ADVANTAGE FIT? BLUE SYSTEM
Report
- Report Number
- 2124215-2025-30632
- Event Type
- Injury
- Date Received
- May 14, 2025
- Date of Event
- January 19, 2023
- Report Date
- April 30, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTN
- UDI-DI
- 08714729961925
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLOCK H2: ADDITIONAL INFORMATION. BLOCKS B2, B5, B6, B7, H2, AND H6 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 4, 2026. BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. (B)(6). BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E0123 - PUDENDAL NEURALGIA, E2330 - PAIN, E1705 - VAGINAL BURNING, E1405 - DYSPAREUNIA, E1906 - YEAST INFECTION, E2326 - VAGINITIS, E2308 - DISFIGUREMENT, E0206 - MENTAL SUFFERING, E1307 - URETHRAL STENOSIS/STRICTURE, E1002 - ABDOMINAL PAIN, E1309 - URINARY RETENTION, E1301 - DYSURIA. THE IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1903 - MESH EXCISION.
BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JANUARY 19, 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS: DR. (B)(6). BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E0123 - CAPTURES THE REPORTABLE EVENT OF PUDENDAL NEURALGIA. E2330 - CAPTURES THE REPORTABLE EVENT OF PAIN. E1705 - CAPTURES THE REPORTABLE EVENT OF VAGINAL BURNING. E1405 - CAPTURES THE REPORTABLE EVENT OF DYSPAREUNIA. E1906 - CAPTURES THE REPORTABLE EVENT OF YEAST INFECTION. E2326 - CAPTURES THE REPORTABLE EVENT OF VAGINITIS. E2308 - CAPTURES THE REPORTABLE EVENT OF DISFIGUREMENT. E0206 - CAPTURES THE REPORTABLE EVENT OF MENTAL SUFFERING. THE IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1903 - CAPTURES THE REPORTABLE EVENT OF MESH EXCISION.
BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS: DR. (B)(6). (B)(6). THE EXPLANTING SURGEON IS: DR. (B)(6). UNITED STATES BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E0123 - PUDENDAL NEURALGIA. E2330 - PAIN. E1705 - VAGINAL BURNING. E1405 - DYSPAREUNIA. E1906 - YEAST INFECTION. E2326 - VAGINITIS. E2308 - DISFIGUREMENT. E0206 - MENTAL SUFFERING. E1307 - URETHRAL STENOSIS/STRICTURE. E1002 - ABDOMINAL PAIN. E1309 - URINARY RETENTION. E1301 - DYSURIA. THE IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1903 - MESH EXCISION. BLOCK H11: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
BLOCK H2: ADDITIONAL INFORMATION: BLOCKS B5 (EVENT DESCRIPTION), D6B (EXPLANT DATE), H6 (PATIENT CODES) HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JANUARY 19, 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS: DR. (B)(6). (B)(6) MEDICAL CENTER. THE EXPLANTING SURGEON IS: DR. (B)(6). BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E0123 - CAPTURES THE REPORTABLE EVENT OF PUDENDAL NEURALGIA. E2330 - CAPTURES THE REPORTABLE EVENT OF PAIN. E1705 - CAPTURES THE REPORTABLE EVENT OF VAGINAL BURNING. E1405 - CAPTURES THE REPORTABLE EVENT OF DYSPAREUNIA. E1906 - CAPTURES THE REPORTABLE EVENT OF YEAST INFECTION. E2326 - CAPTURES THE REPORTABLE EVENT OF VAGINITIS. E2308 - CAPTURES THE REPORTABLE EVENT OF DISFIGUREMENT. E0206 - CAPTURES THE REPORTABLE EVENT OF MENTAL SUFFERING. E1307 - CAPTURES THE REPORTABLE EVENT OF URETHRAL STENOSIS/STRICTURE. THE IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1903 - CAPTURES THE REPORTABLE EVENT OF MESH EXCISION.
BLOCK H2: ADDITIONAL INFORMATION: BLOCKS B5 (EVENT DESCRIPTION) AND B7 (OTHER RELEVANT HISTORY) HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JANUARY 19, 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS: (B)(6). THE EXPLANTING SURGEON IS: (B)(6) UNITED STATES. BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E0123 - CAPTURES THE REPORTABLE EVENT OF PUDENDAL NEURALGIA. E2330 - CAPTURES THE REPORTABLE EVENT OF PAIN. E1705 - CAPTURES THE REPORTABLE EVENT OF VAGINAL BURNING. E1405 - CAPTURES THE REPORTABLE EVENT OF DYSPAREUNIA. E1906 - CAPTURES THE REPORTABLE EVENT OF YEAST INFECTION. E2326 - CAPTURES THE REPORTABLE EVENT OF VAGINITIS. E2308 - CAPTURES THE REPORTABLE EVENT OF DISFIGUREMENT. E0206 - CAPTURES THE REPORTABLE EVENT OF MENTAL SUFFERING. E1307 - CAPTURES THE REPORTABLE EVENT OF URETHRAL STENOSIS/STRICTURE. THE IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F1903 - CAPTURES THE REPORTABLE EVENT OF MESH EXCISION.
IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE ON (B)(6) 2023, TO TREAT URINARY STRESS INCONTINENCE. THE SLING WAS POSITIONED TENSION-FREE, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS NOTED. HOWEVER, THE PATIENT HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. 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. ON (B)(6) 2023, THE PATIENT PRESENTED WITH PERSISTENT GROIN PAIN, MORE PRONOUNCED ON THE LEFT SIDE, WITH INTERMITTENT FLARES SINCE JANUARY. SHE HAD PREVIOUSLY BEEN DIAGNOSED WITH A YEAST INFECTION; HOWEVER, HER SYMPTOMS DID NOT IMPROVE. PRIOR TO THAT, SHE HAD SEEN HER PHYSICIAN IN FEBRUARY, WHO BELIEVED HER PAIN WAS DUE TO A HSV (HERPES SIMPLEX VIRUS) FLARE-UP; HOWEVER, TREATMENT WITH VALACYCLOVIR PROVIDED NO RELIEF, AND THE PAIN HAS PROGRESSIVELY WORSENED. SHE ALSO REPORTED DYSPAREUNIA, GREATER ON THE LEFT, AND DESCRIBED HER PELVIC AND VAGINAL PAIN AS BURNING, ACHING, CONSTANT, AND EXACERBATED BY INTERCOURSE, WITH NO ALLEVIATING FACTORS. SHE HAS BEEN TAKING IBUPROFEN WITH NO PAIN RELIEF. THE PATIENT WAS TEARFUL DURING THE VISIT AND EXPRESSED FRUSTRATION REGARDING LIMITED ACCESS TO A PRIMARY CARE APPOINTMENT FOR SEVERAL MONTHS. SHE REQUESTED REMOVAL OF HER BLADDER SLING. REVIEW OF SYSTEMS WAS NOTABLE FOR ABDOMINAL, PELVIC, AND VAGINAL PAIN. LABORATORY STUDIES, URINALYSIS, AND COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WERE ORDERED TO EVALUATE FOR POSSIBLE INTRA-ABDOMINAL PATHOLOGY. THE PAIN HAS PERSISTED FOR APPROXIMATELY SIX MONTHS; HOWEVER, ABDOMINAL EXAMINATION REVEALED A SOFT, NON-TENDER ABDOMEN. THE PATIENT DENIED CONCERN FOR RECENT STI EXPOSURE AND REPORTED NO VAGINAL DISCHARGE OR BLEEDING. DIFFERENTIAL DIAGNOSES INCLUDE INTRA-ABDOMINAL ABSCESS, DYSPAREUNIA, PELVIC FLOOR DYSFUNCTION, URINARY TRACT INFECTION, CYSTITIS, AND SEXUALLY TRANSMITTED INFECTION. PROBLEMS ADDRESSED DURING THIS VISIT INCLUDED LOWER ABDOMINAL AND VAGINAL PAIN. ON (B)(6) 2023, THE PATIENT PRESENTED REQUESTING MESH REMOVAL. EXTERNAL EXAMINATION REVEALED NO ABNORMALITIES TO ACCOUNT FOR HER REPORTED PAIN. INTERNAL EXAMINATION DEMONSTRATED NO TENDERNESS AT THE SLING OR SUPRAPUBIC SITES. HOWEVER, PALPATION OF THE LEFT LEVATOR MUSCLE REPRODUCED AND EXACERBATED HER PAIN, SUGGESTING POSSIBLE LEVATOR SYNDROME. PUDENDAL NEURALGIA REMAINS DIFFICULT TO FULLY EVALUATE AT THIS TIME. A DETAILED DISCUSSION WAS HELD REGARDING THE CLINICAL FINDINGS AND THE TEMPORAL RELATIONSHIP OF SYMPTOM ONSET. ALTHOUGH HER PAIN BEGAN FOLLOWING SLING PLACEMENT, THERE IS NO CLEAR ANATOMIC CORRELATION ON EXAMINATION. THE PATIENT WAS STARTED ON VAGINAL DIAZEPAM (VALIUM) 10 MG WITH FOLLOW-UP SCHEDULED IN TWO WEEKS. SHOULD SYMPTOMS PERSIST, REFERRAL TO PELVIC FLOOR PHYSICAL THERAPY FOR FURTHER EVALUATION AND MANAGEMENT WAS RECOMMENDED. THE PATIENT WAS DIAGNOSED WITH PELVIC PAIN SECONDARY TO LEVATOR SPASM. ON (B)(6) 2023, THE PATIENT PRESENTED FOR FOLLOW-UP EVALUATION OF CHRONIC VAGINAL PAIN. SHE REPORTED VAGINAL DIAZEPAM PROVIDED SOME DEGREE OF MUSCLE RELAXATION BUT DID NOT ALLEVIATE HER SHOOTING OR BURNING PAIN; DESCRIBED AS PERSISTENT "PINS AND NEEDLE" SENSATION RADIATING INTO HER THIGHS AND LEGS. THE PATIENT WAS CRYING THROUGHOUT THE APPOINTMENT. REVIEW OF SYSTEMS REVEALED INCREASED URINARY FREQUENCY AND URGENCY. THE PATIENT'S CHRONIC VAGINAL PAIN IS SUSPECTED TO BE NEUROPATHIC IN ORIGIN BASED ON HER SYMPTOM DESCRIPTION. SHE DID NOT EXPERIENCE RELIEF WITH VAGINAL DIAZEPAM, SO AMITRIPTYLINE WAS INITIATED TO TARGET SUSPECTED NEUROPATHIC PELVIC PAIN. IN ADDITION, A COMPREHENSIVE EVALUATION WITH PELVIC FLOOR PHYSICAL THERAPY WAS RECOMMENDED, WITH CONSIDERATION FOR ADJUNCTIVE TREATMENTS SUCH AS ACUPUNCTURE AND DRY NEEDLING. EXTENSIVE REASSURANCE WAS PROVIDED, AS THE PATIENT WAS TEARFUL AND SEEKING IMMEDIATE RELIEF. SUPPORTIVE MEASURES DISCUSSED INCLUDED THE USE OF A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT AND EXPLORATION OF EMOTIONAL FREEDOM TECHNIQUES (EFT) TAPPING FOR CHRONIC PAIN MANAGEMENT. THE PATIENT WAS TO FOLLOW UP IN 12 WEEKS. ON (B)(6) 2023, THE PATIENT PRESENTED FOR PAINFUL MESH. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE DYSPAREUNIA, DYSURIA, LEFT-SIDED VAGINAL AND LABIAL PAIN, VAGINAL BURNING, AND POOR QUALITY OF LIFE. FURTHERMORE, SHE DEVELOPED SEVERE SHOOTING PAIN IN THE LEFT GROIN, WHICH SHE DESCRIBED AS THE WORST PAIN OF HER LIFE. SHE HAS BEEN EVALUATED BY MULTIPLE UROGYNECOLOGISTS, ALL OF WHOM REPORTED NO ABNORMAL FINDINGS RELATED TO THE SLING ON VAGINAL EXAMINATION. CONSERVATIVE MANAGEMENT, INCLUDING PELVIC FLOOR PHYSICAL THERAPY, AMITRIPTYLINE, AND VAGINAL DIAZEPAM SUPPOSITORIES, HAS BEEN TRIALED WITHOUT IMPROVEMENT. RISKS AND BENEFITS WERE DISCUSSED AND THE PATIENT EXPRESSED UNDERSTANDING AND AGREEMENT WITH THE PLAN TO PROCEED FOR THE SCHEDULE EXCISION OF THE TVT RETROPUBIC SLING, WITH A PREOPERATIVE APPOINTMENT AND PELVIC EXAMINATION TO BE COMPLETED DURING THE SAME WEEK AS THE SCHEDULED SURGICAL DATE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH ONGOING MESH-RELATED COMPLAINTS THAT BEGAN APPROXIMATELY NINE MONTHS PRIOR AND HAVE PERSISTED DAILY WITH MODERATE SEVERITY. SYMPTOMS ARE LOCALIZED TO THE VAGINA AND ARE AGGRAVATED BY INTERCOURSE AND EXERCISE, WHILE PROLONGED IMMERSION IN WATER PROVIDES SOME RELIEF. SHE DESCRIBES THE CONDITION AS CHRONIC AND UNCONTROLLED. THE PATIENT REPORTS VAGINAL PAIN RADIATING TO THE LEFT GROIN, BUTTOCK, AND DOWN THE LEFT LEG, AS WELL AS RIGHT-SIDED GROIN AND BUTTOCK PAIN WITH PALPATION. SHE WAS PREVIOUSLY EVALUATED IN THE EMERGENCY DEPARTMENT IN MAY AND PRESCRIBED AMITRIPTYLINE, WHICH HAS PROVIDED PARTIAL SYMPTOM RELIEF. SHE IS CURRENTLY NOT SEXUALLY ACTIVE BUT REPORTS PRIOR DYSPAREUNIA CHARACTERIZED BY VAGINAL PAIN AND POSTCOITAL THROBBING ON THE LEFT SIDE. SHE HAS COMPLETED THREE MONTHS OF PELVIC FLOOR PHYSICAL THERAPY WITHOUT IMPROVEMENT. ADDITIONAL SYMPTOMS INCLUDE URINARY FREQUENCY, SENSATION OF INCOMPLETE BLADDER EMPTYING, NOCTURIA ONCE NIGHTLY, AND DYSURIA. REVIEW OF SYSTEMS WAS POSITIVE FOR DYSURIA, GAIT DISTURBANCE, MUSCLE WEAKNESS, AND DYSPAREUNIA. PHYSICAL EXAMINATION REVEALED AN ATTENUATED PERINEUM. VAGINAL EXAMINATION DEMONSTRATED PALPABLE TENDER CORDS, LEFT GREATER THAN RIGHT, WITH PAIN NOTED BILATERALLY. THE ADNEXA WERE NON-PALPABLE BILATERALLY. THE PATIENT WAS DIAGNOSED WITH MECHANICAL COMPLICATION OF A PROSTHETIC IMPLANT OF THE GENITAL TRACT, BILATERAL THIGH PAIN, PELVIC AND PERINEAL PAIN, AND DYSPAREUNIA. SURGICAL MESH REMOVAL WAS RECOMMENDED. THE RISKS AND BENEFITS OF SURGERY WERE THOROUGHLY DISCUSSED, AND THE PATIENT EXPRESSED UNDERSTANDING, AND ELECTED TO PROCEED WITH SURGICAL INTERVENTION. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ADVANTAGE SLING REMOVAL, URETHRAL LYSIS, AND REMOVAL OF ABDOMINAL MESH DUE TO PERSISTENT VAGINAL, PELVIC, LEG, AND GROIN PAIN, AS WELL AS PAIN DURING COITUS PLUS URINARY STRICTURE. THE SURGERY REVEALED THAT BOTH SLING ARMS WERE DEEPLY ADHERENT TO THE PUBIC BONES AND EMBEDDED WITHIN THE OBTURATOR MUSCLES, MAKING REMOVAL CHALLENGING. THE MESH WAS LOCATED IN THE URETHRAL WALL AND WAS CAREFULLY INCISED AND DISSECTED LATERALLY. URETHRAL LYSIS WAS PERFORMED TO RELEASE THE URETHRA FROM SURROUNDING SCAR TISSUE. THE ABDOMINAL MESH COMPONENTS WERE ACCESSED VIA A TRANSVERSE INCISION, AND BOTH RIGHT AND LEFT MESH ARMS WERE FREED FROM THE FASCIA AND RECTUS MUSCLES. THE RETROPUBIC SPACE WAS OPENED TO VISUALIZE AND DETACH THE MESH FROM THE PUBIC BONES AND OBTURATOR MUSCLES. AFTER COMPLETE REMOVAL OF THE SLING ARMS, THE SURGICAL SITE WAS IRRIGATED, AND THE RECTUS MUSCLES, FASCIA, AND SKIN WERE CLOSED APPROPRIATELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN EXCELLENT CONDITION. ON (B)(6) 2024, THE PATIENT PRESENTED WITH COMPLAINTS OF DEEP INTERNAL PELVIC PAIN PRIMARILY INVOLVING THE LEFT OBTURATOR INTERNUS, COCCYX, AND LEVATOR ANI MUSCLES, AS WELL AS INTERMITTENT BURNING PAIN OF THE LEFT LABIA. SHE REPORTS HAVING BEEN TOLD SHE HAS PELVIC FLOOR TRIGGER POINTS AND SIGNIFICANT MUSCLE TIGHTNESS. SYMPTOMS BEGAN APPROXIMATELY SIX WEEKS AFTER MESH PLACEMENT FOR STRESS URINARY INCONTINENCE ON (B)(6) 2023, FOLLOWING SEXUAL INTERCOURSE. SHE ATTRIBUTES THE ONSET OF HER SYMPTOMS TO THE PELVIC SURGERY. THE MESH WAS SUBSEQUENTLY REMOVED ON (B)(6) 2024. SINCE REMOVAL, SHE HAS PARTICIPATED IN FREQUENT PELVIC FLOOR PHYSICAL THERAPY AND REPORTS SLOW, GRADUAL IMPROVEMENT. SHE HAS BEEN EXPERIENCING PAIN RATED AT 6/10, DESCRIBED AS DULL, BURNING, AND CONSTANT. PAIN WAS LOCALIZED TO THE PERINEUM AND LEFT INTERNAL VAGINAL REGION (NOTED AT APPROXIMATELY THE 1-2 O'CLOCK POSITION), WITH WORSENING DURING INTERCOURSE. SITTING, VIGOROUS ACTIVITY, AND SEXUAL ACTIVITY EXACERBATED HER SYMPTOMS, WHILE HEAT, REST, AND MASSAGE PROVIDED RELIEF. SHE DENIED CURRENT ACTIVITY RESTRICTIONS BUT REPORTED INCONSISTENT EXERCISE, PRIMARILY WALKING AND YIN YOGA. HER CURRENT STRESS LEVEL HAS BEEN REPORTED AS LOW. RELEVANT PELVIC AND REPRODUCTIVE HISTORY INCLUDES PELVIC PAIN AND A HISTORY OF SEXUALLY TRANSMITTED INFECTION. ORTHOPEDIC HISTORY WAS NOTABLE FOR LOW BACK PAIN AND PELVIC PAIN WHILE GASTROINTESTINAL REVIEW WAS POSITIVE FOR CONSTIPATION.
IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. 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.
IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE ON (B)(6) 2023, TO TREAT URINARY STRESS INCONTINENCE. THE SLING WAS POSITIONED TENSION-FREE, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS NOTED. HOWEVER, THE PATIENT HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. 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. ON (B)(6) 2023, THE PATIENT PRESENTED WITH PERSISTENT GROIN PAIN, MORE PRONOUNCED ON THE LEFT SIDE, WITH INTERMITTENT FLARES SINCE (B)(6). SHE HAD PREVIOUSLY BEEN DIAGNOSED WITH A YEAST INFECTION; HOWEVER, HER SYMPTOMS DID NOT IMPROVE. PRIOR TO THAT, SHE HAD SEEN HER PHYSICIAN IN (B)(6), WHO BELIEVED HER PAIN WAS DUE TO A HSV (HERPES SIMPLEX VIRUS) FLARE-UP; HOWEVER, TREATMENT WITH VALACYCLOVIR PROVIDED NO RELIEF, AND THE PAIN HAS PROGRESSIVELY WORSENED. SHE ALSO REPORTED DYSPAREUNIA, GREATER ON THE LEFT, AND DESCRIBED HER PELVIC AND VAGINAL PAIN AS BURNING, ACHING, CONSTANT, AND EXACERBATED BY INTERCOURSE, WITH NO ALLEVIATING FACTORS. SHE HAS BEEN TAKING IBUPROFEN WITH NO PAIN RELIEF. THE PATIENT WAS TEARFUL DURING THE VISIT AND EXPRESSED FRUSTRATION REGARDING LIMITED ACCESS TO A PRIMARY CARE APPOINTMENT FOR SEVERAL MONTHS. SHE REQUESTED REMOVAL OF HER BLADDER SLING. REVIEW OF SYSTEMS WAS NOTABLE FOR ABDOMINAL, PELVIC, AND VAGINAL PAIN. LABORATORY STUDIES, URINALYSIS, AND COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WERE ORDERED TO EVALUATE FOR POSSIBLE INTRA-ABDOMINAL PATHOLOGY. THE PAIN HAS PERSISTED FOR APPROXIMATELY SIX MONTHS; HOWEVER, ABDOMINAL EXAMINATION REVEALED A SOFT, NON-TENDER ABDOMEN. THE PATIENT DENIED CONCERN FOR RECENT STI EXPOSURE AND REPORTED NO VAGINAL DISCHARGE OR BLEEDING. DIFFERENTIAL DIAGNOSES INCLUDE INTRA-ABDOMINAL ABSCESS, DYSPAREUNIA, PELVIC FLOOR DYSFUNCTION, URINARY TRACT INFECTION, CYSTITIS, AND SEXUALLY TRANSMITTED INFECTION. PROBLEMS ADDRESSED DURING THIS VISIT INCLUDED LOWER ABDOMINAL AND VAGINAL PAIN. ON (B)(6) 2023, THE PATIENT PRESENTED REQUESTING MESH REMOVAL. EXTERNAL EXAMINATION REVEALED NO ABNORMALITIES TO ACCOUNT FOR HER REPORTED PAIN. INTERNAL EXAMINATION DEMONSTRATED NO TENDERNESS AT THE SLING OR SUPRAPUBIC SITES. HOWEVER, PALPATION OF THE LEFT LEVATOR MUSCLE REPRODUCED AND EXACERBATED HER PAIN, SUGGESTING POSSIBLE LEVATOR SYNDROME. PUDENDAL NEURALGIA REMAINS DIFFICULT TO FULLY EVALUATE AT THIS TIME. A DETAILED DISCUSSION WAS HELD REGARDING THE CLINICAL FINDINGS AND THE TEMPORAL RELATIONSHIP OF SYMPTOM ONSET. ALTHOUGH HER PAIN BEGAN FOLLOWING SLING PLACEMENT, THERE IS NO CLEAR ANATOMIC CORRELATION ON EXAMINATION. THE PATIENT WAS STARTED ON VAGINAL DIAZEPAM (VALIUM) 10 MG WITH FOLLOW-UP SCHEDULED IN TWO WEEKS. SHOULD SYMPTOMS PERSIST, REFERRAL TO PELVIC FLOOR PHYSICAL THERAPY FOR FURTHER EVALUATION AND MANAGEMENT WAS RECOMMENDED. THE PATIENT WAS DIAGNOSED WITH PELVIC PAIN SECONDARY TO LEVATOR SPASM. ON (B)(6) 2023, THE PATIENT PRESENTED FOR FOLLOW-UP EVALUATION OF CHRONIC VAGINAL PAIN. SHE REPORTED VAGINAL DIAZEPAM PROVIDED SOME DEGREE OF MUSCLE RELAXATION BUT DID NOT ALLEVIATE HER SHOOTING OR BURNING PAIN; DESCRIBED AS PERSISTENT "PINS AND NEEDLE" SENSATION RADIATING INTO HER THIGHS AND LEGS. THE PATIENT WAS CRYING THROUGHOUT THE APPOINTMENT. REVIEW OF SYSTEMS REVEALED INCREASED URINARY FREQUENCY AND URGENCY. THE PATIENT'S CHRONIC VAGINAL PAIN IS SUSPECTED TO BE NEUROPATHIC IN ORIGIN BASED ON HER SYMPTOM DESCRIPTION. SHE DID NOT EXPERIENCE RELIEF WITH VAGINAL DIAZEPAM, SO AMITRIPTYLINE WAS INITIATED TO TARGET SUSPECTED NEUROPATHIC PELVIC PAIN. IN ADDITION, A COMPREHENSIVE EVALUATION WITH PELVIC FLOOR PHYSICAL THERAPY WAS RECOMMENDED, WITH CONSIDERATION FOR ADJUNCTIVE TREATMENTS SUCH AS ACUPUNCTURE AND DRY NEEDLING. EXTENSIVE REASSURANCE WAS PROVIDED, AS THE PATIENT WAS TEARFUL AND SEEKING IMMEDIATE RELIEF. SUPPORTIVE MEASURES DISCUSSED INCLUDED THE USE OF A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT AND EXPLORATION OF EMOTIONAL FREEDOM TECHNIQUES (EFT) TAPPING FOR CHRONIC PAIN MANAGEMENT. THE PATIENT WAS TO FOLLOW UP IN 12 WEEKS. ON (B)(6) 2023, THE PATIENT PRESENTED FOR PAINFUL MESH. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE DYSPAREUNIA, DYSURIA, LEFT-SIDED VAGINAL AND LABIAL PAIN, VAGINAL BURNING, AND POOR QUALITY OF LIFE. FURTHERMORE, SHE DEVELOPED SEVERE SHOOTING PAIN IN THE LEFT GROIN, WHICH SHE DESCRIBED AS THE WORST PAIN OF HER LIFE. SHE HAS BEEN EVALUATED BY MULTIPLE UROGYNECOLOGISTS, ALL OF WHOM REPORTED NO ABNORMAL FINDINGS RELATED TO THE SLING ON VAGINAL EXAMINATION. CONSERVATIVE MANAGEMENT, INCLUDING PELVIC FLOOR PHYSICAL THERAPY, AMITRIPTYLINE, AND VAGINAL DIAZEPAM SUPPOSITORIES, HAS BEEN TRIALED WITHOUT IMPROVEMENT. RISKS AND BENEFITS WERE DISCUSSED AND THE PATIENT EXPRESSED UNDERSTANDING AND AGREEMENT WITH THE PLAN TO PROCEED FOR THE SCHEDULE EXCISION OF THE TVT RETROPUBIC SLING, WITH A PREOPERATIVE APPOINTMENT AND PELVIC EXAMINATION TO BE COMPLETED DURING THE SAME WEEK AS THE SCHEDULED SURGICAL DATE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH ONGOING MESH-RELATED COMPLAINTS THAT BEGAN APPROXIMATELY NINE MONTHS PRIOR AND HAVE PERSISTED DAILY WITH MODERATE SEVERITY. SYMPTOMS ARE LOCALIZED TO THE VAGINA AND ARE AGGRAVATED BY INTERCOURSE AND EXERCISE, WHILE PROLONGED IMMERSION IN WATER PROVIDES SOME RELIEF. SHE DESCRIBES THE CONDITION AS CHRONIC AND UNCONTROLLED. THE PATIENT REPORTS VAGINAL PAIN RADIATING TO THE LEFT GROIN, BUTTOCK, AND DOWN THE LEFT LEG, AS WELL AS RIGHT-SIDED GROIN AND BUTTOCK PAIN WITH PALPATION. SHE WAS PREVIOUSLY EVALUATED IN THE EMERGENCY DEPARTMENT IN MAY AND PRESCRIBED AMITRIPTYLINE, WHICH HAS PROVIDED PARTIAL SYMPTOM RELIEF. SHE IS CURRENTLY NOT SEXUALLY ACTIVE BUT REPORTS PRIOR DYSPAREUNIA CHARACTERIZED BY VAGINAL PAIN AND POSTCOITAL THROBBING ON THE LEFT SIDE. SHE HAS COMPLETED THREE MONTHS OF PELVIC FLOOR PHYSICAL THERAPY WITHOUT IMPROVEMENT. ADDITIONAL SYMPTOMS INCLUDE URINARY FREQUENCY, SENSATION OF INCOMPLETE BLADDER EMPTYING, NOCTURIA ONCE NIGHTLY, AND DYSURIA. REVIEW OF SYSTEMS WAS POSITIVE FOR DYSURIA, GAIT DISTURBANCE, MUSCLE WEAKNESS, AND DYSPAREUNIA. PHYSICAL EXAMINATION REVEALED AN ATTENUATED PERINEUM. VAGINAL EXAMINATION DEMONSTRATED PALPABLE TENDER CORDS, LEFT GREATER THAN RIGHT, WITH PAIN NOTED BILATERALLY. THE ADNEXA WERE NON-PALPABLE BILATERALLY. THE PATIENT WAS DIAGNOSED WITH MECHANICAL COMPLICATION OF A PROSTHETIC IMPLANT OF THE GENITAL TRACT, BILATERAL THIGH PAIN, PELVIC AND PERINEAL PAIN, AND DYSPAREUNIA. SURGICAL MESH REMOVAL WAS RECOMMENDED. THE RISKS AND BENEFITS OF SURGERY WERE THOROUGHLY DISCUSSED, AND THE PATIENT EXPRESSED UNDERSTANDING, AND ELECTED TO PROCEED WITH SURGICAL INTERVENTION. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ADVANTAGE SLING REMOVAL, URETHRAL LYSIS, AND REMOVAL OF ABDOMINAL MESH DUE TO PERSISTENT VAGINAL, PELVIC, LEG, AND GROIN PAIN, AS WELL AS PAIN DURING COITUS PLUS URINARY STRICTURE. THE SURGERY REVEALED THAT BOTH SLING ARMS WERE DEEPLY ADHERENT TO THE PUBIC BONES AND EMBEDDED WITHIN THE OBTURATOR MUSCLES, MAKING REMOVAL CHALLENGING. THE MESH WAS LOCATED IN THE URETHRAL WALL AND WAS CAREFULLY INCISED AND DISSECTED LATERALLY. URETHRAL LYSIS WAS PERFORMED TO RELEASE THE URETHRA FROM SURROUNDING SCAR TISSUE. THE ABDOMINAL MESH COMPONENTS WERE ACCESSED VIA A TRANSVERSE INCISION, AND BOTH RIGHT AND LEFT MESH ARMS WERE FREED FROM THE FASCIA AND RECTUS MUSCLES. THE RETROPUBIC SPACE WAS OPENED TO VISUALIZE AND DETACH THE MESH FROM THE PUBIC BONES AND OBTURATOR MUSCLES. AFTER COMPLETE REMOVAL OF THE SLING ARMS, THE SURGICAL SITE WAS IRRIGATED, AND THE RECTUS MUSCLES, FASCIA, AND SKIN WERE CLOSED APPROPRIATELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN EXCELLENT CONDITION. ON (B)(6) 2024, THE PATIENT PRESENTED WITH COMPLAINTS OF DEEP INTERNAL PELVIC PAIN PRIMARILY INVOLVING THE LEFT OBTURATOR INTERNUS, COCCYX, AND LEVATOR ANI MUSCLES, AS WELL AS INTERMITTENT BURNING PAIN OF THE LEFT LABIA. SHE REPORTS HAVING BEEN TOLD SHE HAS PELVIC FLOOR TRIGGER POINTS AND SIGNIFICANT MUSCLE TIGHTNESS. SYMPTOMS BEGAN APPROXIMATELY SIX WEEKS AFTER MESH PLACEMENT FOR STRESS URINARY INCONTINENCE ON (B)(6) 2023, FOLLOWING SEXUAL INTERCOURSE. SHE ATTRIBUTES THE ONSET OF HER SYMPTOMS TO THE PELVIC SURGERY. THE MESH WAS SUBSEQUENTLY REMOVED ON (B)(6) 2024. SINCE REMOVAL, SHE HAS PARTICIPATED IN FREQUENT PELVIC FLOOR PHYSICAL THERAPY AND REPORTS SLOW, GRADUAL IMPROVEMENT. SHE HAS BEEN EXPERIENCING PAIN RATED AT 6/10, DESCRIBED AS DULL, BURNING, AND CONSTANT. PAIN WAS LOCALIZED TO THE PERINEUM AND LEFT INTERNAL VAGINAL REGION (NOTED AT APPROXIMATELY THE 1-2 O'CLOCK POSITION), WITH WORSENING DURING INTERCOURSE. SITTING, VIGOROUS ACTIVITY, AND SEXUAL ACTIVITY EXACERBATED HER SYMPTOMS, WHILE HEAT, REST, AND MASSAGE PROVIDED RELIEF. SHE DENIED CURRENT ACTIVITY RESTRICTIONS BUT REPORTED INCONSISTENT EXERCISE, PRIMARILY WALKING AND YIN YOGA. HER CURRENT STRESS LEVEL HAS BEEN REPORTED AS LOW. RELEVANT PELVIC AND REPRODUCTIVE HISTORY INCLUDES PELVIC PAIN AND A HISTORY OF SEXUALLY TRANSMITTED INFECTION. ORTHOPEDIC HISTORY WAS NOTABLE FOR LOW BACK PAIN AND PELVIC PAIN WHILE GASTROINTESTINAL REVIEW WAS POSITIVE FOR CONSTIPATION.
IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. 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. ON NOVEMBER 15, 2023, THE PATIENT UNDERWENT AN ADVANTAGE SLING REMOVAL, URETHRAL LYSIS, AND REMOVAL OF ABDOMINAL MESH DUE TO PERSISTENT VAGINAL, PELVIC, LEG, AND GROIN PAIN, AS WELL AS PAIN DURING COITUS PLUS URINARY STRICTURE. THE SURGERY REVEALED THAT BOTH SLING ARMS WERE DEEPLY ADHERENT TO THE PUBIC BONES AND EMBEDDED WITHIN THE OBTURATOR MUSCLES, MAKING REMOVAL CHALLENGING. THE MESH WAS LOCATED IN THE URETHRAL WALL AND WAS CAREFULLY INCISED AND DISSECTED LATERALLY. URETHRAL LYSIS WAS PERFORMED TO RELEASE THE URETHRA FROM SURROUNDING SCAR TISSUE. THE ABDOMINAL MESH COMPONENTS WERE ACCESSED VIA A TRANSVERSE INCISION, AND BOTH RIGHT AND LEFT MESH ARMS WERE FREED FROM THE FASCIA AND RECTUS MUSCLES. THE RETROPUBIC SPACE WAS OPENED TO VISUALIZE AND DETACH THE MESH FROM THE PUBIC BONES AND OBTURATOR MUSCLES. AFTER COMPLETE REMOVAL OF THE SLING ARMS, THE SURGICAL SITE WAS IRRIGATED, AND THE RECTUS MUSCLES, FASCIA, AND SKIN WERE CLOSED APPROPRIATELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN EXCELLENT CONDITION.
IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE ON (B)(6) 2023, TO TREAT URINARY STRESS INCONTINENCE. THE SLING WAS POSITIONED TENSION-FREE, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS NOTED. HOWEVER, THE PATIENT HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. 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. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ADVANTAGE SLING REMOVAL, URETHRAL LYSIS, AND REMOVAL OF ABDOMINAL MESH DUE TO PERSISTENT VAGINAL, PELVIC, LEG, AND GROIN PAIN, AS WELL AS PAIN DURING COITUS PLUS URINARY STRICTURE. THE SURGERY REVEALED THAT BOTH SLING ARMS WERE DEEPLY ADHERENT TO THE PUBIC BONES AND EMBEDDED WITHIN THE OBTURATOR MUSCLES, MAKING REMOVAL CHALLENGING. THE MESH WAS LOCATED IN THE URETHRAL WALL AND WAS CAREFULLY INCISED AND DISSECTED LATERALLY. URETHRAL LYSIS WAS PERFORMED TO RELEASE THE URETHRA FROM SURROUNDING SCAR TISSUE. THE ABDOMINAL MESH COMPONENTS WERE ACCESSED VIA A TRANSVERSE INCISION, AND BOTH RIGHT AND LEFT MESH ARMS WERE FREED FROM THE FASCIA AND RECTUS MUSCLES. THE RETROPUBIC SPACE WAS OPENED TO VISUALIZE AND DETACH THE MESH FROM THE PUBIC BONES AND OBTURATOR MUSCLES. AFTER COMPLETE REMOVAL OF THE SLING ARMS, THE SURGICAL SITE WAS IRRIGATED, AND THE RECTUS MUSCLES, FASCIA, AND SKIN WERE CLOSED APPROPRIATELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN EXCELLENT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618863 | ADVANTAGE FIT? BLUE SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | BOSTON SCIENTIFIC CORPORATION | M0068502120 | 0029825358 | 08714729961925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |