Advantage Fit™ System M0068502110Recalls & reported problems

Summary

The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 08714729772880), received between Jan 26, 2017 and Apr 30, 2026 — classified as 429 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (21 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. 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 451 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Y-MESH AND AN ADVANTAGE FIT DEVICE WERE IMPLANTED ON (B)(6), 2017. IN 2018, THE PATIENT WAS DIAGNOSED WITH AN AUTOIMMUNE DISEASE. SUBSEQUENT CLINICAL EVALUATION IDENTIFIED THAT THE MESH ERODED INTO THE BLADDER AT TWO SEPARATE SITES, MIGRATED THROUGH DEEP PELVIC MUSCLES, AND EMBEDDED IN THE PUBIC BONE. DUE TO THESE FINDINGS, THE PATIENT UNDERWENT COMPLEX MESH REMOVAL SURGERIES IN (B)(6) 2024 AND (B)(6) 2025. AT THE TIME OF VAGINAL MESH REMOVAL, A NATIVE TISSUE VAGINAL PROLAPSE REPAIR WAS ALSO PERFORMED. PATHOLOGICAL ASSESSMENT OF BLADDER TISSUE ASSOCIATED WITH MESH EROSION IDENTIFIED A PRECANCEROUS LESION. THE PATIENT REPORTED PERSISTENT NERVE INJURY AND ONGOING CHRONIC PAIN FOLLOWING THESE INTERVENTIONS. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE ADVANTAGE FIT DEVICE.

  Patient problems: Erosion; Hypersensitivity/Allergic reaction; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 25053335 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  MEDICAL HISTORY: URODYNAMIC EVALUATION DEMONSTRATED BLADDER UNDERACTIVITY DURING VOIDING, WITH THE PATIENT REQUIRING STRAINING DURING URINATION. THE PATIENT COMPLETED 30 SESSIONS OF PELVIC FLOOR MUSCLE TRAINING IN 2022 WITHOUT CLINICAL IMPROVEMENT. PROCEDURE SUMMARY: IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED TO THE PATIENT FOR THE TREATMENT OF STRESS URINARY INCONTINENCE DURING A PROCEDURE PERFORMED ON (B)(6) 2023. EVENT SUMMARY: FOLLOWING THE IMPLANTATION, THE PATIENT EXPERIENCED PAIN, RECURRENT URINARY TRACT INFECTIONS, BURNING SENSATION, FEVER, LOWER BACK PAIN, AND INTERMITTENT DIFFICULTY WITH MOBILITY. THE PATIENT HAS BEEN CURRENTLY RECOGNIZED AS DISABLED AND REQUIRES URINARY CATHETERIZATION SIX TIMES DAILY. THE PATIENT STATED THAT SHE PRESENTED FOR TREATMENT OF SIMPLE STRESS URINARY INCONTINENCE AND SUBSEQUENTLY DEVELOPED A DISABLING CONDITION REQUIRING ONGOING CATHETERIZATION HOWEVER, EXPRESSED CONCERN REGARDING SURGICAL OUTCOMES AND TRAINING, NOTING THAT THE ORIGINAL CONDITION WAS BENIGN. ON (B)(6) 2024, THE PATIENT UNDERWENT URINARY CYTOBACTERIOLOGICAL TESTING. MACROSCOPIC EXAMINATION SHOWED CLOUDY URINE. MICROSCOPIC ANALYSIS REVEALED LEUKOCYTES AT 817,500/

  Patient problems: Bacterial Infection; Burning Sensation; Discomfort; Dysuria; Fatigue; Fever; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24632369 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2011, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24335152 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT SLING WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2018, THE PATIENT RETURNED TO THE SAME SURGEON FOR DIVISION OF THE SUBURETHRAL SLING DUE TO VOIDING DYSFUNCTION. AT THAT TIME, THE PATIENT WAS EVALUATED FOR RECURRENT URINARY TRACT INFECTIONS, WITH CONCERN FOR POSSIBLE MESH INVOLVEMENT IN THE BLADDER.

  Patient problems: Erosion; Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 24070314 ↗
• InjuryDec 22, 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 INFECTION, SEVERE PELVIC CRAMPING AND PAIN, BLEEDING, ABSCESS FORMATION, RECURRENCE, AND THE NEED FOR REMOVAL SURGERY. THE PATIENT LATER UNDERWENT REMOVAL SURGERY ON OR ABOUT (B)(6) 2024. AS A RESULT OF THE IMPLANTED DEVICE, THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY REQUIRE FURTHER SURGERY AND COULD, IN THE FUTURE, SUFFER DAMAGES SUCH AS SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND ADDITIONAL MEDICAL EXPENSES RELATED TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abscess; Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23866211 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED IN A PATIENT DURING A PROCEDURE. SINCE THEN, THE PATIENT HAS EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING DYSPAREUNIA, VAGINAL PAIN, MESH EROSION THROUGH THE VAGINAL WALL, A URETHRAL CUTANEOUS FISTULA REQUIRING RECONSTRUCTION, RECURRENT URINARY TRACT INFECTIONS, WORSENING URINARY INCONTINENCE, AND CHRONIC MESH-RELATED ISSUES NECESSITATING MULTIPLE SURGICAL ATTEMPTS TO REMOVE THE MESH.

  Patient problems: Dyspareunia; Erosion; Fistula; Insufficient Information; Pain; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 23293127 ↗
• InjuryJun 18, 2025Adverse 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 THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 2124215-2025-34086 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT SYSTEM AND PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION, MESH EXTRUSION, PHYSICAL IRRITATION FROM MESH RUBBING, PAIN (INCLUDING VAGINAL AND PELVIC PAIN), DYSPAREUNIA, ABDOMINAL BLEEDING, VAGINAL DISCHARGE WITH ODOR, CHRONIC CONSTIPATION, SCARRING, FURTHER OR WORSENING URINARY PROBLEMS, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY SUFFER IN THE FUTURE, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Scar Tissue; Skin Inflammation/ Irritation; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 22275219 ↗
• InjuryMay 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. THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY WITH RIGHT SALPINGECTOMY FOLLOWED BY PELVIC FLOOR RECONSTRUCTIVE PROCEDURES, INCLUDING PLACEMENT OF A MID-URETHRAL SLING TO ADDRESS STRESS URINARY INCONTINENCE. DURING THE SLING PLACEMENT, NO INTRAOPERATIVE COMPLICATIONS RELATED TO THE MESH OR SLING WERE OBSERVED. CYSTOSCOPY CONFIRMED NO INJURY TO THE BLADDER, URETHRA, OR URETERS, AND URINE FLOW FROM BOTH URETERAL ORIFICES VERIFIED URETERAL PATENCY. THE MESH WAS POSITIONED AT THE MID-URETHRA WITHOUT TENSION, AND THE SUPRAPUBIC INCISIONS WERE CLOSED APPROPRIATELY. POSTOPERATIVELY, THE PATIENT WAS STABLE, TOLERATED THE PROCEDURE WELL, AND WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. ON (B)(6) 2024, THE PATIENT PRESENTED WITH OBSTRUCTIVE VOIDING SYMPTOMS AND DYSURIA, DIAGNOSED WITH A URETHRAL DIVERTICULUM INVOLVING A PREVIOUSLY PLACED MID-URETHRAL SLING. AFTER COUNSELING, SHE ELECTED FOR REMOVAL OF VAGINAL MESH WITH DIVERTICULECTOMY. IN THE OPERATING ROOM, GENERAL ANESTHESIA WAS INDUCED WITHOUT COMPLICATION, AND PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. DURING DISSECTION, THE MID-URETHRAL S

  Patient problems: Dysuria; Insufficient Information; Obstruction/Occlusion; Urinary Incontinence

  MAUDE report 22118796 ↗
• InjuryMay 30, 2025Adverse 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 FIT BLUE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE ON (B)(6) 2018. AFTER WHICH, SHE EXPERIENCED CHRONIC MESH-RELATED COMPLICATIONS, INCLUDING PELVIC PAIN, DYSPAREUNIA, VAGINAL PAIN, MESH EROSION, BLADDER STONES, RECURRENT URINARY TRACT INFECTIONS, AND CHRONIC INFLAMMATION, REQUIRING MULTIPLE SURGICAL INTERVENTIONS. THE PATIENT ALLEGES ONGOING PHYSICAL AND EMOTIONAL HARM AND ASSOCIATED ECONOMIC DAMAGES RELATED TO THE IMPLANTED DEVICE. ON (B)(6) 2024, THE PATIENT UNDERWENT CYSTOSCOPY FOR BLADDER STONE REMOVAL, DURING WHICH ERODED BLADDER SUSPENSION MESH WAS IDENTIFIED WITHIN THE BLADDER AND LASERED OUT, WITH RESIDUAL MESH AT THE BLADDER NECK TREATED USING A THULIUM FIBER LASER. ALL STONE FRAGMENTS WERE EVACUATED, AND AN 18 FRENCH FOLEY CATHETER WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION WITHOUT COMPLICATIONS. ON (B)(6) 2024, CYSTOSCOPY REVEALED A CALCIFIED BLADDER MESH ERODING THROUGH THE RIGHT LATERAL BLADDER WALL. THE PATIENT UNDERWENT VAGINAL AND BLADDER MESH RESECTION, DURING WHICH ERODED MESH FROM THE BLADDER AND BLADDER NECK WAS TRIMMED

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Erosion; Inflammation; Insufficient Information; Obstruction/Occlusion; Pain; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 22118633 ↗
• InjuryMay 14, 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 URINARY RETENTION RESULTING IN A SLING LYSIS PROCEDURE, FOLLOWED BY URETHROVAGINAL FISTULA AND RECURRENT STRESS URINARY INCONTINENCE. FOLLOWING A MID-URETHRAL SLING PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE URINARY RETENTION FOR OVER THREE WEEKS. AFTER CONSIDERING THE RISKS, SHE CHOSE TO UNDERGO SLING LYSIS. SUBSEQUENTLY, APPROXIMATELY ONE MONTH AFTER ADVANTAGE FIT IMPLANTATION, SHE HAD A CYSTOURETHROSCOPY, PARTIAL EXCISION OF THE MID-URETHRAL SLING, AND REPAIR OF AN UNAVOIDABLE URETHROTOMY. DURING THE PROCEDURE, THE SLING MESH WAS IDENTIFIED, ELEVATED, AND EXCISED AFTER MAKING A 2 CM INCISION IN THE VAGINAL EPITHELIUM. A 1 CM URETHROTOMY WAS NOTED DURING EXCISION OF THE MIDURETHRAL SLING. THE URETHROTOMY WAS CLOSED WITH MULTIPLE LAYERS OF 3-0 VICRYL SUTURES, AND A VAGINAL FLAP WAS CREATED TO ENSURE WATERTIGHT CLOSURE, CONFIRMED BY CYSTOURETHROSCOPY. THE PATIENT WAS STABLE POSTOPERATIVELY AND WILL HAVE A FOLEY CATHETER FOR 2-3 WEEKS, FOLLOWED BY A VOIDING CYSTOGRAM. APPROXIMATELY 3 MONTHS AFTER THE SLING REVISION PROCEDURE, THE PATIENT W

  Patient problems: Fistula; Urinary Incontinence; Urinary Retention

  MAUDE report 22018385 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING EROSION, VAGINAL DISCHARGE WITH ITCHING AND BURNING, SEVERE PAIN (INCLUDING BACK, ABDOMINAL, AND BLADDER PAIN), SIGNIFICANT SCARRING, RECURRENT URINARY TRACT INFECTIONS, FURTHER URINARY PROBLEMS, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. *ADDITIONAL INFORMATION RECEIVED ON MAY 21, 2025: ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH MIXED URINARY INCONTINENCE, MILD CYSTOCELE, AND BLADDER PAIN FOLLOWING MIDURETHRAL SLING PLACEMENT. SHE SUBSEQUENTLY UNDERWENT SURGICAL MANAGEMENT, INCLUDING EXCISION OF THE MIDURETHRAL SLING, PARAVAGINAL ANTERIOR REPAIR, PERIURETHRAL BULKING INJECTIONS, AND CYSTOSCOPY WITH URETERAL CATHETERIZATION. DURING THE PROCEDURE, THE MIDURETHRAL SLING WAS IDENTIFIED DEEP IN THE CONNECTIVE TISSUE TO THE RIGHT OF MIDLINE, WHERE SIGNIFICANT PERIURETHRAL SCARRING WAS OBSERVED. IT WAS DISSECTED BILATERALLY INTO THE SPACE OF RETZIU

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Burning Sensation; Discomfort; Erosion; Itching Sensation; Pain; Prolapse; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 22018248 ↗
• 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 SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE COMPLICATIONS INCLUDE EROSION OF THE IMPLANTED MESH INTO HER VAGINA, ABDOMINAL AND PELVIC PAIN, FREQUENT URINARY TRACT INFECTIONS, AND PURULENT VAGINAL DISCHARGE. AS A RESULT, THE PATIENT UNDERWENT EXCISION SURGERY. ADDITIONALLY, THE PATIENT HAS SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM DUE TO THE IMPLANTED DEVICE. 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. ON (B)(6) 2023, THE PATIENT PRESENTED TO DISCUSS CONCERNS RELATED TO HER BLADDER MESH AND IRREGULAR MENSTRUAL PERIODS. SHE REPORTED THAT IN 2017 SHE UNDERWENT PLACEMENT OF A RETROPUBIC MIDURETHRAL SLING ALONG WITH INSERTION OF A MIRENA IUD FOR MANAGEMENT OF ABNORMAL UTERINE BLEEDING. THE IUD WAS REMOVED LESS THAN ONE YEAR LATER DUE TO DAILY BLEEDING. SINCE ITS REMOVAL, THE PATIENT REPORTED THAT HER MENSTRUAL CYCLES HAD BE

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Burning Sensation; Deformity/ Disfigurement; Discomfort; Dizziness; Dyspareunia; Dysuria; Erosion; Erythema; High White Blood Cell Count; Insufficient Information; Micturition Urgency; Nausea; Pain; Prolapse; Purulent Discharge; Sore Throat; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21937844 ↗
• InjuryApr 22, 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 MESH EROSION INTO THE URETHRA AND BLADDER, URETHRAL AND BLADDER PAIN, URETHROVAGINAL FISTULA, BLADDER STONES, DYSPAREUNIA, FURTHER OR WORSENING URINARY PROBLEMS, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Bacterial Infection; Dyspareunia; Erosion; Fistula; Micturition Urgency; Obstruction/Occlusion; Pain; Post Operative Wound Infection; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 21886055 ↗
• MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS OPENED AND INTENDED FOR USE IN A PROCEDURE. DURING UNPACKING, THE MESH PACKAGING WAS FOUND TO BE SQUISHED ON ONE SIDE. DUE TO CONCERNS ABOUT THE STERILITY OF THE DEVICE, THE MESH WAS NOT USED ON THE PATIENT. SIMILAR DAMAGE WAS OBSERVED ON THE OTHER FOUR ADVANTAGE FIT DEVICES FROM THE SAME BOX. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIFTH OF FIVE DEVICES OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724114 ↗
• MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS OPENED AND INTENDED FOR USE IN A PROCEDURE. DURING UNPACKING, THE MESH PACKAGING WAS FOUND TO BE SQUISHED ON ONE SIDE. DUE TO CONCERNS ABOUT THE STERILITY OF THE DEVICE, THE MESH WAS NOT USED ON THE PATIENT. SIMILAR DAMAGE WAS OBSERVED ON THE OTHER FOUR ADVANTAGE FIT DEVICES FROM THE SAME BOX. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE THIRD OF FIVE DEVICES OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724083 ↗
• MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS OPENED AND INTENDED FOR USE IN A PROCEDURE. DURING UNPACKING, THE MESH PACKAGING WAS FOUND TO BE SQUISHED ON ONE SIDE. DUE TO CONCERNS ABOUT THE STERILITY OF THE DEVICE, THE MESH WAS NOT USED ON THE PATIENT. SIMILAR DAMAGE WAS OBSERVED ON THE OTHER FOUR ADVANTAGE FIT DEVICES FROM THE SAME BOX. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FOURTH OF FIVE DEVICES OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723995 ↗
• MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS OPENED AND INTENDED FOR USE IN A PROCEDURE. DURING UNPACKING, THE MESH PACKAGING WAS FOUND TO BE SQUISHED ON ONE SIDE. DUE TO CONCERNS ABOUT THE STERILITY OF THE DEVICE, THE MESH WAS NOT USED ON THE PATIENT. SIMILAR DAMAGE WAS OBSERVED ON THE OTHER FOUR ADVANTAGE FIT DEVICES FROM THE SAME BOX. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF FIVE DEVICES OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723620 ↗
• MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS OPENED AND INTENDED FOR USE IN A PROCEDURE. DURING UNPACKING, THE MESH PACKAGING WAS FOUND TO BE SQUISHED ON ONE SIDE. DUE TO CONCERNS ABOUT THE STERILITY OF THE DEVICE, THE MESH WAS NOT USED ON THE PATIENT. SIMILAR DAMAGE WAS OBSERVED ON THE OTHER FOUR ADVANTAGE FIT DEVICES FROM THE SAME BOX. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF FIVE DEVICES OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721516 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO HAD BEEN IMPLANTED WITH AN ADVANTAGE SYSTEM EXPERIENCED A MESH EXPOSURE. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF THE EXPOSED MESH AND CYSTOSCOPY PROCEDURES.

  Patient problems: Erosion

  MAUDE report 21618240 ↗
• InjuryMar 17, 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 A ROBOTIC SACROCOLPOPEXY, BILATERAL SALPINGO-OOPHORECTOMY, ENTEROCELE REPAIR, POSTERIOR REPAIR, MID-URETHRAL SLING PLACEMENT, AND CYSTOSCOPY PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 21616481 ↗
• 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 A ROBOTIC SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, SACROCOLPOPEXY, ENTEROCELE REPAIR, POSTERIOR REPAIR, MID-URETHRAL SLING PLACEMENT, AND CYSTOSCOPY.

  Patient problems: Insufficient Information

  MAUDE report 21611523 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THIS BOSTON SCIENTIFIC MESH EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Abdominal Pain; Discomfort; Dyspareunia; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Micturition Urgency; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 21529674 ↗
• InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THIS ADVANTAGE FIT SYSTEM AND UPSYLON Y-MESH EXPERIENCED INJURIES INCLUDING: PELVIC AND BLADDER PAIN, FISSURES, DYSPAREUNIA, CONSTIPATION, FURTHER OR WORSENING URINARY PROBLEMS, DEPRESSION, LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED ON THE SAME PATIENT. PLEASE REFER TO MFR REPORT 2124215-2025-12251 FOR THE ASSOCIATED DEVICE.

  Patient problems: Constipation; Depression; Dyspareunia; Pain; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 21499482 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME AFTER IMPLANTATION, THE PATIENT EXPERIENCED PELVIC PAIN, FREQUENT BLADDER INFECTION AND URINATION ISSUES, AND BLADDER CONTROL ISSUES. ADDITIONALLY, SHE HAD ALSO ACQUIRED SYMPTOMS OF ASIA SYNDROME FROM THE MESH IMPLANT. THE SLING WAS REMOVED WAS REMOVED IN 2024.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21144681 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ADVANTAGE IMPLANTATION, THE PATIENT'S STRESS INCONTINENCE AND CHRONIC CONSTIPATION HAVE AGGRAVATED. PELVIC PAIN IN THE PUBIC AREA AND VAGINA AFTER EFFORTS AND EVEN A SHORT TIME OF WALKING, FREQUENT NEED TO URINATE, AND VAGINAL INFECTION WERE ALSO EXPERIENCED BY THE PATIENT. ADDITIONALLY, THE PATIENT WAS ON SICK LEAVE SINCE THE SURGERY, AS THE PATIENT'S JOB IS INCOMPATIBLE WITH PAIN ASSOCIATED WITH EFFORT.

  Patient problems: Constipation; Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 21043475 ↗