Advantage™ System M0068502000Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 08714729470274), received between Jan 21, 2014 and Feb 2, 2026 — classified as 160 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE SYSTEM WAS IMPLANTED IN THE PATIENT ON (b)(6), 2021. SOMETIME AFTER IMPLANTATION IN 2025, CLINICAL EXAMINATION REVEALED EXPOSURE OF THE SLING ON THE LEFT VAGINAL SIDE, ASSOCIATED WITH SEVERE PAIN SUCH THAT MINIMAL MANIPULATION RESULTED IN BILATERAL RETROPUBIC PAIN RADIATION. THE PATIENT ALSO EXPERIENCED PERSISTENT URINARY INCONTINENCE. PREOPERATIVE ENDOSCOPY DEMONSTRATED NO EVIDENCE OF URETHRAL OR BLADDER EROSION. GIVEN THE SIGNIFICANT PAIN AND VAGINAL SLING EXPOSURE WITH SUSPECTED INFECTION, COMPLETE REMOVAL OF THE SLING WAS PERFORMED VIA A LAPAROSCOPIC APPROACH ON (b)(6), 2026.***ADDITIONAL INFORMATION RECEIVED ON APRIL 23, 2026:INFORMATION WAS RECEIVED THAT THIS EVENT IS A DUPLICATE. SEE MFR. REPORT # 2124215-2025-92789.

  Patient problems: Erosion; Pain; Unspecified Infection; Urinary Incontinence

  MAUDE report 24233627 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING FEMORAL NERVE DAMAGE, LEFT FEMORAL NEUROPATHY, MOBILITY IMPAIRMENTS, ONGOING LEG PAIN, LEFT GROIN PAIN, LOWER BACK PAIN, PELVIC FLOOR DYSFUNCTION, LEFT LOWER EXTREMITY WEAKNESS, URGE URINARY INCONTINENCE, STRESS URINARY INCONTINENCE, AND VAGINAL BLEEDING. FURTHERMORE, THE PATIENT DEVELOPED A LEFT-SIDED LIMP. AS A RESULT, THE PATIENT UNDERWENT A PARTIAL MESH REMOVAL SURGERY. THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM DUE TO THE IMPLANTED DEVICE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO ADDITIONAL SURGERY AND MAY SUFFER FUTURE DAMAGES SUCH AS SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Muscle Weakness/Atrophy; Nerve Damage; Neuropathy; Pain; Urinary Incontinence

  MAUDE report 21938336 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THE ADVANTAGE FIT SYSTEM EXPERIENCED AN UNSPECIFIED INJURY, LEADING TO THE MESH BEING EXPLANTED. THE PATIENT ALSO UNDERWENT AN OPEN SLING PUBOVAGINAL CYSTOSCOPY PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21612794 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE DURING WHICH AN ADVANTAGE SYSTEM SLING AND AN UPSYLON Y-MESH WERE IMPLANTED. THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF PELVIC ORGAN PROLAPSE WITH CYSTOCELE, RECTOCELE, PARAVAGINAL DEFECT, STRESS URINARY INCONTINENCE, ENTEROCELE, AND INCOMPLETE UTEROVAGINAL PROLAPSE. AFTER A CONCOMITANT HYSTERECTOMY, THE PATIENT UNDERWENT ROBOTIC ABDOMINAL SACROCOLPOPEXY WITH THE REPAIR OF THE AFOREMENTIONED DEFECTS, TENSION-FREE VAGINAL TAPE (TVT) SUB-URETHRAL SLING AND CYSTOSCOPY, AND VAGINAL APPROACH TO A POSTERIOR REPAIR. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH URETROVAGINAL FISTULA, VAGINAL EXPOSURE AND EROSION INTO THE URETHRA AND EXPOSED AT THE VAGINAL WALL, AND URINARY INCONTINENCE. SHE HAD UNDERGONE EXCISION OF URETHROVAGINAL FISTULA WITH REPAIR, PARTIAL MESH REMOVAL OF EXPOSED ERODED POLYPROPYLENE MESH, REMOVAL AND REPLACEMENT OF SUPRAPUBIC CYSTOSTOMY TUBE, AND CYSTOSCOPY. DURING THE PROCEDURE, THE ERODED MESH WAS SEEN AT THE URETHRAL MEATUS-- ERODING INTO THE FULL-THICKNESS URETHRA AND EXPOSED AT THE VAGINAL WALL AT THE SAME TIME, THE REMAINING POR

  Patient problems: Erosion; Fistula; Urinary Incontinence

  MAUDE report 20699164 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE SYSTEM WAS IMPLANTED TO THE PATIENT. AFTER THE PROCEDURE, CYSTOSCOPY CONFIRMED SPILLAGE OF URINE FROM EACH OF THE URETERAL ORIFICES AND THERE WAS NO EVIDENCE OF ANY LOWER URINARY TRACT TRAUMA. THE EXCESS VAGINAL EPITHELIUM WAS SLIGHTLY EXCISED AND REAPPROXIMATED IN THE MIDLINE. THE BLADDER WAS LEFT PARTIALLY FULL TO ALLOW FOR A VOIDING TRIAL IN THE RECOVERY ROOM. THERE WAS EXCELLENT HEMOSTASIS NOTED THROUGHOUT THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH BLADDER OUTLET OBSTRUCTION AND URETHRAL PAIN. SHE UNDERWENT TRANSVAGINAL SLING REMOVAL, SUPRAPUBIC APPROACH, URETHROLYSIS, AND CYSTOSCOPY. SHE CONTINUES TO EXPERIENCE URETHRAL PAIN AND WAS MOST BOTHERED BY HER PELVIC PAIN AND HAS SENSATION OF URINARY TRACT INFECTION. PRIOR TO SLING LYSIS, THE PATIENT DID HAVE INCOMPLETE BLADDER EMPTYING AND OBSTRUCTIVE VOIDING SYMPTOMS. SHE HAS HAD AN EXTENSIVE EVALUATION BY SEVERAL PHYSICIAN'S STRAIN AND FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY. SHE HAS TRIED PELVIC FLOOR PHYSICAL THERAPY, TRIGGER POINT INJECTIONS, AND UNDERGONE HYDRODISTENTION CYSTOSCOPY WITH BOTOX. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED TO RULE OUT ENDOMETRIOS

  Patient problems: Obstruction/Occlusion; Pain; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 20695964 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC MESH WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Adhesion(s); Bowel Perforation; Erosion; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Insufficient Information; Ischemia; Necrosis; Obstruction/Occlusion; Ulcer

  MAUDE report 20466333 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE SYSTEM AND A PROLAPSE REPAIR DEVICE WERE IMPLANTED. ABOUT A YEAR AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SUDDEN COCCYX PAIN. THE PATIENT CURRENTLY HAS TAILBONE PAIN WHILE SITTING. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-53151 FOR THE ADVANTAGE SYSTEM SLING AND 2124215-2024-53766 FOR THE PROLAPSE REPAIR MESH.

  Patient problems: Pain

  MAUDE report 20123287 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE PERFORMED ON (B)(6) 2015. IT WAS NOTED THAT THE PATIENT PRESENTED WITH VAGINAL PAIN AND MESH EROSION CLOSE TO THE VAGINAL SKIN. AN EXPLANT PROCEDURE WAS PERFORMED TO ADDRESS THE SYMPTOMS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Erosion; Pain

  MAUDE report 19043248 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2013, DURING A MID-URETHRAL SLING AND CYSTOURETHROSCOPY PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC STRESS URINARY INCONTINENCE. SHE WAS OBSERVED IN THE RECOVERY ROOM AND WAS GIVEN A TRIAL OF VOIDING. VERBAL AND WRITTEN INSTRUCTIONS WERE PROVIDED. ON (B)(6) 2022, SHE UNDERWENT EXCISION OF MID-URETHRAL SLING MESH, PLACEMENT AND REMOVAL OF THE LEFT OPEN-ENDED URETERAL CATHETER, AND CYSTOURETHROSCOPY DUE TO PAIN RELATED TO MID-URETHRAL SLING MESH AND PAIN IN THAT AREA DURING PHYSICAL EXAMINATION. THE PATIENT WAS COUNSELED REGARDING THE RISKS, BENEFITS, ALTERNATIVES, AND INDICATIONS OF THE PROCEDURE AND ELECTED TO PROCEED WITH MESH EXCISION. FINDINGS OF THE PROCEDURE SHOWED BRISK BILATERAL URETERAL EFFLUX NOTED AFTER CANNULIZATION OF THE LEFT URETER WITH THE LEFT URETERAL CATHETER. NO BLADDER INJURIES AND BLADDER SUTURES WERE NOTED. THE URETHRA WAS INTACT. THE MESH WAS REMOVED FROM THE INFERIOR PUBIC RAMUS TO THE INFERIOR PUBIC RAMUS.

  Patient problems: Pain

  MAUDE report 18753473 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM MESH WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014. AFTER IMPLANTATION, THE PATIENT DEVELOPED PAIN REQUIRING MEDICATIONS TO TREAT PERSISTENT PELVIC PAIN. IT WAS ALSO REPORTED THAT THE PATIENT HAS DYSPAREUNIA.

  Patient problems: Dyspareunia; Pain

  MAUDE report 18387797 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED DURING A TENSION-FREE VAGINAL TAPE PLACEMENT WITH CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2019, THE PATIENT HAD A CYSTOSCOPY AND REMOVAL OF TENSION-FREE VAGINAL TAPE PROCEDURE DUE TO A BLADDER PERFORATION. DURING THE PROCEDURE, THE CYSTOSCOPE WAS PERFORMED AND A SMALL AREA WHERE TAPE WAS VISUALIZED ON THE RIGHT SIDE OF THE BLADDER JUST INSIDE THE BLADDER NECK. THER WAS A MINIMAL AMOUNT OF CLOT PRESENT. THE VAGINAL TAPE WAS VISUALIZED WITHOUT DIFFICULTY AND WAS REMOVED EASILY. THE PATIENT WAS AWAKENED, EXTUBATED, AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Hematoma; Internal Organ Perforation

  MAUDE report 18007863 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TVT PROCEDURE PERFORMED ON (B)(4) 2014, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2023, THE PATIENT PRESENTED WITH BOTHERSOME VAGINAL SPOTTING FROM A POLYPOID MASS OF THE VAGINA. SHE HAD TO UNDERGO EXCISION OF ANTERIOR VAGINAL WALL POLYPS AND REMOVAL OF EXPOSED URETHRAL MESH. FINDINGS SHOWED A POLYPOID FRIABLE SOFT POLYP ORIGINATING FROM THE ANTERIOR MID URETHRA. THERE WAS A DIMPLING OF THE VAGINAL MUCOSA AT THIS LOCATION. CYSTOSCOPY NOW REVEALS EXPOSURE OF MESH WITHIN THE URETHRA, AND THIS WAS PARTIALLY CALCIFIED. DURING THE PROCEDURE, AN ELLIPTICAL INCISION WAS CREATED SHARPLY AROUND THE DIMPLED PORTION OF THE URETHRA INCLUDING THE POLYPOID MASS. THE MASS AND VAGINAL MUCOSA WERE SENT AS A SPECIMEN. MESH WAS EXCISED AND SENT FOR SPECIMEN. THE PHYSICIAN DID NOT CONTINUE TO WORK TO REMOVE THE ENTIRE MESH. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS OR IMPLANTS.

  Patient problems: Calcium Deposits/Calcification; Erosion; Hemorrhage/Blood Loss/Bleeding; Vaginal Mucosa Damage

  MAUDE report 17772237 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2020, FOR THE TREATMENT OF STRESS INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT POSTOPERATIVELY BEGAN TO EXPERIENCE SEVERE COMPLICATIONS RELATED TO THE IMPLANTED ADVANTAGE SYSTEM INCLUDING BUT NOT LIMITED TO; INABILITY TO URINATE, CHRONIC URINARY TRACT INFECTIONS, VAGINAL DISCHARGE, AND SEVERE STOMACH PAIN. ON OR AROUND (B)(6) 2021, THE PATIENT UNDERWENT EXCISION OF EXPOSED SLING MESH, TRANSECTION OF SLING, AND CYSTOSCOPY DUE TO EXPOSURE OF VAGINAL MESH THROUGH THE VAGINAL WALL. AS A DIRECT AND PROXIMATE RESULT OF DEVICE IMPLANT PROCEDURE, PATIENT HAD EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAD SUSTAINED PERMANENT INJURY, HAD UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND OTHER DAMAGES. ADDITIONALLY, THE PATIENT HAD SUFFERED INFLAMMATION OF THE PELVIC TISSUE AND SEVERE ADVERSE REACTIONS TO THE MESH. THE PATIENT UNDERWENT OPERATIONS TO LOCATE AND REMOVE THE MESH, OPERATION

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Erosion; Inflammation; Insufficient Information; Nerve Damage; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Retention; Urinary Tract Infection

  MAUDE report 17660517 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL TAPE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2012, FOR THE TREATMENT OF STRESS INCONTINENCE. NO COMPLICATIONS WERE OBSERVED DURING THE PROCEDURE, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT UNDERWENT A BIOPSY ON (B)(6) 2022, TO ADDRESS A BOTHERSOME MASS IN HER URETHRA RESULTING FROM A URETHRAL DIVERTICULUM. DESPITE INCONCLUSIVE IMAGING, EXAMINATION IN THE CLINIC REVEALED PURULENT DISCHARGE AND MASS COMPRESSION. THE PATIENT OPTED FOR SURGICAL EXPLORATION TO CONFIRM THE SUSPECTED DIAGNOSIS. DURING THE EXAMINATION, THE DOCTOR NOTICED A LARGER AND FIRMER MASS ON THE SIDE OF THE URETHRA. THIS MASS HAD SHIFTED TOWARDS THE RIGHT FROM ITS PREVIOUS POSITION IN THE MIDDLE. TRYING TO COMPRESS THE MASS DID NOT REVEAL ANY FUNCTIONS, AND THERE WAS NO SIGN OF PUS IN THE MASS OR URETHRA. MOREOVER, A FISTULA HAD DEVELOPED BETWEEN THE URETHRA AND VAGINA SINCE THE LAST CHECK-UP. THE OPENING OF THE FISTULA WAS ABOUT 1-2 CM HIGHER THAN THE URETHRAL MEATUS, AND THE MUCOSA WAS HIGHLY FRIABLE. TO CONFIRM THE FISTULA, A 19 FRENCH CYS

  Patient problems: Erosion; Fistula

  MAUDE report 17659425 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A SUSPENSION SLING URETHRA WITH TVT PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF URINARY INCONTINENCE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN STABLE CONDITION. ON (B)(6) 2021, THE PATIENT UNDERWENT SURGICAL INTERVENTION DUE TO ERODED BLADDER MESH IN THE COLON. THE ERODED MESH WAS NOTED IN THE SIGMOID COLON WITH TENTING OF THE MUCOSA. THE MESH WAS CAREFULLY CUT WITH AN ENDOSCOPIC SCISSORS WITHOUT INJURING THE COLON MUCOSA. A SMALL PIECE WAS RETRIEVED WITH A FORCEPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. ON (B)(6) 2021, THE PATIENT HAD ANOTHER SURGERY OF MESH EXCISION DUE TO INFLAMED AND INDURATED TISSUE. EXAM UNDER ANESTHESIA SHOWED MIDLINE EXPOSURE OF SLING MESH FOR APPROXIMATELY 1CM THAT WAS CENTRAL. THERE WAS NO FORNICES EROSION. THIS WAS A VERY DIFFICULT PLACE TO ACCESS DUE TO BODY DYSTOCIA. A SELF-RETAINING RETRACTOR WAS PLACED TO MAXIMIZE EXPOSURE. IT WAS DIFFICULT TO DECIDE HOW TO APPROACH BECAUSE THE TISSUE WAS

  Patient problems: Erosion; Inflammation

  MAUDE report 17585608 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPIC SACRAL COLPOPEXY, CYSTOCELE REPAIR + LAPAROSCOPIC ENTEROCELE REPAIR + RETROPUBIC MIDURETHRAL SLING USING A BOSTON SCIENTIFIC ADVANTAGE SYSTEM + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF PROLAPSE OF VAGINAL VAULT AFTER HYSTEROSCOPY, LATERAL CYSTOCELE VAGINAL ENTEROCELE, RECTOCELE, STRESS INCONTINENCE, STAGE 2 ANTERIOR VAGINAL WALL PROLAPSE, STAGE 2 POSTERIOR VAGINAL WALL PROLAPSE AND STAGE 2 VAGINAL VAULT PROLAPSE. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2022, THE PATIENT UNDERWENT EXCISION OF EXPOSED SURGICAL MESH AND VAGINAL REPAIR DUE TO EROSION OF SURGICAL MESH INTO THE VAGINA. THE PATIENT PRESENTED WITH POSTMENOPAUSAL VAGINAL BLEEDING AND DYSPAREUNIA. PELVIC EXAM REVEALED A 1CM AREA OF EXPOSED SURGICAL MESH AT THE RIGHT APEX CORNER OF THE VAGINAL CUFF. THERE WAS AN APPROXIMATELY 1CM LINEAR AREA OF MESH EROSION INTO RIGHT SIDE OF THE VAGINAL CUFF AT THE APEX. ONLY THE PORTION OF THE EXPOSED MESH WAS EXCISED. THE PATIENT WAS WOKEN UP FROM ANESTHESIA IN STABLE CONDITION. SHE WILL START VAGINAL ESTROGEN THERAPY AFTER DI

  Patient problems: Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17539066 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING POSTERIOR COLPORRHAPHY, PERINEORRHAPHY, PLACEMENT OF A MID-URETHRAL SLING, AND CYSTOURETHROSCOPY PROCEDURES PERFORMED ON (B)(6) 2013, FOR THE TREATMENT OF RECTOCELE AND URODYNAMIC STRESS INCONTINENCE. THE PATIENT'S EXTERNAL GENITALIA WERE FOUND TO BE NORMAL UPON ANESTHETIC EXAMINATION. THE PATIENT LACKED BOTH A UTERUS AND A CERVIX. RECTOCELE WAS DISCOVERED. APICAL AND ANTERIOR SUPPORT WERE NORMAL AND GOOD. THE BLADDER MUCOSA SEEMED NORMAL AND HEALTHY DURING CYSTOSCOPY AFTER THE TENSION-FREE VAGINAL TAPE TROCARS WERE PASSED, WITH NO INJURIES OR DEFECTS IN THE BLADDER. BILATERAL VISUALIZATION OF THE URETERAL ORIFICE WAS PERFORMED. THE URETEROVESICAL JUNCTION AND URETHRAL INTERIOR APPEARED NORMAL AS WELL. FURTHERMORE, THE DOCTOR CONFIRMED THE PRESENCE OF A RECTOCELE DURING THE RECTAL EXAMINATION, AND AFTER THE RECTOCELE REPAIR, THEY PERFORMED ANOTHER DIGITAL EXAMINATION, ENABLING THEM TO CONFIRM THE ABSENCE OF AN ENTEROCELE. A RECTAL EXAM WAS PERFORMED ONCE THE SURGERY WAS COMPLETED. NO SUTURE INJURY WAS PALPABLE THROUGH THE RECTAL MUCOSA. IN ADDITION, NO COMPLICATION

  Patient problems: Insufficient Information

  MAUDE report 17205927 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY + RIGHT SALPINGO-OOPHORECTOMY + TENSION-FREE VAGINAL TAPE URETHRAL SUSPENSION + CYSTOSCOPY + REMOVAL OF PIGMENTED AREA + RIGHT LABIAL MAJORA PROCEDURE PERFORMED ON (B)(6) 2007 FOR THE TREATMENT OF SYMPTOMATIC AND CHRONIC PELVIC PAIN WITH STRESS INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17205866 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MANUFACTURER REPORT 3005099803-2023-02861 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM AND POLYFORM GRAFT DEVICES WERE IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2008, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND SECOND-DEGREE PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORT, THERE WERE NO INTRAOPERATIVE COMPLICATIONS DURING THE SURGERY. THE PATIENT HAS SUFFERED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AS A RESULT OF THE ADVANTAGE SLING AND POLYFORM GRAFT, SUSTAINED PERMANENT INJURY AND A PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, WILL MOST LIKELY CONTINUE TO UNDERGO CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING BUT NOT LIMITED TO OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 27, 2023 THE FOLLOWING PHYSICAL AILMENTS WERE REPORTED BY THE PATIENT: PAIN, PELVIC PAIN, SCARRING, BLEEDING, DYSPAREUNIA, INFECTIONS, URINARY PROBLEMS, EROSION, EXTRUSION, RECURRENCE, NEUROMUSCULAR PROBLEMS, AND MESH REMOVAL S

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Discomfort; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Prolapse; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 17114804 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TENSION-FREE VAGINAL TAPE PLACEMENT, CYSTOSCOPY, POSTERIOR REPAIR AND EXTERNAL ANAL SPHINCTEROPLASTY PROCEDURE PERFORMED ON (B)(6) 2011, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE, GRADE-4 RECTOCELE AND DISRUPTED EXTERNAL ANAL SPHINCTER. DURING THE PROCEDURE, URETHRAL HYPERMOBILITY WAS SEEN, AS WELL AS EXTERNAL AND SPHINCTER DISRUPTION. IN ADDITION, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE POSTOPERATIVE AREA IN EXCELLENT CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17044203 ↗
• InjuryMay 22, 2023Positioning Problem; Positioning Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-02755 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WERE IMPLANTED INTO THE PATIENT DURING TENSION-FREE VAGINAL TAPE PLACEMENT ON (B)(6) 2006 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, THERE WERE NO COMPLICATIONS IDENTIFIED. THE PROCEDURE WAS ALSO WELL TOLERATED BY THE PATIENT, WHO WAS WOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN A STABLE CONDITION. PER THE PATIENT'S ATTORNEY, A SECOND ADVANTAGE DEVICE WAS IMPLANTED ON THE SAME DATE. AFTER SURGERY, THE PATIENT'S URINARY INCONTINENCE PERSISTED. AT THE DOCTOR'S CLINIC, FURTHER EXAMINATION OF THE PATIENT REVEALED THAT THE CAUSE OF THE ABNORMAL DISCHARGE WAS MESH EXPOSURE. THE PATIENT DECIDED TO HAVE A SLING REVISION OR PARTIAL EXCISION ON (B)(6) 2007, TO ADDRESS THE PROBLEM. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE MESH EXPOSURE HAD A LENGTH OF APPROXIMATELY 1.5 CM, STARTING CLOSE TO THE MIDLINE AND EXTENDING TO THE SULCUS ITSELF. ADDITIONALLY, A PORTION OF THE MESH WAS EXCISED, AND ADDITIONAL VA

  Patient problems: Abnormal Vaginal Discharge; Erosion; Urinary Incontinence

  MAUDE report 16979540 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A VAGINAL HYSTERECTOMY + ANTERIOR AND POSTERIOR REPAIR + TVT (TENSION-FREE VAGINAL TAPE) PROCEDURE PERFORMED ON (B)(6) 2011 DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. FINDINGS SHOWED GRADE 2 UTERINE PROLAPSE, RECTOCELE AND CYSTOCELE AND PATENT URETERS BILATERALLY AFTER TVT PLACEMENT. DURING THE IMPLANT, THERE WAS SOME BLEEDING NOTED FROM BOTH THE OVARIAN PEDICLES AND INTERRUPTED STITCHES AS WELL AS CAUTERY WERE USED. ONCE HEMOSTASIS WAS ASSURED, THE REMAINDER OF THE PEDICLES WAS CHECKED. THERE WAS SOME MILD BLEEDING AND INTERRUPTED STITCHES WERE PLACED UNTIL BLEEDING WAS ASSURED. IT WAS DIFFICULT TO GET GOOD HEMOSTASIS, HENCE THE MORE AVERAGE BLOOD LOSS WITH THE CASE. THE PATIENT TOLERATED THE PROCEDURE WELL AND DISCHARGED TO PAR (POSTANESTHESIA RECOVERY) IN STABLE CONDITION. POSTOPERATIVELY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY RELATED TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16972588 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ADVANTAGE SUBURETHRAL SLING PLACEMENT ON (B)(6) 2006, FOR THE TREATMENT STRESS URINARY INCONTINENCE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT LEFT FROM THE OPERATING ROOM IN GOOD CONDITION AFTER THE BLADDER HAD BEEN INSPECTED TO ENSURE THAT THERE WAS NO INDICATION OF PERFORATION INTO THE BLADDER. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16962395 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR COLPORRHAPHY, VAGINAL PARAVAGINAL REPAIR, INSERTION OF MESH INTO THE VESICOVAGINAL SPACE, AND SUBURETHRAL SLING PLACEMENT PROCEDURES PERFORMED ON (B)(6) 2009, FOR THE TREATMENT OF VAGINAL VAULT PROLAPSE, SYMPTOMATIC CYSTOCELE, PARAVAGINAL DEFECT, WEAKENED ENDOPELVIC FASCIA, FAILED CONSERVATIVE MANAGEMENT, AND OCCULT STRESS URINARY INCONTINENCE. THROUGHOUT THE PROCEDURE, THERE WERE NO COMPLICATIONS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AS A RESULT OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16801611 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING DIFFERENT PROCEDURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TVT PROCEDURE PERFORMED ON (B)(6), 2010 DUE TO PREDOMINANT STRESS INCONTINENCE WITH A MINOR COMPONENT OF URGENCY AND URGE INCONTINENCE. ON (B)(6), 2017, THE PATIENT WAS DIAGNOSED WITH STRESS INCONTINENCE AND WAS THEN IMPLANTED WITH A LYNX SYSTEM DEVICE.

  Patient problems: Urinary Incontinence

  MAUDE report 16627334 ↗