GORE DUALMESH BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00202
- Event Type
- Injury
- Date Received
- July 16, 2019
- Date of Event
- May 14, 2015
- Report Date
- October 11, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601004
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2010; INCLUDING SMALL BOWEL OBSTRUCTION SURGERY, WERE NOT PROVIDED. ON (B)(6) 2010: (B)(6). INTRAOPERATIVE REPORT. IMPLANTS: BARD MESH SIZE 3 X 6. SITE: ABDOMEN. MANUFACTURER: DAVOL INC. ON (B)(6) 2010: (B)(6). (B)(6), MD; (B)(6), MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: VENTRAL HERNIA. PROCEDURE: VENTRAL HERNIA REPAIR WITH OVERLAY MARLEX MESH AND EXTENSIVE LYSIS OF ADHESIONS. FINDINGS: ¿SIGNIFICANT AMOUNT DENSE ADHESIONS INVOLVING THE SMALL BOWEL TO THE ABDOMINAL WALL.¿ IMPLANTS: MARLEX MESH. SPECIMEN REMOVED: HERNIA SAC. COMPLICATIONS: ¿NONE. PROCEDURE WELL TOLERATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ INDICATION: MR. (B)(6) IS A 61-YEAR-OLD MALE PATIENT WHO DR. (B)(6) HAS OPERATED PREVIOUSLY FOR A SMALL BOWEL OBSTRUCTION. HE DEVELOPED AN INCISIONAL HERNIA LATER. HE WAS ADMITTED PREVIOUSLY ALSO WITH SMALL-BOWEL RESECTION WHICH HAS RESOLVED WITH NONOPERATIVE MANAGEMENT. HE STATED THAT HE WOULD LIKE TO HAVE THIS HERNIA REPAIRED IN AN ELECTIVE FASHION. UPON PHYSICAL EXAM HE WAS NOTED TO HAVE A MIDLINE SUPRAUMBILICAL INCISION WITH A LARGE BULGE. THE PATIENT REQUESTED THAT [SIC] HAVE THE HERNIA REPAIRED AND IT [SIC] ALSO GIVEN HIS PREVIOUS HISTORY OF SMALL BOWEL OBSTRUCTION, THE VENTRAL HERNIA REPAIR WAS AGREED TO BE PERFORMED. THE PROCEDURE, RISKS, AND BENEFITS WERE EXPLAINED. THE PATIENT UNDERSTOOD AND AGREED TO HAVE THE PROCEDURE PERFORMED. DESCRIPTION: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN DORSAL DECUBITUS POSITION. ONCE ADEQUATE ANESTHESIA WAS ACHIEVED, THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A MIDLINE SUPRA AND INFRAUMBILICAL INCISION WAS MADE. SUBCUTANEOUS TISSUE WAS TAKEN ALL THE WAY DOWN TO THE FASCIA AT THE INFERIOR MARGIN. CAREFUL DISSECTION WAS PERFORMED AT THE LEVEL OF THE SAC. ONCE THE SAC WAS PROPERLY IDENTIFIED IT WAS ENTERED WITH METZENBAUM SCISSORS AND COMPLETED WITH ELECTROCAUTERY AT WHICH TIME WE NOTICED A SMALL SUPERFICIAL CAUTERY MARK PRESENT IN THE SMALL BOWEL. AT THIS TIME TO [SIC] 3-0 SILK INTERRUPTED SUTURES WERE PLACED IN A LEMBERT FASHION. WE THEN ENCOUNTERED A SIGNIFICANT AMOUNT OF DENSE ADHESIONS INVOLVING SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL. THESE WERE CAREFULLY TAKEN DOWN WITH METZENBAUM SCISSORS. OF NOTE [SIC]. AFTER LYSING ALL THE ADHESIONS FROM THE ABDOMINAL WALL, THE HERNIA SAC WAS EXCISED AND SENT TO PATHOLOGY FOR FURTHER EXAMINATION. WE THEN IDENTIFIED HEALTHY MARGINS OF THE FASCIA BY CREATING BILATERAL SUPERIOR AND INFERIOR SUBCUTANEOUS FLAPS. WE DETERMINED THEN THAT THE INFERIOR PORTION OF THE FASCIA WAS STILL WITH SOME SMALL DEFECT AND VERY TENSE, SO WE EXTENDED THE FASCIAL INCISION INFERIORLY. AFTER WE DEEMED THAT WE HAD A GOOD QUALITY FASCIA AND WE HAD GREAT ADEQUATE BILATERAL SUPERIOR INFERIOR SUBCUTANEOUS FLAPS, WE THEN PLACED A OVERLAY MARLEX MESH BY SECURING IT IN THE LEFT LATERAL WALL WITH A RUNNING ZERO PROLENE. WE THEN PLACED SEVERAL INTERRUPTED ZERO PROLENE AT THE RIGHT LATERAL PORTION. THE MARLEX MESH UTILIZED WAS MEASURED APPROXIMATELY 3 X 6 INCHES. WE THEN PROCEEDED TO THE [SIC] APPROXIMATE THE FASCIA IN A RUNNING FASHION WITH A #1 PROLENE AND THEN THE MARLEX MESH WAS PARACHUTED AND TIED DOWN [SIC] WITH THE PREVIOUSLY PLACED RIGHT LATERAL INTERRUPTED PROLENE SUTURES. THE MESH SEEMED TO BE PERFECTLY PLACED, NO TENSION OR EXCESSIVELY LOOSENESS. AT THIS TIME WE IRRIGATED THE WOUND WITH A LITER OF NORMAL SALINE. WE THEN PLACED A 15 BLAKE DRAIN INTO THE SUBCUTANEOUS CAVITY TO PROTECT FROM A SEROMA AND POTENTIAL INFECTION. INTERRUPTED 3-0 VICRYL WAS UTILIZED TO APPROXIMATE THE SUBCUTANEOUS TISSUE IN AN ATTEMPT TO OBLITERATE OR REDUCE THE DEAD SPACE AND POTENTIAL SEROMA FORMATION. THE SKIN WAS THEN CLOSED WITH 4-0 MONOCRYL IN A SUBCUTICULAR RUNNING FASHION. BENZOIN, STERI-STRIPS, TELFA AND TEGADERM WERE APPLIED. THE PATIENT TOLERATED WELL THE PROCEDURE. THERE WERE NO COMPLICATIONS. HE WAS SUCCESSFULLY EXTUBATED IN THE OPERATING ROOM AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ ON (B)(6) 2010: (B)(6). (B)(6), MD. PATHOLOGY REPORT. ACCESSION #: (B)(4). DIAGNOSIS: CONSISTENT WITH VENTRAL HERNIA SAC. CLINICAL INFORMATION: PRE-OPERATIVE DX: VENTRAL HERNIA. SPECIMENS SUBMITTED: 1 HERNIA, VENTRAL. GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN LABELED ¿VENTRAL HERNIA SAC¿. IT CONSISTS OF AN 11 X 6 X 4 CM AGGREGATE TAN PURPLE FIBROADIPOSE TISSUE FRAGMENTS. NO FOCAL AREAS OF NODULARITY ARE GROSSLY IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. ON (B)(6) 2010: (B)(6). (B)(6), MD. DISCHARGE SUMMARY. DIAGNOSIS: VENTRAL INCISIONAL HERNIA. POSTOP DID WELL, BUT BOWEL FUNCTION WAS SLOW TO RETURN. POSTOP DAY 2, COMPLAINING OF ABDOMINAL DISTENTION, BLOATING, SOME NAUSEA, VOMITING. (B)(6) ABDOMEN BETTER, DISCHARGED HOME. HE WAS TOLD TO WEAR BINDER AT ALL TIMES. ON (B)(6) 2013: [MISSING RECORDS: RADIOLOGY REPORT FOR ¿DEFECT IN THE FASCIA WITH LOOP OF BOWEL ENTERING AND LEAVING THE FASCIAL DEFECT¿ WAS NOT PROVIDED.] ON (B)(6) 2013: (B)(6). (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PRE/POSTOP DIAGNOSIS: SMALL BOWEL OBSTRUCTION WITH INCARCERATED INCISIONAL HERNIA. PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS, REPAIR OF VENTRAL HERNIA WITH GORE DUALMESH 25 X 20 CM. INDICATION: THIS IS A 64-YEAR-OLD GENTLEMAN WITH A PREVIOUS EXPLORATORY LAPAROTOMY FOR SMALL BOWEL OBSTRUCTION AND ALSO AN OPEN VENTRAL HERNIA REPAIR WITH MARLEX MESH IN AN ONLAY FASHION WHO PRESENTED WITH 5 DAYS OF PARTIAL SMALL BOWEL OBSTRUCTION. THE PATIENT WAS PASSING GAS AND HAVING BOWEL MOVEMENTS, HOWEVER STILL HAD NAUSEA AND VOMITING AND REQUIRED AN NG TUBE DECOMPRESSION. HIS X-RAY ON HOSPITAL DAY 4 STILL DEMONSTRATED DILATED LOOPS OF SMALL BOWEL WITH AIR-FLUID LEVELS. THEREFORE, HE WAS CONSENTED FOR LAPAROSCOPIC LYSIS OF ADHESIONS, POSSIBLE BOWEL RESECTION, AND REPAIR OF HIS VENTRAL HERNIA. HIS CAT SCAN DEMONSTRATED A DEFECT IN THE FASCIA WITH LOOP OF BOWEL ENTERING AND LEAVING THE FASCIAL DEFECT. AFTER ALL QUESTIONS WERE ANSWERED, THE CONSENT WAS SIGNED. DESCRIPTION: ¿THE PATIENT WAS BROUGHT TO THE OPERATING ROOM. HE WAS PLACED SUPINE ON THE OR TABLE AND WAS INTUBATED BY ANESTHESIA WITH LITTLE DIFFICULTY. THE ABDOMEN WAS THEN PREPPED AND DRAPED IN THE STANDARD STERILE FASHION. PREOPERATIVE ANTIBIOTICS WERE GIVEN, AND SUBCUTANEOUS HEPARIN WAS GIVEN AS WELL. AFTER A TIMEOUT WAS PERFORMED, A SUBXIPHOID HASSON PORT WAS PLACED. THIS WAS CREATED WITH A 2 CM VERTICAL INCISION BELOW THE XIPHOID. THE FASCIA WAS GRABBED, AND 2-0 PROLENE STAY SUTURES WERE PLACED. THE HASSON PORT WAS THEN INSERTED INTO THE ABDOMEN, AND THE ABDOMEN WAS INSUFFLATED TO 15 MMHG. NO STRUCTURES WERE INJURED DURING INSERTION OF THE HASSON PORT. AT THIS POINT IN TIME, THE LEFT SIDE OF THE ABDOMINAL WALL WAS IDENTIFIED, AND TWO 5 MM PORTS WERE PLACED 1 HANDBREADTH AWAY FROM EACH OTHER AT THE LATERAL MOST ASPECT OF THE ABDOMINAL WALL. FOLLOWING THIS, A RIGHT 5 MM PORT WAS PLACED IN THE LATERAL MIDABDOMEN AS WELL. WE THEN PROCEEDED TO SHARPLY LYSE ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL. THE BOWEL WAS ADHERENT TO THE MARLEX MESH WHICH WAS IDENTIFIED. THE ANTERIOR ABDOMINAL WALL FASCIA WAS FOUND TO BE A ¿SWISS-CHEESE¿ CONFIGURATION WITH MULTIPLE DEFECTS IN THE FASCIA. THE MARLEX MESH AGAIN WAS SEEN, AND THE SMALL BOWEL WAS PEELED AWAY FROM IT. CARE WAS TAKEN TO ENSURE THAT THE SEROSA OF THE BOWEL WAS NOT INJURED. THE BOWEL WAS FINALLY TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL AND THEN WAS REEXAMINED ONCE MORE. THERE WAS NO EVIDENCE OF SEROSAL TEARS OR FULL-THICKNESS INJURIES. WE THEN PROCEEDED TO RUN THE SMALL BOWEL FROM THE LIGAMENT OF TREITZ UP UNTIL THE MIDJEJUNUM, AFTER WHICH THERE WAS OVERABUNDANCE OF OMENTUM, WE WERE UNABLE TO DO SO. WE THEN PROCEEDED TO MEASURE OUR FASCIAL DEFECT, WHICH WAS MEASURED TO BE APPROXIMATELY 25 CM VERTICALLY X 20 CM ACROSS. WE CHOSE A GORE DUALMESH TO BE PLACED IN AN INLAY FASHION. PROLENE 0 SUTURES WERE USED TO TAG THE NORTH, SOUTH, EAST, AND WEST SIDES OF THE MESH IN ORDER TO CREATE STAY SUTURES. THE MESH WAS THEN ROLLED UP INTO A CIGAR AND PLACED THROUGH A 15 MM PORT, WHICH WAS PLACED IN THE SUBXIPHOID REGION AND REPLACED THE 12 MM HASSON THAT WAS INITIALLY THERE . THE MESH WAS THEN UNFOLDED, AND USING THE CARTER-THOMPSON ENDO CLOSURE DEVICE, A SMALL INCISION WAS MADE OVERLYING THE LATERAL ASPECT OF THE HERNIA DEFECT, AND THE CARTER-THOMPSON NEEDLE WAS USED TO PULL THE TAIL ENDS OF THE 0 PROLENE SUTURES THROUGH THE SKIN. THIS WAS DONE AT ALL 4 QUADRANTS, AND THE SUTURES WERE THEN TIED DOWN UNTIL THE MESH WAS CINCHED AGAINST THE ANTERIOR ABDOMINAL WALL. AT THIS POINT IN TIME, WE USED THE ABSORBATACK WAS USED [SIC] TO TACK THE MESH TO THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY. THE MESH WAS HELD SLIGHTLY TAUT SO AS TO GET THE EDGES OF THE MESH FIRMLY AGAINST THE ANTERIOR ABDOMINAL WALL AND PERITONEUM. SEVERAL TACKS WERE PLACED IN THE CENTER OF THE MESH AS WELL TO HELP THE MESH SIT EVEN MORE FLUSH WITH THE ABDOMINAL WALL AND POTENTIALLY PREVENT A SEROMA. AT THIS POINT IN TIME, WE WERE SATISFIED WITH THE POSITION OF HER MESH, AND THE ABDOMEN WAS ALLOWED TO DESUFFLATE. THE 5 MM PORTS WERE REMOVED UNDER DIRECT VISION, AND THERE WAS NO BLEEDING NOTED. THE 15 MM HASSON PORT WAS THEN REMOVED, AND STAY SUTURES WERE USED TO CLOSE THE FASCIAL LAYER. ADDITIONALLY, A 0 VICRYL SUTURE WAS USED IN A FIGURE-OF-EIGHT FASHION TO CLOSE THIS DEFECT AS WELL. THE SUBCUTANEOUS TISSUE WAS THEN IRRIGATED, AND THE SKIN WAS CLOSED USING 4-0 MONOCRYL SUBCUTICULAR CLOSURE, STERI-STRIPS, TELFA, AND TEGADERM. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS EXTUBATED IN THE OR WITH NO DIFFICULTY. HE WAS BROUGHT TO THE PACU IN STABLE CONDITION. I WAS PRESENT FOR THE ENTIRE PROCEDURE, AND THERE WERE NO COMPLICATIONS NOTED, AND ALL SPONGE AND INSTRUMENT COUNTS WERE CORRECT AT THE CONCLUSION OF THE PROCEDURE.¿ ON (B)(6) 2013: [ASSIGNED PER OPERATIVE REPORT 06/10/13] (B)(6). [ILLEGIBLE]. BRIEF OP NOTE. PRE/POSTOP DIAGNOSIS: SBO, RECURRENT VENTRAL HERNIA. PROCEDURE: LAPAROSCOPIC ENTEROLYSIS, REDUCTION AND REPAIR OF RECURRENT VENTRAL HERNIA WITH DUALMESH. SURGEON: (B)(6).. ASSISTANT: [ILLEGIBLE]. IMPLANTS: YES. TYPE: MESH. SPECIMEN REMOVED: NO. IMPLANT STICKER. GORE® DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER (B)(4). LOT BATCH CODE 8588984. W.L. GORE & ASSOCIATES. ON (B)(6) 2013: (B)(6). INTRAOPERATIVE RECORD. IMPLANTS: PATCH DUALMESH SURG PLUS 20 CM C 30 CM X 1 MM. LOT #: 8588984. CATALOG #: 1DLMC07. IMPLANT SIZE: 20 X 30 X 0.1. SITE: ABDOMEN. MANUFACTURER: W.L. GORE & ASSOCIATES INC. EXPIRATION: 12/01/2015. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC07/8588984) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2013: (B)(6). (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: ON (B)(6) 2013. DIAGNOSIS: SMALL BOWEL OBSTRUCTION WITH INCARCERATED INCISIONAL HERNIA. HOSPITAL COURSE: PREVIOUS EXPLORATORY LAPAROTOMY FOR SMALL BOWEL OBSTRUCTION, ALSO OPEN VENTRAL HERNIA REPAIR WITH MARLEX MESH IN AN ONLAY FASHION . TOLERATED PROCEDURE WELL, UNEVENTFUL POSTOP. POSTOP DAY 3, DISCHARGED HOME. INSTRUCTED NOT TO LIFT ANYTHING HEAVIER THAN 15 POUNDS. ON (B)(6) 2015: (B)(6). (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. CO-SURGEON: (B)(6), MD. PRE/POSTOP DIAGNOSIS: RECURRENT VENTRAL HERNIA . PROCEDURE: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF OLD UNDERLAY MESH AS WELL AS REMOVAL OF OVERLAY MESH , VENTRAL HERNIA REPAIR PERFORMED BY DR. (B)(6), WITH AN OVERLYING MESH AS WELL AS ABDOMINAL COMPONENT SEPARATION. IMPLANTS: GORE DUAL-MESH. SPECIMEN REMOVED: 2 SEPARATE MESHES. INDICATION: MR. (B)(6) IS A 66-YEAR-OLD MALE WHO HAD A PREVIOUS LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH PERFORMED BY ME SEVERAL YEARS AGO. HE PRESENTED WITH RECURRENT SMALL BOWEL OBSTRUCTIONS, WHICH RESOLVED WITH CONSERVATIVE MANAGEMENT. HOWEVER, HAD A RECURRENT HERNIA. HE WAS ADVISED TO UNDERGO DIETARY CHANGES AND LOST A SIGNIFICANT AMOUNT OF WEIGHT. HE IS THEREFORE HERE TODAY FOR A COMBINED GENERAL AND PLASTIC SURGERY CLOSURE OF HIS LARGE ABDOMINAL WALL HERNIA. DESCRIPTION: ¿AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON A ROLLING STRETCHER. HE WAS PLACED ON THE OPERATING ROOM TABLE IN A SUPINE POSITION. GENERAL ANESTHESIA WAS GIVEN AND THE PATIENT WAS INTUBATED WITH NO DIFFICULTY. THE PATIENT¿S ABDOMEN WAS THEN PREPPED AND DRAPED IN THE STANDARD STERILE FASHION. A TIME-OUT WAS THEN PERFORMED AS PER PROTOCOL. WE BEGAN THE PROCEDURE BY ENTERING THE PATIENT¿S ABDOMEN APPROXIMATELY 8 CM FROM THE XIPHOID AND CARRYING OUR INCISION DOWN TO THE LEVEL OF HIS PREVIOUS INCISION IN THE SUPRAPUBIC REGION. WE ENTERED THE ABDOMEN IN A VIRGIN PLANE AND WERE ABLE TO IDENTIFY THE PREVIOUSLY PLACED UNDERLYING MESH. WE HAD TO LYSE A NUMBER OF ADHESIONS TO THE ANTERIOR ABDOMINAL WALL AS WELL AS TO THE UNDERLAY MESH AND WE CAREFULLY DISSECTED IT AWAY FROM THE FASCIA. A SMALL SEROMYOTOMY WAS MADE IN THE SMALL BOWEL, WHICH WAS REPAIRED WITH INTERRUPTED 3-0 VICRYL LEMBERT SUTURES. ONCE THE BOWEL WAS ALL TAKEN DOWN, THE REMAINDER OF THE ABDOMINAL FASCIA WAS OPENED AND THE PREVIOUSLY PLACED UNDERLAY MESH WAS REMOVED IN ITS ENTIRETY USING ELECTROCAUTERY FROM THE ABDOMINAL WALL FASCIA . AT THIS POINT, THE INTESTINES WERE RUN FROM THE LIGAMENT OF TREITZ TO THE ILEOCECAL VALVE TO ENSURE THERE WERE NO FURTHER ADHESIONS TO BOTH THE ABDOMINAL WALL AS WELL AS TO THE SIDEWALLS. AT THIS POINT, ONCE THE BOWEL WAS COMPLETELY FREED UP, DR. (B)(6) SCRUBBED IN AND PERFORMED HIS PORTION OF THE PROCEDURE, CONSISTING OF A ABDOMINAL COMPONENT SEPARATION, AS WELL AS REPAIR OF VENTRAL HERNIA WITH AN OVERLYING MESH. AT THIS POINT, MY PORTION OF THE PROCEDURE CONCLUDED AND THE PATIENT¿S ABDOMEN WAS CLOSED BY DR. (B)(6). THERE WERE NO COMPLICATIONS WITH MY PORTION OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE PACU IN STABLE CONDITION, AFTER BEING EXTUBATED IN THE OPERATING ROOM. AGAIN, PLEASE SEE DR. DANIEL SCHMID¿S DICTATION FOR THE REMAINDER OF THE CASE.¿ ON (B)(6) 2015: [ASSIGNED PER DISCHARGE SUMMARY ON (B)(6) 2015] (B)(6). (B)(6), MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: MULTIPLE VENTRAL HERNIAS WITH INTERMITTENT OBSTRUCTION AND ILEUS. PROCEDURES: BILATERAL MUSCLE FLAP CLOSURE OF VENTRAL HERNIA. IMPLANTATION OF MESH FOR VENTRAL HERNIA REPAIR. VENTRAL HERNIA REPAIR. CO-SURGEON: DR. (B)(6). DVT [DEEP VEIN THROMBOSIS] PROPHYLAXIS. 5000 UNITS OF HEPARIN WAS GIVEN PREOPERATIVELY SUBCUTANEOUSLY, AND SCDS [SEQUENTIAL COMPRESSION DEVICE] WERE PLACE PRIOR TO INDUCTION OF ANESTHESIA FOR DVT PROPHYLAXIS. INDICATION: THE PATIENT IS A 66-YEAR-OLD MALE WHO HAS UNDERGONE MULTIPLE ABDOMINAL SURGERIES. UNFORTUNATELY, HE DEVELOPED MULTIPLE INCISIONAL HERNIAS AND HAS HAD 2 PRIOR HERNIA REPAIRS WITH BOTH AN UNDERLAY AND ONLAY MESH. HE HAS DEVELOPED A RECURRENCE OF THESE HERNIAS AND RECENTLY HAD A SMALL BOWEL OBSTRUCTION DUE TO BOWEL COMING THROUGH THE HERNIA SACS AND NOT PERISTALSING WELL. HE WAS ABLE TO BE TREATED WITH AN NG TUBE DECOMPRESSION AND WAS DISCHARGED TO FOLLOW UP WITH US AND TO SCHEDULE THIS AS AN OUTPATIENT PROCEDURE. HE SAW ME IN MY OFFICE ABOUT 2 WEEKS AGO, AND WE DISCUSSED THE PROCEDURE IN DETAIL. I DISCUSSED THE BILATERAL COMPONENT SEPARATION, WHICH INVOLVES DISSECTION UNDERNEATH THE SKIN ON TOP OF THE ANTERIOR ABDOMINAL WALL AND CUTTING THROUGH THE EXTERNAL OBLIQUE MUSCLE TO ALLOW SLIDING OF THE MUSCULATURE MORE MEDIALLY. THIS WILL ALLOW FOR A PRIMARY CLOSURE AND REMOVAL OF ANY PRIOR MESH AND HERNIA SAC IN THE MIDLINE WHERE HIS HERNIAS ARE FOUND. HE UNDERSTANDS THE RISKS AND BENEFITS OF THIS INCLUDING INFECTION, BLEEDING, PAIN, RECURRENCE OF THE HERNIA, SEROMA, HEMATOMA, NEED FOR FURTHER OPERATIONS. I WANTED TO A [SIC] STRATTICE-TYPE MESH GIVEN THE FACT THAT HE HAS HAD MULTIPLE PRIOR OPERATIONS AND MULTIPLE OTHER MESHES PLACED IN THE ABDOMEN INCLUDING GORE-TEX MESH, WHICH HE HAD RECURRED THROUGH. I ATTEMPTED TO HAVE THIS APPROVED BY HIS INSURANCE CARRIER AND TALKED TO THE INSURANCE CARRIER WITH A PEER-TO-PEER, AND THEY BELIEVE THAT STRATTICE IS AN EXPERIMENTAL PRODUCT AND WOULD NOT APPROVE IT. THEREFORE, WE WILL ALSO USE A DUAL-MESH GORE-TEX MESH AS AN UNDERLAY TO REINFORCE THE COMPONENT SEPARATION PRIMARY REPAIR. DESCRIPTION: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE A TIME-OUT WAS PERFORMED AND CONFIRMED SITE AND SIDE OF OPERATION. DR. (B)(6) BEGAN THE FIRST PART OF THE PROCEDURE. THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION, AND DR. (B)(6) BEGAN WITH A VENTRAL MIDLINE INCISION TO EXPOSE THE HERNIA SACS, LYSE ALL THE ADHESIONS, EXPOSE THE OLD MESH AND REMOVE IT, AND THEN PREPARE THE WOUND FOR CLOSURE. AFTER HE HAD COMPLETED ALL THIS, I BEGAN BY REMOVING THE REMAINING ONLAY MESH WHICH WAS LEFT BEHIND. THIS MESH WAS ON ONLAY FASHION ON TOP OF THE ANTERIOR RECTUS FASCIA. THIS WAS REMOVED WITH RETRACTION AND PICKUPS AND SCISSORS AND THE ELECTROCAUTERY. AFTER ALL THE MESH HAD BEEN ADEQUATELY REMOVED, WE THEN BEGAN BY OPENING UP THE MORE LATERAL RIGHT SIDED ABDOMINAL WALL HERNIA WHERE A LARGE AMOUNT OF BOWEL HAD BEEN PROTRUDING PREOPERATIVELY . THE INTERVENING FASCIA AND HERNIA SAC WERE EXCISED AND REMOVED. AFTER DOING THIS, WE DID FIND THAT THE EDGE WAS HEALTHY AFTER REMOVING THE PRIOR MESH AS WELL AS THE HERNIA SAC ON THE RIGHT SIDE. NEXT, DISSECTION WAS CARRIED OUT ON TOP OF THE ANTERIOR RECTUS FASCIA LATERALLY ON THE RIGHT SIDE. WE CARRIED DISSECTION ALL THE WAY TO THE ANTERIOR AXILLARY LINE. NEXT, AN INCISION WAS MADE WITH THE ELECTROCAUTERY IN THE EXTERNAL OBLIQUE FASCIA AND THROUGH THE EXTERNAL OBLIQUE MUSCLE ITSELF. THEN, DISSECTION WAS CARRIED OUT THROUGH THE PLANE BETWEEN THE EXTERNAL OBLIQUE AND THE INTERNAL OBLIQUE MUSCLES TO ALLOW SLIDING OF THE RIGHT-SIDED ANTERIOR ABDOMINAL WALL MUSCULATURE TOWARDS THE MIDLINE. THIS WAS ONE OF THE MUSCLE FLAPS FOR CLOSURE OF THE ABDOMEN. ON THE LEFT SIDE, WE AGAIN USED DOUBLE HOOKS TO EXPOSE THE ANTERIOR RECTUS FASCIA AND DISSECTED ON TOP OF THE ANTERIOR RECTUS FASCIA WITH ELECTROCAUTERY. DISSECTION WAS CARRIED TO THE ANTERIOR AXILLARY LINE, WHERE AGAIN, AN INCISION WAS MADE IN THE EXTERNAL OBLIQUE FASCIA AND THE EXTERNAL OBLIQUE MUSCLE. DISSECTION WAS THEN CARRIED OUT PAST THE ANTERIOR AXILLARY LINE LATERALLY TO ALLOW FOR SLIDING OF THE POSTERIOR MUSCULATURE OF THE INTERNAL OBLIQUE AND TRANSVERSALIS MUSCLES TOWARDS THE MIDLINE. WE GOT VERY GOOD MOTION OF THE MUSCLE AND WERE ABLE TO GET EACH EDGE OF THE RECTUS MUSCLE AND THE ANTERIOR RECTUS FASCIA TOUCHING WITHOUT ANY TENSION. NEXT, WE BEGAN BY PLACING A DUAL-MESH UNDERLAY GORE-TEX MESH IN THE ABDOMEN. CARE WAS TAKEN TO MEASURE THIS CORRECTLY. A PIECE OF 20 X 30 GORE-TEX DUAL MESH WAS OPENED, LOT #11171312, REFERENCE #(B)(4). THIS WAS CUT TO THE APPROPRIATE SIZE FOR THE HERNIA. IT WAS SOAKED IN BACITRACIN SOLUTION. NEXT, IT WAS PLACED IN THE ABDOMEN WITH THE NONADHERENT SIDE DOWN TOWARDS THE BOWEL. 0 PDS SUTURES WERE THEN USED TO SECURE THE MESH IN PLACE. CARE WAS TAKEN TO PLACE ALL OF THE TENSION ON THE ABDOMINAL CLOSURE ON THE MESH ITSELF AND NOT ON THE ANTERIOR RECTUS FASCIA OR THE RECTUS MUSCLES THEMSELVES. THE MESH WAS WIDELY PLACED UNDERNEATH THE HERNIA TO REINFORCE THE HERNIA AND TAKE ALL THE TENSION OFF OF THE PRIMARY CLOSURE OF THE ANTERIOR ABDOMINAL WALL MUSCULATURE. THESE SUTURES WERE PLACED WHILE THERE WAS STILL A LAP IN THE ABDOMEN TO PROTECT THE BOWEL. CARE WAS TAKEN TO AVOID STRIKING THE BOWEL WITH ANY OF THE STITCHES DURING THE ENTIRE PROCESS OF PLACING THE MESH. GREATER THAN 20 STITCHES WERE PLACED AROUND THE BORDER OF THE MESH THROUGH THE ANTERIOR ABDOMINAL INTO THE MESH AND BACK OUT THE ANTERIOR ABDOMINAL WALL IN FIGURE-OF-EIGHT FASHION. THESE WERE THEN SEQUENTIALLY TIED, AND THE HERNIA WAS CLOSED WITH A GOOD UNDERLAY MESH. NEXT, THE WOUND WAS IRRIGATED OUT WITH 2 L OF NORMAL SALINE THAT WAS WARM. HEMOSTASIS WAS CONFIRMED OVER THE ENTIRE SPACE OF THE DISSECTION. PRIOR TO SUTURING DOWN THE MESH, THE LAPS WERE REMOVED FROM WITHIN THE ABDOMEN THAT HAD BEEN PROTECTING THE BOWEL. AFTER HEMOSTASIS WAS CONFIRMED, TWO 19 BLAKE DRAINS WERE PLACED, 1 ON EACH SIDE OF THE ABDOMEN JUST BELOW THE SUBCUTANEOUS SPACE ON TOP OF THE ANTERIOR RECTUS FASCIA. THESE WERE PLACED IN THE GUTTERS ON EACH SIDE. NEXT, WE THEN USED 2-0 PDSS TO CLOSE THE RECTUS MUSCLES TO EACH OTHER IN THE MIDLINE. THIS WAS DONE IN RUNNING FASHION, 1 FROM THE BOTTOM, 1 FROM THE TOP, AND TIED IN THE MIDDLE. THERE WAS ABSOLUTELY NO TENSION ON THIS CLOSURE DUE TO THE FACT THAT THE TENSION WAS ALL ON THE MESH INSIDE THE ABDOMEN. WE GOT VERY GOOD PRIMARY CLOSURE WITH GOOD BLEEDING FASCIAL EDGES ON EACH SIDE. THIS COMPLETED THE INCISIONAL VENTRAL HERNIA REPAIR. NEXT, THE EDGES OF THE SKIN INCISION WERE TRIMMED WITH MAYO SCISSORS, AND GOOD BLEEDING WAS FOUND. 2-0 VICRYL STITCHES WERE PLACED IN THE DEEP DERMAL LAYER FOLLOWED BY STAPLES IN THE SKIN. AN ISLAND DRESSING WAS PLACED OVER THE INCISION. BIOPATCHES AND TEGADERM WERE PLACED OVER THE DRAINS, AND THE PATIENT WAS PLACED IN AN ABDOMINAL BINDER PRIOR TO WAKING HIM UP. HE WAS AWOKEN AND TAKEN TO THE PACU IN STABLE CONDITION WHERE HE WILL BE ADMITTED FOR PAIN CONTROL AND OBSERVATION.¿ ON (B)(6) 2015: [ASSIGNED PER OPERATIVE REPORT DATE] (B)(6). [ILLEGIBLE]. BRIEF OP NOTE. PRE/POSTOP DIAGNOSIS: RECURRENT VENTRAL HERNIA. PROCEDURE: EXLAP, LOA [LYSIS OF ADHESIONS], REMOVAL OF ABD MESH (UNDERLAY/OVERLAY), VHR [VENTRAL HERNIA REPAIR] UNDERLAY MESH, ABDOMINAL COMPARTMENT SEPARATION. SURGEON: (B)(6); (B)(6). ASSISTANT: (B)(6). IMPLANTS: YES. TYPE: MESH. SPECIMEN REMOVED: YES. TYPE: MESH X 2. IMPLANT STICKER. GORE® DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER (B)(4). LOT BATCH CODE 11171312. W.L. GORE & ASSOCIATES. ON (B)(6) 2015: (B)(6). INTRAOPERATIVE RECORD. IMPLANTS: PATCH DUALMESH PLUS 20X30X1. MODEL #: 1DLMC07. MANUFACTURER: W.L. GORE & ASSOCIATES INC. SITE: ABDOMEN. LOT #: 11171312. EXPIRATION: 01/01/2018. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC07/11171312) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2015: (B)(6). (B)(6), MD. PATHOLOGY REPORT. ACCESSION #: (B)(4). CLINICAL INFORMATION: NONE GIVEN. PREOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA WITH OBSTRUCTION. EX. LAP, LYSIS OF ADHESIONS, REMOVAL OF MESH COMPONENT SEPARATION, INLAY MESH, VENTRAL HERNIA REPAIR. POSTOP DIAGNOSIS: NONE GIVEN. SPECIMEN SUBMITTED: ABDOMINAL MESH. ABDOMINAL MESH. DIAGNOSIS: ABDOMINAL MESH #1, HERNIA REPAIR: MESH MATERIAL AND FIBROADIPOSE TISSUE WITH FOREIGN BODY GIANT CELL REACTION. ABDOMINAL MESH #2, HERNIA REPAIR: MESH MATERIAL AND FIBROADIPOSE TISSUE WITH FOREIGN BODY GIANT CELL REACTION. GROSS DESCRIPTION: 1) THE SPECIMEN IS RECEIVED IN FORMALIN LABELED WITH THE PATIENT¿S NAME AND ¿ABDOMINAL MESH #1¿ AND CONSISTS OF TWO IRREGULAR FRAGMENTS OF SYNTHETIC MESH MATERIAL BOTH WITH ATTACHED TAN-GRAY FIBROUS TISSUE AND TAN-YELLOW FATTY TISSUE MEASURING 11.5 X 10.0 X 0.4 CM AND 15.5 X 14.8 X 0.4 CM. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES. 2) THE SPECIMEN IS RECEIVED IN FORMALIN LABELED WITH THE PATIENT¿S NAME AND ¿ABDOMINAL MESH #2¿ AND CONSISTS OF A [SIC] TWO IRREGULAR FRAGMENTS OF SYNTHETIC MESH MATERIAL BOTH WITH ATTACHED TAN-YELLOW FATTY TISSUE AND TAN-GRAY FIBROMEMBRANOUS TISSUE WITH FOCAL HEMORRHAGE MEASURING 15.0 X 8.6 X 1.0 CM AND 5.5 X 4.5 X 2.0 CM. SECTIONING REVEALS FIBROSIS SURROUNDING THE SYNTHETIC MESH. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES. ON (B)(6) 2015: (B)(6). (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: ON (B)(6) 2015. HOSPITAL COURSE: ADMITTED FOLLOWING ELECTIVE COMPLEX VENTRAL HERNIA REPAIR, PERFORMED IN CONJUNCTION WITH DR. (B)(6) OF PLASTIC SURGERY. HOSPITAL COURSE UNEVENTFUL. POST OP DAY 2 OUT OF BED IN ABDOMINAL BINDER. DISCHARGED WITH JACKSON PRATT DRAINS IN PLACE. INSTRUCTIONS TO WEAR ABDOMINAL BINDER, TAUGHT HOW TO CARE FOR DRAINS . A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT THE GORE DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2009: (B)(6) , MD. HISTORY AND PHYSICAL. 2 DAYS NAUSEA, VOMITING, DIARRHEA. UNABLE TO KEEP FOOD DOWN, ABDOMINAL DISCOMFORT. EXAM ABDOMEN: POSITIVE BOWEL SOUNDS, SOFT, MILD TENDERNESS LEFT LOWER QUADRANT. WAS AN INCISIONAL HERNIA. IMPRESSION: FOOD POISONING VERSUS VIRAL GASTROENTERITIS. (B)(6) 09: [FACILITY NI]. (B)(6) , MD. EMERGENCY ROOM VISIT. ABDOMINAL PAIN, SORENESS LEFT UPPER QUADRANT AND RIGHT LOWER QUADRANT, ASSOCIATED WITH NAUSEA, VOMITING PAST 3 DAYS. HISTORY: STATUS POST EXPLORATORY LAPAROTOMY, ABDOMINAL WALL HERNIA. EXAM ABDOMEN: BOWEL SOUNDS ACTIVE, MILD TENDERNESS LEFT UPPER QUADRANT, PALPABLE RIGHT PARA-MEDIAN REDUCIBLE ABDOMINAL HERNIA. REVIEW CT SCAN, SURGICAL CONSULT OBTAINED. IMPRESSION: SMALL BOWEL OBSTRUCTION. PLAN: ADMITTED. (B)(6) 2009: (B)(6) HOSPITAL. (B)(6) , DO, RESIDENT; (B)(6) , MD. RADIOLOGY ¿ CT ABDOMEN. LEFT UPPER QUADRANT PAIN. FINDINGS: DILATED STOMACH AND PROXIMAL SMALL BOWEL LOOPS WITH TRANSITION POINT IDENTIFIED WITHIN ANTERIOR ABDOMINAL WALL HERNIA INVOLVING DISTAL ILEUM. RELATIVE DECOMPRESSION OF TERMINAL ILEUM IN COMPARISON WITH DECOMPRESSED SMALL BOWEL LOOPS. AIR WITHIN COLON. INDURATION AROUND ABDOMINAL WALL HERNIA. IMPRESSION: ANTERIOR WALL HERNIA SMALL BOWEL OBSTRUCTION INVOLVING DISTAL ILEUM. (B)(6) 2009: (B)(6) , MD. PROGRESS NOTES. DENIES NAUSEA, VOMITING. TOLERATING SIPS OF CLEARS, POSITIVE FLATUS, NO BOWEL MOVEMENT. ABDOMEN SOFT, NONTENDER, NONDISTENDED, NORMOACTIVE BOWEL SOUNDS, REDUCIBLE VENTRAL HERNIA. (B)(6) 2010: [FACILITY NI]. (B)(6) , MD. HISTORY AND PHYSICAL. DIAGNOSIS: VENTRAL INCISIONAL HERNIA. HAD SURGERY FOR SMALL BOWEL OBSTRUCTION. DEVELOPED INCISIONAL HERNIA ON PORT. ADMITTED, SIGNS AND SYMPTOMS OF SMALL BOWEL OBSTRUCTION WHICH RESOLVED. SCHEDULE REPAIR OF HERNIA. HOPED HE COULD LOSE WEIGHT, NOW 10 POUNDS LIGHTER. EXAM ABDOMEN: VERTICAL INCISION BULGE 6 CM IN DIAMETER THAT PROTRUDES, NO REDUCIBLE. ASSESSMENT/PLAN: VENTRAL INCISIONAL HERNIA, TROUBLE IN PAST WITH SMALL BOWEL OBSTRUCTION FROM THIS HERNIA. PROCEED WITH REPAIR OF HERNIA NOW THAT STARTED TO LOSE WEIGHT. (B)(6) 2013: (B)(6) , DO. EMERGENCY DEPARTMENT VISIT. ABDOMINAL PAIN. ONSET CENTRAL ABDOMINAL PAIN AROUND 1PM YESTERDAY, INTERMITTENT BLOATING, ¿FEELS LIKE IT¿S FROM MY HERNIA REPAIR¿. EXPERIENCING ALTERNATING DIARRHEA AND CONSTIPATION OVER PAST 6 MONTHS, INCREASED DIARRHEA THIS MORNING. EXAM ABDOMEN: BOWEL SOUNDS ACTIVE, 15 CM VENTRAL SCAR WITH TENDERNESS OVER SCAR, 2 CM PALPABLE MASS PATIENT STATES CHRONIC AND SCAR TISSUE. ADMITTED. (B)(6) 2013: (B)(6) CENTER. (B)(6) , RESIDENT; (B)(6) , MD. RADIOLOGY¿CT ABDOMEN/PELVIS WITH CONTRAST. HISTORY: NAUSEA, VOMITING, ABDOMINAL PAIN. FINDINGS: DILATED LOOPS OF SMALL BOWEL, MEASURING UP TO 3.3 CM WITHIN ABDOMEN. VENTRAL WALL ABDOMINAL HERNIA, WHERE TRANSITION POINT AT EXITING LOOP OF BOWEL. MORE DISTALLY DECOMPRESSED LOOPS OF BOWEL. MILD INDURATION SURROUNDING LOOPS OF BOWEL WITHIN HERNIA AND ADJACENT TO THE HERNIA. IMPRESSION: SMALL BOWEL OBSTRUCTION, WITH TRANSITION POINT LIKELY ARISING FROM VENTRAL HERNIA. NO FREE AIR. (B)(6) 2013: (B)(6) CENTER. (B)(6) , MD. RADIOLOGY¿PORT ABDOMEN. HISTORY: VOMITING. IMPRESSION: MULTIPLE DILATED LOOPS OF SMALL BOWEL IN UPPER ABDOMEN WORRISOME FOR SMALL BOWEL OBSTRUCTION. (B)(6) 2014: (B)(6) SYSTEM. (B)(6) , MD. OFFICE NOTES. DIAGNOSIS: ABDOMINAL BULGE, POSSIBLE RECURRENT VENTRAL HERNIA. NOTICED FEW MONTHS AGO FELT BULGE WHEN STRAINING, ON RIGHT SIDE MID ABDOMEN LATERAL TO MESH. SUSPECTED RECURRENCE OF HERNIA. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. UPON ASKING TO STRAIN WHILE IN SUPINE POSITION, FOUND TO HAVE LARGE DIASTASIS RECTI IN SUPRAUMBILICAL REGION IN UPPER ABDOMEN. UPON PALPATING TO RIGHT OF MESH AND TO RIGHT OF INCISION, 6 X 6 CM AREA WITH PALPABLE FASCIAL DEFECT AND REDUCIBLE CONTENTS. AREA NONTENDER. PLAN: OBTAIN CT. MORE THAN LIKELY NEED LAPAROSCOPIC OR LESS LIKELY OPEN REPAIR OF RESIDUAL HERNIA. (B)(6) 2014: (B)(6) CENTER. (B)(6) , MD. RADIOLOGY¿CT ABDOMEN/PELVIS WITH CONTRAST. HISTORY: INCISIONAL HERNIA. IMPRESSION: 3 SEPARATE AREAS OF VENTRAL AND INCISIONAL HERNIA. MOST SUPERIOR VENTRAL HERNIA CONTAINING OMENTAL FAT ONLY. SECOND VENTRAL HERNIA IS A RICHTER¿S HERNIA OF PORTION OF WALL OF SMALL BOWEL. THIRD MOST INFERIOR HERNIA PRESUMED TO REPRESENT AN INCISIONAL HERNIA TO RIGHT OF ABDOMINAL MESH CONTAINING LOOP OF SMALL INTESTINE. THESE ARE NONOBSTRUCTIVE. (B)(6) 2014: (B)(6) , MD. OFFICE NOTES. RECURRENT ABDOMINAL BULGE. ASSESSMENT/PLAN: RECURRENCE OF VENTRAL HERNIA. SEE DR. COLIN FAILEY, PLASTIC SURGEON, EVALUATE HIM FOR COMPONENT SEPARATION AT TIME OF HERNIA REPAIR. SURGICAL OPTIONS INCLUDE OPEN VERSUS LAPAROSCOPIC REPAIR, TRY TO PERFORM REDUCTION OF SMALL INTESTINE LAPAROSCOPICALLY, REMOVE OLD MESH LAPAROSCOPICALLY, SEE IF AMENABLE TO LAPAROSCOPIC REPAIR. GIVEN NUMBER OF HERNIAS AND RECURRENCE THUS FAR, I BELIEVE EXTENSIVE REPAIR MAY BE IN ORDER THAT IS WHY GETTING DR. FAILEY INVOLVED. ??/??/14: [MISSING RECORDS: RECORDS FOR ¿DR. COLIN FAILEY, PLASTIC SURGEON, EVALUATE FOR COMPONENT SEPARATION AT TIME OF HERNIA REPAIR¿ WAS NOT PROVIDED.] (B)(6) 2015: (B)(6) CENTER. (B)(6) , MD. OFFICE NOTES. RECURRENT VENTRAL/INCISIONAL HERNIA. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. NO EVIDENCE OF INCARCERATED HERNIAS. ASSESSMENT/PLAN: DISCUSSION ABOUT NEED TO LOSE WEIGHT, TARGET WEIGHT BELOW 220. CURRENTLY 239. RECONVENE IN 3 MONTHS FURTHER EVALUATION AND HOPES OF SCHEDULING FOR ELECTIVE SURGERY. (B)(6) 2015: (B)(6) CENTER. (B)(6) , MD. RADIOLOGY¿XR ABDOMEN COMPLETE 2 OR MORE VIEW. HISTORY: ABDOMINAL PAIN. IMPRESSION: PAUCITY OF BOWEL GAS WITHOUT SIGNIFICANT SMALL BOWEL DILATATION. NO FREE AIR. (B)(6) 2015: (B)(6) . [SIGNATURE ILLEGIBLE]. HISTORY AND PHYSICAL. ABDOMINAL BLOATING SINCE 3PM. ASSESSMENT/PLAN: OBSTRUCTING CHRONIC INCARCERATED VENTRAL HERNIA, ADMIT, NOTHING BY MOUTH, IV FLUIDS, NASOGASTRIC TUBE. (B)(6) 2015: (B)(6) CENTER. (B)(6) , RESIDENT; (B)(6) , MD. RADIOLOGY¿CT ABDOMEN/PELVIS. HISTORY: ABDOMINAL PAIN, EVALUATE FOR OBSTRUCTION. FINDINGS: MULTIPLE DILATED AND FLUID-FILLED LOOPS OF SMALL BOWEL WITHIN MIDABDOMEN EXTENDING TO LEVEL OF DILATED SMALL BOWEL LOOP WITHIN INCISIONAL HERNIA IMMEDIATELY TO RIGHT OF VENTRAL HERNIA MESH REPAIR. SMALL BOWEL LOOP REENTERING ABDOMEN AT LEVEL OF INCISIONAL HERNIA IS DECOMPRESSED. IMPRESSION: SMALL BOWEL OBSTRUCTION AT LEVEL OF INCISIONAL HERNIA TO RIGHT OF VENTRAL ABDOMINAL HERNIA MESH. SUPERIOR TO INCISIONAL HERNIA THERE IS A STABLE VENTRAL HERNIA CONTAINING OMENTAL FAT ONLY. STABLE SECOND VENTRAL HERNIA WHICH IS A RICHTER¿S HERNIA CONTAINING A PORTION OF ANTERIOR WALL OF SMALL BOWEL LOOP. COLONIC DIVERTICULOSIS. (B)(6) 2015: (B)(6) CENTER. (B)(6) , MD. DISCHARGE SUMMARY. DIAGNOSIS: SMALL BOWEL OBSTRUCTION. HOSPITAL COURSE: ADMITTED FROM EMERGENCY ROOM DUE TO SMALL BOWEL OBSTRUCTION, LIKELY SECONDARY TO RECURRENT VENTRAL HERNIA. NASOGASTRIC TUBE PLACED, HAD FECULENT CONTENTS REMOVED. SEVERAL HOURS AFTER, HAD FLATUS AND BOWEL FUNCTION, FELT BETTER. NASOGASTRIC TUBE REMOVED, TOLERATED REGULAR DIET DAY 2, DISCHARGED HOME DAY 3. FOLLOWUP 10-14 DAYS, DISCUSSIONS LARGE VENTRAL HERNIA REPAIR WITH AID OF PLASTIC SURGERY. FELT WELL AT DISCHARGE. (B)(6) 2015: (B)(6) . [SIGNATURE ILLEGIBLE]. HISTORY AND PHYSICAL. CANNOT KEEP DOWN FOOD OR LIQUIDS SINCE (B)(6) 2015 IN EVENING AFTER DISCHARGE FOR NONOPERATIVE MANAGEMENT OF PARTIAL SMALL BOWEL OBSTRUCTION. REPORTS NAUSEA, VOMITING FOR 1 DAY, MILD ABDOMINAL PAIN, INCREASED ABDOMINAL DISTENSION. PASSING FLATUS, LAST BOWEL MOVEMENT 1 DAY AGO. EXAM: DISTENDED, NONTENDER, 2 VENTRAL HERNIAS PALPABLE WITH REDUCIBLE (RIGHT PERIUMBILICAL AND EPIGASTRIC). ASSESSMENT/PLAN: LIKELY PARTIAL SMALL BOWEL OBSTRUCTION. (B)(6) 2015: MORRISTOWN MEDICAL CENTER. JOSE C. RIOS, MD. RADIOLOGY¿X-RAY ABDOMEN 2 VIEW WITH 1 VIEW CHEST. HISTORY: EVALUATE BOWEL OBSTRUCTION. IMPRESSION: WORSENING DILATATION SMALL BOWEL LOOPS WITH AIR-FILLED LEVEL SEEN, MOST COMPATIBLE WITH SMALL BOWEL OBSTRUCTION. (B)(6) 2015: (B)(6) CENTER. (B)(6) , MD. CONSULTATION. RECENTLY ADMITTED FOR PARTIAL SMALL BOWEL OBSTRUCTION. CONTINUED NAUSEA, VOMITING. READMITTED FOR MILD ABDOMINAL DISTENTION AND PAIN. PLAN: CONSERVATIVE TREATMENT. GOOD CANDIDATE FOR COMPONENT SEPARATION AND INLAY BIOLOGIC MESH HERNIA REPAIR. BETTER TO DO AT A LATER DATE WHEN ABLE TO LOSE WEIGHT. (B)(6) 2015: (B)(6) CENTER. (B)(6) , MD. HISTORY AND PHYSICAL. OCCASIONAL SORENESS IN ABDOMEN WITH SLIGHT QUEASINESS, LIKELY RELATED TO INCISIONAL HERNIA. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. REDUCIBLE HERNIA IN SUBXIPHOID REGION. ALSO, RIGHT-SIDED MID ABDOMINAL HERNIA RIGHT OF UNDERLAY MESH. NO INCARCERATION. (B)(6) 2015: (B)(6) , MD. OFFICE NOTES. POST-OP VISIT. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. JP DRAIN PUTTING OUT LESS THAN 60 CC DAY, WILL BE REMOVED 1 WEEK. INCISION CLEAN, DRY, NO INFECTION. RETURN TO WORK LIGHT DUTIES, AVOID HEAVY LIFTING FOR NEXT MONTH. (B)(6) 2015: (B)(6) , MD. OFFICE NOTES. POSSIBLE RECURRENT VENTRAL HERNIA. LAST SEEN 6 WEEKS AGO, DOING WELL. NOTED LAST FEW DAYS BULGE IN LEFT UPPER QUADRANT, MAY HAVE OCCURRED AFTER LIFTING HEAVY BAG OF GRAVEL. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. LEFT UPPER QUADRANT BULGE, MINIMALLY TENDER. NO DISCRETE FASCIAL DEFECT APPRECIATED. ASSESSMENT/PLAN: 3 MONTHS STATUS POST COMPONENT SEPARATION VENTRAL HERNIA REPAIR WITH MESH. NEW BULGE LEFT UPPER ASPECT OF ABDOMEN, MAY REPRESENT EITHER RECURRENCE OF VENTRAL HERNIA, NEW HERNIA, OR DIASTASIS OF MUSCLE LAYERS SECONDARY TO COMPONENT SEPARATION. ORDERED CT SCAN ABDOMEN/PELVIS. (B)(6) 2015: [MISSING RECORDS: RECORDS FOR ¿CT ABDOMEN/PELVIS, RECURRENT VENTRAL HERNIA¿ WERE NOT PROVIDED.] A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON GORE¿S INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES (1695, 3191 APPROPRIATE TERM NOT AVAILABLE FOR "SMALL BOWEL VOLVULIZED AROUND ROLLED MESH") WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: ¿ THE KNOWN MEDICAL RECORDS SPAN (B)(6), 2009 THROUGH (B)(6), 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. PATIENT INFORMATION: MEDICAL HISTORY: ¿ GASTROENTERITIS ¿ INCISIONAL HERNIA ¿ SMALL BOWEL OBSTRUCTION INVOLVING DISTAL ILEUM ¿ OBESITY ? (B)(6) 2009: 230 LBS.; BMI 34.0 ? (B)(6) 2010: 225 LBS.; BMI 33.2 ? (B)(6) 2013: 238 LBS.; BMI 35.1 ? (B)(6) 2014: 243 LBS.; BMI 36 ¿ RECURRENT VENTRAL HERNIA ¿ CROHN¿S DISEASE ¿ DIVERTICULOSIS SURGICAL PROCEDURES: ¿ 2004: LYSIS OF ADHESIONS ¿ 2005: COLON SURGERY FOR INTESTINAL BLOCKAGE ¿ (B)(6) 2005: LYSIS OF ADHESIONS ¿ (B)(6) 2010: VENTRAL HERNIA REPAIR WITH OVERLAY MARLEX MESH AND LYSIS OF ADHESIONS ¿ (B)(6) 2013: LAPAROSCOPIC LYSIS OF ADHESIONS, REPAIR OF VENTRAL HERNIA WITH ¿GORE DUALMESH¿ 25X 20CM. IMPLANT: GORE® DUALMESH® BIOMATERIAL. ¿ (B)(6) 2015: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF OLD UNDERLAY MESH AS WELL AS REMOVAL OF OVERLAY MESH, VENTRAL HERNIA REPAIR PERFORMED BY DR. S. WITH AN OVERLYING MESH AS WELL AS ABDOMINAL COMPONENT SEPARATION. IMPLANT: GORE® DUALMESH® BIOMATERIAL. RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2010: VENTRAL HERNIA REPAIR WITH OVERLAY MARLEX MESH AND EXTENSIVE LYSIS OF ADHESIONS. IMPLANT: MARLEX MESH. ? INDICATION: ¿OPERATED PREVIOUSLY FOR A SMALL BOWEL OBSTRUCTION. HE DEVELOPED AN INCISIONAL HERNIA LATER. HE WAS ADMITTED PREVIOUSLY ALSO WITH SMALL-BOWEL RESECTION WHICH HAS RESOLVED WITH NONOPERATIVE MANAGEMENT. HE STATED THAT HE WOULD LIKE TO HAVE THIS HERNIA REPAIRED IN AN ELECTIVE FASHION. UPON PHYSICAL EXAM HE WAS NOTED TO HAVE A MIDLINE SUPRAUMBILICAL INCISION WITH A LARGE BULGE. THE PATIENT REQUESTED THAT [SIC] HAVE THE HERNIA REPAIRED AND IT [SIC] ALSO GIVEN HIS PREVIOUS HISTORY OF SMALL BOWEL OBSTRUCTION, THE VENTRAL HERNIA REPAIR WAS AGREED TO BE PERFORMED.¿ ? PROCEDURE: ¿A MIDLINE SUPRA AND INFRAUMBILICAL INCISION WAS MADE. SUBCUTANEOUS TISSUE WAS TAKEN ALL THE WAY DOWN TO THE FASCIA AT THE INFERIOR MARGIN. CAREFUL DISSECTION WAS PERFORMED AT THE LEVEL OF THE SAC. ONCE THE SAC WAS PROPERLY IDENTIFIED IT WAS ENTERED WITH METZENBAUM SCISSORS AND COMPLETED WITH ELECTROCAUTERY AT WHICH TIME WE NOTICED A SMALL SUPERFICIAL CAUTERY MARK PRESENT IN THE SMALL BOWEL. AT THIS TIME TO [SIC] 3-0 SILK INTERRUPTED SUTURES WERE PLACED IN A LEMBERT FASHION. WE THEN ENCOUNTERED A SIGNIFICANT AMOUNT OF DENSE ADHESIONS INVOLVING SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL. THESE WERE CAREFULLY TAKEN DOWN WITH METZENBAUM SCISSORS. OF NOTE [SIC]. AFTER LYSING ALL THE ADHESIONS FROM THE ABDOMINAL WALL, THE HERNIA SAC WAS EXCISED AND SENT TO PATHOLOGY FOR FURTHER EXAMINATION. WE THEN IDENTIFIED HEALTHY MARGINS OF THE FASCIA BY CREATING BILATERAL SUPERIOR AND INFERIOR SUBCUTANEOUS FLAPS. WE DETERMINED THEN THAT THE INFERIOR PORTION OF THE FASCIA WAS STILL WITH SOME SMALL DEFECT AND VERY TENSE, SO WE EXTENDED THE FASCIAL INCISION INFERIORLY. AFTER WE DEEMED THAT WE HAD A GOOD QUALITY FASCIA AND WE HAD GREAT ADEQUATE BILATERAL SUPERIOR INFERIOR SUBCUTANEOUS FLAPS, WE THEN PLACED A [SIC] OVERLAY MARLEX MESH BY SECURING IT IN THE LEFT LATERAL WALL WITH A RUNNING ZERO PROLENE. WE THEN PLACED SEVERAL INTERRUPTED ZERO PROLENE AT THE RIGHT LATERAL PORTION. THE MARLEX MESH UTILIZED WAS MEASURED APPROXIMATELY 3 X 6 INCHES. WE THEN PROCEEDED TO THE [SIC] APPROXIMATE THE FASCIA IN A RUNNING FASHION WITH A #1 PROLENE AND THEN THE MARLEX MESH WAS PARACHUTED AND TIED DOWN [SIC] WITH THE PREVIOUSLY PLACED RIGHT LATERAL INTERRUPTED PROLENE SUTURES. THE MESH SEEMED TO BE PERFECTLY PLACED, NO TENSION OR EXCESSIVELY LOOSENESS. AT THIS TIME WE IRRIGATED THE WOUND WITH A LITER OF NORMAL SALINE. WE THEN PLACED A 15 BLAKE DRAIN INTO THE SUBCUTANEOUS CAVITY TO PROTECT FROM A SEROMA AND POTENTIAL INFECTION. INTERRUPTED 3-0 VICRYL WAS UTILIZED TO APPROXIMATE THE SUBCUTANEOUS TISSUE IN AN ATTEMPT TO OBLITERATE OR REDUCE THE DEAD SPACE AND POTENTIAL SEROMA FORMATION. THE SKIN WAS THEN CLOSED WITH 4-0 MONOCRYL IN A SUBCUTICULAR RUNNING FASHION.¿ IMPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2013: CT ABDOMEN/PELVIS: ¿SMALL BOWEL OBSTRUCTION, WITH TRANSITION POINT LIKELY ARISING FROM VENTRAL HERNIA.¿ ¿ (B)(6) 2013: X-RAY ABDOMEN: ¿MULTIPLE DILATED LOOPS OF SMALL BOWEL IN UPPER ABDOMEN WORRISOME FOR SMALL BOWEL OBSTRUCTION.¿ ¿ (B)(6) 2013: ¿THIS IS A 64-YEAR-OLD GENTLEMAN WITH A PREVIOUS EXPLORATORY LAPAROTOMY FOR SMALL BOWEL OBSTRUCTION AND ALSO AN OPEN VENTRAL HERNIA REPAIR WITH MARLEX MESH IN AN ONLAY FASHION WHO PRESENTED WITH 5 DAYS OF PARTIAL SMALL BOWEL OBSTRUCTION. THE PATIENT WAS PASSING GAS AND HAVING BOWEL MOVEMENTS, HOWEVER STILL HAD NAUSEA AND VOMITING AND REQUIRED AN NG TUBE DECOMPRESSION. HIS X-RAY ON HOSPITAL DAY 4 STILL DEMONSTRATED DILATED LOOPS OF SMALL BOWEL WITH AIR-FLUID LEVELS. THEREFORE, HE WAS CONSENTED FOR LAPAROSCOPIC LYSIS OF ADHESIONS, POSSIBLE BOWEL RESECTION, AND REPAIR OF HIS VENTRAL HERNIA. HIS CAT SCAN DEMONSTRATED A DEFECT IN THE FASCIA WITH LOOP OF BOWEL ENTERING AND LEAVING THE FASCIAL DEFECT.¿ IMPLANT PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS, REPAIR OF VENTRAL HERNIA WITH ¿GORE DUALMESH 25X 20CM. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC07/8588984 20CM X 30CM X 1MM THICK] IMPLANT DATE: (B)(6), 2013 [HOSPITALIZED (B)(6), 2013] ¿ DESCRIPTION OF HERNIA BEING TREATED: ¿WE THEN PROCEEDED TO SHARPLY LYSE ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL. THE BOWEL WAS ADHERENT TO THE MARLEX MESH WHICH WAS IDENTIFIED. THE ANTERIOR ABDOMINAL WALL FASCIA WAS FOUND TO BE A ¿SWISS-CHEESE¿ CONFIGURATION WITH MULTIPLE DEFECTS IN THE FASCIA. THE MARLEX MESH AGAIN WAS SEEN, AND THE SMALL BOWEL WAS PEELED AWAY FROM IT. CARE WAS TAKEN TO ENSURE THAT THE SEROSA OF THE BOWEL WAS NOT INJURED. THE BOWEL WAS FINALLY TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL AND THEN WAS REEXAMINED ONCE MORE. THERE WAS NO EVIDENCE OF SEROSAL TEARS OR FULL-THICKNESS INJURIES. WE THEN PROCEEDED TO RUN THE SMALL BOWEL FROM THE LIGAMENT OF TREITZ UP UNTIL THE MIDJEJUNUM, AFTER WHICH THERE WAS OVERABUNDANCE OF OMENTUM, WE WERE UNABLE TO DO SO. WE THEN PROCEEDED TO MEASURE OUR FASCIAL DEFECT, WHICH WAS MEASURED TO BE APPROXIMATELY 25 CM VERTICALLY X 20 CM ACROSS .¿ ¿ IMPLANT SIZE AND FIXATION: ¿WE CHOSE A GORE DUALMESH TO BE PLACED IN AN INLAY FASHION. PROLENE 0 SUTURES WERE USED TO TAG THE NORTH, SOUTH, EAST, AND WEST SIDES OF THE MESH IN ORDER TO CREATE STAY SUTURES. THE MESH WAS THEN ROLLED UP INTO A CIGAR AND PLACED THROUGH A 15 MM PORT, WHICH WAS PLACED IN THE SUBXIPHOID REGION AND REPLACED THE 12 MM HASSON THAT WAS INITIALLY THERE. THE MESH WAS THEN UNFOLDED, AND USING THE CARTER-THOMPSON ENDO CLOSURE DEVICE, A SMALL INCISION WAS MADE OVERLYING THE LATERAL ASPECT OF THE HERNIA DEFECT, AND THE CARTER-THOMPSON NEEDLE WAS USED TO PULL THE TAIL ENDS OF THE 0 PROLENE SUTURES THROUGH THE SKIN. THIS WAS DONE AT ALL 4 QUADRANTS, AND THE SUTURES WERE THEN TIED DOWN UNTIL THE MESH WAS CINCHED AGAINST THE ANTERIOR ABDOMINAL WALL. AT THIS POINT IN TIME, WE USED THE ABSORBATACK WAS USED [SIC] TO TACK THE MESH TO THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY. THE MESH WAS HELD SLIGHTLY TAUT SO AS TO GET THE EDGES OF THE MESH FIRMLY AGAINST THE ANTERIOR ABDOMINAL WALL AND PERITONEUM. SEVERAL TACKS WERE PLACED IN THE CENTER OF THE MESH AS WELL TO HELP THE MESH SIT EVEN MORE FLUSH WITH THE ABDOMINAL WALL AND POTENTIALLY PREVENT A SEROMA. AT THIS POINT IN TIME, WE WERE SATISFIED WITH THE POSITION OF HER MESH, AND THE ABDOMEN WAS ALLOWED TO DESUFFLATE. THE 5 MM PORTS WERE REMOVED UNDER DIRECT VISION, AND THERE WAS NO BLEEDING NOTED. THE 15 MM HASSON PORT WAS THEN REMOVED, AND STAY SUTURES WERE USED TO CLOSE THE FASCIAL LAYER. ADDITIONALLY, A 0 VICRYL SUTURE WAS USED IN A FIGURE-OF-EIGHT FASHION TO CLOSE THIS DEFECT AS WELL. THE SUBCUTANEOUS TISSUE WAS THEN IRRIGATED, AND THE SKIN WAS CLOSED USING 4-0 MONOCRYL SUBCUTICULAR CLOSURE ...¿ ¿ (B)(6) 2013: DISCHARGE SUMMARY: ¿PREVIOUS EXPLORATORY LAPAROTOMY FOR SMALL BOWEL OBSTRUCTION, ALSO OPEN VENTRAL HERNIA REPAIR WITH MARLEX MESH IN AN ONLAY FASHION. TOLERATED PROCEDURE WELL, UNEVENTFUL POSTOP. POSTOP DAY 3, DISCHARGED HOME. INSTRUCTED NOT TO LIFT ANYTHING HEAVIER THAN 15 POUNDS.¿ RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2014: ¿ABDOMINAL BULGE, POSSIBLE RECURRENT VENTRAL HERNIA. NOTICED FEW MONTHS AGO FELT BULGE WHEN STRAINING, ON RIGHT SIDE MID ABDOMEN LATERAL TO MESH. SUSPECTED RECURRENCE OF HERNIA. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. UPON ASKING TO STRAIN WHILE IN SUPINE POSITION, FOUND TO HAVE LARGE DIASTASIS RECTI IN SUPRAUMBILICAL REGION IN UPPER ABDOMEN. UPON PALPATING TO RIGHT OF MESH AND TO RIGHT OF INCISION, 6 X 6 CM AREA WITH PALPABLE FASCIAL DEFECT AND REDUCIBLE CONTENTS .¿ ¿ (B)(6) 2014: CT ABDOMEN/PELVIS: ¿3 SEPARATE AREAS OF VENTRAL AND INCISIONAL HERNIA. MOST SUPERIOR VENTRAL HERNIA CONTAINING OMENTAL FAT ONLY. SECOND VENTRAL HERNIA IS A RICHTER¿S HERNIA OF PORTION OF WALL OF SMALL BOWEL. THIRD MOST INFERIOR HERNIA PRESUMED TO REPRESENT AN INCISIONAL HERNIA TO RIGHT OF ABDOMINAL MESH CONTAINING LOOP OF SMALL INTESTINE. THESE ARE NONOBSTRUCTIVE. ¿ ¿ (B)(6) 2015: ¿DISCUSSION ABOUT NEED TO LOSE WEIGHT, TARGET WEIGHT BELOW 220. CURRENTLY 239. RECONVENE IN 3 MONTHS FURTHER EVALUATION AND HOPES OF SCHEDULING FOR ELECTIVE SURGERY.¿ ¿ (B)(6) 2015: INPATIENT HOSPITALIZATION. ? (B)(6) 2015: X-RAY ABDOMEN: ¿PAUCITY OF BOWEL GAS WITHOUT SIGNIFICANT SMALL BOWEL DILATATION. NO FREE AIR.¿ ? (B)(6) 2015: ¿OBSTRUCTING CHRONIC INCARCERATED VENTRAL HERNIA, ADMIT, NOTHING BY MOUTH, IV FLUIDS, NASOGASTRIC TUBE.¿ ? (B)(6) 2015: CT ABDOMEN/PELVIS: ¿MULTIPLE DILATED AND FLUID-FILLED LOOPS OF SMALL BOWEL WITHIN MIDABDOMEN EXTENDING TO LEVEL OF DILATED SMALL BOWEL LOOP WITHIN INCISIONAL HERNIA IMMEDIATELY TO RIGHT OF VENTRAL HERNIA MESH REPAIR. SMALL BOWEL LOOP REENTERING ABDOMEN AT LEVEL OF INCISIONAL HERNIA IS DECOMPRESSED.¿ ? (B)(6) 2015: DISCHARGE SUMMARY: ¿ADMITTED FROM EMERGENCY ROOM DUE TO SMALL BOWEL OBSTRUCTION, LIKELY SECONDARY TO RECURRENT VENTRAL HERNIA . NASOGASTRIC TUBE PLACED, HAD FECULENT CONTENTS REMOVED. SEVERAL HOURS AFTER, HAD FLATUS AND BOWEL FUNCTION, FELT BETTER. NASOGASTRIC TUBE REMOVED, TOLERATED REGULAR DIET DAY 2, DISCHARGED HOME DAY 3.¿ ¿ (B)(6) 2015: ¿CANNOT KEEP DOWN FOOD OR LIQUIDS SINCE (B)(6) 2015 IN EVENING AFTER DISCHARGE FOR NONOPERATIVE MANAGEMENT OF PARTIAL SMALL BOWEL OBSTRUCTION. REPORTS NAUSEA, VOMITING FOR 1 DAY, MILD ABDOMINAL PAIN, INCREASED ABDOMINAL DISTENSION. PASSING FLATUS, LAST BOWEL MOVEMENT 1 DAY AGO. EXAM: DISTENDED, NONTENDER, 2 VENTRAL HERNIAS PALPABLE WITH REDUCIBLE (RIGHT PERIUMBILICAL AND EPIGASTRIC).¿ ¿ (B)(6) 2015: X-RAY ABDOMEN: ¿WORSENING DILATATION SMALL BOWEL LOOPS WITH AIR-FILLED LEVEL SEEN, MOST COMPATIBLE WITH SMALL BOWEL OBSTRUCTION.¿ ¿ (B)(6) 2015: ¿GOOD CANDIDATE FOR COMPONENT SEPARATION AND INLAY BIOLOGIC MESH HERNIA REPAIR. BETTER TO DO AT A LATER DATE WHEN ABLE TO LOSE WEIGHT.¿ EXPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2015: ¿OCCASIONAL SORENESS IN ABDOMEN WITH SLIGHT QUEASINESS, LIKELY RELATED TO INCISIONAL HERNIA. EXAM: ABDOMEN SOFT, NONTENDER, NONDISTENDED. REDUCIBLE HERNIA IN SUBXIPHOID REGION. ALSO, RIGHT-SIDED MID ABDOMINAL HERNIA RIGHT OF UNDERLAY MESH. NO INCARCERATION.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF OLD UNDERLAY MESH AS WELL AS REMOVAL OF OVERLAY MESH , VENTRAL HERNIA REPAIR PERFORMED BY DR. (B)(6). WITH AN OVERLYING MESH AS WELL AS ABDOMINAL COMPONENT SEPARATION. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC07/11171312, 20CM X 30CM X 1MM] (NO ALLEGATIONS FOR THIS DEVICE, NOT ADDED TO COMPLAINT) EXPLANT DATE: (B)(6), 2015 [HOSPITALIZED (B)(6), 2015] ¿ ¿WE ENTERED THE ABDOMEN IN A VIRGIN PLANE AND WERE ABLE TO IDENTIFY THE PREVIOUSLY PLACED UNDERLYING MESH. WE HAD TO LYSE A NUMBER OF ADHESIONS TO THE ANTERIOR ABDOMINAL WALL AS WELL AS TO THE UNDERLAY MESH AND WE CAREFULLY DISSECTED IT AWAY FROM THE FASCIA. A SMALL SEROMYOTOMY WAS MADE IN THE SMALL BOWEL, WHICH WAS REPAIRED WITH INTERRUPTED 3-0 VICRYL LEMBERT SUTURES. ONCE THE BOWEL WAS ALL TAKEN DOWN, THE REMAINDER OF THE ABDOMINAL FASCIA WAS OPENED AND THE PREVIOUSLY PLACED UNDERLAY MESH WAS REMOVED IN ITS ENTIRETY USING ELECTROCAUTERY FROM THE ABDOMINAL WALL FASCIA. AT THIS POINT, THE INTESTINES WERE RUN FROM THE LIGAMENT OF TREITZ TO THE ILEOCECAL VALVE TO ENSURE THERE WERE NO FURTHER ADHESIONS TO BOTH THE ABDOMINAL WALL AS WELL AS TO THE SIDEWALLS. AT THIS POINT, ONCE THE BOWEL WAS COMPLETELY FREED UP, DR. S. SCRUBBED IN AND PERFORMED HIS PORTION OF THE PROCEDURE, CONSISTING OF AN ABDOMINAL COMPONENT SEPARATION, AS WELL AS REPAIR OF VENTRAL HERNIA WITH AN OVERLYING MESH¿ ¿ ¿DR. (B)(6). BEGAN WITH A VENTRAL MIDLINE INCISION TO EXPOSE THE HERNIA SACS, LYSE ALL THE ADHESIONS, EXPOSE THE OLD MESH AND REMOVE IT, AND THEN PREPARE THE WOUND FOR CLOSURE. AFTER HE HAD COMPLETED ALL THIS, I BEGAN BY REMOVING THE REMAINING ONLAY MESH WHICH WAS LEFT BEHIND. THIS MESH WAS ON ONLAY FASHION ON TOP OF THE ANTERIOR RECTUS FASCIA. THIS WAS REMOVED WITH RETRACTION AND PICKUPS AND SCISSORS AND THE ELECTROCAUTERY. AFTER ALL THE MESH HAD BEEN ADEQUATELY REMOVED, WE THEN BEGAN BY OPENING UP THE MORE LATERAL RIGHT SIDED ABDOMINAL WALL HERNIA WHERE A LARGE AMOUNT OF BOWEL HAD BEEN PROTRUDING PREOPERATIVELY. THE INTERVENING FASCIA AND HERNIA SAC WERE EXCISED AND REMOVED. AFTER DOING THIS, WE DID FIND THAT THE EDGE WAS HEALTHY AFTER REMOVING THE PRIOR MESH AS WELL AS THE HERNIA SAC ON THE RIGHT SIDE.¿ ¿ ¿NEXT, WE BEGAN BY PLACING A DUAL-MESH UNDERLAY GORE-TEX MESH IN THE ABDOMEN. CARE WAS TAKEN TO MEASURE THIS CORRECTLY. A PIECE OF 20 X 30 GORE-TEX DUAL MESH WAS OPENED, LOT #11171312, REFERENCE #(B)(4). THIS WAS CUT TO THE APPROPRIATE SIZE FOR THE HERNIA. IT WAS SOAKED IN BACITRACIN SOLUTION. NEXT, IT WAS PLACED IN THE ABDOMEN WITH THE NONADHERENT SIDE DOWN TOWARDS THE BOWEL. 0 PDS SUTURES WERE THEN USED TO SECURE THE MESH IN PLACE. CARE WAS TAKEN TO PLACE ALL OF THE TENSION ON THE ABDOMINAL CLOSURE ON THE MESH ITSELF AND NOT ON THE ANTERIOR RECTUS FASCIA OR THE RECTUS MUSCLES THEMSELVES. THE MESH WAS WIDELY PLACED UNDERNEATH THE HERNIA TO REINFORCE THE HERNIA AND TAKE ALL THE TENSION OFF OF THE PRIMARY CLOSURE OF THE ANTERIOR ABDOMINAL WALL MUSCULATURE. THESE SUTURES WERE PLACED WHILE THERE WAS STILL A LAP IN THE ABDOMEN TO PROTECT THE BOWEL. CARE WAS TAKEN TO AVOID STRIKING THE BOWEL WITH ANY OF THE STITCHES DURING THE ENTIRE PROCESS OF PLACING THE MESH. GREATER THAN 20 STITCHES WERE PLACED AROUND THE BORDER OF THE MESH THROUGH THE ANTERIOR ABDOMINAL INTO THE MESH AND BACK OUT THE ANTERIOR ABDOMINAL WALL IN FIGURE-OF-EIGHT FASHION. THESE WERE THEN SEQUENTIALLY TIED, AND THE HERNIA WAS CLOSED WITH A GOOD UNDERLAY MESH.¿ ¿ (B)(6) 2015: DISCHARGE SUMMARY: ¿HOSPITAL COURSE UNEVENTFUL. POST OP DAY 2 OUT OF BED IN ABDOMINAL BINDER. DISCHARGED WITH JACKSON PRATT DRAINS IN PLACE. INSTRUCTIONS TO WEAR ABDOMINAL BINDER, TAUGHT HOW TO CARE FOR DRAINS.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ THE INSTRUCTIONS FOR USE FURTHER STATE: ¿USE ONLY NONABSORBABLE SUTURES, SUCH AS GORE-TEX® SUTURE, WITH A NONCUTTING NEEDLE (SUCH AS TAPER OR PIERCING POINT) OF APPROPRIATE SIZE TO ANCHOR THE DEVICE. THE USE OF ABSORBABLE SUTURES MAY LEAD TO INADEQUATE ANCHORING OF GORE® DUALMESH® BIOMATERIAL TO THE HOST TISSUE AND NECESSITATE REOPERATION. FOR BEST RESULTS, USE MONOFILAMENT SUTURES. SUTURE SIZE SHOULD BE DETERMINED BY SURGEON PREFERENCE AND THE NATURE OF THE RECONSTRUCTION.¿ INDIVIDUAL MEDICAL DECISIONS, IF INCONSISTENT AND/OR NON-CONFORMING TO THE DEVICE MANUFACTURER¿S RECOMMENDATIONS, IFU, OR RECOGNIZED BEST PRACTICES, MAY RESULT IN OR CONTRIBUTE TO AN ADVERSE EVENT. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(4). (B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2013, WHEREBY A GORE DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, LYSIS OF ADHESIONS, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588481 | GORE DUALMESH BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC07 | 8588984 | 00733132601004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |