Aris 93-4400Recalls & reported problems

Summary

The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 05708932442961), received between Aug 9, 2016 and Apr 2, 2026 — classified as 212 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (30 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 215 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Device Markings/Labelling Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE EXPIRATION ON THE OUTSIDE OF THE BOX IS IN 2029; HOWEVER, THE MESH IN THE BOX HAS AN EXPIRATION DATE OF JUNE 30,2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765432 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT ALSO EXPERIENCED GENERALIZED ANXIETY DISORDER AND DEPRESSION ASSOCIATED WITH CATASTROPHIC NERVE INJURY/ SURGERY AND PAIN, BILATERAL OBTURATOR NEUROPATHY, OVERACTIVE BLADDER AND VAGINAL ATROPHY. THE PATIENT STATES IT HAS TAKEN TWO YEARS TO RECOVER FROM THE MESH REVISION AND THAT SHE HAS BEEN BACK TO WORK FOR ONE YEAR. REPORTEDLY, URINARY INCONTINENCE WORSENED SINCE MESH REMOVAL AND THERE IS POSSIBLE CYSTOCELE. SYMPTOMS SUGGEST A MIX OF OVERACTIVE BLADDER AND POSSIBLE URETHRAL PROLAPSE. CHRONIC POSTOPERATIVE OBTURATOR NEURALGIA AND CHRONIC REGIONAL PAIN SYNDROME. PAIN EXACERBATED BY STRESS AND ACTIVITIES.

  Patient problems: Abnormal Vaginal Discharge; Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Atrophy; Burning Sensation; Chills; Complex regional pain syndrome; Cramp(s) /Muscle Spasm(s); Depression; Dyspareunia; Fever; Hemorrhage/Blood Loss/Bleeding; Hyperesthesia; Hypokalemia; Inflammation; Intermenstrual Bleeding; Low Blood Pressure/ Hypotension; Micturition Urgency; Muscle Weakness/Atrophy; Neuralgia; Neuropathy; Numbness; Pain; Paresthesia; Pelvic Pain; Prolapse; Scar Tissue; Tactile Disorders; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24284371 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD AN ARIS IMPLANTED IN (B)(6) 2018. REPORTEDLY, THE PATIENT EXPERIENCED PELVIC PAIN, GROIN PAIN, ABDOMINAL PAIN, VAGINAL PAIN, DYSPAREUNIA, BLADDER ISSUES, AND URINARY ISSUES, AMONG OTHER SYMPTOMS. PATIENT IS CURRENTLY RECEIVING ONGOING MEDICAL TREATMENT FOR HER INJURIES AND IS SCHEDULED FOR MESH REMOVAL IN THE NEAR FUTURE. HER FUTURE PROGNOSIS IS UNKNOWN.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Cramp(s) /Muscle Spasm(s); Discomfort; Dyspareunia; Dysuria; Erosion; Foreign Body In Patient; Hematuria; Hemorrhage/Blood Loss/Bleeding; Interstitial Cystitis; Micturition Urgency; Pain; Pelvic Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24188365 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS ADDITIONALLY REPORTED THOUGH NOT VERIFIED, THE PATIENT HAD PELVIC PAIN SINCE MESH PLACEMENT AND WAS HOSPITALIZED FOR SUICIDAL IDEATIONS DUE TO PAIN. THE PATIENT ALSO EXPERIENCED URINARY TRACT INFECTIONS.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Constipation; Cramp(s) /Muscle Spasm(s); Depression; Dyspareunia; Erosion; Inflammation; Interstitial Cystitis; Neuralgia; Neuropathy; Numbness; Pain; Pelvic Pain; Scar Tissue; Sexual Dysfunction; Suicidal Ideation; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 23637440 ↗
• InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT ALSO EXPERIENCED URGE INCONTINENCE, URINARY ANALYSIS POSITIVE FOR BLOOD AND LEUKOCYTES LIKELY DUE TO RECTOCELE, CONSTIPATION, VAGINITIS AND TRICHOMONIASIS REQUIRING ANTIBIOTICS. PATIENT ALSO UNDERWENT DA VINCI BILATERAL OOPHORECTOMY WITH LYSIS OF ADHESIONS, ANTERIOR AND POSTERIOR REPAIR WITH LEVATOR ANI MUSCLE PLICATION, PERINEOPLASTY AND CYSTOSCOPY UNDER GENERAL ANAESTHESIA AT THE TIME OF MESH REMOVAL. SURGICAL FINDINGS: GRADE 2 CYSTOCELE AND A GRADE 2 RECTOCELE AS WELL AS PELVIC ADHESIONS (A SIGNIFICANT PART OF THE SIGMOID COLON WAS ADHERED TO THE LEFT PELVIC SIDEWALL ON THE LEFT OVARY). SURGICAL PATHOLOGY REPORT ¿ FOREIGN BODY MESH REMOVAL CONSISTENT WITH MESH, VAGINAL MUCOSA WITH MILD CHRONIC INFLAMMATION.

  Patient problems: Abnormal Vaginal Discharge; Adhesion(s); Constipation; Deformity/ Disfigurement; Dyspareunia; Emotional Changes; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Pelvic Pain; Prolapse; Scar Tissue; Unspecified Infection; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 23085934 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED ACUTE POST-OPERATIVE URINARY RETENTION WITH ABDOMINAL PRESSURE AND WAS PASSING BLOOD CLOTS. THE PATIENT WAS DISCHARGED HOME WITH A CATHETER. IN 2025, THE PATIENT EXPERIENCED NERVE PAIN, PULLING SENSATION IN THE LEFT GROIN AND PALPABLE MESH TO THE LEFT LATERAL SIDE OF THE URETHRA WITH 1 CM EXPOSED. MESH REMOVAL RECOMMENDED.

  Patient problems: Dyspareunia; Erosion; Hematuria; Neuralgia; Pain; Pelvic Pain; Urinary Retention

  MAUDE report 22286394 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION IN MW5168334: "CALL RECEIVED WITH COMPLAINT OF URETHRAL/VAGINAL SLING FAILURE. REPORTER STATED THAT SOMETIME AFTER THE DEVICE WAS IMPLANTED, SHE STARTED EXPERIENCING SEVERE URINARY TRACT INFECTIONS AND VAGINAL BLEEDING. OVER TIME, THESE ISSUES WORSENED TO THE POINT THAT SHE NOW HAS URINARY RETENTION (INTERMITTENT), PRESSURE IN HER ABDOMEN, ABDOMINAL/PELVIC PAIN (CONSTANT), PAIN WITH MOVEMENT, HEMATURIA, AND IS FREQUENTLY CONFINED TO HER BED. SHE HAS RECENTLY HAD TWO PAP SMEARS: FIRST ONE ON (B)(6) 2024, AND SECOND ONE ON (B)(6) 2025, AND IS SCHEDULED TO UNDERGO A SCOPE THIS COMING FRIDAY ((B)(6) 2025). FROM HER FIRST PAP SMEAR, SHE LEARNED THAT THE SLING MATERIAL (WIRES) HAS ADHERED AND GROWN INTO, AND THROUGH, HER VAGINAL WALL APPROXIMATELY 1CM IN LENGTH. REPORTER STATED THAT AS OF TODAY, SHE HAS CONTINUOUS VAGINAL BLEEDING WHICH HAS AN OVERALL IMPACT ON HER PHYSICAL AND MENTAL HEALTH.

  Patient problems: Abdominal Pain; Adhesion(s); Ambulation or Postural Difficulties; Emotional Changes; Erosion; Genital Bleeding; Hematuria; Pain; Pelvic Pain; Urinary Retention; Urinary Tract Infection

  MAUDE report 21894981 ↗
• InjuryApr 17, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED EXPOSED VAGINAL MESH, URINARY TRACT INFECTION, FEVER, INFECTION CONSISTING OF ESCHERICHIA COLI AND WOUND BREAKDOWN.

  Patient problems: Bacterial Infection; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Fever; Hematuria; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21858187 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED VAGINAL DISCHARGE, EROSION OF IMPLANTED VAGINAL MESH (VAGINAL MESH PALPABLE IN THE ANTERIOR VAGINAL WALL AT THE LEVEL OF THE MID URETHRA) AND DYSPAREUNIA. THE PATIENT UNDERWENT MESH REVISION UNDER GENERAL ANESTHESIA. THE PATIENT EXPERIENCED FURTHER MESH EROSION WITH VAGINAL MESH PROTRUDING THROUGH THE MUCOSA. FURTHER REVISION OF VAGINAL MESH WAS PERFORMED.

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion

  MAUDE report 21753609 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED ONGOING AND RECURRENT URINARY TRACT INFECTIONS, DYSURIA, PAIN, BLOATING, PELVIC PAIN, PYURIA, URINARY FREQUENCY AND URGENCY, NAUSEA, DYSPAREUNIA, RECURRENT INCONTINENCE, CYSTITIS, SLING EROSION, BLADDER STONE AND REMOVAL OF ERODED SEGMENT OF DEVICE. A 1CM BLADDER STONE WAS FOUND ADHERED TO THE SEGMENT OF ERODED SLING.

  Patient problems: Dyspareunia; Dysuria; Erosion; Interstitial Cystitis; Micturition Urgency; Nausea; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection; Urolithiasis

  MAUDE report 21605673 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED EXCISION OF DEVICE. CYSTOSCOPY INTRAOPERATIVE FINDINGS: 1.3 X 3 CM EXPOSED SUBURETHRAL MESH. PATHOLOGY REPORT: THE SPECIMEN CONSISTS OF A PORTION OF CLEAR MEDICAL MESH WITH ADHERENT VAGINAL TISSUE AND HEMORRHAGIC TISSUE MEASURING 3.5 CM IN LENGTH AND 1.3 CM IN DIAMETER. THE ADHERENT VAGINAL TISSUE AND HEMORRHAGIC TISSUE IS REMOVED AND MEASURES 2.0 X 1.0 X 0.1 CM IN AGGREGATE.

  Patient problems: Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Dysuria; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Micturition Urgency; Pain; Pelvic Pain; Sexual Dysfunction; Unspecified Infection; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21313732 ↗
• InjuryJan 3, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT WAS IMPLANTED WITH AN ARIS DEVICE IN (B)(6) 2021 FOR STRESS URINARY INCONTINENCE (SUI). A REVISION PROCEDURE WAS PERFORMED TO REMOVE A PORTION OF THE ARIS DEVICE IN (B)(6) 2022 DUE TO EROSION. IN (B)(6) 2024, ANOTHER PROCEDURE WAS PERFORMED TO REMOVE THE REMAINDER OF THE ARIS MESH DUE TO EROSION. IT IS ALLEGED THAT THE PATIENT SUFFERED AND CONTINUES TO SUFFER SERIOUS AND PERMANENT INJURIES, INCLUDING PELVIC, GROIN, AND VAGINAL PAIN, EROSION, FAILURE OF THE ARIS TO TREAT HER SUI, WORSENING SUI, AND THE NEED FOR MULTIPLE PAINFUL SURGERIES TO REVISE AND REMOVE THE ERODED ARIS DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Dyspareunia; Erosion; Fibrosis; Inflammation; Intermenstrual Bleeding; Pain; Perforation; Urinary Incontinence

  MAUDE report 21071860 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH AN ARIS ON (B)(6) 2019. THE FOLLOWING MONTH, THE PATIENT EXPERIENCED PAIN AT THE SLING SITE AND REQUESTED REMOVAL OF THE IMPLANT. SURGERY UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2019, WITH PARTIAL REMOVAL OF THE DEVICE, BUT IT DID NOT ALLEVIATE THE PAIN. A SECOND-OPINION CONSULTATION IS PERFORMED AND CONSERVATIVE TREATMENT IS RECOMMENDED FIRST, WITH REMOVAL OF THE SLING DEPENDING ON PROGRESS. THE PATIENT REFUSED THE RECOMMENDATION AND CONSULTED OUTSIDE (USA) AND HAD THE SLING COMPLETELY REMOVED, FOLLOWED BY 2 RECONSTRUCTIVE SURGERIES FOR RELAPSE OF PROLAPSE AND STRESS URINARY INCONTINENCE. THERE WAS A NOTICEABLE IMPROVEMENT IN PAIN AFTER REMOVAL OF THE SLING.

  Patient problems: Pain; Prolapse; Urinary Incontinence

  MAUDE report 20559478 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED ON (B)(6) 2017. AT A FOLLOW-UP ON (B)(6) 2017, THE PATIENT EXPERIENCED EROSION OF THE STRIP, WHICH WAS TREATED LOCALLY ON EACH OCCASION, WITH A RECOMMENDATION TO APPLY A TOPICAL ESTROGEN. IT IS NOTED THAT THE PATIENT DOES NOT FOLLOW THE RECOMMENDATIONS. A THIRD EROSION OCCURS ON (B)(6) 2019. A COMPLEX MULTIFACTORIAL PROBLEM ASSOCIATED WITH POSSIBLE PUDENDAL NERVE INVOLVEMENT WAS REVEALED. THE PATIENT REFUSES LOCAL TREATMENT AND PREFERS TO CONSULT OUTSIDE (USA). SHE WAS ASSESSED ON (B)(6) 2021, AND THE BANDLET WAS RADICALLY RETREATED ON (B)(6) 2021. THE CONSULTATION MADE NO MENTION OF NEUROLOGICAL DAMAGE AND FOCUSED ON STRIP EROSION ASSOCIATED WITH INFECTION AND PAIN. THE FOLLOW-UP SHOWS AN IMPROVEMENT IN VAGINAL PAIN, BUT NO GREAT IMPROVEMENT IN CHRONIC GENERALIZED MULTIFACTORIAL PAIN OR IN LEFT PUDENDAL NEUROPATHY.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 20558612 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2005 AND THE IMMEDIATE AFTER-EFFECTS WERE NORMAL. THE PATIENT COMPLAINED OF PROGRESSIVE HIP PAIN FROM 2011 TO 2017, WITH NO LOWER BACK PAIN. UNSUCCESSFUL INFILTRATIONS WERE ATTEMPTED, AND EXAMINATION REVEALED GLUTEAL AND LEG PAIN ASSOCIATED WITH MUSCLE WEAKNESS. IT SHOULD BE NOTED THAT SHE WAS NOT REASSESSED IN UROLOGY FOR THIS CONDITION. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OUTPATIENT CONSULTATION (USA) AND THE REMOVAL OF THE SLING WAS RECOMMENDED, CONSIDERING AN EXAMINATION DEMONSTRATING BILATERAL OBTURATOR PAIN OPPOSITE THE SLING PATHS. RADICAL REMOVAL OF THE SLING WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 20557532 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2019. THE PATIENT CONSULTED IN 2020 FOR SIGNIFICANT RIGHT GROIN PAIN AND WAS REFERRED TO A MULTIDISCIPLINARY CENTER SPECIALIZING IN POST-STRIP COMPLICATIONS. SUBSEQUENT COMPREHENSIVE ASSESSMENT REVEALS PELVIC PAIN WITH NO IMPROVEMENT WITH CONSERVATIVE TREATMENT. ON (B)(6) 2022, THIS PATIENT UNDERWENT A COMPLETE REMOVAL OF THE SLING.

  Patient problems: Pain

  MAUDE report 20553141 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE AND PELVIC PAIN SECONDARY TO A UTERINE FIBROID PROBLEM. THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2018 WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT SUBSEQUENTLY DEVELOPED DISABLING BILATERAL GLUTEAL PAIN TREATED WITH PHYSIOTHERAPY AND UNSUCCESSFUL INFILTRATIONS. THE BAND WAS RADICALLY REMOVED ON (B)(6) 2022, WITH A MARKED IMPROVEMENT IN PAIN AND NO FURTHER COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 20551204 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2016. POSTOPERATIVELY, THE PATIENT COMPLAINS OF PAIN AT THE BANDAGE SITE, WHICH IS PROGRESSIVE AND RESPONDS POORLY TO PHYSIOTHERAPY AND MULTIPLE INFILTRATIONS. IN VIEW OF THE EVOLUTION, REMOVAL OF THE SLING IS RECOMMENDED, BUT ACCORDING TO THE FILE, THIS PROCEDURE DOES NOT APPEAR TO HAVE BEEN CARRIED OUT TO DATE.

  Patient problems: Pain

  MAUDE report 20551006 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2018 WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT PRESENTED WITH A LEFT "PARAURETHRAL" EROSION OF HER SLING IN 2018 AND UNDERWENT PARTIAL REMOVAL AND PRIMARY CLOSURE ON (B)(6) 2018 WITH SUCCESS BUT THERE WAS A RECURRENCE OF STRESS INCONTINENCE. AT FOLLOW-UP SHE PRESENTED WITH NEW PAIN AVERC POSSIBLE EROSION OF THE RIGHT SIDE AND CONSIDERING THE RESIDUAL INCONTINENCE AND PAIN THE PATIENT WAS REFERRED TO SPECIALIST CARE FOR MANAGEMENT.

  Patient problems: Erosion; Pain; Urinary Incontinence

  MAUDE report 20550425 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2016. MEDICAL FOLLOW-UP REVEALED STRIP EROSION IN (B)(6) 2016, ACCOMPANIED BY LOCAL PAIN. THERE WAS PARTIAL REMOVAL OF THE STRIP AND PRIMARY CLOSURE UNDER LOCAL ANESTHESIA, BUT THE PAIN PERSISTED CHRONICALLY DESPITE CONSERVATIVE TREATMENT (LOCAL HORMONES, PHYSIOTHERAPY). THE PATIENT WAS RE-EVALUATED AT A PROVINCIAL CENTER OF EXPERTISE AND, FOLLOWING A THOROUGH ASSESSMENT, A RADICAL REMOVAL OF THE SLING WAS RECOMMENDED IN VIEW OF THE NEUROPATHIC SEQUELAE. SURGERY HAS NOT YET BEEN PERFORMED BUT IS PLANNED.

  Patient problems: Erosion; Pain

  MAUDE report 20550120 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2020. THE IMMEDIATE POST-OPERATIVE PERIOD WAS FAVORABLE. INCREASINGLY TROUBLESOME PELVIC PAIN APPEARED IN 2023. A HYSTERECTOMY FOR DYSMENORRHEA DOES NOT IMPROVE THE CONDITION. CLINICAL EXAMINATION REVEALED LEFT AND RIGHT OBTURATOR PAIN, AND A COMPLETE REMOVAL OF THE SLING WAS PERFORMED ON (B)(6) 2024. SUBSEQUENT EVOLUTION WAS POSITIVE, WITH RESOLUTION OF LOCO-REGIONAL PAIN.

  Patient problems: Pain

  MAUDE report 20549932 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT PRESENTED WITH PURE STRESS INCONTINENCE, CLINICALLY WELL DOCUMENTED AND UNRESPONSIVE TO PERINEAL EXERCISES. A TRANS OBTURATOR URETHROPEXY WITH ARIS WAS PERFORMED ON (B)(6) 2010 WITHOUT COMPLICATION. AT FOLLOW-UP, CONTINENCE HAD IMPROVED BUT INCOMPLETELY. THERE WAS MARKED DETERIORATION IN CONTINENCE AFTER 6 YEARS, ASSOCIATED WITH PELVIC PAIN AND PAIN IN BOTH HIPS. LOCAL INFILTRATIONS WERE ATTEMPTED WITH TEMPORARY IMPROVEMENT, BUT THE PATIENT CONTINUED TO EXPERIENCE BOTHERSOME PAIN AND DYSPAREUNIA. FINALLY, SHE UNDERWENT COMPLETE REMOVAL OF THE TAPE ON (B)(6) 2020. PROGRESSION SHOWED AN OVERALL DECREASE IN PAIN, BUT BILATERAL OBTURATOR MYOFASCIAL PAIN PERSISTED, REQUIRING PERINEAL PHYSIOTHERAPY AND OSTEOPATHIC TREATMENT. CONTINENCE STATUS IS UNDETERMINED.

  Patient problems: Dyspareunia; Pain; Pelvic Pain; Urinary Incontinence

  MAUDE report 20533742 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT CONSULTED FOR UTERINE PROLAPSE AND STRESS INCONTINENCE. AN ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO- OOPHORECTOMY, AND TRANS OBTURATOR BAND URETHROPEXY WITH ARIS WAS PERFORMED IN (B)(6) 2018. THE HYSTERECTOMY WAS COMPLICATED BY AN ABSCESSED HEMATOMA, WHICH WAS SUCCESSFULLY TREATED CONSERVATIVELY. IN 2019 THE PATIENT EXPERIENCED PELVIC PAIN AND DYSPAREUNIA AS WELL AS URINARY URGENCY. REMOVAL OF THE SLING WAS PERFORMED IN (B)(6) 2021.

  Patient problems: Dyspareunia; Pelvic Pain

  MAUDE report 20507252 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT CONSULTED FOR STRESS URINARY INCONTINENCE, AND A TRANS OBTURATOR SLING (ARIS) WAS IMPLANTED IN (B)(6) 2016, WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT COMPLAINED OF PAIN AND AN EROSION OF THE STRIP WAS OBSERVED IN (B)(6) 2017. CORRECTION BY URETHROLYSIS AND PARTIAL EXCISION OF THE STRIP WAS PERFORMED IN (B)(6) 2018. THE EVOLUTION WAS FAVORABLE, BUT IN 2023 THE PATIENT DEVELOPED A NEW EROSION OF HER DIAPHRAGM, WITH FEW OR NO SYMPTOMS. CONSERVATIVE TREATMENT IS UNDERTAKEN WITH NO NOTION OF CHRONIC PAIN OR SIGNIFICANT PROBLEMS.

  Patient problems: Erosion; Pain

  MAUDE report 20506922 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT CONSULTED FOR PURE STRESS URINARY INCONTINENCE AND A TRANS OBTURATOR SLING (ARIS) WAS PERFORMED IN (B)(6) 2017. AT FOLLOW-UP IN (B)(6) 2017, THE PATIENT COMPLAINED OF VAGINAL DISCOMFORT AND CENTRAL STRIP EROSION WAS CONFIRMED. PARTIAL REMOVAL OF THE STRIP WITH PRIMARY CLOSURE WAS PERFORMED IN (B)(6) 2018. PERSISTENT AND INCREASING HIP AND GROIN PAIN PREDOMINANTLY ON THE RIGHT WERE REPORTED, ALL IN ASSOCIATION WITH HER GENERALIZED CHRONIC PAIN PROBLEM. THE PAIN WAS CONSIDERED CENTRALIZED AND OF MIXED ORIGIN. ULTIMATELY RADICAL REMOVAL OF THE SLING WAS PERFORMED IN (B)(6) 2023. FOLLOW-UP SHOWED A PARTIAL IMPROVEMENT IN PAIN, BUT CHRONIC PERSISTENCE OF PAIN LINKED TO PREVIOUS CHRONIC PAIN AND FIBROMYALGIA.

  Patient problems: Discomfort; Erosion; Pain

  MAUDE report 20505693 ↗