UPSYLON
Report
- Report Number
- 3005099803-2022-05817
- Event Type
- Injury
- Date Received
- October 11, 2022
- Date of Event
- March 9, 2015
- Report Date
- March 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTO
- UDI-DI
- 08714729839217
- PMA / PMN Number
- K122794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2015, THE DATE THE SLING WAS IMPLANTED, AS NO EVENT DATE WAS REPORTED. ALTHOUGH THE REPORTED UPN NUMBER (B)(4) AND LOT NUMBER C0024909 WAS NOT FOUND IN THE SYSTEM SEARCH, THE MOST PROBABLE UPN NUMBER AND LOT NUMBER BASED ON WHAT WAS REPORTED WERE M0068318200 AND C002409, RESPECTIVELY. HENCE, THESE WERE USED IN PROCESSING THE COMPLAINT. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE. THE IMPLANT SURGEON IS: (B)(6). OTHER ATTORNEYS AND LAWFIRM: (B)(6). (B)(4).
BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2015, THE DATE THE SLING WAS IMPLANTED, AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: ALTHOUGH THE REPORTED UPN NUMBER M006831820 AND LOT NUMBER C0024909 WAS NOT FOUND IN THE SYSTEM SEARCH, THE MOST PROBABLE UPN NUMBER AND LOT NUMBER BASED ON WHAT WAS REPORTED WERE M0068318200 AND C002409, RESPECTIVELY. HENCE, THESE WERE USED IN PROCESSING THE COMPLAINT. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE. THE IMPLANT SURGEON IS: (B)(6). OTHER ATTORNEYS AND LAWFIRM: (B)(6). BLOCK H6: PATIENT CODES E2006, E2330, E1405, E1906, E1715, E1311, E0206 AND E2401 CAPTURE THE REPORTABLE EVENTS OF EROSION, PAIN (CHRONIC PAIN, PHYSICAL PAIN), DYSPAREUNIA, UNSPECIFIED INFECTION (INFECTIONS), SCAR TISSUE, UNSPECIFIED KIDNEY OR URINARY PROBLEM (URINARY DYSFUNCTION), UNSPECIFIED MENTAL, EMOTIONAL OR BEHAVIOURAL PROBLEM (MENTAL ANGUISH), AND INJURY, NOT OTHERWISE SPECIFIED (PHYSICAL IMPAIRMENT), RESPECTIVELY. IMPACT CODE F1905 CAPTURES THE REPORTABLE EVENT OF DEVICE REVISION OR REPLACEMENT (REVISION SURGERIES). BLOCK H11: BLOCKS A2, A4, B5, B7, D6B, H6 AND H10 WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 3, 2022. BLOCK H6: PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. PATIENT CODE E2402 CAPTURES THE REPORTABLE EVENT OF DISTENTION. IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMPACT CODE F1903 CAPTURES THE REPORTABLE EVENT OF DEVICE EXPLANTAION PROCEDURE ON (B)(6) 2021. IMPACT CODE F12 HAS BEEN USED IN THE LIGHT OF THE PATIENT SOUGHT LEGAL RECOURSE FOR A PERSONAL INJURY RELATED TO THE DEVICE.
BLOCKS B5 AND E1 (HEALTHCARE FACILITY ADDRESS) WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 16, 2023. BLOCK H11: BLOCK A2 DATE OF BIRTH HAS BEEN CORRECTED. BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO MARCH 09, 2015, THE DATE THE SLING WAS IMPLANTED, AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: ALTHOUGH THE REPORTED UPN NUMBER M006831820 AND LOT NUMBER C0024909 WAS NOT FOUND IN THE SYSTEM SEARCH, THE MOST PROBABLE UPN NUMBER AND LOT NUMBER BASED ON WHAT WAS REPORTED WERE M0068318200 AND C002409, RESPECTIVELY. HENCE, THESE WERE USED IN PROCESSING THE COMPLAINT. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE. THE IMPLANT SURGEON IS: (B)(6). OTHER ATTORNEYS AND LAWFIRM: (B)(6). BLOCK H6: IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF EROSION. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF PAIN (CHRONIC PAIN, PHYSICAL PAIN). IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF DYSPAREUNIA. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION (INFECTIONS). IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF SCAR TISSUE. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED KIDNEY OR URINARY PROBLEM (URINARY DYSFUNCTION). IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED MENTAL, EMOTIONAL OR BEHAVIOURAL PROBLEM (MENTAL ANGUISH). IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF INJURY, NOT OTHERWISE SPECIFIED (PHYSICAL IMPAIRMENT). IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF DISTENTION. IMDRF IMPACT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF DEVICE EXPLANTATION PROCEDURE ON (B)(6) 2021. IMDRF IMPACT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF DEVICE REVISION OR REPLACEMENT (REVISION SURGERIES). IMDRF IMPACT CODE (B)(6) HAS BEEN USED IN THE LIGHT OF THE PATIENT SOUGHT LEGAL RECOURSE FOR A PERSONAL INJURY RELATED TO THE DEVICE. IMDRF IMPACT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. THE PATIENT EXPERIENCED EROSION, DYSPAREUNIA, CHRONIC PAIN, URINARY DYSFUNCTION, INFECTIONS, REVISION SURGERIES, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT HAD PHYSICAL PAIN, MENTAL ANGUISH AND PHYSICAL IMPAIRMENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. THE PATIENT EXPERIENCED EROSION, DYSPAREUNIA, CHRONIC PAIN, URINARY DYSFUNCTION, INFECTIONS, REVISION SURGERIES, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT HAD PHYSICAL PAIN, MENTAL ANGUISH AND PHYSICAL IMPAIRMENT. ***ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 3, 2022*** ON (B)(6) 2015, THE PATIENT UNDERWENT AN ABDOMINAL SACRAL COLPOPEXY WITH CYSTOSCOPY AND TOTAL ABDOMINAL HYSTERECTOMY FOR TREATMENT DYSFUNCTIONAL UTERINE BLEEDING, VAGINAL PROLAPSE, AND ABDOMINAL AND PELVIC PAIN. ON (B)(6) 2020, THE PATIENT WAS REFERRED DUE TO PELVIC DISCOMFORT AND FEELING OF BLADDER DISTENTION AND INCOMPLETE BLADDER EMPTYING. THE PATIENT COMPLETED THE DETAILED PELVIC FLOOR QUESTIONNAIRE. THERE WAS NO VAGINAL BLEEDING NOTED. UPON EXAMINATION, IT WAS NOTED THAT THE URETHRA WAS HYPERMOBILE AND ATROPHIC. IT WAS ALSO NOTED THAT THE PATIENT HAD A VAGINAL MESH AND SUTURE EROSION AT THE APEX. IT WAS NOTED TO BE TENDER AND THE EXAMINATION CAUSED BLEEDING. A SMALL GRADE 1-2 RECTOCELE WAS ALSO NOTED. THE PATIENT ALSO HAD AN UMBILICAL HERNIA. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT HAD A SUBSEQUENT ENCOUNTER OF AN EROSION OF THE IMPLANTED URETHRAL MESH TO SURROUNDING ORGAN OR TISSUE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED PELVIC AND PERINEAL PAIN. THE PATIENT ALSO EXPERIENCED POSTMENOPAUSAL ATROPHIC VAGINITIS. THE PATIENT WAS SCHEDULED FOR A CYSTOSCOPY PROCEDURE AND AN EXCISION OF THE MESH WAS CONSIDERED IF SYMPTOMATIC. ON (B)(6) 2020, THE PATIENT WAS SEEN FOR A CYSTOSCOPY PROCEDURE DUE TO HER LOWER URINARY TRACT SYMPTOMS INCLUDING SENSATION OF INCOMPLETE BLADDER EMPTYING AND MESH EROSION. THE PROCEDURE WAS EXPLAINED TO PATIENT AND INFORMED CONSENT WAS SIGNED. TIMEOUT WAS DONE VERBALLY AND PATIENT AGREED TO PROCEED WITH CYSTOSCOPY. THERE WAS NO EVIDENCE OF ACTIVE URINARY TRACT INFECTION AT THIS TIME. THE PATIENT WAS INSTRUCTED TO INCREASE FLUID INTAKE AFTER THE TEST AND VOID MORE FREQUENTLY TO AVOID RISK OF URINARY TRACT INFECTION (UTI). UTI PRECAUTIONS WERE REVIEWED WITH THE PATIENT. SHE UNDERWENT CYSTOSCOPIC EVALUATION AFTER LOCAL BETADINE PREPARATION AND TOPICAL APPLICATION OF 2% LIDOCAINE GEL. USING RIGID 70 AND 0 DEGREE CYSTOSCOPES SEQUENTIALLY AND RETROGRADELY FILLING THE BLADDER WITH 200 CC NORMAL SALINE, THE FOLLOWING FINDINGS WERE NOTED. THE PATIENT'S URETHRA HAS NORMAL PINK MUCOSA WITH NO DISCRETE LESIONS NOTED. URETHROVESICAL JUNCTION (UV) HAS ADEQUATE COAPTATION. NO DISCRETE LESIONS WERE NOTED. THE TRIGONE REVEALED METAPLASIA PRESENT. THE URETERAL ORIFICES WERE VISUALIZED AND APPEARED PATENT BILATERALLY. THE BLADDER REVEALED NO SUSPICIOUS LESIONS, STONES, OR FOREIGN BODIES IDENTIFIED. BASE AND SIDEWALLS WITH HYPERVASCULARITY. URETERAL ORIFICES APPEARED NORMAL BILATERALLY AND NO MESH IN THE BLADDER NOTED. IN THE PHYSICIAN'S ASSESSMENT, HE WAS CONSIDERING PROLAPSE REPAIR AND REMOVAL OF SUTURE OR MESH. ON (B)(6) 2021, THE PATIENT WAS SCHEDULED FOR EXCISION OF VAGINAL MESH, ANTERIOR COLPORRHAPHY, VAGINAL PARAVAGINAL REPAIR, INSERTION OF BIOLOGIC GRAFT- AXIS DERMIS AND CYSTOURETHROSCOPY PROCEDURES DUE TO MESH EROSION AND RECURRENT CYSTOCELE. DURING THE PROCEDURE, THE PATIENT WAS TAKEN TO OPERATING ROOM WHERE SHE WAS IDENTIFIED AND GIVEN GENERAL ENDOTRACHEAL ANESTHESIA. A TIMEOUT WAS TAKEN AND THE PROCEDURE WAS AGREED UPON. THE PATIENT WAS PLACED IN THE DORSAL LITHOTOMY POSITION. IN THE DORSAL LITHOTOMY POSITION, THE PHYSICIAN TOOK EXTRA CARE TO AVOID ANY EXCESSIVE TENSION OR PRESSURE ON THE PERINEAL NERVES. THE LOWER ABDOMEN, PERINEUM AND VAGINA WERE STERILELY PREPPED AND DOUBLY DRAPED USING THE DOUBLE DRAPE TECHNIQUE. A FOLEY CATHETER WAS INSERTED TO DRAIN THE BLADDER DURING THE CASE. RETRACTING SUTURES TO THE LABIA WAS PLACED FOR BETTER EXPOSURE. THESE SUTURES WERE REMOVED AT THE END OF THE CASE. THE VAGINAL EPITHELIUM SURROUNDING THE MESH WAS EXCISED AFTER INJECTION OF 5 CC OF 0.25% MARCAINE WITH EPINEPHRINE. AFTER ADEQUATE FLAP WAS OBTAINED, THE MESH WAS GRASPED AND EXCISED USING SHARP AND BLUNT TECHNIQUE. THE EXCISED MESH WAS SENT TO PATHOLOGY. IRRIGATION WITH NORMAL SALINE WAS DONE AND GOOD HEMOSTASIS WAS OBTAINED. VAGINAL EPITHELIUM WAS CLOSED USING #2-0 VICRYL SUTURE IN INTERRUPTED FASHION. A 70-DEGREE CYSTOURETHROSCOPE WAS INSERTED AND THE BLADDER WAS RETROGRADELY FILLED WITH 200 CC OF NORMAL SALINE. COMPLETE INTRAVESICAL SURVEY INCLUDING ALL THE BLADDER EDGES WERE PERFORMED IN A SYSTEMATIC WAY. BLADDER AND URETHRA APPEARED TO BE INTACT AND EFFLUX OF URINE FROM BOTH URETERAL ORIFICES WITH GOOD FLOW NOTED. THE PROCEDURE CONTINUED BY PLACING MARKING SUTURE AT THE APEX OF THE VAGINA, WHERE THE SACROSPINOUS SUTURES WILL BE PLACED LATER. A VERTICAL INCISION WAS MADE FROM THE APEX AFTER INJECTION OF MARCAINE WITH EPINEPHRINE. THE VAGINAL EPITHELIUM WAS DISSECTED OFF FROM BLADDER SHARPLY AND BLUNTLY ALL THE WAY TO THE PELVIC SIDE WALLS WHERE THE PHYSICIANS WERE ABLE TO IDENTIFY ARCUS TENDINUOUS FASCIA PELVIS AND SACROSPINOUS LIGAMENTS. ANTERIOR REPAIR WAS DONE USING SERIES OF #2-0 VICRYL SUTURES. THE ENTEROCELE WAS REDUCED IN A SIMILAR FASHION USING PURSE STRING SUTURES OF VICRYL. USING CAPIO SELF-RETRIEVING DEVICE, 3 SUTURES OF PDS WERE PASSED THROUGH THE ATFP ON EACH SIDE APPROXIMATELY 1 CM APART. SUTURE OF PDS WERE PASSED 1 CM MEDIAL TO ISCHIAL SPINE AND THEN SECOND SUTURE AT 1 CM MORE MEDIAL TO THE FIRST SUTURE. THESE SUTURES WE PASSED THROUGH A TAILORED PIECE OF TAILORED AXIS DERMIS THAT WAS TRAPEZOID SHAPE TO MATCH THE PATIENT'S ANATOMY. THEN USING FREE MAYO NEEDLE THEY WERE PASSED THROUGH VAGINAL MUSCULARIS. CYSTOURETHROSCOPY WAS DONE AGAIN AND EFFLUX OF URINE WAS NOTED FROM BOTH URETERAL ORIFICES. THERE WAS NO EVIDENCE OF SUTURE OR ANY DAMAGE TO THE BLADDER. VAGINAL EPITHELIUM WAS CLOSED AND USING #2-0 VICRYL IN AN INTERRUPTED FASHION. THE SUSPENSION SUTURES THEN WERE TIED WITH EXCELLENT SUPPORT OBTAINED. FINDINGS INCLUDE A 2 X 2 CM VAGINAL MESH AND ETHIBOND SUTURE EROSION AT APEX. THE INTRAVESICAL CAVITY WAS INTACT WITH EFFLUX OF URINE FROM BOTH URETERAL ORIFICES. RECTAL EXAMINATION INTACT AT THE END OF THE CASE. THE SPECIMEN WAS RECEIVED IN FORMALIN LABELED WITH THE PATIENT'S NAME AND "VAGINAL MESH." IT CONSISTS OF A 1.5 X 1.5 X 0.5 CM PORTION OF MESH-LIKE MATERIAL WITH GREEN SURGICAL SUTURES. THERE WAS ATTACHED CAUTERIZED SOFT TISSUE. NO SECTIONS WERE SUBMITTED. THE SPECIMEN WAS FOR GROSS EXAMINATION ONLY.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. THE PATIENT EXPERIENCED EROSION, DYSPAREUNIA, CHRONIC PAIN, URINARY DYSFUNCTION, INFECTIONS, REVISION SURGERIES, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT HAD PHYSICAL PAIN, MENTAL ANGUISH AND PHYSICAL IMPAIRMENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 3, 2022. ON (B)(6) 2015, THE PATIENT UNDERWENT AN ABDOMINAL SACRAL COLPOPEXY WITH CYSTOSCOPY AND TOTAL ABDOMINAL HYSTERECTOMY FOR TREATMENT DYSFUNCTIONAL UTERINE BLEEDING, VAGINAL PROLAPSE, AND ABDOMINAL AND PELVIC PAIN. ON (B)(6) 2020, THE PATIENT WAS REFERRED