GYNECARE TVT-ABBREVO MINI LCM
Report
- Report Number
- 2210968-2023-02965
- Event Type
- Injury
- Date Received
- April 25, 2023
- Date of Event
- January 1, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- UDI-DI
- 10705031062368
- PMA / PMN Number
- K100936
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION RECEIVED: AFTER NUMEROUS EXAMINATIONS (ULTRASOUND, MRI, FIBROSCOPY, ETC.), IT TURNS OUT THAT THE PATIENT HAVE URETHRAL EROSION OF THE MESH. REPORT OF THE EXAMINATION DATED (B)(6) 2023 - (B)(6): REASON FOR CONSULTATION/CLINICAL HISTORY: PATIENT PRESENTING FOR MANAGEMENT OF URETHRAL EROSION ON A TRANSOBTURATOR SLING IMPLANTED IN 2016. SHE PRESENTED WITH AN EPISODE OF ACUTE POSTOPERATIVE URINE RETENTION REQUIRING THE USE OF AN INDWELLING PROBE FOR SEVERAL DAYS. SHE HAS A FAIRLY POOR TOLERANCE OF URINARY CATHETERS, WITH AN IRRITATE COMPONENT. SHE NOTED AN IMPROVEMENT IN HER STRESS URINARY INCONTINENCE. FOR SOME YEARS NOW, SHE HAS BEEN SUFFERING FROM PAIN, AND HAS ALSO HAD EPISODES OF CHRONIC BACTERIAL COLONISATION WHICH HAVE NOT RESOLVED WITH APPROPRIATE ANTIBIOTIC THERAPY. A URETHRAL EROSION WITH CALCIFICATION WAS FOUND, CONFIRMED BY ULTRASOUND, WHICH ALSO SUGGESTED A TWIST OF THE BAND ON THE LEFT. THE URETHRA WAS PARTIALLY NARROWED AT THE LEVEL OF CONTACT WITH THE SUBURETHRAL BAND AND URETHRAL MOBILITY WAS POOR. THERE IS A CLEAR INDICATION TO DISCUSS REMOVAL OF THIS EROSIVE MATERIAL. THE PATIENT HAS ALREADY HAD A GREAT DEAL OF INFORMATION ON THE SUBJECT, AND HAS DONE HER OWN RESEARCH. WE BEGIN TO DISCUSS WITH HER VAGINAL REMOVAL OF THE MESH OVER THE ENTIRE SUB-URETHRAL PORTION WITH SUTURE OF THE URETHRAL WOUND AND, IF NECESSARY, THE INSERTION OF BIOLOGICAL MATERIAL AND THE NEED TO KEEP AN INDWELLING PROBE FOR 15 DAYS. TIME IS NEEDED FOR REFLECTION, WHICH WILL ALLOW US TO ORGANISE A FOLLOW-UP FIBROSCOPY TO ASSESS THE URETHRA, BLADDER CAVITY AND VAGINAL CAVITY ACCURATELY. FIBROSCOPY: URETHRA: ANOMALY, THE EXAMINATION IS MADE DIFFICULT BY A SIGNIFICANT ALGIC COMPONENT AS SOON AS WE TRY TO MOBILISE THE URETHRA. THERE IS A SMALL STENOSIS OF THE MEATUS WHICH IS GRADUALLY DILATED USING AN 18-GAUGE CANDLE. THE FIBERSCOPE CAN THEN BE INSERTED. THE EXAMINATION IS VERY PAINFUL. WE GO DIRECTLY INTO THE BLADDER CAVITY, WHICH IS HEALTHY. ON MOVING BACKWARDS, THE FIBERSCOPE FINDS A URETHRAL EROSION FROM 19 HOURS TO 21 HOURS WITH THE PRESENCE OF LITHIASIS WHICH EXPLAINS THE PAINFUL SYMPTOMATOLOGY WHICH EXPLAINS THE PAINFUL SYMPTOMS AND CHRONICAL BACTERIAL COLONISATION. EXPLORATION OF THE VAGINA REVEALED NO EROSION OF THE CUL-DE-SACS. THE URETHRA IS RIGID, VERY FIRM AND PAINFUL, PARTICULARLY DUE TO THE PRESENCE OF LITHIASIS. BLADDER: NORMAL, LOWER BLADDER: OTHER, NO ASSOCIATED ABNORMALITY OF THE VULVA OR OBTURATOR ORIFICES. THE ISCHIALS ARE SUPPLE. THE PATIENT DESCRIBES A BUT WITHOUT ANY REAL TRIGGER POINT. AFTER A LENGTHY DISCUSSION WITH THE PATIENT, WHO HAD ENQUIRED AT LENGTH ABOUT THE TREATMENT OPTIONS, THE FOLLOWING WAS PROPOSED REMOVAL OF THE SUBURETHRAL PART OF THE BAND. THERE WAS NO REASON TO REMOVE THE MATERIAL FROM THE OBTURATOR FORAMEN. ONE OF HER CONCERNS IS THE RISK OF A RECURRENCE OF HER URINARY INCONTINENCE, WHICH CAN OCCUR IN 30% OF CASES. WE TAKE THE TIME, USING DIAGRAMS, TO EXPLAIN THE NEED TO FRAGMENT THE LITHIASIS AND REPAIR THE URETHRAL WOUND. THE MAIN RISK IS DECOMPENSATION, WITH HEALING PROBLEMS LEADING TO URETHROVAGINAL FISTULA. FORTUNATELY, THE EROSIVE ZONE IS AT A DISTANCE FROM THE CERVIX. SHE IS WARNED OF THE NEED TO KEEP A URINARY CATHETER IN PLACE FOR 10 TO 15 DAYS AND, FOR THIS PURPOSE, SHE IS ASKED TO START ANTICHOLINERGIC TREATMENT A FEW DAYS BEFORE THE OPERATION. THE PRESCRIPTION WAS MADE ON THE SAME DAY AS THE CONTINUATION OF A COVER COURSE OF ANTIBIOTICS, WHICH IMPROVED HER SYMPTOMS AND COLONISATION. WE LOOK AT HOW THE URETHRAL WOUND IS REPAIRED, STARTING WITH THE USE OF A BIOLOGICAL FLAP OF THE SURGICIS TYPE FLAP TO INTERPOSE TISSUE BETWEEN THE URETHRAL REPAIR ZONE AND THE VAGINAL INCISION. THE POSSIBILITY OF A MARTIUS FLAP HAS BEEN MENTIONED BUT, FOR THE TIME BEING, IT IS PREFERABLE TO PRESERVE NEARBY TISSUE IN CASE OF RECURRENCE OR COMPLICATION. AN OPERATION WAS ORGANISED FOR NOVEMBER, ADAPTED TO THE AVAILABILITY OF THE OPERATING ROOM AND THE PATIENT. CURRENT STATE OF THE PATIENT: A REMOVAL OF THE SUB-URETHRAL PART OF THE MESH MUST BE PERFORMED ON (B)(6) 2023, WITH REPAIR OF THE URETHRAL WOUND AND A RISK OF DECOMPENSATION DUE TO HEALING PROBLEMS LEADING TO A URETHROVAGINAL FISTULA. IN THE MEANTIME, THE PATIENT IS BEING KEPT ON A COURSE OF ANTIBIOTICS, WHICH HAS IMPROVED SYMPTOMS AS WELL AS THE CHRONIC BACTERIAL COLONISATION (BACTRIM FORTE).
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION RECEIVED: REFERENCE NUMBER : (B)(4). LOT NUMBER : 3895683.
(B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION RECEIVED: 49-YEAR-OLD FEMALE PATIENT IMPLANTED WITH A TOT GYNECARE ABBREVO TRANSOBTURATOR BAND ON (B)(6) 2016 AT HOSPITAL. SHE PRESENTED WITH URETHRAL PAIN ASSOCIATED WITH CHRONIC BACTERIAL COLONISATION. ENDOSCOPIC INVESTIGATIONS REVEALED URETHRAL EROSION WITH THE APPEARANCE OF CENTIMETRIC LITHIASIS. IT SHOULD BE NOTED THAT THE POST-OPERATIVE PERIOD FOLLOWING IMPLANTATION OF THE STRIP IN 2016 HAD BEEN AFFECTED BY DIFFICULTY IN MICTURITION. THE PATIENT WAS ALSO REFERRED TO UROLOGY IN 2016 THREE MONTHS AFTER IMPLANTATION FOR ASSESSMENT OF URETHRAL BURNING ASSOCIATED WITH URGENCY THAT DID NOT EXIST PRE-OPERATIVELY. REMOVAL OF THE SUB-URETHRAL PART OF THE SLING ON (B)(6) 2023 WITH NO POST-OPERATIVE COMPLICATIONS. PATIENT OBSERVED A FEW WEEKS AFTER ABLATION OF AN EROSIVE SUBURETHRAL SLING. COMPLETE HEALING. FLOWMETRY IS SATISFACTORY. NO RESIDUAL MICTURITION. PATHOLOGY ANALYSIS: MACROSCOPIC CONFIRMATION OF A FULLY CALCIFIED STRIP.
PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT: "DESCRIPTION OF THE INCIDENT: I HAD A TVT ABBREVO SINCE 2016. I EXPERIENCED SIGNIFICANT ISSUES AFTER IT WAS PLACED: CYSTITIS, BURNING SENSATIONS, AND PAIN. A UROLOGIST EVENTUALLY PRESCRIBED ME AN ANTISPASMODIC MEDICATION OVER SEVERAL MONTHS THAT COMBATS THE ABNORMAL CONTRACTION OF THE BLADDER: CÉRID. THIS TEMPORARILY RESOLVED THE PROBLEM. HOWEVER, IN 2018, I SUFFERED FROM SEVERAL DIFFICULT-TO-TREAT CYSTITIS EPISODES....ANTIBIOTICS EVENTUALLY LED TO A VAGINAL INFECTION. I MANAGED TO RECOVER WITH D-MANNOSE, A NATURAL TREATMENT THAT WORKS FOR CYSTITIS. SINCE THEN, I REGULARLY FELT AT BEST A DISCOMFORT, AT WORST BURNING SENSATIONS, LIKE STABBING PAINS. IT COMES AND GOES. I ALSO HAD RECURRING CYSTITIS, WHICH I COULD ALLEVIATE WITH D-MANNOSE. HOWEVER, SINCE (B)(6) 2022, NONE OF THESE SYMPTOMS SUBSIDED. THE CYSTITIS COMES AND GOES. ANTIBIOTICS PROVIDED TEMPORARY RELIEF FOR A FEW WEEKS BUT THEN IT RECURRED. THE PELVIC PAIN PERSISTS (DISCOMFORT, BURNING, LIKE A STABBING PAIN). AFTER NUMEROUS EXAMINATIONS (ULTRASOUND, MRI, FIBROSCOPY,), IT TURNED OUT THAT I HAD A URETHRAL EROSION FROM THE TAPE. A REMOVAL OF THE SUB-URETHRAL PART OF THE TAPE WAS PERFORMED ON (B)(6) 2023, WITH REPAIR OF THE URETHRAL WOUND AND A RISK OF DECOMPENSATION DUE TO HEALING DISORDERS LEADING TO A URETHRO-VAGINAL FISTULA. I WAS KEPT UNDER ANTIBIOTIC THERAPY, WHICH IMPROVED MY SYMPTOMS AND THE CHRONIC BACTERIAL COLONIZATION (STRONG BACTRIM). CLINICAL CONSEQUENCES AND CURRENT STATE OF THE PATIENT OR INVOLVED PERSON: URINARY CATHETER FOR 15 DAYS, SICK LEAVE FOR 1.5 MONTHS. LONG PERINEAL AND ANAL REHABILITATION (STILL ONGOING): URINARY LEAKS, PROLAPSE. HUGE SCAR TISSUE THAT PREVENTS ME FROM USING A PESSARY AND RESTRICTS INTIMATE RELATIONSHIPS, ANXIETY, DISTRESS, SIGNIFICANT WEIGHT GAIN, EXTREME FATIGUE, RECTOCELE, AND CYSTOCELE, MISTRUST OF THE MEDICAL WORLD, HYPOCHONDRIA. OPERATIVE REPORT DATED NOVEMBER 30, 2023: REMOVAL OF SUB-URETHRAL TAPE OF TYPE TOT PATIENT WITH A TRANSOBTURATOR TAPE OF TYPE TOT GYNECARE ABBREVO IMPLANTED IN 2016. SHE PRESENTS WITH URETHRAL PAIN ASSOCIATED WITH CHRONIC BACTERIAL COLONIZATION. ENDOSCOPIC EXPLORATIONS HIGHLIGHTED A URETHRAL EROSION WITH THE APPEARANCE OF A CENTIMETER-SIZED STONE. IT IS NOTED THAT THE POST-OPERATIVE FOLLOW-UP OF THE TAPE IMPLANTATION IN 2016 WAS MARKED BY DIFFICULTIES RESUMING URINATION. THE PATIENT HAD ALSO CONSULTED A UROLOGIST IN 2016, THREE MONTHS AFTER THE IMPLANTATION, FOR EVALUATION OF URETHRAL BURNING ASSOCIATED WITH URGENCY THAT DID NOT EXIST PRE-OPERATIVELY. THE ULTRASOUND OF THE TAPE CONFIRMED THE FINDINGS FROM THE CLINICAL EXAMINATION AND ENDOSCOPIC EXPLORATION WITHOUT REVEALING ANY ASSOCIATED ANOMALIES. AFTER LENGTHY DISCUSSION WITH THE PATIENT, WHO HAD RESEARCHED THE THERAPEUTIC OPTIONS, WE PROPOSED THE REMOVAL OF THE SUB-URETHRAL PORTION OF THE TAPE. THERE WAS NO INDICATION TO REMOVE THE MATERIAL AT THE LEVEL OF THE OBTURATOR HOLE. ONE OF HER CONCERNS IS THE RISK OF RECURRENCE OF HER URINARY INCONTINENCE, WHICH CAN INDEED OCCUR IN 30% OF CASES. WE TOOK THE TIME TO EXPLAIN TO HER THROUGH DIAGRAMS THE NECESSITY TO FRAGMENT THE STONE AND REPAIR THE URETHRAL WOUND. THE MAIN RISK IS DECOMPENSATION DUE TO HEALING DISORDERS LEADING TO A URETHRO-VAGINAL FISTULA. FORTUNATELY, THE EROSIVE ZONE IS DISTANT FROM THE CERVIX. WE INFORMED HER OF THE NECESSITY TO MAINTAIN A URINARY CATHETER FOR 10 TO 15 DAYS AND FOR THIS PURPOSE, SHE REQUESTED TO START AN ANTICHOLINERGIC TREATMENT A FEW DAYS BEFORE THE INTERVENTION. WE DISCUSSED THE MODALITIES FOR REPAIRING THE URETHRAL WOUND, INITIALLY USING A BIOLOGICAL FLAP OF TYPE SURGICIS TO INTERPOSE TISSUE BETWEEN THE URETHRAL REPAIR AREA AND THE VAGINAL INCISION. WE MENTIONED THE POSSIBILITY OF A MARTIUS FLAP, BUT FOR NOW, IT IS BETTER TO PRESERVE THE NEARBY TISSUES IN CASE OF RECURRENCE OR COMPLICATION. WE SCHEDULED AN INTERVENTION FOR NOVEMBER, TO BE ADAPTED BASED ON THE OPERATING ROOM AVAILABILITY AND THE PATIENT'S SCHEDULE. ANESTHESIA: GENERAL ANESTHESIA. INSTALLATION: INTERVENTION UNDER GENERAL ANESTHESIA AFTER VERIFYING THE STERILITY OF URINE. IMMEDIATE PRE-OPERATIVE ANTIBIOTIC PROPHYLAXIS. THROMBOEMBOLIC PROPHYLAXIS WITH COMPRESSION STOCKINGS. POSITIONED IN DORSAL DECUBITUS IN A HIGH GYNECOLOGICAL POSITION. BLADDER CATHETERIZATION PERI-OPERATIVELY WITH A FOLEY CATHETER SIZE 16. SURGICAL TECHNIQUE: THE FINDINGS UNDER GENERAL ANESTHESIA: THERE IS NO VAGINAL EROSION. THE ENTIRE SUB-URETHRAL AREA IS INDURATED, FIRM, WITH A VISIBLE STONE ALONG THE ENTIRE PATH OF THE TAPE FROM ONE OBTURATOR HOLE TO THE OTHER. WE BEGIN WITH A CYSTOSCOPY THAT CONFIRMS THE URETHRAL EROSION FROM 19 TO 21 O'CLOCK. USING A LASER 120 AND A 550 FIBER, WE VAPORIZE THE ENTIRE VISIBLE SEGMENT OF THE STONE IN THE URETHRAL LUMEN UNTIL WE HIGHLIGHT THE SUB-URETHRAL TAPE, WHICH IS BLUE. A REVERSED U-SHAPED INCISION IS MADE EXTENDING FROM THE SUB-URETHRA TOWARD THE BLADDER NECK. INTER-URETHRO-VAGINAL DISSECTION ON EACH SIDE ALLOWS US TO RETRIEVE EACH ARM OF THE SUB-URETHRAL TAPE, WHICH WILL BE DISSECTED AS FAR AS POSSIBLE AT ITS ENTRY INTO THE OBTURATOR HOLE. THE ENTIRE MIDDLE PORTION OF THE TAPE IS CALCIFIED, WITH A FIBROUS SHEATH SURROUNDING THE STONE. SECTION AT THE ENTRY INTO THE OBTURATOR HOLE OF EACH ARM. THE PROCEDURE IS PERFORMED UNDER THE COVER OF A SIZE 9 HEGAR INTRA-URETHRAL DILATOR. DISSECTION OF THE ARMS AND THE SUB-URETHRAL PORTION OF THE TAPE USING A DISSECTOR. THE ENTIRE VAGINAL PORTION OF THE TAPE IS THUS REMOVED. A PART IS SENT FOR HISTOLOGICAL STUDY AND ANOTHER FOR BACTERIOLOGICAL STUDY. EXAMINATION WITH THE DILATOR ALLOWS US TO RESTORE THE INITIAL CONTINUITY HIGHLIGHTED DURING CYSTOSCOPY. CLOSURE WITH 5 SUTURES OF PDS 3/0. WE THEN CREATE A SECOND MUSCLE LAYER TO COVER THE ENTIRE SUB-URETHRAL AREA USING SEPARATE VICRYL 2/0 STITCHES. WE COMPLETE THE REPAIR WITH THE PLACEMENT OF A SURGICIS FLAP FOLDED IN 3 LAYERS, HELD BY 4 VICRYL 2/0 STITCHES AT EACH CORNER. CLOSURE OF THE VAGINA WITH SEPARATE VICRYL 2/0 STITCHES AFTER CLEANING THE OBTURATOR ORIFICES WITH BETADINE. COUNTING OF SPONGES. A VAGINAL PACK IS PLACED FOR 24 HOURS.
IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING BIG WORRIES AFTER THE INSTALLATION INCLUDING CYSTITIS, BURNS AND PAIN. THE PATIENT FURTHER REPORTED THAT A UROLOGIST ENDED UP GIVING HER SEVERAL MONTHS OF ANTISPASMODIC TREATMENT TO FIGHT AGAINST THE ABNORMAL CONTRACTION OF THE BLADDER: CERID. THIS FIXED THE PROBLEM FOR A WHILE, HOWEVER, IN 2018, THE PATIENT HAD SEVERAL DIFFICULT TO TREAT CYSTITIS AND ANTIBIO WHICH ENDED UP BRINGING VAGINAL INFECTION. THE PATIENT GOT AWAY WITH D-MANNOSE, A NATURAL TREATMENT THAT WORKS ON CYSTITIS. REGULARLY SINCE THEN, THE PATIENT FEELS AT BEST DISCOMFORT AND AT WORST BURNS, LIKE STAB WOUNDS. IT'S COMING HERE GO. THE PATIENT ALSO REGULARLY HAS CYSTITIS, WHICH SHE MANAGED TO DISSIPATE WITH THE D-MANNOSE. ONLY FOR 3 MONTHS, ALL THESE SYMPTOMS DID NOT GO AWAY. THE CYSTITIS COMES AND GOES. ANTIBIOTICS CALM FOR A FEW WEEKS AND IT STARTS AGAIN. THE PATIENT REPORTED ALWAYS HAVING THE PUBIC PAINS (EMBARRASSMENT, BURNING, LIKE A STAB WOUND) AND REPEAT URINARY TRACT INFECTIONS. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1186314 | GYNECARE TVT-ABBREVO MINI LCM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | TVTOML | 3895683 | 10705031062368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |