ARTISYN ARTY (UDI 10705031218475)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031218475), received between Dec 14, 2017 and Feb 5, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Migration” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APICAL COLPOPEXY ON (B)(6) 2023 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT MESH WAS VISIBLE ON (B)(6) 2025. ON 2 YEAR INSPECTION, THERE WAS LIGHT HERBAL CYGENS, SLIGHT POP GENES. THE MESH WAS VISIBLE AT THE TOP OF THE VAGINA, SINGLE THREAD. NO PALPABLE MESH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erosion; Incontinence; Micturition Urgency; Prolapse

  MAUDE report 24270008 ↗
• InjurySep 30, 2024Migration; Migration

  TITLE: MIDTERM COMPARISON OF LAPAROSCOPIC HIGH UTEROSACRAL LIGAMENT SUSPENSION AND SACROCOLPOPEXY IN THE TREATMENT OF MODERATE TO SEVERE APICAL PROLAPSE. THE OBJECTIVE WAS TO RETROSPECTIVELY ANALYZE THE MIDTERM EFFICACY OF LAPAROSCOPIC HIGH UTEROSACRAL LIGAMENT SUSPENSION (HUS) AND SACROCOLPOPEXY (SC) IN THE TREATMENT OF MODERATE TO SEVERE APICAL PROLAPSE. PATIENTS WITH PELVIC ORGAN PROLAPSE (POP) WHO UNDERWENT LAPAROSCOPIC HUS (GROUP A, N=72) AND THOSE WHO UNDERWENT LSC (MESH ADDED, GROUP B, N=54) BETWEEN 1 JANUARY 2013 AND 31 DECEMBER 2019 WERE INCLUDED IN THE STUDY. THEIR MEAN AGE WAS 57.11±9.14 YEARS AND 56.93±7.52 YEARS, RESPECTIVELY. IN THE HUS GROUP, THE SACRAL LIGAMENTS ON BOTH SIDES ARE SUTURED TO THE VAGINAL STUMP OR THE POSTERIOR WALL OF THE CERVIX USING PDS II POLYDIOXANONE MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE AND KNOTTED. IN THE LSC GROUP, A Y-SHAPED PIECE OF MESH (ARTY,ETH201 V002, JOHNSON&JOHNSON INTERNATIONAL, NORDERSTEDT, GERMANY) IS CUT OUT AND PLACED IN THE ABDOMINAL CAVITY. THE MEDIAN POSTOPERATIVE FOLLOW-UP DURATION WAS 48 MONTHS (RANGE 24¿84). REPORTED COMPLICATIONS IN GROUP A INCLUDE RECURRENT VAGINAL ANTERIOR WALL PROLAPSE (N=4), ABNORMAL URINATION (N=5.

  Patient problems: Erosion; Insufficient Information; Micturition Urgency; Pain; Prolapse; Unspecified Kidney or Urinary Problem

  MAUDE report 20334781 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. ON (B)(6) 2021, AT 3 MONTHS, THERE WAS CONTROL, BUT 0.5 X 0.5 CM MESH EROSION IN VAG TOP AND A FEW MILLIMETERS OF MESH WAS CUT OFF. ON (B)(6) 2022, AT THE 1-YEAR FOLLOW-UP, THERE WERE NO PROLAPSE ANNOYANCES, BUT UNCHANGED MESH EXPOSURE, WHICH WAS CUT A LITTLE. ON (B)(6) 2023, AT THE 2-YEAR CHECK, THERE WAS UNCHANGED MESH EXPOSURE. ON (B)(6) 2024, AT THE 3-YEAR CHECK, PROLAPSE WHEN TOILET VISIT WAS NOTED AND ANTERIOR WALL PLASTIC SURGERY WAS PLANNED. ON (B)(6) 2024, THE PATIENT UNDERWENT ANTERIOR COLPORAPHY AND REMOVAL OF FOREIGN BODIES IN THE VAGINA. THE MESH WAS EXPOSED AND REMOVED. ON (B)(6) 2024, FINDING OF ACTIOMYCES IN SYNTHETIC MESH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion

  MAUDE report 19939727 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. ON (B)(6) 2021, AT 3 MONTHS, THERE WAS CONTROL, BUT 0.5 X 0.5 CM MESH EROSION IN VAG TOP AND A FEW MILLIMETERS OF MESH WAS CUT OFF. ON (B)(6) 2022, AT THE 1-YEAR FOLLOW-UP, THERE WERE NO PROLAPSE ANNOYANCES, BUT UNCHANGED MESH EXPOSURE, WHICH WAS CUT A LITTLE. ON (B)(6) 2023, AT THE 2-YEAR CHECK, THERE WAS UNCHANGED MESH EXPOSURE. ON (B)(6) 2024, AT THE 3-YEAR CHECK, PROLAPSE WHEN TOILET VISIT WAS NOTED AND ANTERIOR WALL PLASTIC SURGERY WAS PLANNED. ON (B)(6) 2024, THE PATIENT UNDERWENT ANTERIOR COLPORAPHY AND REMOVAL OF FOREIGN BODIES IN THE VAGINA. THE MESH WAS EXPOSED AND REMOVED. ON (B)(6) 2024, FINDING OF ACTIOMYCES IN SYNTHETIC MESH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion

  MAUDE report 19939703 ↗
• InjuryAug 8, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. ON (B)(6) 2021, AT 3 MONTHS, THERE WAS CONTROL, BUT 0.5 X 0.5 CM MESH EROSION IN VAG TOP AND A FEW MILLIMETERS OF MESH WAS CUT OFF. ON (B)(6) 2022, AT THE 1-YEAR FOLLOW-UP, THERE WERE NO PROLAPSE ANNOYANCES, BUT UNCHANGED MESH EXPOSURE, WHICH WAS CUT A LITTLE. ON (B)(6) 2023, AT THE 2-YEAR CHECK, THERE WAS UNCHANGED MESH EXPOSURE. ON (B)(6) 2024, AT THE 3-YEAR CHECK, PROLAPSE WHEN TOILET VISIT WAS NOTED AND ANTERIOR WALL PLASTIC SURGERY WAS PLANNED. ON (B)(6) 2024, THE PATIENT UNDERWENT ANTERIOR COLPORAPHY AND REMOVAL OF FOREIGN BODIES IN THE VAGINA. THE MESH WAS EXPOSED AND REMOVED. ON (B)(6) 2024, FINDING OF ACTIOMYCES IN SYNTHETIC MESH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Foreign Body In Patient; Prolapse

  MAUDE report 19939681 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. ON (B)(6) 2021, AT 3 MONTHS, THERE WAS CONTROL, BUT 0.5 X 0.5 CM MESH EROSION IN VAG TOP AND A FEW MILLIMETERS OF MESH WAS CUT OFF. ON (B)(6) 2022, AT THE 1-YEAR FOLLOW-UP, THERE WERE NO PROLAPSE ANNOYANCES, BUT UNCHANGED MESH EXPOSURE, WHICH WAS CUT A LITTLE. ON (B)(6) 2023, AT THE 2-YEAR CHECK, THERE WAS UNCHANGED MESH EXPOSURE. ON (B)(6) 2024, AT THE 3-YEAR CHECK, PROLAPSE WHEN TOILET VISIT WAS NOTED AND ANTERIOR WALL PLASTIC SURGERY WAS PLANNED. ON (B)(6) 2024, THE PATIENT UNDERWENT ANTERIOR COLPORAPHY AND REMOVAL OF FOREIGN BODIES IN THE VAGINA. THE MESH WAS EXPOSED AND REMOVED. ON (B)(6) 2024, FINDING OF ACTIOMYCES IN SYNTHETIC MESH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 19939680 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY IN (B)(6)2021 AND MESH WAS USED. THE PATIENT WAS ADMITTED WITH DISCITIS AFTER EXPERIENCING BACK PAIN, AND REQUIRED IV ANTIBIOTICS LONG TERM WITH ANALGESICS. AT PRESENT, NO CONFIRMED EVIDENCE MESH OR ANCHORAGE DEVICE ARE CAUSING INFECTION FROM IMAGING, BUT GIVEN TIMING OF OPERATION TO ADMISSION, THIS IS SUSPECTED. NO FURTHER INFORMATION IS AVAILABLE AS THE REPORTER CONTACT DETAILS WERE NOT DISCLOSED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19249198 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2015 AND MESH WAS IMPLANTED. ON (B)(6) 2022, A LARGE URINARY BLADDER STONE 4 X4 CM WAS PARTIALLY REMOVED BY A PRIVATE UROLOGIST. PART OF THE MESH AND POSSIBLE BLADDER STONE LEFT WERE NOTED. THE PATIENT WAS REFERRED TO THE HOSPITAL FOR PLANNING AN OPERATION TO REMOVE MESH AND BLADDER STONE. THE PATIENT HAS HAD A BURNING SENSATION BELOW FOR A LONG TIME, BUT DOES NOT HAVE SYMPTOMS OF URINARY TRACT INFECTION NOW. NO PAIN, BUT FEELING OF STRETCH ON THE LEFT SIDE. USES VAGIFEM EVERY 2 DAYS. URINARY INCONTINENCE PRESENT BEFORE THE OPERATION HAS POSSIBLE WORSENING, BOTH URGENCY AND STRESS URINARY INCONTINENCE AND UNEXPECTED INCONTINENCE EPISODES. CYSTOSCOPIC REMOVAL OF MESH FROM THE BLADDER WITH A UROLOGIST WAS MENTIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Burning Sensation; Calcium Deposits/Calcification; Erosion; Incontinence; Micturition Urgency

  MAUDE report 16724263 ↗
• InjuryJan 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 GYNECOLOGICAL PROCEDURE ON (B)(6) 2022 AND MESH WAS IMPLANTED. ON (B)(6) 2022, A MILD URINARY TRACT INFECTION WAS NOTED AND UNSPECIFIED DRUG THERAPY WAS PROVIDED. AS OF (B)(6) 2022, THE URINARY TRACT INFECTION HAS RECOVERED/RESOLVED WITHOUT SEQUELAE. THIS EVENT WAS REPORTED AS NOT RELATED TO THE STUDY DEVICE, BUT A PROBABLE RELATIONSHIP WITH THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 16248615 ↗
• InjuryOct 12, 2022Adverse 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 SACROCOLPOPEXY ON (B)(6) 2019 AND MESH WAS IMPLANTED. THE PATIENT WENT IN FOR ROUTINE CONTROL ON (B)(6) 2022 AND 2.5 MM MESH EXPOSURE WAS SEEN ON TOP OF THE VAGINA. LOCAL ESTROGEN TREATMENT WAS INITIATED AND POSSIBLE SURGERY MAY BE NECESSARY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Erosion

  MAUDE report 15587261 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROPEXI AM DA VINCI ROBOTIC ASSISTED REPAIR OF THE VAGINAL TOP ON (B)(6) 2020 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT CAME TO A ROUTINE CHECK UP AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EXPOSURE AT THE VAGINAL TOP 0.5 X 0.5 CM. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE PROBLEMS (INCONVENIENCE) DUE TO THE SMALL MESH EXPOSURE. IT WAS ALSO REPORTED THAT THE PATIENT HAS LARGE CELL B-CELL LYMPHOMA AND HAS BEEN IN CHEMOTHERAPY. IT WAS ALSO REPORTED THAT THE DOCTOR SEES THE PATIENT AFTER 1.5 YEARS AFTER THE PRIMARY OPERATION DATE. IT WAS REPORTED THAT THE MESH EXPOSURE HAS NOT GROWN, AND THE PATIENT HAS NO PROBLEMS (GENES). IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH LOCAL ESTROGEN UNTIL FURTHER NOTICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erosion; Lymphoma

  MAUDE report 13552136 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APICAL COLPOPEXY ON (B)(6) 2020 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT DURING SURGERY THE DOCTOR OBSERVED FIBROSIS AROUND BLADDER TRANSITION TOWARD VAGINA. IT WAS REPORTED THAT DURING TISSUE DISSECTION, THE DOCTOR MADE A 2CM LARGE HOLE IN THE VAGINA AND USED SUTURE IN TWO LAYERS FOR CLOSING THE HOLE. IT WAS ALSO REPORTED THAT THE DOCTOR COULD NOT LOOSEN THE BLADDER WITHOUT A HIGH RISK OF BLADDER LESION, BUT THE OPERATION WAS PROCEEDED AS UNCOMPLICATED. IT WAS REPORTED THAT THE PATIENT HAD A THREE-MOTH CHECK UP VISIT ON AN UNKNOWN DATE IN (B)(6) 2021, AND THE PATIENT STILL HAD PROLAPSED GENES. IT WAS REPORTED THAT UPON GYNECOLOGICAL EXAMINATION, THE DOCTOR SAW A 5X5MM MESH EROSION IN THE VAGINAL TOP/WOMB AND CUT AND REMOVED A FEW MILLIMETERS OF MESH EROSION. IT WAS ALSO REPORTED THAT A TRANSVAGINAL ULTRASOUND SCAN FOUND THE MESH WAS SMOOTH AROUND THE VAGINA TUBE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erosion

  MAUDE report 12781119 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY OF LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL ADNEXECTOMY, VAGINAL VAGINOSACRAL SUSPENSION, ANTERIOR AND POSTERIOR VAGINAL WALL REPAIR ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ABDOMINAL PAIN AND LUMBOSACRAL REFERRED PAIN AFTER USING THE PRODUCT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED POST-OP INFLAMMATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS GIVEN SYMPTOMATIC MANAGEMENT AND REGULAR REEXAMINATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pain

  MAUDE report 12605443 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY AND POSTERIOR VAGINAL WALL REPAIR AND PERINEOPLASTY AND LAPAROSCOPIC DOUBLE ADNEXECTOMY AND VAGINOSACRAL FIXATION PROCEDURE ON 01/04/2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS NO ANOMALY OBSERVED DURING PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATION INFECTION AND ACQUIRED A FEVER SEVEN DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S BODY TEMPERATURE WENT TO 39.6C. IT WAS REPORTED THAT LUNG INFECTION WAS INDICATED IN THE CT REPORT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH CEFTAZIDIME COMBINED WITH MOXIFLOXACIN. IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH PIPERACILLIN SODIUM, TAZOBACTAM SODIUM AND PERIODIC WOUND DISINFECTION FOR ANTI-INFECTION FROM 01/20/2021. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO FIRST AFFILIATED HOSPITAL OF BEIJING MEDICAL UNIVERSITY FOR TREATMENT. IT WAS ALSO REPORTED THAT THE PATIENT'S CONDITION IS STABLE VIA SEVERAL TREATMENTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 11742955 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY AND POSTERIOR VAGINAL WALL REPAIR AND PERINEOPLASTY AND LAPAROSCOPIC DOUBLE ADNEXECTOMY AND VAGINOSACRAL FIXATION PROCEDURE ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS NO ANOMALY OBSERVED DURING PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATION INFECTION AND ACQUIRED A FEVER IN FOUR DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AMOXICILLIN AND CLAVULANATE POTASSIUM AND THE PATIENT'S CONDITION BECAME STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 11742954 ↗
• InjuryDec 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR SURGERY ON (B)(6) 2019 DUE TO EROSION AND PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 10945805 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. FROM THE BEGINNING, THE PATIENT EXPERIENCED SEVERE PAIN IN RIGHT HAND SIDE, SACRAL AREA, GROIN, TOP OF BOTH THIGHS AND DOWN RIGHT LEG TO FEET. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED NUMBNESS AND LINE AND NEEDLES IN THESE AREAS. THE PATIENT WAS EXPERIENCING STABBING PAIN IN SACRAL AREA AND RECTUM. OVER TIME THIS PAIN WORSENED, A RIGHT-HAND SIDE PELVIS TWISTED, AND THE PATIENT CANNOT PUT FULL WEIGHT ON RIGHT FOOT AS THIS WORSENS THE STABBING PAIN. WHEN DRIVING, IT WAS TRIGGERING SEVERE PINS AND NEEDLES PAIN AND THE RIGHT LEG WOULD GO NUMB CAUSING VERY LITTLE FEELING IN IT. THIS ALSO CAUSED PROBLEMS WITH FALLING. THE PATIENT WAS ADMITTED TO THE HOSPITAL LAST YEAR TO FIX A RECTOCELE AND REQUESTED THAT ANY MESH THERE BE REMOVED. THE DOCTOR OPINED THAT THERE WOULD BE VERY LITTLE CHANCE IF ANY MESH THERE BECAUSE OF THE TYPE OF MESH WAS USED. IT WAS ALSO REPORTED THAT DURING OPENING, IT WAS FOUND THAT THE MESH HAD SOLIDIFIED AND TURNED IN ON ITSELF FORMING A TUBE AND HAD GLUED ITSELF TO THE BACK WALL AND WAS COVERED IN A THICK LAYER OF ADHESIONS. AS REPORTED BY PATIEN

  Patient problems: Adhesion(s); Hypoesthesia; Not Applicable; Pain

  MAUDE report 9475540 ↗
• InjuryOct 22, 2019Adverse 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) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 9217635 ↗
• InjuryJan 18, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOT-ASSISTED LAPAROSCOPIC COLPOSACROPEXY ON (B)(6) 2017 AND THE MESH WAS IMPLANTED. UNDER THE OPERATION PROCEDURE AN IATROGENIC HOLE IS FORMED ON THE BLADDER, AND IT IS BEING SUTURED. AFTER SURGERY, THE PATIENT HAD NO COMPLICATION AT THE CONTROL. ONE YEAR LATER, THE PATIENT REPORTS PAIN IN THE TOP OF THE VAGINA AND PAIN ASSOCIATED WITH COITUS. ON (B)(6) 2018, CYSTOSCOPY IS MADE SHOWING EROSION OF THE MESH MATERIAL TO THE BLADDER ACCOMPANIED BY BLADDER STONE FORMATION. NO FURTHER ACTION HAS YET BEEN TAKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Calcium Deposits/Calcification; Erosion; Pain

  MAUDE report 8262224 ↗
• InjuryAug 16, 2018Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2015 AND THE MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND VESICOVAGINAL FISTULA. THE PATIENT UNDERWENT A MESH EXCISION SURGERY ON (B)(6) 2017. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Fistula; Not Applicable; Pain

  MAUDE report 7787917 ↗
• InjuryDec 14, 2017Migration 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) 2015 AND THE MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND UNDERWENT REVISIONARY PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Not Applicable; Pain

  MAUDE report 7117898 ↗