONTINUOUS DISCOMFORT, AND THE SITUATION HAS WORSENED OVER THE MONTHS AND YEARS, REQUIRING VARIOUS PAINKILLERS UNTIL FINALLY TODAY, IT IS ACKNOWLEDGED THAT MY PROBLEMS MAY STEM FROM THESE PROSTHESES. I PRIMARILY SUFFER FROM NUMEROUS AND VARIED PAINS THAT HAVE INTENSIFIED OVER TIME, BUT IT WAS ONLY RECENTLY THAT IT WAS ACCEPTED THAT THESE NEUROPATHIC PAINS ARE, IN FACT, COMPLICATIONS FROM THE SURGICAL INTERVENTION I UNDERWENT ON (B)(6) 2025: PROMONTOFIXATION WITH SUBTOTAL INTERANNEXIAL LAPAROSCOPIC HYSTERECTOMY, AND THE IMPLANTATION OF A MID-URETHRAL SLING." THE PATIENT FURTHER REPORTED: "UNTIL RECENTLY, NUMEROUS EXAMINATIONS WERE CARRIED OUT CONCERNING MY VERTEBRAE, HIPS, AND MORE, LOOKING FOR POSSIBLE CAUSES AND SOLUTIONS WITHOUT CONVICTION OR SUCCESS. IN 2018, I HAD TO REVISIT MY SURGEON AFTER EXPERIENCING A PARTICULARLY LONG AND PROBLEMATIC EPISODE OF CONSTIPATION. DURING OUR POSTOPERATIVE APPOINTMENT IN 2015, I DETAILED EVERYTHING I WAS SUFFERING FROM THAT SEEMED POTENTIALLY RELATED TO THE SURGERY, ASKING HIM TO SIFT TH

  Patient problems: Autoimmune Disorder; Burning Sensation; Loss of Range of Motion; Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 21882669 ↗
• InjuryFeb 22, 2024Adverse 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 AN UNKNOWN DATE AND MESH WAS IMPLANTED. AN ALLERGIC REACTION OCCURRED. IT HAS NOT BEEN DETERMINED IF THE CAUSE WAS THE PRODUCT, BUT AN ALLERGIC REACTION OCCURRED AROUND THE AREA WHERE THE PRODUCT WAS USED. THE SITUATION HAS BEEN DEALT WITH BY SUPPRESSING THE REACTION WITH STEROIDS. THE PATIENT IS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18760002 ↗
• InjuryFeb 6, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTIONS, BLEEDING, CHRONIC PAIN, DYSPAREUNIA AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18648284 ↗
• InjuryFeb 5, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTIONS, BLEEDING, CHRONIC PAIN, DYSPAREUNIA AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18647887 ↗
• InjuryNov 15, 2023Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WERE 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 18138872 ↗
• InjuryNov 14, 2023Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, DYSPAREUNIA, MESH EROSION, INFLAMMATION, INFECTION AND DRAINAGE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Fluid Discharge; Inflammation; Pain; Unspecified Infection

  MAUDE report 18136668 ↗
• InjuryApr 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY ON (B)(6) 2010 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANDIDAL VULVOVAGINITIS THAT WAS CLASSIFIED WITH MILD SEVERITY. IT WAS REPORTED THAT THE PATIENT WAS GIVEN DRUG THERAPY AND THE EVENT ENDED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT RECOVERED, AND THE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS ALSO REPORTED THAT THE EVENT HAD AN UNLIKELY RELATIONSHIP TO THE STUDY DEVICE AND AN UNLIKELY RELATIONSHIP TO THE PRIMARY STUDY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14131585 ↗
• InjuryNov 25, 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) 2007 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12876213 ↗
• InjuryNov 16, 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) 2008 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 12823575 ↗
• InjuryNov 10, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6)2011 AND GYNEMESH PS PROLENE AND TVT ABBREVO 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.

  Patient problems: Erosion; Pain

  MAUDE report 12785482 ↗
• InjuryNov 2, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND GYNEMESH PS WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED EROSION OF HER INTERNAL BODILY TISSUE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12741426 ↗
• InjuryNov 1, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED AND ON (B)(6) 2009, PERIGEE (AMS) AND APOGEE (AMS) WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2009. IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUE FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12728120 ↗
• InjuryOct 22, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND GYNEMESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN IN HER LOWER ABDOMEN, INCREASING DYSPAREUNIA WITH BLEEDING, PROLAPSE, DISCOMFORT, EROSION, SCARRING AND INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Pain; Scar Tissue

  MAUDE report 12686114 ↗
• InjuryOct 22, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005 AND GYNEMESH PS WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUES. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12685987 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 9987050 ↗
• InjuryNov 22, 2019Adverse 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) 2009 AND MESH WERE IMPLANTED DUE TO MIXED URINARY INCONTINENCE, CYSTOCELE, RECTOCELE, ENTEROCELE, COMPLETE PROCIDENTIA OF THE VAGINAL CUFF AND BILATERAL PARAVAGINAL DEFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 9361532 ↗
• InjuryJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY ON (B)(6) 2017 AND MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT HAD SEPTIC SHOCK AND SEPSIS OCCURRED IMMEDIATELY AFTER SURGERY. IT WAS REPORTED THAT THE BLOOD STATE WAS ALREADY BAD AND THE LEUKOCYTE COUNT WAS RISING DURING THE OPERATION. THE PATIENT WAS PROVIDED TREATMENT FOR SEPSIS WITH VASOPRESSOR DRUG, BLOOD CIRCULATION, VENTILATOR. THE PATIENT WAS ADMITTED TO ICU AND CURRENTLY THE BLOOD CONDITION IS REPORTED TO BE PRETTY BAD. THE SURGEON OPINED THERE WAS NO CAUSE AND RELATIONSHIP BETWEEN MESH AND SEPSIS. THE PATIENT IS IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Septic Shock

  MAUDE report 7212545 ↗

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