ADVANTAGE FIT SYSTEM

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT UNDERWENT VAGINAL SURGERY WHICH INCLUDED POSTERIOR AND ANTERIOR PROLAPSE REPAIR WHERE AN ADVANTAGE FIT SLING SYSTEM WAS IMPLANTED ON (B)(6) 2018. FOLLOWING THE IMPLANTATION, THE PATIENT EXPERIENCED SIGNIFICANT PAIN AND DEVELOPED BACTERIAL VAGINOSIS WHICH REQUIRED TWO ROUNDS OF ANTIBIOTICS TO RESOLVE. THE PATIENT WAS THEN REFERRED TO PELVIC FLOOR PHYSIOTHERAPY AND UNDERWENT TREATMENT WITH VAGINAL DILATORS FOR OVER SIX MONTHS. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH MESH EROSION. 3D ULTRASOUND REVEALED RETROPUBIC SLING POSTEROLATERAL INDENTATION AND EMBEDDING INTO THE OUTER URETHRAL WALL WITH TENDERNESS ALONG THE SLING ARMS. ON (B)(6) 2023, MRI IMAGING DEMONSTRATED MEDIAL DEVIATION AND DEFORMATION OF THE RIGHT SLING ARM IN THE RETROPUBIC REGION, WITH ASSOCIATED INFLAMMATION AND EMBEDDING INTO THE URETHRA. ON (B)(6) 2023, URODYNAMIC STUDIES WERE UNDERTAKEN WHICH CONFIRMED THAT THE SLING WAS EMBEDDED INTO THE URETHRA, WITH BUNCHING OF THE SLING ARM AND ASSOCIATED INFLAMMATION. FULL REMOVAL OF SLING WAS RECOMMENDED AS THE PREFERRED TREATMENT OPTION. ON (B)(6) 2024, THE PATIENT UNDERWENT MESH REVISION SURGERY FOR REMOVAL OF THE IMPLANTED SLING. AT THIS TIME, THE PATIENT CONTINUED TO EXPERIENCED MOBILITY LIMITATIONS AND SEVERE PELVIC PAIN. DURING SURGERY, THE SLING WAS FOUND TO BE EMBEDDED IN THE URETHRA AND ADHERED TO THE BLADDER NECK WITH MORE INFLAMMATION, SO REMOVAL REQUIRED DISSECTION IN CLOSE PROXIMITY TO THE PELVIC BONE AND CRITICAL ANATOMICAL STRUCTURES. AND DESPITE CAREFUL SURGICAL TECHNIQUE, THE REMOVAL RESULTED IN ADDITIONAL INJURY. AFTER THE REMOVAL SURGERY, THE PATIENT PRESENTED AN INCISIONAL HERNIA IN THE SUPRAPUBIC REGION AND ON (B)(6) 2025, THE PATIENT UNDERWENT FURTHER REVISION SURGERY FOR INCISIONAL HERNIA REPAIR AND COMPLEX ABDOMINAL WALL RECONSTRUCTION. THIS REQUIRED AN EXTENDED HIP-TO-HIP ABDOMINAL INCISION WITH REMOVAL OF THE UMBILICUS AND SHARP DISSECTION OF THE BLADDER FROM THE PELVIC BONE. FOLLOWING THE PROCEDURE, THE PATIENT REQUIRED A PROLONGED HOSPITAL STAY AND EXTENSIVE RECOVERY FOR SEVERAL MONTHS AND UNABLE TO MOBILISE FOR A SIGNIFICANT PERIOD. POST-OPERATIVE AND ASSESSMENTS CONFIRMED THAT THE PATIENT HAS SUSTAINED SEVERE AND PERMANENT INJURY, INCLUDING LOSS OF CORE STABILITY, CONNECTIVE TISSUE DAMAGE, NERVE-RELATED IMPAIRMENT, CHRONIC PAIN, AND REDUCED MOBILITY. THE PATIENT HAS ALSO EXPERIENCED SECONDARY COMPLICATIONS, INCLUDING POSTURAL HYPOTENSION, NERVE DISRUPTION CAUSING DIZZINESS, WEAKNESS, FATIGUE, AND EPISODIC HYPOTENSION. PATIENT'S CURRENT CONDITION INCLUDES SEVERE AND PERMANENT IMPAIRMENT, ONGOING SEVERE PAIN, LOSS OF INDEPENDENCE, EMBARRASSMENT, LOSS OF CORE STABILITY, REDUCED MOBILITY, INABILITY TO PERFORM ACTIVITIES OF DAILY LIVING, RELIANCE ON ASSISTIVE DEVICES AND OTHER PERSONS FOR BASIC FUNCTIONING, AND WILL CONTINUE TO REQUIRE MEDICAL TREATMENTS, THERAPIES AND SUPPORT.

Additional Manufacturer Narrative

BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JULY 2, 2024 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF MESH WAS EXPLANTED. BLOCK E1: THIS EVENT WAS REPORTED THROUGH THE LEGAL PROCESS. BLOCK H6: THE FOLLOWING IMDRF PATIENT CODE CAPTURE THE REPORTABLE EVENT OF: E2330 - PAIN, E2006 - EROSION, E1901 - VAGINAL INFECTION, E2312- INFLAMMATION. THE FOLLOWING IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1905 - VAGINAL MESH REMOVAL, F1202 - DISABILITY, F08 - PROLONGED HOSPITALIZATION, F1901 - ADDITIONAL SURGERY, E0206 - EMBARRASSMENT.