BIODESIGN HERNIA GRAFT
Report
- Report Number
- 1835959-2022-00005
- Event Type
- Injury
- Date Received
- October 10, 2022
- Date of Event
- October 25, 2013
- Report Date
- October 5, 2022
- Manufacturer
- COOK BIOTECH
- Product Code
- OXK
- UDI-DI
- 10827002482163
- PMA / PMN Number
- K133306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
INVESTIGATION INTO THIS FEEDBACK INCLUDED 1) A REVIEW OF THE FEEDBACK DETAILS, 2) A REVIEW OF THE DEVICE LOT HISTORY RECORD, 3) A REVIEW OF THE CBI COMPLAINT DATABASE, AND 4) A REVIEW OF THE BIODESIGN SURGISIS 8-LAYER TISSUE GRAFT/SURGISIS HERNIA GRAFT IFU FP0036-2G. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF MEDICAL RECORDS. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE PRODUCT LIABILITY CLAIM DETAILS. ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. SUMMARY OF INVESTIGATION FINDINGS A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE LOT PRODUCED A TOTAL OF (B)(4) DEVICES. THE DEVICE LOT HISTORY RECORDS INDICATE THAT THE (B)(4) DEVICES THAT WERE RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. PER THE IFU, POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE OF TISSUE DEFECT. COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, HERNIA RECURRENCE, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS. BASED ON THE AVAILABLE DETAILS, A SPECIFIC CORRELATION BETWEEN THE DEVICE'S PERFORMANCE AND THE PATIENT'S OUTCOME ARE UNKNOWN. A ROOT CAUSE OF THE PATIENT'S EXPERIENCE IS INCONCLUSIVE DUE TO A LACK OF DETAILS. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, THEN THE COMPLAINT WILL BE REOPENED. UPDATE: BASED ON THE REVIEW OF MEDICAL RECORDS, THE PATIENT EXPERIENCED A CHRONIC/RECURRENT DRAINING WOUND AFTER A SPONTANEOUS ABSCESS HAD FORMED IN A PREVIOUS UPPER MIDLINE INCISION SITE. THE PATIENT'S VENTRAL HERNIA ALSO RECURRED AGAIN. PER THE MEDICAL RECORD REVIEW, THE PATIENT'S COURSE OF EVENTS IS DUE TO THE PATIENT'S UNDERLYING CONDITION. THE MEDICAL RECORDS REPEATEDLY INDICATE THE PATIENT WOULD CONTINUE TO EXPERIENCE VENTRAL HERNIA RECURRENCE DUE TO HER OBESITY. THE PATIENT HAD MULTIPLE NON-BIODESIGN MESHES PRIOR TO RECEIVING BIODESIGN. THE MESH COMPLICATIONS DO NOT APPEAR TO BE RELATED TO THE USE OF BIODESIGN, BUT RATHER THE PRIOR NON-BIODESIGN MESHES. ADDITIONALLY, THE CHRONIC WOUND, ABSCESS, AND FISTULA(S) ARE LIKELY DUE TO THE PATIENT'S OVERALL HEALTH AND REPEATED OPERATIONS. UPDATE: BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN HERNIA MESH'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE. HOWEVER, THE PRIOR ROOT CAUSE ANALYSIS (BASED ON THE REVIEW OF THE PATIENT'S MEDICAL RECORDS SUBMITTED TO CBI), REMAINS UNCHANGED AT THIS TIME. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED THE COMPLAINT WILL BE REOPENED.
A LAWYER CONTACTED COOK MEDICAL TO INFORM THEM OF A POTENTIAL PRODUCT LIABILITY CLAIM. PATIENT: (B)(6). LOT #: LB504039; CATALOG #: G48216. (B)(6) 2022 - COOK LEGAL INDICATED NO ADDITIONAL DETAILS RECEIVED. (B)(6) 2022 - COOK LEGAL INDICATED STILL NO ADDITIONAL DETAILS RECEIVED. UPDATE: THIS UPDATE WILL REFLECT MEDICAL RECORDS FINDINGS THAT APPEAR PERTINENT TO HERNIA REPAIR AND FACTORS THAT MAY PERTAIN TO THAT. PER MEDICAL RECORDS RECEIVED ON 04/15/2022, THE MOST RECENT RECORDS RECEIVED WERE FROM OCTOBER 2013. AT THAT TIME, THE PATIENT HAD A HISTORY OF EPIGASTRIC HERNIA REPAIR IN 2004, VENTRAL HERNIA REPAIR WITH MESH IN 2008, OPEN VENTRAL HERNIA REPAIR WITH MESH IN 2011, UNILATERAL RIGHT COMPONENT SEPARATION WITH LARGE OPEN VENTRAL HERNIA REPAIR WITH A 20X30 CM BIODESIGN GRAFT IN 2012, LEFT THYROID LOBECTOMY FOR LEFT THYROID GOITER 2012, AND ABDOMINAL WOUND DEBRIDEMENT IN 2013. MEDICAL RECORDS RECEIVED ARE IN THE ATTACHED FILES. IN RELATION TO BIODESIGN, THE PATIENT RECEIVED A BIODESIGN HERNIA GRAFT ON (B)(6) 2012 FOR A RECURRENT VENTRAL HERNIA. THE PATIENT'S HISTORY PRIOR TO THIS DATE WAS NOTED AS 3 PREVIOUS VENTRAL HERNIA REPAIRS THAT HAVE RECURRED ALL 3 TIMES. LAST HERNIA REPAIR WAS IN (B)(6) 2011 WITH A DUALMESH. PER THAT OP NOTE, OPERATIVE FINDINGS INCLUDED A LARGE VENTRAL HERNIA THAT MEASURED 10X15 CM SIZE IN GREATEST DIMENSION WITH THE PREVIOUS MESHES (NOT BIODESIGN) THAT HAVE FALLEN AWAY FROM THE FASCIA EDGES AND WAS ROLLED UP TO 1 SIDE. THERE WERE DENSE SMALL-BOWEL ADHESIONS TO THE MESH WHICH WERE METICULOUSLY DISSECTED AWAY IN ORDER TO CLEAR UP THE FASCIA EDGES AS WELL AS THE MESH IN ORDER TO COMPLETE THE HERNIA REPAIR. ATTEMPTED TO PERFORM A COMPONENT SEPARATION ON THE PATIENT¿S LEFT SIDE. ONCE THE EXTERNAL OBLIQUE FASCIA WAS ENCOUNTERED AND THEN INCISED AND BLUNT DISSECTION BEGAN, THE SURGEON WAS UNABLE TO DEVELOP AN AVASCULAR SPACE WITHIN THE EXTERNAL OBLIQUE AND THE INTERNAL OBLIQUE IN THIS REGION. THE SURGEON WAS UNABLE TO DO IT VIA BLUNT DISSECTION AS WELL AS A BALLOON DISSECTOR UNDER DIRECT VISUALIZATION. THIS SPACE WAS MOST LIKELY OBLITERATED FROM THE PATIENT¿S PREVIOUS MULTIPLE VENTRAL HERNIA REPAIRS. ATTENTION WAS THEN TURNED TO THE VENTRAL HERNIA PORTION OF THE CASE. UPON ENTRY INTO THE HERNIA SAC, THERE WERE SIGNIFICANT SMALL BOWEL ADHESIONS TO THE ADJACENT MESH WHICH WAS MOST LIKELY THE PATIENT¿S RECENT HERNIA REPAIR. THERE WERE MULTIPLE AREA IN WHICH THE SMALL BOWEL WAS DENSELY ADHERENT AND THIS REQUIRED METICULOUS DISSECTION TO CAREFULLY TEASE OFF THE BOWEL FROM THE MESH. THERE WERE MULTIPLE SEROSAL INJURIES WHICH WERE REPAIRED. THE ADHESIOLYSIS TOOK APPROXIMATELY 2 HOURS. THERE WAS RELATIVELY MINIMAL ADHESIONS OF THE PATIENT¿S SMALL BOWEL TO THE NATIVE ABDOMINAL WALL ON THE UNDERSURFACE; HOWEVER, MOST OF THE ADHESIONS WERE DUE TO THE PATIENT¿S PREVIOUS MESH. THERE WAS 1 IN THE INFERIOR ASPECT OF THE HERNIA SAC EDGE WHICH WAS ALL ROLLED UP AND WAS VERY DENSE AND THEREFORE, THIS WAS METICULOUSLY DISSECTED FROM THE ABDOMINAL WALL AND WAS PASSED OFF AS A SPECIMEN. THERE WAS ALSO MESH IN THE CEPHALAD ASPECT OF THE VENTRAL HERNIA WHICH HAD SHARP ROLLED UP EDGES WHICH THE SURGEON ELECTED TO ALSO RESECT AS WELL SINCE THIS AREA COULD POTENTIALLY BE THE SITE OF FISTULA FORMATION OR OTHER POTENTIAL PROBLEMS. AFTER ALL THE UNDERLYING FASCIA EDGE WAS FREED UP, THE 20X30 CM BIODESIGN BIOLOGIC MESH WAS PLACED IN ORDER TO REPAIR THE 10X14 CM FASCIA DEFECT. THE SURGEON ELECTED TO USE A BIOLOGIC MESH GIVEN THAT THE PATIENT WAS MORBIDLY OBESE WITH A BMI OF 55, AND GIVEN THE AMOUNT OF SUBCUTANEOUS TISSUE, THE PATIENT IS AT INCREASED RISK FOR INFECTION. FURTHERMORE, GIVEN THAT THE PATIENT HAD MULTIPLE PROSTHETIC MESH IN HER ABDOMEN WHICH HAS BEEN CAUSING SIGNIFICANT PROBLEMS, THE SURGEON ELECTED TO USE A BIOLOGIC MESH WHICH COULD POTENTIALLY REMODEL HER ABDOMINAL WALL SO IT GETS STRONGER WITHOUT LASTING IN HER PERITONEAL CAVITY FOR A PROLONGED DURATION OF TIME CAUSING SIGNIFICANT ADHESIONS. THE BIODESIGN WAS PLACED IN AN UNDERLAY FASHION IN ORDER TO REINFORCE THE PRIMARY CLOSURE OF THE FASCIA DEFECT. THE BIODESIGN WAS PLACED IN AN UNDERLAY POSITION WITH A FOUR-POINT FIXATION WITH WIDE OVERLAP USING TRANSFASCIAL SUTURE PASSERS USING #1 PROLENE SUTURES IN ORDER TO SECURE THE MESH IN GOOD POSITION WITH EXCELLENT COAPTATION OF THE GRAFT TO THE UNDERSURFACE OF THE ABDOMINAL WALL. THE SURGEON WAS ABLE TO GET THE FASCIAL EDGES TOGETHER WITH MINIMAL TENSION GIVEN THE RELEASE OF THE ABDOMINAL WALL FROM THE COMPONENT SEPARATION. THE SURGEON ALSO INCORPORATED A SMALL BITE OF THE GRAFT AS PART OF THE FASCIAL CLOSURE IN ORDER TO ENCOURAGE GOOD TISSUE TO GRAFT COAPTATION FOR THE TISSUE INGROWTH INTO THE GRAFT. A #19 BLAKE DRAIN WAS PLACED BELOW THE FASCIA AROUND THE MESH IN ORDER TO PROPERLY DRAIN ANY SEROMA COLLECTION BETWEEN THE GRAFT AND THE ANTERIOR ABDOMINAL WALL. THE DRAIN EXITED THE PATIENT¿S ABDOMEN THROUGH THE RIGHT LOWER QUADRANT. ANOTHER #19 BLAKE DRAIN WAS PLACED EXITING THE PATIENT¿S LEFT LOWER QUADRANT TO DRAIN THE SUBCUTANEOUS DISSECTED SPACE ABOVE THE ABDOMINAL WALL FASCIA. THE WOUND WAS IRRIGATED WITH WARM SALINE AND ALL THE SKIN INCISION WERE CLOSED USING SKIN STAPLES. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS. PER THE DISCHARGE SUMMARY ON (B)(6) 2012 NOTED THAT GIVEN THE MAGNITUDE OF THE OPERATION AND PLUS HER BODY HABITUS, SHE REQUIRED ADDITIONAL ATTENTION INCLUDING PHYSICAL THERAPY AND ADDITIONAL ASSISTANCE DURING THE EARLY POSTOPERATIVE PERIOD IN ORDER TO HELP HER AMBULATE. ON (B)(6) 2013, THE PATIENT WAS SEEN FOR A WOUND INFECTION. PER THAT RECORD, THE PATIENT WAS NOTED AS VERY WELL KNOWN TO THE SURGEON AS SHE HAS HAD A LARGE VENTRAL HERNIA REPAIR COMPLICATED BY A WOUND INFECTION THAT DEVELOPED OVER A YEAR AFTER HER SURGERY. AREA HAS BEEN INCISED AND DRAINED 2 SEPARATE TIMES AND HAS SPONTANEOUSLY HEALED. THIS HAS OCCURRED 2 MORE TIMES SINCE THE LAST TIME SHE HAS WAS SEEN REGARDING THIS. BOWEL FUNCTION NORMAL AND NO FEVERS OR SIGNS OF INFECTION AT HOME. SURGEON INFORMED PATIENT THIS MAY BE A SMALL NIDUS OF SOME RESIDUAL HERNIA SAC THAT HAS BECOME NECROTIC AND IS SPONTANEOUSLY CAUSING SOME PROBLEMS OFF AND ON. SURGEON EXPLAINED TO PATIENT THAT AS LONG AS THIS AREA SPONTANEOUSLY DRAINED AND DOES NOT CAUSE SIGNIFICANT PROBLEMS, THAT THIS MAY BE A SELF-RESOLVING ISSUE. HOWEVER, SURGEON TOLD PATIENT THAT IF SHE FEELS THAT THIS IS SIGNIFICANTLY AFFECTING HER QUALITY OF LIFE, SURGEON CAN GO BACK IN THERE SURGICALLY AND DO A LOCAL WOUND DEBRIDEMENT. HOWEVER, IF THE AREA IS FOUND TO BE INFECTED AT THE TIME OF THE OPERATION, SURGEON WOULD NOT BE ABLE TO CLOSE HER WOUND PRIMARILY. SHE MAY END UP WITH AN OPEN WOUND WITH DRESSING CHANGES AND POSSIBLY EVEN A WOUND VAC. PATIENT WISHES TO GIVE THIS FURTHER CONSIDERATION AND SHE WILL CALL IF SHE DECIDES TO PROCEED WITH SURGERY. ON (B)(6) 2013, THE PATIENT UNDERWENT WOUND EXPLORATION AND DEBRIDEMENT WITH WOUND VAC PLACEMENT. BRIEF CLINICAL HISTORY: PATIENT UNDERWENT LARGE COMPLEX VENTRAL HERNIA REPAIR OVER A YEAR AGO, WHO HAS BEEN AFFLICTED WITH A CHRONIC DRAINING WOUND AFTER A SPONTANEOUS ABSCESS HAD FORMED IN A PREVIOUS UPPER MIDLINE INCISION SITE. CT SCAN WAS PERFORMED AND THIS APPEARED ALL SUBCUTANEOUS AND THIS HAS BEEN INCISED AND DRAINED AT BEDSIDE AT LEAST 2 TIMES WITH SUBSEQUENT RECURRENCE. DESCRIPTION OF PROCEDURE: THERE WAS AN AREA OF THICK FIBRINOUS MATERIAL WITHIN THE SUBCUTANEOUS SPACE WAS CAUTERIZED. THIS AREA WAS PASSED OFF FOR PATHOLOGIC ANALYSIS. AFTER THE DEBRIDEMENT, THE LEVEL OF HEALTHY FASCIA WALL WAS REACHED AND THERE WAS NO EVIDENCE OF RECURRENT HERNIA AND EVIDENCE OF ANY TYPE OF FISTULA TRACT. THE SPECIMEN OBTAINED APPEARED CHRONICALLY INFECTED, THE SURGEON ELECTED NOT TO CLOSE THE WOUND AND INSTEAD USED A WOUND VAC SPONGE, PLACED IN A WOUND VAC TO COVER THE 7X4X4 CM DEFECT. PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS. ON (B)(6) 2013, THE PATIENT WAS SEEN FOR PERIUMBILICAL AREA PAIN. INTERVAL HISTORY: PATIENT WELL KNOWN TO SURGEON; HAD COMPLEX VENTRAL HERNIA REPAIR OVER A YEAR AGO THAT DEVELOPED A SUPERFICIAL SKIN INFECTION JUST ABOVE HER INCISION RECENTLY. THIS WAS DEBRIDED OPERATIVELY DUE TO ITS RECURRENT PATTERN. PATIENT HAVING WORSENING PAIN IN THE PERIUMBILICAL AREA IN WHICH THE RECURRENT HERNIA WAS DIAGNOSED ALMOST A YEAR AGO. SURGEON SPOKE TO PATIENT IN LENGTH IN THE PAST ABOUT HER WEIGHT CONTRIBUTING TO HER RECURRENCE AS WELL AS THE RECURRENT NATURE OF HER HERNIAS AND THE ATTENUATION THEREOF. ASSESSMENT AND PLAN: RECURRENT VENTRAL HERNIA IN THE SETTING OF MORBID OBESITY AND MULTIPLE RECURRENT HERNIA REPAIRS IN THE PAST. ¿AGAIN, I TOLD (PATIENT) ABOUT THE IMPORTANCE OF LOSING WEIGHT IN ORDER TO DECREASE THE RISK OF HER HERNIA RECURRING IN THE FUTURE. I TOLD HER THAT AT HER CURRENT WEIGHT, NO MATTER HOW MANY TIMES WE FIX HER HERNIA, THAT HER HERNIA WILL LIKELY RECUR AT OTHER SITES AND CONTINUE TO DO SO.¿ ON (B)(6) 2013, THE PATIENT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA. PREOP DIAGNOSIS ¿ RECURRENT VENTRAL HERNIA. POSTOP DIAGNOSES: 1. RECURRENT VENTRAL HERNIA, 2. ENTEROCUTANEOUS FISTULA, 3. INFECTED PROSTHETIC MESH. PROCEDURE PERFORMED: 1. LAPAROSCOPIC CONVERTED TO OPEN VENTRAL HERNIA REPAIR WITH MESH (20X30 CM BIO-A MESH), 2. PARTIAL COLECTOMY WITH ANASTOMOSIS (RIGHT COLECTOMY; AREA OF ENTEROCUTANEOUS FISTULA SITE REMOVED EN-BLOC ALONG WITH THE INFECTED MESH), 3. REMOVAL OF FOREIGN BODY (MESHOMA/INFECTED) PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED PRIOR TO SKIN INCISION. UPON GENERAL EXPLORATION, THE PATIENT HAD SIGNIFICANT OMENTAL ADHESIONS AS WELL AS OTHER ADHESIONS ALL THROUGHOUT THE ABDOMEN. TWO HOURS SPENT PERFORMING LAPAROSCOPIC ADHESIOLYSIS IN ORDER TO SAFELY GET DOWN ALL THE OMENTAL ADHESIONS ALL ALONG THE PATIENT¿S ABDOMINAL WALL. DURING THE METICULOUS DISSECTION OF THE SMALL INTESTINES IN THIS AREA, AN ENTEROTOMY WAS PERFORMED, GIVEN THE DENSENESS OF THE SMALL LOCATION OF THE SMALL BOWEL ENTEROTOMY, THE CASE WAS CONVERTED TO AN OPEN OPERATION DUE THE TECHNICAL CHALLENGE GIVEN HER ABDOMINAL WALL, TO GET THE PROPER TRAJECTORY OF THE INSTRUMENTS AS WELL AS THE DENSE NATURE OF THE SMALL BOWEL ADHESIONS, DESPITE SPENDING OVER 2 HOURS ON THE ADHESIOLYSIS. THE OPEN PROCEDURE REVEALED DENSE INFLAMMATION WITHIN THE AREOLAR SPACE THAT WAS IMMEDIATELY ENCOUNTERED AND FOLLOWED BY AN AREA OF THICK FIBROTIC RIND THAT CONSISTED OF THE ENTIRE ABDOMINAL WALL. THE ABDOMINAL WALL IN THIS AREA WAS SO THICK THAT THE INCISION HAD TO BE EXTENDED IN ORDER TO ENTER INTO THE SPACE THAT WAS SOFTER. THERE WAS AN APPARENT FISTULOUS TRACT THAT EXITED THE PATIENT¿S UPPER MIDLINE WOUND THAT WAS DEBRIDED IN THE OR A FEW MONTHS AGO. THIS AREA RECURRED AND OVER THE PAST COUPLE WEEKS, THE AREA REDEVELOPED THE SIMILAR APPEARANCE IT PREVIOUSLY HAD. THERE WAS AN AREA OF A PROSTHETIC MESH THAT WAS ERODING INTO WHAT APPEARED TO BE THE COLON. THE PROSTHETIC MESH USED IN THE PREVIOUS REPAIR APPEARED TO HAVE GOTTEN INFECTED AND CAUSED AN EROSION INTO THE INTESTINES. ONE AREA INVOLVED THE SMALL BOWEL AND A SECOND SITE INVOLVED THE LARGE BOWEL. BOTH SITES WERE LOW OUTPUT, OCCULT FISTULA AT BOTH SITES. PURULENT DRAINAGE WAS EVACUATED. METICULOUS DISSECTION OF THE INFLAMMATORY RIND AND THE MESHOMA OFF THE ABDOMINAL WALL LEFT A LARGE DEFECT IN THE PATIENT¿S ABDOMINAL WALL. THE MESH WAS DISSECTED FROM THE RECTUS MUSCLE ON BOTH RIGHT AND LEFT SIDE TO WHAT WAS ATTACHED. IT APPEARED THAT SOME OF THE PROSTHETIC MESH MAY HAVE BEEN IN THE INTRAMUSCULAR SPACE THAT GOT INFECTED THAT CAUSED A MASSIVE INFLAMMATORY REACTION. METICULOUS DISSECTION WAS PERFORMED FOR OVER AN HOUR AND A HALF. IT APPEARED THAT THE ASCENDING COLON AND THE HEPATIC FLEXURE OF THE COLON WAS DENSELY ADHERENT TO THE INFECTED MESH THAT WAS NOT AMENDABLE TO SHARP DISSECTION. THE AREA HAD TO HAVE BEEN THE FISTULOUS SITE. THERE WAS ALSO AN AREA OF SMALL INTESTINES THAT WERE ALSO DENSELY ADHERENT IN A SIMILAR FASHION, IN WHICH THE ENTEROTOMY WAS CREATED JUST ADJACENT TO THE MESH THAT WAS VERY DENSE, AND THIS AREA WAS MOST LIKELY THE OTHER SIDE OF THE SMALL BOWEL FISTULA. THAT SMALL BOWEL THAT WAS DENSELY ADHERENT REPRESENTED APPROXIMATELY 20 CM OF THE DISTAL SMALL BOWEL BEFORE IT BECAME THE TERMINAL ILEUM. THE SURGEON ELECTED TO PERFORM AN EN-BLOCK RESECTION OF THE PATIENT¿S RIGHT COLON ALONG WITH THE 20 CM OF TERMINAL ILEUM, ALONG WITH THE MESHOMA AND THE ENTEROCUTANEOUS FISTULA SITE. A FUNCTIONAL END-TO-END SMALL BOWEL TO COLON ANASTOMOSIS WAS PERFORMED JUST PROXIMAL AND DISTAL TO THE RESECTION SIDE RESPECTIVELY. ABDOMEN WOUND WAS COPIOUSLY IRRIGATED. VENTRAL HERNIA REPAIR WAS THEN PERFORMED WITH PLACEMENT OF A 20X30 CM BIO-A MESH IN AN UNDERLAY/BRIDGE REPAIR. BRIDGE REPAIR WAS PERFORMED DUE TO THE SIGNIFICANT DEFECT IN THE ABDOMINAL WALL AND BECAUSE THE PATIENT HAD FAILED THE PREVIOUS COMPONENT SEPARATION. TWO BLAKE DRAINS WERE PLACED ON TOP OF THE MESH AND IN THE SUBCUTANEOUS TISSUE. VAC WAS PLACED ON TOP OF THE WOUND IN ORDER TO MINIMIZE THE RISK OF SEROMA FORMATION AS WELL AS SOME WOUND INFECTION. PATIENT TOLERATED PROCEDURE WITHOUT COMPLICATIONS. ADMITTED (B)(6) 2013; DISCHARGED (B)(6) 2013. UPDATE: THIS UPDATE IS IN RELATION DETAILS PROVIDED IN A PRODUCT LIABILITY CLAIM PRESENTED TO CBI ON (B)(6) 2022. THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN HERNIA MESH DEVICE, ON OR ABOUT (B)(6) 2012, AT (B)(6) HOSPITAL. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE CLAIM REPORTS THAT AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013, FOR A REVISION OPERATION WHEREIN THE BIODESIGN HERNIA MESH WAS FOUND TO BE CAUSING AND/OR CASUALLY CONTRIBUTING TO A FISTULA. ADDITIONALLY, THE CLAIM ALLEGES THAT THE BIODESIGN MESH HAD BECOME ENCOMPASSED IN FIBROTIC TISSUE AND CAUSED A SEVERE INFLAMMATORY, FIBROTIC, AND INFECTIOUS RESPONSE WHICH NECESSITATED A MESH REMOVAL SURGERY ALONG WITH REMOVAL AND DRAINAGE OF THE FISTULA ALONG AND A SIGNIFICANT AMOUNT OF THE PATIENT'S INJURED BOWEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275613 | BIODESIGN HERNIA GRAFT | HERNIA GRAFT | OXK | COOK BIOTECH | G48216 | LB504039 | 10827002482163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Hospitalization |