DUE TO PELVIC DISCOMFORT AND FEELING OF BLADDER DISTENTION AND INCOMPLETE BLADDER EMPTYING. THE PATIENT COMPLETED THE DETAILED PELVIC FLOOR QUESTIONNAIRE. THERE WAS NO VAGINAL BLEEDING NOTED. UPON EXAMINATION, IT WAS NOTED THAT THE URETHRA WAS HYPERMOBILE AND ATROPHIC. IT WAS ALSO NOTED THAT THE PATIENT HAD A VAGINAL MESH AND SUTURE EROSION AT THE APEX. IT WAS NOTED TO BE TENDER AND THE EXAMINATION CAUSED BLEEDING. A SMALL GRADE 1-2 RECTOCELE WAS ALSO NOTED. THE PATIENT ALSO HAD AN UMBILICAL HERNIA. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT HAD A SUBSEQUENT ENCOUNTER OF AN EROSION OF THE IMPLANTED URETHRAL MESH TO SURROUNDING ORGAN OR TISSUE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED PELVIC AND PERINEAL PAIN. THE PATIENT ALSO EXPERIENCED POSTMENOPAUSAL ATROPHIC VAGINITIS. THE PATIENT WAS SCHEDULED FOR A CYSTOSCOPY PROCEDURE AND AN EXCISION OF THE MESH WAS CONSIDERED IF SYMPTOMATIC. ON (B)(6) 2020, THE PATIENT WAS SEEN FOR A CYSTOSCOPY PROCEDURE DUE TO HER LOWER URINARY TRACT SYMPTOMS INCLUDING SENSATION OF INCOMPLETE BLADDER EMPTYING AND MESH EROSION. THE PROCEDURE WAS EXPLAINED TO PATIENT AND INFORMED CONSENT WAS SIGNED. TIMEOUT WAS DONE VERBALLY AND PATIENT AGREED TO PROCEED WITH CYSTOSCOPY. THERE WAS NO EVIDENCE OF ACTIVE URINARY TRACT INFECTION AT THIS TIME. THE PATIENT WAS INSTRUCTED TO INCREASE FLUID INTAKE AFTER THE TEST AND VOID MORE FREQUENTLY TO AVOID RISK OF URINARY TRACT INFECTION (UTI). UTI PRECAUTIONS WERE REVIEWED WITH THE PATIENT. SHE UNDERWENT CYSTOSCOPIC EVALUATION AFTER LOCAL BETADINE PREPARATION AND TOPICAL APPLICATION OF 2% LIDOCAINE GEL. USING RIGID 70 AND 0 DEGREE CYSTOSCOPES SEQUENTIALLY AND RETROGRADELY FILLING THE BLADDER WITH 200 CC NORMAL SALINE, THE FOLLOWING FINDINGS WERE NOTED. THE PATIENT'S URETHRA HAS NORMAL PINK MUCOSA WITH NO DISCRETE LESIONS NOTED. URETHROVESICAL JUNCTION (UV) HAS ADEQUATE COAPTATION. NO DISCRETE LESIONS WERE NOTED. THE TRIGONE REVEALED METAPLASIA PRESENT. THE URETERAL ORIFICES WERE VISUALIZED AND APPEARED PATENT BILATERALLY. THE BLADDER REVEALED NO SUSPICIOUS LESIONS, STONES, OR FOREIGN BODIES IDENTIFIED. BASE AND SIDEWALLS WITH HYPERVASCULARITY. URETERAL ORIFICES APPEARED NORMAL BILATERALLY AND NO MESH IN THE BLADDER NOTED. IN THE PHYSICIAN'S ASSESSMENT, HE WAS CONSIDERING PROLAPSE REPAIR AND REMOVAL OF SUTURE OR MESH. ON (B)(6) 2021, THE PATIENT WAS SCHEDULED FOR EXCISION OF VAGINAL MESH, ANTERIOR COLPORRHAPHY, VAGINAL PARAVAGINAL REPAIR, INSERTION OF BIOLOGIC GRAFT- AXIS DERMIS AND CYSTOURETHROSCOPY PROCEDURES DUE TO MESH EROSION AND RECURRENT CYSTOCELE. DURING THE PROCEDURE, THE PATIENT WAS TAKEN TO OPERATING ROOM WHERE SHE WAS IDENTIFIED AND GIVEN GENERAL ENDOTRACHEAL ANESTHESIA. A TIMEOUT WAS TAKEN AND THE PROCEDURE WAS AGREED UPON. THE PATIENT WAS PLACED IN THE DORSAL LITHOTOMY POSITION. IN THE DORSAL LITHOTOMY POSITION, THE PHYSICIAN TOOK EXTRA CARE TO AVOID ANY EXCESSIVE TENSION OR PRESSURE ON THE PERINEAL NERVES. THE LOWER ABDOMEN, PERINEUM AND VAGINA WERE STERILELY PREPPED AND DOUBLY DRAPED USING THE DOUBLE DRAPE TECHNIQUE. A FOLEY CATHETER WAS INSERTED TO DRAIN THE BLADDER DURING THE CASE. RETRACTING SUTURES TO THE LABIA WAS PLACED FOR BETTER EXPOSURE. THESE SUTURES WERE REMOVED AT THE END OF THE CASE. THE VAGINAL EPITHELIUM SURROUNDING THE MESH WAS EXCISED AFTER INJECTION OF 5 CC OF 0.25% MARCAINE WITH EPINEPHRINE. AFTER ADEQUATE FLAP WAS OBTAINED, THE MESH WAS GRASPED AND EXCISED USING SHARP AND BLUNT TECHNIQUE. THE EXCISED MESH WAS SENT TO PATHOLOGY. IRRIGATION WITH NORMAL SALINE WAS DONE AND GOOD HEMOSTASIS WAS OBTAINED. VAGINAL EPITHELIUM WAS CLOSED USING #2-0 VICRYL SUTURE IN INTERRUPTED FASHION. A 70-DEGREE CYSTOURETHROSCOPE WAS INSERTED AND THE BLADDER WAS RETROGRADELY FILLED WITH 200 CC OF NORMAL SALINE. COMPLETE INTRAVESICAL SURVEY INCLUDING ALL THE BLADDER EDGES WERE PERFORMED IN A SYSTEMATIC WAY. BLADDER AND URETHRA APPEARED TO BE INTACT AND EFFLUX OF URINE FROM BOTH URETERAL ORIFICES WITH GOOD FLOW NOTED. THE PROCEDURE CONTINUED BY PLACING MARKING SUTURE AT THE APEX OF THE VAGINA, WHERE THE SACROSPINOUS SUTURES WILL BE PLACED LATER. A VERTICAL INCISION WAS MADE FROM THE APEX AFTER INJECTION OF MARCAINE WITH EPINEPHRINE. THE VAGINAL EPITHELIUM WAS DISSECTED OFF FROM BLADDER SHARPLY AND BLUNTLY ALL THE WAY TO THE PELVIC SIDE WALLS WHERE THE PHYSICIANS WERE ABLE TO IDENTIFY ARCUS TENDINUOUS FASCIA PELVIS AND SACROSPINOUS LIGAMENTS. ANTERIOR REPAIR WAS DONE USING SERIES OF #2-0 VICRYL SUTURES. THE ENTEROCELE WAS REDUCED IN A SIMILAR FASHION USING PURSE STRING SUTURES OF VICRYL. USING CAPIO SELF-RETRIEVING DEVICE, 3 SUTURES OF PDS WERE PASSED THROUGH THE ATFP ON EACH SIDE APPROXIMATELY 1 CM APART. SUTURE OF PDS WERE PASSED 1 CM MEDIAL TO ISCHIAL SPINE AND THEN SECOND SUTURE AT 1 CM MORE MEDIAL TO THE FIRST SUTURE. THESE SUTURES WE PASSED THROUGH A TAILORED PIECE OF TAILORED AXIS DERMIS THAT WAS TRAPEZOID SHAPE TO MATCH THE PATIENT'S ANATOMY. THEN USING FREE MAYO NEEDLE THEY WERE PASSED THROUGH VAGINAL MUSCULARIS. CYSTOURETHROSCOPY WAS DONE AGAIN AND EFFLUX OF URINE WAS NOTED FROM BOTH URETERAL ORIFICES. THERE WAS NO EVIDENCE OF SUTURE OR ANY DAMAGE TO THE BLADDER. VAGINAL EPITHELIUM WAS CLOSED AND USING #2-0 VICRYL IN AN INTERRUPTED FASHION. THE SUSPENSION SUTURES THEN WERE TIED WITH EXCELLENT SUPPORT OBTAINED. FINDINGS INCLUDE A 2 X 2 CM VAGINAL MESH AND ETHIBOND SUTURE EROSION AT APEX. THE INTRAVESICAL CAVITY WAS INTACT WITH EFFLUX OF URINE FROM BOTH URETERAL ORIFICES. RECTAL EXAMINATION INTACT AT THE END OF THE CASE. THE SPECIMEN WAS RECEIVED IN FORMALIN LABELED WITH THE PATIENT'S NAME AND "VAGINAL MESH." IT CONSISTS OF A 1.5 X 1.5 X 0.5 CM PORTION OF MESH-LIKE MATERIAL WITH GREEN SURGICAL SUTURES. THERE WAS ATTACHED CAUTERIZED SOFT TISSUE. NO SECTIONS WERE SUBMITTED. THE SPECIMEN WAS FOR GROSS EXAMINATION ONLY. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 16, 2023. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2702418 | UPSYLON | MESH, SURGICAL, SYNTHETIC | OTO | BOSTON SCIENTIFIC CORPORATION | M0068318200 | C002409 | 08714729839217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |