GYNECARE GYNEMESH GPSL (UDI 10705031037731)Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10705031037731), received between Apr 30, 2014 and Mar 24, 2025 — classified as 164 injuries.

The most frequently reported specific device problem is “Migration” (80 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 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 31, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. ON (B)(6) 2007, EROSION OF A MESH WEB WAS NOTED IN THE PATIENT WHO HAS ALREADY HAD EROSION OF THIS PLAQUE. UNDER LOCAL ANESTHESIA, THIS IS AN EXHIBITION ON 1/3 CM3, THE CANVAS WILL BE CAUGHT AND THE VAGINAL WALL RESECTED AROUND THIS EXHIBITION. ABOUT 1/3 CM3 WILL BE REMOVED AND THEN THE VAGINAL WALL WILL BE CLOSED WITH VICRYL 2/0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 20578885 ↗
• InjuryOct 31, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED VAGINAL DISCHARGE AND VAGINAL EROSION IN 2005. ON (B)(6) 2006, PATIENT PRESENTING MORE THAN ONE YEAR AFTER CYSTOCELE REPAIR WITH MESH EROSION OF THE STRIP ABOUT 1 CM AND 5 MM WIDE. REVISION INDICATION. THE PATIENT UNDERWENT TRACTOR PLACEMENT AT THE 2 ENDS OF THE EROSION ZONE AND EXCISION OF THE PLATE ON THE EXPOSED PART. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Abnormal Vaginal Discharge; Erosion

  MAUDE report 20578737 ↗
• InjuryAug 28, 2024Adverse 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) 2022 AND MESH WAS IMPLANTED. BEGINNING THE SUMMER OF 2023, THE PATIENT EXPERIENCED SUDDEN PAIN IN THE SITTING POSITION TO THE COCCYX WITHOUT FALLING. NO FURTHER INFORMATION IS AVAILABLE AS THE REPORTER CONTACT DETAILS WERE NOT DISCLOSED.

  Patient problems: Pain

  MAUDE report 20085320 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  TITLE: CLINICAL OUTCOME AND URODYNAMIC CHANGES OF TAILORED TRANSVAGINAL MESH SURGERY FOR PELVIC ORGAN PROLAPSE: A MID-TERM 40 MONTHS FOLLOW-UP THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE CHANGES IN CLINICAL OUTCOME AND URODYNAMIC PARAMETERS AFTER TAILORED ANTERIOR TRANSVAGINAL MESH (ATVM) SURGERIES IN A MID-TERM FOLLOW-UP. BETWEEN NOVEMBER 2011 AND DECEMBER 2015, A TOTAL OF 160 WOMEN (MEAN AGE OF 64.1 ± 9.5 YEARS; MEAN BMI OF 24.7 ± 2.8 KG/M2) WITH STAGE II PELVIC ORGAN PROLAPSE (POP) WHO UNDERWENT ATVM SURGERIES WERE INCLUDED IN THE STUDY. THE DATA REVIEWING TIMEFRAME WAS UNTIL DECEMBER 2021. CLINICAL AND URODYNAMIC DIAGNOSES REGARDING URINARY SYMPTOMS WERE EVALUATED BEFORE AND AFTER THE OPERATION. A POLYPROPYLENE MESH (GYNEMESH PS NONABSORBABLE PROLENE SOFT MESH, GPSL 10 CM X 15 CM, ETHICON, US) WAS USED AND TRIMMED TO A CENTRAL DIAMOND SHAPE (7 X 6 CM) WITH TWO SETS OF PAIRED ARMS. THE ANTERIOR VAGINAL WALL WAS SUTURED IN TWO LAYERS WITHOUT TRIMMING THE REDUNDANT PORTION USING A VICRYL 1-0 SUTURE. CONCOMITANT POSTERIOR REPAIR WITH POSTERIOR TRANSVAGINAL MESH SURGERY (PTVM), PERINEORRHAPHY, OR APICAL SUSPENSION WAS PERFORMED AS NEEDED. THE MEDIAN FOLLOW-UP INTERVAL WA

  Patient problems: Erosion; Incontinence; Prolapse; Unspecified Kidney or Urinary Problem

  MAUDE report 19771738 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECTOPEXY, CYSTOPEXY AND HYSTEROPEXY SURGERY USING PROMOTO-FIXATION FOLLOWING GRADE IV RECTAL PROLAPSE ASSOCIATED WITH CERVICO-CYSTOPTOSIS AND HYSTEROCELE ON (B)(6) 2020 AND MESH WAS IMPLANTED. THE ANTERIOR AND POSTERIOR PROMOTO-FIXATION OPERATION INCLUDED PLACEMENT OF THE MESH ON THE ANTERIOR VAGINAL WALL WITH7 AUTOSURE ENDOUNIVERSAL STAPLES AND ON THE ISTHMUS WITH 2 ETHIBOND 0 STITCHES + INSERTION OF A GYNEMECHE OF 15/5 CM FIXED TO THE LEVATOR MUSCLES ON THE ANTERIOR FACE OF THE RECTUM BY ENDO-HERNIA. FIXATION OF THE 2 PROSTHESES TO THE PROMONTORY USING CAPSURE AND CLOSURE OF THE PERITONEAL BREACH USING V-LOCH 3/0. FIRST RHEUMATOLOGICAL/NEUROPATHIC PATHOLOGY DIAGNOSED IN 2021 VIA SPINAL MRI FOLLOWING A VISIT TO EMERGENCY WITH DEGENERATIVE DISC DISEASE AND DISCARTHROSIS, C4/C5, C5/C6, C6/C7, L5S1.THE PATIENT COULD HARDLY WALK OR DRIVE WITHOUT VERY QUICKLY FEELING TINGLING, NUMBNESS, PARESTHESIA AND INTENSE PAIN. HE IS REGULARLY BENT DOUBLE WITH NEUROPATHIC PAIN ASSOCIATED WITH NECK PAIN, BACK PAIN AND LOWER BACK PAIN. HE HAS TO WALK WITH A CRUTCH OR CANE REGULARLY, WHEN HE IS NOT PARALYZED, ESPECIALLY ON THE LEFT SIDE, LEGS AND ARMS. HE H

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Incontinence; Insufficient Information; Neuropathy; Numbness; Pain; Prolapse; Unspecified Kidney or Urinary Problem; Urinary Frequency / Polyuria

  MAUDE report 19637790 ↗
• InjuryMay 30, 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 WITH PROMONTO FIXATION AND BILATERAL SALPINGECTOMY ON (B)(6) 2023 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING PELVIC PAIN, VAGINAL PAIN, ABDOMINAL PAIN, BACK PAIN, LOWER LIMBS FARTHER TO THE RIGHT, DIFFICULTY WALKING MEDIUM DISTANCES, DIGESTIVE PROBLEMS AND INABILITY TO RESUME SPORTS. ON (B)(6) 2023, CONSULTATION WITH THE OB GYNECOLOGIST FOUND ABDO SUPPLE, NO PAIN ON PALPATION, FLEXIBLE LAPARO SCAR, SMALL KELOID FLEXIBLE VAGINAL WALLS, SENSITIVE TO PALPATION OF RIGHT VAGINAL CDS, AND PALPATION OF STRIP WITH INDURATION. AT THIS TIME, THE PATIENT WAS EXPERIENCING DIFFICULTY FEEDING WITH FEELING TIGHT AT THE ABDOMINAL LEVEL, REDUCED ITS INTAKE TO ONE MEAL A DAY, PAIN ON MOBILIZATION OF THE RIGHT LEG (DIFFICULTY DRIVING), UNABLE TO HAVE SR, BLOCKAGE, LOSS OF LIBIDO AND APPREHENSION OF PAIN. MANAGEMENT INCLUDED RESUMPTION OF PHYSICAL ACTIVITY, SCAR MASSAGE, VALUE OF PHYSIOTHERAPY AND IN CASE OF ABSENCE OF IMPROVEMENT, TENS. ON (B)(6) 2024, CONSULTATION WITH GENERAL MEDICINE DOCTOR NOTED MASSAGE SESSIONS WITH PHYSIOTHERAPY AND REHABILITATION OF THE LUMBAR SPINE AND LOWER LIMB DUE TO COMPLICATED GYNECOLOGICAL SURGERY

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Discomfort; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Weight Changes

  MAUDE report 19425149 ↗
• InjuryMay 10, 2024Migration; Migration

  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 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 19283577 ↗
• InjuryApr 3, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2021 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PELVIC, PERINEAL, VAGINAL AND ABDOMINAL PAIN THAT RADIATES FROM HER BACK AND TAILBONE DOWN TO HER THINGS AND LEGS, DYSPAREUNIA, VAGINAL DISCHARGE, INFECTIONS, ABDOMINAL BLEEDING, MESH EROSION AND SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE PATHOLOGY REPORT SHOWED FOREIGN BODY GIANT CELL REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Erosion; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 19030896 ↗
• InjuryMar 17, 2024Adverse 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 THE PATIENT EXPERIENCED URGENCY, FREQUENCY, INCOMPLETE EMPTYING, PAIN IN BACK AND ABDOMEN AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Micturition Urgency; Pain; Unspecified Kidney or Urinary Problem; Urinary Frequency / Polyuria

  MAUDE report 18919223 ↗
• InjuryMar 10, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2015 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 18872234 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRACERVICAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, LAPAROSCOPIC SACRAL COLPOPEXY AND CYSTOSCOPY ON (B)(6) 2013 AND MESH WAS IMPLANTED. ON (B)(6) 2013, MILD CANDIDA INFECTION WAS NOTED. THE PATIENT RECEIVED A ONE TIME DOSE OF DIFLUCAN 100MG AND THE EVENT WAS RESOLVED AS OF (B)(6) 2013. THIS WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP WITH THE STUDY DEVICE AND STUDY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Incontinence; Unspecified Infection

  MAUDE report 18015156 ↗
• InjuryApr 21, 2023Migration; Migration

  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 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 16782556 ↗
• InjuryMar 27, 2023Appropriate 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) 2018 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16625197 ↗
• InjuryMar 22, 2023Adverse 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 THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; Pain; Vomiting

  MAUDE report 16595572 ↗
• InjuryDec 13, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 DUE TO MESH EROSION. IT WAS REPORTED THAT PATIENT EXPERIENCED BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15966694 ↗

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