GYNECARE GYNEMESHRecalls & reported problems across all models

We found 3 models of GYNECARE GYNEMESH by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2014 and Aug 22, 2025 — classified as 195 injuries.

The most frequently reported specific device problem is “Migration” (93 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GYNECARE GYNEMESH problems

GYNECARE GYNEMESH models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GYNECARE GYNEMESH GPSL

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  164 reports
• GYNECARE GYNEMESH GPSXL3

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  17 reports
• GYNECARE GYNEMESH GPSL

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  14 reports

Recent GYNECARE GYNEMESH adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• InjuryMar 24, 2025Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED AN INFLAMMATORY MASS OF BOWEL WAS FOUND ADHERED TO THE BLADDER. DURING DISSECTION, THE SACROCOLPOPEXY MESH WAS ENCOUNTERED AND NOTED TO BE NECROTIC AND INFECTED. THE MESH WAS PEELED OFF OF THE SACRAL PROMONTORY AND TRACED TO THE BLADDER. WITH GENTLE TRACTION ON THE MESH, THE FISTULOUS TRACT WAS EXCISED WITH ELECTROCAUTERY AND FOUND TO EXTEND INTO THE TRIGONE. WITH THE ASSISTANCE OF GENERAL SURGERY, THE BLADDER WAS DISSECTED OFF OF THE VAGINA, WHICH WAS VERY ADHERENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EROSION, FISTULA FORMATION, CHRONIC PELVIC, VAGINAL, AND BLADDER PAIN, HEMATURIA, CHRONIC INFECTIONS AND SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Erosion; Fistula; Hematuria; Inflammation; Necrosis; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 21684729 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. FROM THE TIME THE STRIP WAS PLACED, THE PATIENT EXPERIENCED RECURRENT CYSTITIS, INTERSTITIAL CYSTITIS FOLLOWING POOR EMPTYING, RAZOR EFFECT, PAIN AND DISCOMFORT AND URINARY DISORDERS. NO FURTHER INFORMATION CAN BE OBTAINED AS THE EVENT WAS REPORTED IN CONFIDENCE.

  Patient problems: Inflammation; Pain; Urinary Retention

  MAUDE report 21404152 ↗
• InjuryJan 21, 2025Migration; 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 21195527 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR AND POSTERIOR PROSTHESIS PROMONTOFIXATION IN 2017 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED COMPLICATED BY HEMATOMA OF RETROPERITONEAL PROSTHETIC LODGE EVACUATED AT D2. PERSISTENCE OF A THICK INFILTRATED SHELL ON IMAGING IN THE PATH OF THE ANTERIOR PROSTHESIS. ONSET OF BLEEDING SINCE 2020, ALMOST DAILY, WITH NO TRIGGERS. HYSTEROSCOPY IN (B)(6) 2022 WITH EXCISION OF A SMALL BENIGN ENDOCERVICAL POLYP. ON THE VAGINA, PRESENCE OF A SMALL RETRACTION ON THE POSTERIOR VAGINA OPPOSITE THE PALPATED PROSTHESIS, BUT WITHOUT VISIBLE EROSION OR GRANULOMA. NO PAIN OR BLEEDING VISUALIZED. DECISION TO REPEAT HYSTEROSCOPY WITH POSSIBLE THERMOCOAGULATION AND CLINICAL EXAMINATION UNDER GA PERFORMED ON (B)(6) 2024. HYSTEROSCOPY NORMAL AND MINIMAL EROSION AT THE BOTTOM OF THE POSTERIOR VAGINAL RETRACTION AT MID-VAGINA WITH EXCISION OF A MERSUTURE WIRE AND A SMALL PROSTHETIC FRAGMENT. RESUMPTION OF ANTICOAGULANTS POSTOPERATIVELY WITH THE APPEARANCE OF A VERY LIMITED HEMATOMA OF THE POSTERIOR VAGINAL WALL, WORSENING AT D4 WITH THE APPEARANCE OF PELVIC PAIN. BIOLOGICAL INFLAMMATORY SYNDROME WITH WBC 14,000 AND CRP 250. ULTRASOUND REVEALED A PROBABLY

  Patient problems: Abscess; Hematoma; Inflammation; Unspecified Infection

  MAUDE report 20848301 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR AND POSTERIOR PROSTHESIS PROMONTOFIXATION IN 2017 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED COMPLICATED BY HEMATOMA OF RETROPERITONEAL PROSTHETIC LODGE EVACUATED AT D2. PERSISTENCE OF A THICK INFILTRATED SHELL ON IMAGING IN THE PATH OF THE ANTERIOR PROSTHESIS. ONSET OF BLEEDING SINCE 2020, ALMOST DAILY, WITH NO TRIGGERS. HYSTEROSCOPY IN (B)(6) 2022 WITH EXCISION OF A SMALL BENIGN ENDOCERVICAL POLYP. ON THE VAGINA, PRESENCE OF A SMALL RETRACTION ON THE POSTERIOR VAGINA OPPOSITE THE PALPATED PROSTHESIS, BUT WITHOUT VISIBLE EROSION OR GRANULOMA. NO PAIN OR BLEEDING VISUALIZED. DECISION TO REPEAT HYSTEROSCOPY WITH POSSIBLE THERMOCOAGULATION AND CLINICAL EXAMINATION UNDER GA PERFORMED ON (B)(6) 2024. HYSTEROSCOPY NORMAL AND MINIMAL EROSION AT THE BOTTOM OF THE POSTERIOR VAGINAL RETRACTION AT MID-VAGINA WITH EXCISION OF A MERSUTURE WIRE AND A SMALL PROSTHETIC FRAGMENT. RESUMPTION OF ANTICOAGULANTS POSTOPERATIVELY WITH THE APPEARANCE OF A VERY LIMITED HEMATOMA OF THE POSTERIOR VAGINAL WALL, WORSENING AT D4 WITH THE APPEARANCE OF PELVIC PAIN. BIOLOGICAL INFLAMMATORY SYNDROME WITH WBC 14,000 AND CRP 250. ULTRASOUND REVEALED A PROBABLY

  Patient problems: Hematoma; Pain

  MAUDE report 20846933 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR AND POSTERIOR PROSTHESIS PROMONTOFIXATION IN 2017 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED COMPLICATED BY HEMATOMA OF RETROPERITONEAL PROSTHETIC LODGE EVACUATED AT D2. PERSISTENCE OF A THICK INFILTRATED SHELL ON IMAGING IN THE PATH OF THE ANTERIOR PROSTHESIS. ONSET OF BLEEDING SINCE 2020, ALMOST DAILY, WITH NO TRIGGERS. HYSTEROSCOPY IN (B)(6) 2022 WITH EXCISION OF A SMALL BENIGN ENDOCERVICAL POLYP. ON THE VAGINA, PRESENCE OF A SMALL RETRACTION ON THE POSTERIOR VAGINA OPPOSITE THE PALPATED PROSTHESIS, BUT WITHOUT VISIBLE EROSION OR GRANULOMA. NO PAIN OR BLEEDING VISUALIZED. DECISION TO REPEAT HYSTEROSCOPY WITH POSSIBLE THERMOCOAGULATION AND CLINICAL EXAMINATION UNDER GA PERFORMED ON (B)(6) 2024. HYSTEROSCOPY NORMAL AND MINIMAL EROSION AT THE BOTTOM OF THE POSTERIOR VAGINAL RETRACTION AT MID-VAGINA WITH EXCISION OF A MERSUTURE WIRE AND A SMALL PROSTHETIC FRAGMENT. RESUMPTION OF ANTICOAGULANTS POSTOPERATIVELY WITH THE APPEARANCE OF A VERY LIMITED HEMATOMA OF THE POSTERIOR VAGINAL WALL, WORSENING AT D4 WITH THE APPEARANCE OF PELVIC PAIN. BIOLOGICAL INFLAMMATORY SYNDROME WITH WBC 14,000 AND CRP 250. ULTRASOUND REVEALED A PROBABLY

  Patient problems: Cyst(s); Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20846927 ↗
• InjuryDec 4, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR AND POSTERIOR PROSTHESIS PROMONTOFIXATION IN 2017 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED COMPLICATED BY HEMATOMA OF RETROPERITONEAL PROSTHETIC LODGE EVACUATED AT D2. PERSISTENCE OF A THICK INFILTRATED SHELL ON IMAGING IN THE PATH OF THE ANTERIOR PROSTHESIS. ONSET OF BLEEDING SINCE 2020, ALMOST DAILY, WITH NO TRIGGERS. HYSTEROSCOPY ON (B)(6) 2022 WITH EXCISION OF A SMALL BENIGN ENDOCERVICAL POLYP. ON THE VAGINA, PRESENCE OF A SMALL RETRACTION ON THE POSTERIOR VAGINA OPPOSITE THE PALPATED PROSTHESIS, BUT WITHOUT VISIBLE EROSION OR GRANULOMA. NO PAIN OR BLEEDING VISUALIZED. DECISION TO REPEAT HYSTEROSCOPY WITH POSSIBLE THERMOCOAGULATION AND CLINICAL EXAMINATION UNDER GA PERFORMED ON (B)(6) 2024. HYSTEROSCOPY NORMAL AND MINIMAL EROSION AT THE BOTTOM OF THE POSTERIOR VAGINAL RETRACTION AT MID-VAGINA WITH EXCISION OF A MERSUTURE WIRE AND A SMALL PROSTHETIC FRAGMENT. RESUMPTION OF ANTICOAGULANTS POSTOPERATIVELY WITH THE APPEARANCE OF A VERY LIMITED HEMATOMA OF THE POSTERIOR VAGINAL WALL, WORSENING AT D4 WITH THE APPEARANCE OF PELVIC PAIN. BIOLOGICAL INFLAMMATORY SYNDROME WITH WBC 14,000 AND CRP 250. ULTRASOUND REVEALED A PROBABLY

  Patient problems: Abscess; Erosion

  MAUDE report 20846891 ↗
• InjuryDec 4, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR AND POSTERIOR PROSTHESIS PROMONTOFIXATION IN 2017 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED COMPLICATED BY HEMATOMA OF RETROPERITONEAL PROSTHETIC LODGE EVACUATED AT D2. PERSISTENCE OF A THICK INFILTRATED SHELL ON IMAGING IN THE PATH OF THE ANTERIOR PROSTHESIS. ONSET OF BLEEDING SINCE 2020, ALMOST DAILY, WITH NO TRIGGERS. HYSTEROSCOPY IN (B)(6) 2022 WITH EXCISION OF A SMALL BENIGN ENDOCERVICAL POLYP. ON THE VAGINA, PRESENCE OF A SMALL RETRACTION ON THE POSTERIOR VAGINA OPPOSITE THE PALPATED PROSTHESIS, BUT WITHOUT VISIBLE EROSION OR GRANULOMA. NO PAIN OR BLEEDING VISUALIZED. DECISION TO REPEAT HYSTEROSCOPY WITH POSSIBLE THERMOCOAGULATION AND CLINICAL EXAMINATION UNDER GA PERFORMED ON (B)(6) 2024. HYSTEROSCOPY NORMAL AND MINIMAL EROSION AT THE BOTTOM OF THE POSTERIOR VAGINAL RETRACTION AT MID-VAGINA WITH EXCISION OF A MERSUTURE WIRE AND A SMALL PROSTHETIC FRAGMENT. RESUMPTION OF ANTICOAGULANTS POSTOPERATIVELY WITH THE APPEARANCE OF A VERY LIMITED HEMATOMA OF THE POSTERIOR VAGINAL WALL, WORSENING AT D4 WITH THE APPEARANCE OF PELVIC PAIN. BIOLOGICAL INFLAMMATORY SYNDROME WITH WBC 14,000 AND CRP 250. ULTRASOUND REVEALED A PROBABLY

  Patient problems: Erosion

  MAUDE report 20846298 ↗
• InjuryNov 7, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. SACROHYSTEROPEXY MESH- PROLENE SUTURE EXPOSED IN VAGINA. REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 20634691 ↗
• InjuryOct 31, 2024Adverse 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) 2004 AND MESH WAS IMPLANTED. THE CURRENT STATE OF THE PATIENT WAS REPORTED TO INCLUDE VAGINAL DISCHARGE DUE TO EROSION IN (2005) AND (2007), CHRONIC PELVIC PAIN, CHRONIC PAIN AND DISCOMFORT DURING INTERCOURSE. ADDITIONALLY, ACHILLES TENDON PAIN, LEFT HIP PAIN, RIGHT KNEE PAIN, CHRONIC LOW BACK PAIN, TINNITUS, SINUSITIS, HEADACHE, CERVICAL OSTEOARTHRITIS AND HIGH BLOOD PRESSURE WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Abnormal Vaginal Discharge; Headache; High Blood Pressure/ Hypertension; Inflammation; Pain; Respiratory Tract Infection; Tinnitus

  MAUDE report 20578894 ↗

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