GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00084
- Event Type
- Injury
- Date Received
- April 12, 2019
- Date of Event
- July 11, 2017
- Report Date
- April 20, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601158
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. H6: 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: ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. HISTORY AND PHYSICAL. PERIUMBILICAL PAIN, STARTED 4 DAYS AGO. HISTORY OF UMBILICAL HERNIA WITH REPAIR 2 TO 3 YEARS AGO, HAS NEVER GOTTEN BETTER SINCE SURGERY. ABDOMEN: DISTENDED WITH PERIUMBILICAL DISTENSION, TENDERNESS. IMPRESSION: ABDOMINAL PAIN, INCARCERATED VENTRAL HERNIA, SMALL BOWEL OBSTRUCTION. PLAN: EXPLORATORY LAPAROTOMY TONIGHT. ON (B)(6) 2010: [FACILITY NI]. (B)(6), MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: ABD [ABDOMINAL] PAIN. FINDINGS: A LARGE WIDE-MOUTH VENTRAL HERNIA NEAR LEVEL OF UMBILICUS. CONTAINS SOME MILDLY DISTENDED FLUID-FILLED SMALL BOWEL LOOPS, MEASURE UP TO 3.9 CM. IMPRESSION: LARGE VENTRAL HERNIA CONTAINS SOME MILDLY DILATED FLUID-FILLED SMALL BOWEL LOOPS. APPEARANCE SUGGESTS AT LEAST A PARTIAL MECHANICAL OBSTRUCTION, ALTHOUGH LOCALIZED ILEUS COULD HAVE SIMILAR APPEARANCE. SIGMOID DIVERTICULOSIS. ON (B)(6) 2010: [FACILITY NI]. (B)(6), MD. RADIOLOGY ¿ ACUTE ABDOMEN. INDICATION: PAIN. IMPRESSION: DILATED SMALL BOWEL LOOPS WITHIN VENTRAL HERNIA IDENTIFIED ON CT OF SAME EVENING CANNOT BE APPRECIATED ON RADIOGRAPH. ON (B)(6) 2010: [FACILITY NI]. NURSE NOTES. PT [PATIENT] REFUSAL NG [NASOGASTRIC TUBE].. ON (B)(6) 2010: (B)(6) HOSPITAL. NURSE NOTES. INSTRUCTED TO WEAR ABDOMINAL BINDER WHEN OOB [OUT OF BED]. OK TO LEAVE BINDER OFF WHILE IN BED. VERBALIZES UNDERSTANDING. ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: 06/06/10. DIAGNOSES: SMALL BOWEL OBSTRUCTION RELATED TO VENTRAL HERNIA. CONDITION ON DISCHARGE: GOOD. PRESENTS WITH ABDOMINAL PAIN. FOUND TO HAVE INCARCERATED VENTRAL HERNIA. ON (B)(6) 2010: (B)(6) HOSPITAL. DISCHARGE INSTRUCTIONS. ACTIVITY: RESUME NORMAL ACTIVITY. ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. HISTORY AND PHYSICAL. ACUTE ONSET ABDOMINAL PAIN. REPORTS FEELING A POP IN LEFT LOWER QUADRANT WHEN HAVING DRY HEAVES. IMPRESSION/PLAN: RECTUS SHEATH HEMATOMA. WILL REQUIRE SECOND SURGERY FOR RECURRENCE OF VENTRAL HERNIA. ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. CONSULTATION. STATES 3 DAYS AGO, FELT POP IN LEFT LOWER QUADRANT WHEN HE WAS HAVING DRY HEAVES. DEVELOPED ABDOMINAL PAIN LAST NIGHT. ABDOMEN: DISTENDED. MILDLY TENDER MIDLINE. IMPRESSION: RECTUS HEMATOMA, MOST LIKELY FROM POSTOPERATIVE ANTICOAGULATION. RECURRENT VENTRAL HERNIA. PLAN: WILL NEED REPAIR OF HIS RECURRENT HERNIA WHICH IS CAUSING A PARTIAL OBSTRUCTION. ON (B)(6) 2010: [FACILITY NI]. (B)(6), MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: PATIENT ON ANTI-COAGULATION FOR HISTORY OF PULMONARY EMBOLUS, RECENT HERNIA REPAIR. FINDINGS: ABNORMAL AREA OF HIGH ATTENUATION IN LEFT RECTUS MUSCULATURE, 5.1 X 7.8 X 11 CM. IMPRESSION: RECTUS SHEATH HEMATOMA WITH RECURRENT ANTERIOR MIDLINE HERNIA AND PROMINENT SMALL BOWEL. PROMINENT SMALL BOWEL CAN SUGGEST EARLY SMALL BOWEL OBSTRUCTION OR ILEUS. ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY ¿ XRY [X-RAY] ABDOMEN. INDICATION: ABD [ABDOMINAL] PAIN. IMPRESSION: MINIMAL RESIDUAL SMALL BOWEL DILATATION CENTRALLY. EQUIVOCAL FINDING. GAS SEEN THROUGHOUT COLON. ON (B)(6) 2010: (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: 06/12/10. DIAGNOSES: RECTUS SHEATH HEMATOMA. CONDITION ON DISCHARGE: GOOD. PRESENTS WITH RECURRENT ABDOMINAL PAIN. HERNIA IS NOT FELT TO HAVE RECURRED PER SURGERY. ON (B)(6) 2010: (B)(6) HOSPITAL. DISCHARGE INSTRUCTIONS. ACTIVITY: RESUME NORMAL ACTIVITY. WEAR ABDOMINAL BINDER AT ALL TIMES WHEN OUT OF BED OR AMBULATING. ON (B)(6) 2017: [FACILITY NI]. (B)(6), MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: ABDOMINAL PAIN. FINDINGS: LARGE LOCULATED FLUID COLLECTION WHICH APPEARS TO BE ASSOCIATED WITH THE MESH. MEASURES 10.8 CM AP, 14.3 CM TRANSVERSE, 16.2 CM CRANIOCAUDAL. IMPRESSION: SMALL BOWEL OBSTRUCTION IS SEEN. APPEARS TO BE A LARGE VENTRAL HERNIA WHICH HAS INCREASED IN SIZE AND CONTAINS INCREASED BOWEL LOOPS COMPARED WITH 2011. THERE APPEARS TO HAVE BEEN A PRIOR ATTEMPT AT REPAIRING THIS HERNIA WHICH APPEARS TO HAVE RECURRED. THERE IS A LARGE DOUBLE LAYER OF SURGICAL MESH ANTERIORLY AT MIDLINE. WITHIN THE LAYERS OF MESH, THERE IS CONTAINED FLUID COLLECTION WHICH IS INCREASED IN SIZE COMPARED WITH 2011. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. PROGRESS NOTES. ABDOMEN: OBESE, MILD PERIUMBILICAL TTP [TENDER TO PALPATION], LARGE VENTRAL HERNIA WITH WELL-HEALED MIDLINE INCISION. PLAN: OR TOMORROW FOR EXPLORATIVE LAPAROTOMY. ON (B)(6) 2017: (B)(6) HOSPITAL. NURSE NOTES. EPISODE OF VOMITING. ENCOURAGED, EDUCATED ON PURPOSE, BENEFIT OF NG [NASOGASTRIC] TUBE AND RISKS OF REFUSING. PT [PATIENT] REFUSED AND VERBALIZED UNDERSTANDING. ON (B)(6) 2017: BETHESDA HEALTH. [ILLEGIBLE]. ANESTHESIA RECORD. PT [PATIENT] REFUSES AN NG [NASOGASTRIC] TUBE. INSISTS IT BE PLACED ASLEEP DESPITE ASPIRATION RISK. ON (B)(6) 2017: (B)(6) HOSPITAL. NURSE NOTES. ABDOMINAL BINDER TO STAY ON AT ALL TIMES. ON (B)(6) 2017: (B)(6) HOSPITAL. NURSE NOTES. PT [PATIENT] REFUSING SCHEDULED MEDS, STATES THEY MAKE HIS ABDOMEN FEEL BAD. PROVIDED EDUCATION REGARDING MEDS. ON (B)(6) 2017: (B)(6) HOSPITAL. NURSE NOTES. PT [PATIENT] HAS REFUSED ANY MEDS THIS SHIFT, REFUSED ANY WOUND CARE. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: 04/10/17. ADMISSION DIAGNOSIS: ABD [ABDOMINAL] PAIN. PATIENT CONDITION: GOOD. HOSPITAL COURSE: CRAMPING DULL ACHING ABDOMINAL PAIN X 1 DAY. STATES FEELS LIKE PREVIOUS BOWEL OBSTRUCTION. DIAGNOSIS: SMALL BOWEL OBSTRUCTION ASSOCIATED WITH LARGE VENTRAL HERNIA. S/P [STATUS POST] REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA WITH ATRIUM PROLITE MESH. DISCHARGED TO HOME. ON (B)(6) 2017: BETHESDA HEALTH, INC. DISCHARGE INSTRUCTIONS. HOME HEALTH, ONE HOME CARE SOLUTION. ACTIVITY: AS TOLERATED, WEAR ABDOMEN HERNIA REPAIR [SIC]. PERFORM ONLY THOSE ACTIVITIES THAT YOU ARE COMFORTABLE DOING. [PATIENT EDUCATION FACT SHEET] HERNIA REPAIR WITH LAPAROSCOPE: YOU MAY CONTINUE YOUR NORMAL ACTIVITIES BUT AVOID HEAVY LIFTING (MORE THAN 10 POUNDS) OR STRAINING. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. PROGRESS NOTES. ABDOMEN MILDLY DISTENDED, INCISION CLEAN, DRY. ON (B)(6) 2017: BETHESDA HEALTH, INC. DISCHARGE INSTRUCTIONS. HOME HEALTH, HATS HOME HEALTH. ACTIVITY: AS TOLERATED. PERFORM ONLY THOSE ACTIVITIES THAT YOU ARE COMFORTABLE DOING. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. EMERGENCY ROOM VISIT. FOLLOWING MOST RECENT SURGERY, REQUIRED HOSPITALIZATION FOR DEHISCENCE AND DRAINAGE. DAY PRIOR TO ARRIVAL BEGAN TO NOTE DRAINAGE ON HERNIA DRESSING. DRAINAGE FROM ABDOMINAL WOUND. ABDOMEN: 10 CM MASS SURROUNDING PREVIOUS INCISION SITE, DEHISCENCE NOTED TO CENTER OF PREVIOUS SURGICAL WOUND. SEROUS YELLOW DRAINAGE. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. CONSULTATION. GENERAL SURGERY. INDICATION: OPEN MIDLINE WOUND, WITH EVISCERATED SMALL BOWEL. MOST RECENTLY STITCHES REMOVED IN OFFICE, STERI-STRIPS APPLIED. TWO DAYS AGO HE REMOVED 2 OF THE STERI-STRIPS BECAUSE THEY WERE FALLING OFF AFTER WHICH A SMALL AREA OF THE BULGE APPEARED IN MIDLINE. HE ALSO NOTED DRAINAGE FROM WOUND. GASTROINTESTINAL: EVIDENCE OF SMALL BOWEL EVISCERATION IN MIDDLE OF MIDLINE WOUND A 2 CM IN LENGTH, WHERE STERI-STRIPS ARE ABSENT. THE REST OF THE STERI-STRIPS ARE INTACT. PLAN: OR FOR EXPLORATORY LAPAROTOMY. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6) , MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: VENTRAL WALL HERNIA PRIOR REPAIR. FINDINGS: LINEAR HYPERDENSE AIR AND FLUID COLLECTION SEEN. WITHIN SUBCUTANEOUS FAT WITHIN AREA OF HERNIA REPAIR MEASURING 6.5 X 12.1 X 13.5 CM. THIS WAS SEEN ON PRIOR EXAMINATION AND MEASURED 13.0 CM IN GREATEST DIMENSION. IMPRESSION: PERSISTENT AIR AND FLUID COLLECTION SEEN IN AREA OF VENTRAL HERNIA REPAIR. HAS SLIGHTLY INCREASED WHEN COMPARED TO REFERENCE EXAMINATION. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD; (B)(6), MD. IMMEDIATE POST-OP [POSTOPERATIVE] NOTE. POST OP [POSTOPERATIVE] DIAGNOSIS: ABDOMINAL WALL ABSCESS, INFECTED MESH. FINDINGS: ¿INFECTED MESH, PUS IN THE ABDOMINAL WALL ABSCESS.¿ SPECIMENS: NONE. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. PROGRESS NOTES. KERLEX DRESSING REMOVED. EXPOSED MESH LOOKS INTACT. IMPRESSION/PLAN: PACKING OF MIDLINE WOUND. CONSULT PLASTIC SURGERY. PLAN FOR REMOVAL OF EXPOSED MESH AND ABDOMINAL WALL RECONSTRUCTION AT A LATER TIME. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. PROGRESS NOTES. BID [TWICE DAILY] WET-TO-DRY DRESSING CHANGES. ABD [ABDOMEN]: MIDLINE ABDOMINAL WOUND WITH EXPOSED MESH. IMPRESSION/PLAN: PRESENTED WITH SMALL BOWEL EVISCERATION. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), PA. PROGRESS NOTES. BINDER IN PLACE, WOUND CLEAN, DRY. IMPRESSION/PLAN: CONTINUE NGT [NASOGASTRIC TUBE] UNTIL ILEUS RESOLVES. ON (B)(6) 2017: BETHESDA HEALTH. (B)(6), MD. PROGRESS NOTES. IMPRESSION/PLAN: POSTOP [POSTOPERATIVE] ILEUS RESOLVED. 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® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING WARNING AMONG OTHERS: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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.
PREVIOUS PATIENT CODES (1690, 1930, 1994) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2007 THROUGH (B)(6) 2017 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. RECORDS FROM (B)(6) 2007 THROUGH (B)(6) 2010; FROM (B)(6) 2011 THROUGH (B)(6) 2017 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY; ASTHMA; GASTROESOPHAGEAL REFLUX DISEASE [GERD]; DIABETES; SIGMOID DIVERTICULOSIS. PRIOR SURGICAL PROCEDURES: 2007: EXPLORATORY REDUCTION AND REPAIR OF INCARCERATED SUPRAUMBILICAL VENTRAL AND UMBILICAL HERNIA, LYSIS OF ADHESIONS AND OMENTECTOMY, PLACEMENT [SIC] OF SURGIMEND SURGICAL MESH. 2010: DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, REDUCTION INCARCERATED VENTRAL HERNIA, LAPAROSCOPIC REPAIR INCARCERATED VENTRAL HERNIA WITH MESH. RELEVANT MEDICAL INFORMATION: (B)(6) 2007: EXPLORATORY REDUCTION AND REPAIR OF INCARCERATED SUPRAUMBILICAL VENTRAL AND UMBILICAL HERNIA, LYSIS OF ADHESIONS AND OMENTECTOMY, PLACEMENT [SIC] OF SURGIMEND SURGICAL MESH. ¿WE FELT THIS HERNIA EXTENDED ABOVE THE UMBILICUS SO WE WENT ABOVE THE UMBILICUS WHERE INDEED THERE WAS BULGING THROUGH AS WELL AS THE UMBILICUS. WE OPENED THE SAC AND FOUND OMENTUM INCARCERATED. WE OPENED THROUGH THE VENTRAL HERNIA AS WELL AS UMBILICAL HERNIA; THERE WERE SEPARATE HERNIAS. OPENING THROUGH BOTH HERNIAS AND EXTENDING THE INCISION ON THE ATTENUATED FASCIA TO GOOD FASCIA SUPERIORLY AND INFERIORLY. WE IDENTIFIED AGAIN THIS WAS INCARCERATED OMENTUM WHICH WE CLAMPED, EXCISED, AND TIED AND SENT TO PATHOLOGY. IRRIGATED OUT [SIC] ADHESIONS WERE ALL BROKEN UP RELEASING THE OMENTUM SO WE COULD CLAMP AND TIE IT AND SECURE IT WITHOUT ANY PROBLEMS. AFTER THE ADHESIONS WERE ALL BROKEN UP, WE SENT TO PATHOLOGY, IRRIGATED OUT COPIOUSLY, MAKING SURE HE WAS DRY AND HEMOSTATIC. ON VIEWING THE BOWEL, NO SIGNIFICANT PROBLEMS [SIC] GOOD POSITION, MAKE SURE THAT WE HAD GOOD [SIC] ALL THE WAY AROUND AND STARTED OUR CLOSURE. WE CLOSED WITH HEAVY ETHIBOND [SIC] RETENTIONS AND # 1 DOUBLE STRANDED PDS. WE RAN IT FROM EACH END, THE PDS, MAKING SURE TO GET GOOD FASCIAL SUTURES ALL THE WAY UP, MADE SURE THERE WERE NO PROBLEMS WITH THE BOWEL [SIC], TIED THIS ALL UP SO [SIC]. AFTER SECURING EVERYTHING UP AND MADE SURE WE TIED IT UP WITHOUT ANY PROBLEMS, WE THEN PLACED THE SUGIMEND DOWN AND THEN WENT AHEAD AND SECURED [SIC]. THIS PATIENT WITH THIS LARGE ABDOMINAL AREA NEEDED MESH. WE FELT SURGIMEND COLLAGEN MESH WAS THE BEST SINCE A LOT OF THE OMENTUM APPEARED TO BE STUCK AND WE DID NOT FEEL WE SHOULD PUT IN ANY TYPE OF MARLEX MESH. WE SECURED WITH THE SURGIMEND [SIC] HEAVY VICRYL ALL THE WAY AROUND TO THE FASCIA, INTERRUPTED FASCIA ALL THE WAY AROUND TO MAKE SURE [SIC] PROBLEMS. IT WAS PLACED ALL THE WAY AROUND.¿ (B)(6) 2010: ¿HISTORY OF UMBILICAL HERNIA WITH REPAIR 2 TO 3 YEARS AGO, HAS NEVER GOTTEN BETTER SINCE SURGERY. ABDOMEN: DISTENDED WITH PERIUMBILICAL DISTENSION, TENDERNESS. IMPRESSION: ABDOMINAL PAIN, INCARCERATED VENTRAL HERNIA, SMALL BOWEL OBSTRUCTION.¿ (B)(6) 2010: CT ABDOMEN/PELVIS: ¿LARGE VENTRAL HERNIA CONTAINS SOME MILDLY DILATED FLUID-FILLED SMALL BOWEL LOOPS. APPEARANCE SUGGESTS AT LEAST A PARTIAL MECHANICAL OBSTRUCTION, ALTHOUGH LOCALIZED ILEUS COULD HAVE SIMILAR APPEARANCE. SIGMOID DIVERTICULOSIS.¿ (B)(6) 2010: ¿PT [PATIENT] REFUSAL NG [NASOGASTRIC TUBE].¿ (B)(6) 2010: DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC LYSIS OF ADHESIONS WITH REDUCTION OF AN INCARCERATED VENTRAL HERNIA, AND LAPAROSCOPIC REPAIR OF AN INCARCERATED VENTRAL HERNIA WITH MESH. ¿HE WAS EXPLORED THROUGH THREE LATERAL LAPAROSCOPY PORTS ON THE LEFT MIDAXILLARY LINE THROUGH WHICH LAPAROSCOPIC LYSIS OF ADHESIONS WAS PERFORMED AND REDUCTION OF THE HERNIA. THE HERNIA DEFECT WAS LARGE. IT INVOLVED THE MIDLINE ABDOMEN. IT WAS A SUBSTANTIAL DEFECT CONTAINING A LARGE HERNIA SAC. THE HERNIA WAS REPAIRED WITH A BARD SEPRAMESH ANCHORED IN PLACE WITH ABSORBATACK SUTURES WITHOUT DIFFICULTY, HOWEVER, THE PATIENT DID HAVE ELEMENTS OF WEAKNESS IN HIS ABDOMINAL FASCIA THAT COULD BE DETECTED BY PALPATION DURING INSUFFLATION. WE WERE AFFECTIVE [SIC], HOWEVER, IN REDUCING THE INCARCERATED BOWEL THAT WAS CAUSING THE BOWEL OBSTRUCTION AND RELIEVING THE OBSTRUCTION, AND LYSING THE ADHESIONS, AND SUBSEQUENTLY REPAIRING THE MESH. AT THE END OF THE PROCEDURE, THE 10 MM WOUND WAS CLOSED WITH # 0 VICRYL AND THE SKIN CLOSED WITH STAPLES.¿ (B)(6) 2010: DISCHARGE SUMMARY: ¿ADMIT DATE: (B)(6) 2010. DIAGNOSES: SMALL BOWEL OBSTRUCTION RELATED TO VENTRAL HERNIA. CONDITION ON DISCHARGE: GOOD. PRESENTS WITH ABDOMINAL PAIN. FOUND TO HAVE INCARCERATED VENTRAL HERNIA.¿ (B)(6) 2010: ¿ACUTE ONSET ABDOMINAL PAIN. REPORTS FEELING A POP IN LEFT LOWER QUADRANT WHEN HAVING DRY HEAVES. IMPRESSION/PLAN: RECTUS SHEATH HEMATOMA. WILL REQUIRE SECOND SURGERY FOR RECURRENCE OF VENTRAL HERNIA.¿ (B)(6) 2010: CT ABDOMEN/PELVIS: ¿ABNORMAL AREA OF HIGH ATTENUATION IN LEFT RECTUS MUSCULATURE, 5.1 X 7.8 X 11 CM. IMPRESSION: RECTUS SHEATH HEMATOMA WITH RECURRENT ANTERIOR MIDLINE HERNIA AND PROMINENT SMALL BOWEL. PROMINENT SMALL BOWEL CAN SUGGEST EARLY SMALL BOWEL OBSTRUCTION OR ILEUS.¿ (B)(6) 2010: DISCHARGE SUMMARY: ¿ADMIT DATE: (B)(6) 2010. DIAGNOSES: RECTUS SHEATH HEMATOMA. CONDITION ON DISCHARGE: GOOD. PRESENTS WITH RECURRENT ABDOMINAL PAIN. HERNIA IS NOT FELT TO HAVE RECURRED PER SURGERY.¿ IMPLANT PREOPERATIVE COMPLAINTS: IMPLANT PROCEDURE: REPAIR OF INCARCERATED VENTRAL HERNIA WITH TWO LAYERS OF DUAL PLUS MESH. REMOVAL OF MESH FROM PREVIOUS SURGERY. LYSIS OF ADHESIONS. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (7828732/1DLMCP08) 26CM X 34CM, OVAL. IMPLANT DATE: (B)(6) 2011. DESCRIPTION OF HERNIA BEING TREATED: ¿A MIDLINE INCISION IS MADE. THE FIRST LEVEL OF BULGE IS ENCOUNTERED AND DISSECTED FREE. THIS BULGE IS OPENED. THIS TURNS OUT TO BE THE MESH THAT WAS IMPLANTED AT WELLINGTON HOSPITAL WITH A FOREIGN BODY REACTION AROUND IT. THE MESH IS RESECTED. CAREFULLY, FURTHER DISSECTION IS PERFORMED. THEN IT BECOMES APPARENT THAT THERE IS, INDEED, AN INCARCERATED VENTRAL HERNIA AND THAT THE MESH PLACED AT THE TIME OF THE LAPAROSCOPIC SURGERY HAS NOW DEHISCED FROM THE ABDOMINAL WALL. VERY, VERY CAREFULLY, THE INCISION IN THE FASCIA IS CARRIED CEPHALAD SO THAT THE BOWEL IS NOT GOING TO BE INJURED IN THE PROCESS OF DOING THE LYSIS OF ADHESIONS AND SEPARATING THE BOWEL FROM THE MESH THAT WAS PLACE AT THE TIME OF THE LAPAROSCOPIC REPAIR. THE PERITONEAL CAVITY IS ENTERED CEPHALAD AND A CEPHALAD TO CAUDAD DISSECTION IS PERFORMED. THE SMALL BOWEL IS DISSECTED OFF THE ABDOMINAL WALL, DISSECTED OFF THE LAPAROSCOPIC-PLACED MESH, AND RETURNED TO THE ABDOMINAL CAVITY. A CLEAR TRANSITION ZONE BETWEEN DILATED SMALL BOWEL AND COLLAPSED SMALL BOWEL IS IDENTIFIED. PROBABLY 80% OF THE LAPAROSCOPIC MESH IS NOW REMOVED. THERE IS MESH THAT IS FIRMLY EMBEDDED IN THE ABDOMINAL WALL IN THE RIGHT SIDE OF THE WOUND THAT I AM NOT GOING TO REMOVE. THE EXTRA-LARGE PIECE OF DUAL MESH PLUS IS USED.¿ IMPLANT SIZE AND FIXATION: ¿IT IS CUT IN HALF AND THEN FASHIONED SO THAT IT IS 20 CM OR THEREABOUTS IN LENGTH AND PROBABLY 15 CM IN WIDTH, IN AN OVAL. ONE PIECE OF MESH IS PLACED BELOW THE FASCIA WITH THE SLICK SIDE FACING THE SMALL BOWEL. THE OTHER PIECE OF MESH IS PLACED ABOVE THE FASCIA WITH THE ROUGH SIDE FACING THE SUBCUTANEOUS FAT. THE SUTURES THAT ARE USED ARE VERTICAL MATTRESS SUTURES OF # 0 ETHIBOND. THEY ARE INITIALLY USED TO AFFIX THE PIECE OF MESH THAT IS BELOW THE FASCIA. THEN, USING FRENCH-EYE NEEDLES AND THE SAME SUTURES, A SANDWICH IS NOW CREATED, TAKING THE SUPERFICIAL PIECE OF MESH AND PLACING IT ON TOP OF THE DEFECT. THE SUTURES ARE NOW TIED TO CREATED THIS TWO LAYER MESH REPAIR. TWO DRAINS ARE PLACED ON TOP OF THE MESH. THE WOUND IS CLOSED WITH # 0 VICRYL AND SKIN STAPLES.¿ POST-OPERATIVE PERIOD: [6 DAYS]. (B)(6) 2011: DISCHARGE SUMMARY: ¿PRINCIPAL DIAGNOSIS: INCISIONAL HERNIA WITH OBSTRUCTION. SECONDARY DIAGNOSIS: SYMPTOMS INVOLVING THE RESPIRATORY SYSTEM & CHEST. ASTHMA. PROCEDURE: OTHER LYSIS OF PERITONEAL ADHESIONS. OTHER OPEN INCISIONAL HERNIA REPAIR WITH GRAFT OR PROSTHESIS.¿ PARTIAL EXPLANT PREOPERATIVE COMPLAINTS #1: (B)(6) 2017: CT ABDOMEN/PELVIS: ¿LARGE LOCULATED FLUID COLLECTION WHICH APPEARS TO BE ASSOCIATED WITH THE MESH. MEASURES 10.8 CM AP, 14.3 CM TRANSVERSE, 16.2 CM CRANIOCAUDAL. IMPRESSION: SMALL BOWEL OBSTRUCTION IS SEEN. APPEARS TO BE A LARGE VENTRAL HERNIA WHICH HAS INCREASED IN SIZE AND CONTAINS INCREASED BOWEL LOOPS COMPARED WITH 2011. THERE APPEARS TO HAVE BEEN A PRIOR ATTEMPT AT REPAIRING THIS HERNIA WHICH APPEARS TO HAVE RECURRED. THERE IS A LARGE DOUBLE LAYER OF SURGICAL MESH ANTERIORLY AT MIDLINE. WITHIN THE LAYERS OF MESH, THERE IS CONTAINED FLUID COLLECTION WHICH IS INCREASED IN SIZE COMPARED WITH 2011.¿ (B)(6) 2017: ¿OBESE, MILD PERIUMBILICAL TTP [TENDER TO PALPATION], LARGE VENTRAL HERNIA WITH WELL-HEALED MIDLINE INCISION.¿ PARTIAL EXPLANT PROCEDURE: REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA WITH ATRIUM PROLITE MESH. PARTIAL EXPLANT DATE: (B)(6) 2017 [HOSPITALIZED (B)(6) 2017]. (B)(6) 2017: ¿THE ABDOMEN WAS PREPPED AND DRAPED IN ROUTINE FASHION. THE PREVIOUS MIDLINE INCISION WAS OPENED. THE FIRST PART OF THE SURGERY WAS DESIGNED TO IDENTIFY THE HERNIA SAC, WHICH WAS RIGHT LATERAL. THE SAC WAS HUGE, IT WAS DISSECTED FREE CIRCUMFERENTIALLY, AND THE INCARCERATED CONTENTS WERE LARGELY REDUCED. IT WAS RECOGNIZED THAT THERE WAS FLUID BETWEEN THE TWO LAYERS OF MESH. SO, THE MESH WAS MOBILIZED ANTERIORLY, INCISIONS MADE IN THE MESH. THIS FLUID WAS EVACUATED AND CULTURED. NOW, THE NEXT THING THAT WAS DONE WAS AN EXTRAORDINARILY TEDIOUS LYSIS OF ADHESIONS SEPARATING THE SMALL BOWEL FROM THE MARGINS OF THE HERNIA DEFECT THAT WAS IN THE RIGHT LATERAL ASPECT OF THE ABDOMINAL WALL. ONCE THIS WAS COMPLETED, THEN THE REPAIR WAS ACCOMPLISHED SUTURING A PIECE OF ATRIUM PROLITE MESH WITH INTERRUPTED MATTRESS SUTURES OF 0 ETHIBOND. THE TISSUE THAT WAS UTILIZED IS FASCIA, SUPERIORLY, INFERIORLY, LATERALLY AND MEDIALLY, THE OLD MESH WAS SUTURED TO THE NEW MESH. THE FASCIA WAS THEN CLOSED OVER THE ATRIUM PROLITE MESH WITH NUMBER # 1 VICRYL. A PORTION OF THE ANTERIOR WALL OF THE MESH THAT HAD THE FLUID BETWEEN THE TWO LAYERS OF MESH WAS EXCISED SO AS TO PLICATE AND REDUCE THIS POTENTIAL SPACE FOR FURTHER FLUID DEVELOP. THIS EXCISION WAS THEN CLOSED WITH RUNNING # 1 PROLENE. A SINGLE JACKSON-PRATT DRAIN WAS BROUGHT IN SUPERIORLY AND LEFT IN THE SOFT TISSUE DEFECT, LEFT BEHIND BY THE REDUCTION OF THIS HUGE HERNIA. THE ABDOMINAL WOUND WAS CLOSED WITH 3-0 VICRYL AND SKIN WITH STAPLES.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2017: PATHOLOGY: ¿THE SPECIMEN IS LABELED WITH THE PATIENT¿S NAME, MEDICAL RECORD NUMBER, AND CLINICALLY IDENTIFIED AS MESH. IT IS RECEIVED IN FORMALIN. IT CONSISTS OF A PORTION OF TAN TISSUE MEASURING 10 X 5 X 0.4 CM.¿ (B)(6) 2017: ¿PT [PATIENT] REFUSING SCHEDULED MEDS, STATES THEY MAKE HIS ABDOMEN FEEL BAD. PROVIDED EDUCATION REGARDING MEDS.¿ (B)(6) 2017: ¿PT HAS REFUSED ANY MEDS THIS SHIFT, REFUSED ANY WOUND CARE.¿ (B)(6) 2017: DISCHARGE SUMMARY: ¿ADMIT DATE: (B)(6) 2017. ADMISSION DIAGNOSIS: ABD [ABDOMINAL] PAIN. PATIENT CONDITION: GOOD. HOSPITAL COURSE: CRAMPING DULL ACHING ABDOMINAL PAIN X 1 DAY. STATES FEELS LIKE PREVIOUS BOWEL OBSTRUCTION. DIAGNOSIS: SMALL BOWEL OBSTRUCTION ASSOCIATED WITH LARGE VENTRAL HERNIA. S/P [STATUS POST] REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA WITH ATRIUM PROLITE MESH.¿ (B)(6) 2017: ¿ABDOMEN: WELL HEALING MIDLINE WOUND WITH STAPLES IN PLACE. MINIMAL SWELLING. ALL STAPLES REMOVED AND STERI STRIPS PLACED. JP DRAINING MINIMAL, REMOVED. IMPRESSION/PLAN: NO HEAVY LIFTING 4 WEEKS.¿ (B)(6) 2017: ¿7 WEEKS AGO OPEN VENTRAL HERNIA REPAIR WITH MESH. PRESENTS TO ED FROM DR (B)(6) OFFICE WITH POSSIBLE INFECTION INVOLVING ABDOMINAL MESH. LUMP AT SITE OF SURGERY, DID NOT GO AWAY, OVER LAST COUPLE DAYS IT WAS LARGE AND BECAME MORE TENDER, WITH EARLY SIGNS OF CELLULITIS WITH REDDENED SKIN WARM TO TOUCH. DR (B)(6) SAW HIS SURGICAL SITE, WAS INCISED AND DRAINED, AGAIN SUSPICIOUS FOR COLLECTION. PATIENT SENT TO ED FOR ADMISSION FOR FURTHER RADIOLOGIC IMAGING, ID CONSULTATIONS AND FOR PROPER IV ANTIBIOTIC THERAPY. CULTURES WERE TAKEN IN OFFICE.¿ (B)(6) 2017: MICROBIOLOGY: ¿FINAL REPORT: NO GROWTH NO ANAEROBES ISOLATED.¿ (B)(6) 2017: CT ABDOMEN/PELVIS: ¿PERSISTENT 13 CM AREA OF FLUID WITHIN THE VENTRAL HERNIA MESH AND IN THE LOWER VENTRAL ABDOMINAL WALL WITH MULTIPLE FOCI OF AIR. FLUID IS OVERALL LESS LOCULATED AND DECREASED IN SIZE COMPARED TO PRIOR.¿ (B)(6) 2017: ¿DUE TO CONCERN FOR INTRAABDOMINAL ABSCESS WITH UNDERLYING MESH, WE WILL NEED BROAD IV ANTIBIOTIC COVERAGE. CONTINUE IV VANCOMYCIN, ADD IV ZOSYN TO COVER BOTH GRAM-POSITIVE AND GRAM-NEGATIVE. AGREE WITH SURGICAL INTERVENTION WITH POSSIBLE MESH REMOVAL.¿ (B)(6) 2017: ¿SURGICAL SITE INFECTION WHICH APPEARS TO INVOLVE THE NEWLY PLACED MESH.¿ (B)(6) 2017: DRAINAGE OF ABDOMINAL WALL FLUID COLLECTION: ¿THE INCISION WAS MADE IN THE OFFICE IS ENLARGED WITH THE CEPHALAD AND CAUDAD. SOFT MATERIAL IS EVACUATED. THERE WAS NO GROSS PURULENCE PRESENT. MESH WAS EXPOSED; HOWEVER, THE MESH THAT WAS EXPOSED IS THE DUAL MESH. THE ATRIUM MESH WAS NOT EXPOSED. THE 3000 ML WERE USED FROM THE SURGICAL LAVAGE SYSTEM TO FORCEFULLY WASH DOWN THE ENTIRE AREA. TWO DRAINS WERE PLACED. THERE WAS A 10 MM DRAIN, ONE CEPHALAD TO CAUDAD AND OTHER CAUDAD TO CEPHALAD. THE WOUND WAS CLOSED WITH 2-0 NYLON. STERILE DRESSINGS APPLIED. THE PLAN WILL BE TO SEE WITH CULTURES THAT WERE DONE YESTERDAY PRIOR TO PATIENT ON ANTIBIOTICS.¿ (B)(6) 2017: DISCHARGE SUMMARY: ¿SURGICAL SITE INFECTION, STATUS POST I AND D [INCISION AND DRAINAGE]. HOSPITAL COURSE: ADMITTED WITH A SEVEN-WEEK POST VENTRAL HERNIA REPAIR WITH MESH WITH SURGICAL SITE INFECTION. UNDERWENT SUCCESSFUL SURGERY. STARTED ON IV ANTIBIOTICS PER ID. ALL CULTURES WERE ESSENTIALLY NEGATIVE EXCEPT FOR CORYNEBACTERIUM IN THE SKIN, WHICH HAS COLONIZATION. WILL NEED 2 MORE WEEKS OF IV ANTIBIOTICS, WILL BE ARRANGED WITH HOME HEALTHCARE. HAS PICC LINE IN PLACE. WILL NEED IV VANCOMYCIN 1 G TWICE A DAY FOR 14 DAYS. WILL NEED TO HAVE FOLLOWUP OF LABS WEEKLY. INSTRUCTED TO FOLLOW UP WITH INFECTIOUS DISEASE AND SURGERY. TO RESUME HOME MEDICATIONS, INCLUDING METFORMIN.¿ (B)(6) 2017: ¿WELL HEALING MIDLINE SCAR. STAPLES REMOVED; STERI-STRIPS PLACED.¿ (B)(6) 2017: EMERGENCY DEPARTMENT: ¿FOLLOWING MOST RECENT SURGERY, REQUIRED HOSPITALIZATION FOR DEHISCENCE AND DRAINAGE. DAY PRIOR TO ARRIVAL BEGAN TO NOTE DRAINAGE ON HERNIA DRESSING. DRAINAGE FROM ABDOMINAL WOUND. ABDOMEN: 10 CM MASS SURROUNDING PREVIOUS INCISION SITE, DEHISCENCE NOTED TO CENTER OF PREVIOUS SURGICAL WOUND. SEROUS YELLOW DRAINAGE.¿ (B)(6) 2017: ¿OPEN MIDLINE WOUND, WITH EVISCERATED SMALL BOWEL. MOST RECENTLY STITCHES REMOVED IN OFFICE, STERI-STRIPS APPLIED. TWO DAYS AGO HE REMOVED 2 OF THE STERI-STRIPS BECAUSE THEY WERE FALLING OFF AFTER WHICH A SMALL AREA OF THE BULGE APPEARED IN MIDLINE. HE ALSO NOTED DRAINAGE FROM WOUND. GASTROINTESTINAL: EVIDENCE OF SMALL BOWEL EVISCERATION IN MIDDLE OF MIDLINE WOUND A 2 CM IN LENGTH, WHERE STERI-STRIPS ARE ABSENT. THE REST OF THE STERI-STRIPS ARE INTACT. PLAN: OR FOR EXPLORATORY LAPAROTOMY.¿ (B)(6) 2017: CT ABDOMEN/PELVIS: ¿LINEAR HYPERDENSE AIR AND FLUID COLLECTION SEEN. WITHIN SUBCUTANEOUS FAT WITHIN AREA OF HERNIA REPAIR MEASURING 6.5 X 12.1 X 13.5 CM. THIS WAS SEEN ON PRIOR EXAMINATION AND MEASURED 13.0 CM IN GREATEST DIMENSION.¿ (B)(6) 2017: INCISION AND DRAINAGE OF COMPLICATED ABSCESS: ¿PATIENT¿S WOUND WAS OPENED AND A SIGNIFICANT AMOUNT OF ABSCESS FLUID WAS SUCTIONED OUT, IT WAS CULTURED. THERE WAS EXCESSIVE AMOUNT OF NECROTIC TISSUE IN THE SUBCUTANEOUS AREA THAT WAS EXCISED AND THEN THE AREA WAS FULLY IRRIGATED. THE PATIENT¿S MESH WAS NOT REMOVED BECAUSE I FELT THAT THERE WAS TOO MUCH INFLAMMATION GOING ON AT THE TIME TO REMOVE THIS MESH THAT WAS SECURE AND KEEPING HIS BOWELS FROM EVISCERATING. FOLLOWING THIS, THE AREA WAS THEN PACKED WITH WET-TO-DRY DRESSING.¿ (B)(6) 2017: MICROBIOLOGY: ¿ABDOMINAL WOUND FOR CULTURE # 1. GRAM STAIN: MODERATE WBCS, NO ORGANISMS SEEN. WOUND CULTURE WITH ANAE: CULTURE IN PROGRESS. NO GROWTH AT THIS TIME, CULTURE IN PROGRESS. NO ANAEROBES ISOLATED. FINAL REPORT: NO GROWTH. ABDOMINAL WOUND FOR CULTURE # 2. GRAM STAIN: MODERATE WBCS, NO ORGANISMS SEEN. WOUND CULTURE WITH ANAE: NO GROWTH AT THIS TIME, CULTURE IN PROGRESS. NO ANAEROBES ISOLATED. FINAL REPORT: NO GROWTH.¿ (B)(6) 2017: ¿KERLEX DRESSING REMOVED. EXPOSED MESH LOOKS INTACT.¿ (B)(6) 2017: ¿MIDLINE ABDOMINAL WOUND WITH EXPOSED MESH.¿ (B)(6) 2017: MICROBIOLOGY: ¿ABDOMINAL FLUID ABSCESS. DIRECT FUNGAL SMEAR: NO FUNGAL ELEMENTS SEEN. FUNGUS CULTURE: NO FUNGUS PRESENT AT 4 WEEKS, FINAL REPORT. ACID FAST BACILLUS STAIN: NO ACID FAST BACILLI SEEN ON DIRECT KINYOUN SMEAR. ACID FAST BACILLUS CULTURE: CANCELLED ON (B)(6) 2017, INADEQUATE SPECIMEN/AEROBIC SWAB ONLY SUBMITTED.¿ (B)(6) 2017: MICROBIOLOGY: ¿ABDOMINAL FLUID. ACID FAST BACILLUS STAIN: NO ACID-FAST BACILLI SEEN ON CONCENTRATED SMEAR. ACID FAST BACILLUS CULTURE: NO ACID FAST BACILLI ISOLATED AT 6 WEEKS, FINAL REPORT.¿ COMPLETE EXPLANT PROCEDURE: LAPAROTOMY AND LYSIS OF ADHESIONS (TOTAL TIME DOING LYSIS OF ADHESIONS 1 TO 1-1/2 HOURS). EXCISION OF PREVIOUSLY PLACED MESH. VENTRAL HERNIA REPAIR. IMPLANTATION OF 15 CM X 20 CM XENMATRIX PORCINE DERMAL MATRIX. COMPLETE EXPLANT DATE: (B)(6) 2017. ¿AN ELLIPTICAL SKIN INCISION WAS MADE TO ENCOMPASS THE OPEN WOUND AND THE INCISION WAS EXTENDED PROXIMALLY TO NORMAL FASHION IN THE UPPER MIDLINE AND DISTALLY INTO NORMAL FASCIA IN THE MIDLINE BELOW THE PREVIOUSLY IMPLANTED MESH. THE ABDOMINAL CAVITY WAS ENTERED CEPHALAD AND THEN WHAT ENSUED WAS A 3-HOUR LYSIS OF ADHESIONS TO SEPARATE THE SMALL BOWEL FROM THE PREVIOUSLY IMPLANTED MESH. THIS WAS DONE IN A SLOW AND DELIBERATE FASHION WITH EXTRAORDINARY CARE TAKEN TO AVOID A TRANSMURAL INJURY TO THE BOWEL. AT THE COMPLETION OF THE 1 TO 1-1/2 HOUR LYSIS OF ADHESIONS, THE SMALL BOWEL HAD BEEN SUCCESSFULLY SEPARATED FROM THE PREVIOUSLY IMPLANTED MESH AND THERE WAS NOT EVIDENCE OF TRANSMURAL INJURY TO SMALL BOWEL. AT THIS POINT, THEN FLAPS WERE ELEVATED BETWEEN THE SUBCUTANEOUS TISSUE AND THE ANTERIOR RECTUS FASCIA, AS WELL AS THE EXTERNAL OBLIQUE FASCIA. THESE FLAPS WERE ELEVATED LATERALLY TO THE ANTERIOR SUPERIOR ILIAC SPINES BILATERALLY WITH THE INTENT OF DOING LONG RELAXING INCISIONS. SUPERIORLY, THE FLAPS WERE ELEVATED WELL TO THE COSTAL MARGIN, WHICH VERTICALLY COINCIDED WITH THE LEVEL OF THE ANTERIOR SUPERIOR ILIAC SPINE. THIS WAS DONE BILATERALLY. NOW, THE PREVIOUSLY IMPLANTED MESH WAS EXCISED COMPLETELY TAKING BOTH THE GORE-TEX SILVER IMPREGNATED DUAL MESH, WHICH APPEARED TO HAVE THE FOREIGN BODY REACTION, AS WELL AS THE PREVIOUSLY IMPLANTED ATRIUM PROLITE MESH, WHICH REALLY DID NOT SEEM TO HAVE A FOREIGN BODY REACTION, NOW RELAXING INCISIONS WERE PERFORMED LATERALLY. THESE GO FROM THE ANTERIOR SUPERIOR ILIAC SPINE VERTICALLY TO THE COSTAL MARGIN AT THE POINT OF THE LATERAL ASPECT OF THE RECTUS SHEATH EXPOSING THE EXTERNAL OBLIQUE MUSCULATURE. THESE RELAXING INCISIONS WERE PERFORMED SYMMETRICALLY BILATERALLY. NOW, A STRATEGY HAS TO BE DEVELOPED TO CLOSE THE ABDOMINAL WALL. MY HOPE WOULD BE TO CLOSE THE ABDOMINAL WALL PRIMARILY AND THEN REINFORCE IT WITH BIOLOGIC MESH. MY HOPE THEY ARE NOT TO HAVE TO IMPLANT ANY PROSTHETIC MESH. WITH THIS IN MIND, A SLOW AND DELIBERATE CLOSURE OF THE ABDOMINAL WALL WAS INITIATED WITH ALTERNATING INTERRUPTED SUTURES OF # 1 VICRYL AND # 1 PROLENE, WORKING ALTERNATELY FROM THE CEPHALAD PORTION OF THE WOUND AND THEN THE CAUDAD PORTION OF THE WOUND. EVENTUALLY, IT BECOMES APPARENT THAT PRIMARY CLOSURE IS GOING TO BE ACHIEVED ALTHOUGH IT IS CLEAR THAT IT IS UNDER TENSION. ONCE THIS PRIMARY CLOSURE WAS ACHIEVED, THEN A 15 CM X 20 CM PIECE OF PORCINE DERMAL MATRIX WAS PROCURED AND THEN IT WAS SUTURED TO THE ANTERIOR FASCIA CIRCUMFERENTIALLY WITH INTERRUPTED SUTURES OF #1 VICRYL. MY HOPE IS THAT THIS WILL PROVIDE SOME REINFORCEMENT FOR THE REPAIR. TWO JACKSON-PRATT DRAINS WERE PLACED UNDER THE FLAPS. THE SUBCUTANEOUS FAT WAS THEN CLOSED WITH 0 VICRYL. THE SKIN WAS CLOSED WITH RUNNING 3-0 NYLON. STERILE DRESSING AND A BINDER WERE APPLIED.THE PATIENT TOLERATED THE PROCEDURE WELL. IT SHOULD BE NOTED THAT THE ENTIRE DURATION OF THIS OPERATION SLIGHTLY IN EXCESS OF 3 HOURS, WHICH GIVES SOME ESTIMATION OF THE COMPLEXITY OF THE SERVICE RENDERED.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2017: ¿S/P MESH EXPLANT AND ABDOMINAL WALL RECONSTRUCTION WITH SEPARATION OF EXTERNAL OBLIQUE FASCIA, PRIMARY CLOSURE AND APPLICATION OF XENOGRAFT MESH IN ONLAY FASHION. PROCEDURE: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESION. EXPLANT OF REJECTED MESH. SEPARATION OF EXTERNAL OBLIQUE FASCIA TILL ANTERIOR SUPERIOR ILIAC CREST AND BILATERAL COASTAL MARGINS. PRIMARY CLOSURE OF ABDOMINAL WALL DEFECT WITH PROLENE AND VICRYL AND APPLICATION OF XENMATRIX MESH IN AN ONLAY FASHION.¿ ¿SMALL BOWEL ADHERED DENSELY TO FASCIA AND MESH, LYSIS OF ADHESIONS PERFORMED. ABDOMINAL MESH EXPLANTED AND EXTERNAL OBLIQUE FASCIA SEPARATED; PRIMARY CLOSURE ACHIEVED. XENOGRAFT MESH PLACED IN ONLAY FASHION, JP DRAINS X 2 PLACED IN WOUND BED.¿ (B)(6) 2017: PATHOLOGY: ¿RECEIVED FRESH FOR INTRAOPERATIVE EVALUATION AND DOCUMENTATION, LABELED WITH PATIENT¿S NAME, MEDICAL RECORD NUMBER, AND DESIGNATED AS ¿INFECTED ABDOMINAL MESH¿, TWO PORTIONS OF SYNTHETIC MESH MATERIAL MEASURING 15 X 15 X 0.3 CM, WITH PARTIAL SKIN AND SOFT TISSUE COMPONENTS THAT ARE ATTACHED TO THE MESH MATERIAL. FIBRINOPURULENT MATERIAL IS PRESENT.¿ (B)(6) 2017: DISCHARGE SUMMARY: ¿HISTORY OF VENTRAL HERNIA REQUIRING MULTIPLE SURGERIES, NOW ABDOMINAL DEHISCENCE WITH SEROUS DRAINAGE FOR 24 HOURS. JUST FINISHED A COURSE OF ANTIBIOTICS LAST WEEK. S/P INCISION, DRAINAGE, IRRIGATION AND PACKING OF ABDOMINAL WALL. LAST BOWEL WAS THIS MORNING WHICH WAS REPORTED TO BE NORMAL, HE HAS BEEN PASSING GAS. DIAGNOSIS/COURSE/PROCEDURE: INFECTED VENTRAL HERNIA, I&D, MESH REMOVAL. ANTIBX PER ID VANCO/ROCEPHIN AT LEAST TWO WEEKS. DISCHARGE INSTRUCTIONS: DISCHARGED TO HOME. ADDENDUM. ANEMIA DUE TO ACUTE BLOOD LOSS ANEMIA FROM SURGERY AS WELL AS CHRONIC DISEASE IN PATIENT S/P MULTIPLE SURGERIES AND LIMITED NUTRITION FOR SOME TIME POST OPERATIVELY.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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 WARNS, ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ THE INSTRUCTIONS FOR USE FURTHER WARNS, ¿IMPROPER POSITIONING OF THE SMOOTH, NON-TEXTURED SURFACE ADJACENT TO FASCIAL OR SUBCUTANEOUS TISSUE WILL RESULT IN MINIMAL TISSUE ATTACHMENT. PERSISTENT SEROMA MAY RESULT.¿ THE INSTRUCTIONS FOR USE ALSO WARNS, ¿WHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.¿ THE INSTRUCTIONS FOR USE FURTHER STATES ¿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® PLUS 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. PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. 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, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. 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. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE "D15: CAUSE NOT ESTABLISHED" IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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 AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 7828732. ADDITIONAL MANUFACTURER NARRATIVE: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. 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.
UPDATED RESULTS CODE. CONCLUSION REMAINS UNCHANGED.
B7: ADDED MEDICAL HISTORY. H6: 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 2007 WERE NOT PROVIDED. ON (B)(6) 2007: OPERATIVE REPORT. ¿ABDOMINAL PAIN AND TENDERNESS UPPER UMBILICAL, VENTRAL AND UMBILICAL AREA. SWOLLEN, TENDER, CONCERNED, WANTS SOMETHING DONE, DENIES PROBLEMS OTHER THAN ASTHMA. IMPRESSION/PLAN: INCARCERATED HERNIA, VENTRAL AND UMBILICAL. RECOMMEND SURGERY. PREOPERATIVE DIAGNOSIS: INCARCERATED VENTRAL SUPRAUMBILICAL AND UMBILICAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED VENTRAL SUPRAUMBILICAL AND UMBILICAL HERNIA. INCARCERATED OMENTUM. ADHESIONS.¿ OPERATION: EXPLORATORY REDUCTION AND REPAIR OF INCARCERATED SUPRAUMBILICAL VENTRAL AND UMBILICAL HERNIA, LYSIS OF ADHESIONS AND OMENTECTOMY, PLACEMEN [SIC] OF SURGIMEND SURGICAL MESH. PROCEDURE AND FINDINGS: ¿AGAIN, THE PATIENT IS HIGHLY RECOMMENDED FOR SURGERY. AFTER I SET HIM UP, BROUGHT TO THE OR WHERE PREOPERATIVELY HE WAS PREPPED AND DRAPED STERILELY. I WENT THROUGH A MIDLINE INCISION. WE FELT THIS HERNIA EXTENDED ABOVE THE UMBILICUS SO WE WENT ABOVE THE UMBILICUS WHERE INDEED THERE WAS BULGING THROUGH AS WELL AS THE UMBILICUS. WE OPENED THE SAC AND FOUND OMENTUM INCARCERATED. WE OPENED THROUGH THE VENTRAL HERNIA AS WELL AS UMBILICAL HERNIA; THERE WERE SEPARATE HERNIAS. OPENING THROUGH BOTH HERNIAS AND EXTENDING THE INCISION ON THE ATTENUATED FASCIA TO GOOD FASCIA SUPERIORLY AND INFERIORLY. WE IDENTIFIED AGAIN THIS WAS INCARCERATED OMENTUM WHICH WE CLAMPED, EXCISED, AND TIED AND SENT TO PATHOLOGY. IRRIGATED OUT [SIC] ADHESIONS WERE ALL BROKEN UP RELEASING THE OMENTUM SO WE COULD CLAMP AND TIE IT AND SECURE IT WITHOUT ANY PROBLEMS. AFTER THE ADHESIONS WERE ALL BROKEN UP, WE SENT TO PATHOLOGY, IRRIGATED OUT COPIOUSLY, MAKING SURE HE WAS DRY AND HEMOSTATIC. ON VIEWING THE BOWEL, NO SIGNIFICANT PROBLEMS [SIC] GOOD POSITION, MAKE SURE THAT WE HAD GOOD [SIC] ALL THE WAY AROUND AND STARTED OUR CLOSURE. WE CLOSED WITH HEAVY ETHIBOND [SIC] RETENTIONS AND # 1 DOUBLE STRANDED PDS. WE RAN IT FROM EACH END, THE PDS, MAKING SURE TO GET GOOD FASCIAL SUTURES ALL THE WAY UP, MADE SURE THERE WERE NO PROBLEMS WITH THE BOWEL [SIC], TIED THIS ALL UP SO [SIC]. AFTER SECURING EVERYTHING UP AND MADE SURE WE TIED IT UP WITHOUT ANY PROBLEMS, WE THEN PLACED THE SUGIMEND DOWN AND THEN WENT AHEAD AND SECURED [SIC]. THIS PATIENT WITH THIS LARGE ABDOMINAL AREA NEEDED MESH. WE FELT SURGIMEND COLLAGEN MESH WAS THE BEST SINCE A LOT OF THE OMENTUM APPEARED TO BE STUCK AND WE DID NOT FEEL WE SHOULD PUT IN ANY TYPE OF MARLEX MESH. WE SECURED WITH THE SURGIMEND [SIC] HEAVY VICRYL ALL THE WAY AROUND TO THE FASCIA, INTERRUPTED FASCIA ALL THE WAY AROUND TO MAKE SURE [SIC] PROBLEMS. IT WAS PLACED ALL THE WAY AROUND. WE PLACED JACKSON-PRATT THROUGH THE LATERAL STAB WOUND, PULLED IT DOWN, SECURE THE WOUND AND CLOSED WITH 0-VICRYL AND 2-0 VICRYL [SIC] CLIPS.¿ ON (B)(6) 2007: IMPLANT RECORD. SURGIMEND DEVICE. CAT # 606-001-006. LOT # 0707008. EXP. 2010-04. RECORDS BETWEEN 2007 AND 2010 WERE NOT PROVIDED. ON (B)(6) 2010 : OPERATIVE REPORT. ¿PRE/POSTOP DIAGNOSIS: INCARCERATED VENTRAL HERNIA. OPERATION: DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC LYSIS OF ADHESIONS WITH REDUCTION OF AN INCARCERATED VENTRAL HERNIA, AND LAPAROSCOPIC REPAIR OF AN INCARCERATED VENTRAL HERNIA WITH MESH.¿ INDICATION: ¿PATIENT PRESENTED TO HOSPITAL WITH AN INCARCERATED VENTRAL HERNIA THAT WAS TENDER AND WAS ASSOCIATED WITH AN ELEVATED WHITE BLOOD CELL COUNT. IT COULD NOT BE REDUCED THROUGH SIMPLE MECHANICAL MEANS SO HE WAS TAKEN TO THE OPERATING ROOM FOR EXPLORATION AND REPAIR.¿ SUMMARY: ¿HE WAS EXPLORED THROUGH THREE LATERAL LAPAROSCOPY PORTS ON THE LEFT MIDAXILLARY LINE THROUGH WHICH LAPAROSCOPIC LYSIS OF ADHESIONS WAS PERFORMED AND REDUCTION OF THE HERNIA. THE HERNIA DEFECT WAS LARGE. IT INVOLVED THE MIDLINE ABDOMEN. IT WAS A SUBSTANTIAL DEFECT CONTAINING A LARGE HERNIA SAC. THE HERNIA WAS REPAIRED WITH A BARD SEPRAMESH ANCHORED IN PLACE WITH ABSORBATACK SUTURES WITHOUT DIFFICULTY, HOWEVER, THE PATIENT DID HAVE ELEMENTS OF WEAKNESS IN HIS ABDOMINAL FASCIA THAT COULD BE DETECTED BY PALPATION DURING INSUFFLATION. WE WERE AFFECTIVE, HOWEVER, IN REDUCING THE INCARCERATED BOWEL THAT WAS CAUSING THE BOWEL OBSTRUCTION AND RELIEVING THE OBSTRUCTION, AND LYSING THE ADHESIONS, AND SUBSEQUENTLY REPAIRING THE MESH. AT THE END OF THE PROCEDURE, THE 10 MM WOUND WAS CLOSED WITH # 0 VICRYL AND THE SKIN CLOSED WITH STAPLES. STERILE DRESSINGS WERE APPLIED. THERE WERE NO COMPLICATIONS. SPONGE AND NEEDLE COUNTS WERE REPORTED CORRECT TIMES THREE. AN ABDOMINAL WALL BINDER WAS APPLIED.¿ ON (B)(6) 2010: OR CASE RECORD REPORT ¿PROCEDURES: DIAGNOSTIC LAPAROSCOPY WITH LAPAROSCOPIC INCARCERATED HERNIA REPAIR WITH MESH. PRE-OP AND POST-OP DIAGNOSIS: INCARCERATED VENTRAL HERNIA. WOUND CLASS: I-CLEAN. ASA: III-EMERGENCY. IMPLANT: SEPRAMESH IP 8¿ X 12¿, 20.3 CM X 30.5 CM. REF # 5959812. EXP 2012-02. LOT # HUUB0660. BARD.¿ ON (B)(6) 2011: OPERATIVE REPORT. ¿PRE/POSTOP DIAGNOSIS: INCARCERATED, RECURRENT VENTRAL HERNIA. OPERATION: REPAIR OF INCARCERATED VENTRAL HERNIA WITH TWO LAYERS OF DUAL PLUS MESH. REMOVAL OF MESH FROM PREVIOUS SURGERY. LYSIS OF ADHESIONS.¿ PROCEDURE/FINDINGS: ¿A MIDLINE INCISION IS MADE. THE FIRST LEVEL OF BULGE IS ENCOUNTERED AND DISSECTED FREE. THIS BULGE IS OPENED. THIS TURNS OUT TO BE THE MESH THAT WAS IMPLANTED AT WELLINGTON HOSPITAL WITH A FOREIGN BODY REACTION AROUND IT. THE MESH IS RESECTED. CAREFULLY, FURTHER DISSECTION IS PERFORMED. THEN IT BECOMES APPARENT THAT THERE IS, INDEED, AN INCARCERATED VENTRAL HERNIA AND THAT THE MESH PLACED AT THE TIME OF THE LAPAROSCOPIC SURGERY HAS NOW DEHISCED FROM THE ABDOMINAL WALL. VERY, VERY CAREFULLY, THE INCISION IN THE FASCIA IS CARRIED CEPHALAD SO THAT THE BOWEL IS NOT GOING TO BE INJURED IN THE PROCESS OF DOING THE LYSIS OF ADHESIONS AND SEPARATING THE BOWEL FROM THE MESH THAT WAS PLACE AT THE TIME OF THE LAPAROSCOPIC REPAIR. THE PERITONEAL CAVITY IS ENTERED CEPHALAD AND A CEPHALAD TO CAUDAD DISSECTION IS PERFORMED. THE SMALL BOWEL IS DISSECTED OFF THE ABDOMINAL WALL, DISSECTED OFF THE LAPAROSCOPIC-PLACED MESH, AND RETURNED TO THE ABDOMINAL CAVITY. A CLEAR TRANSITION ZONE BETWEEN DILATED SMALL BOWEL AND COLLAPSED SMALL BOWEL IS IDENTIFIED. PROBABLY 80% OF THE LAPAROSCOPIC MESH IS NOW REMOVED. THERE IS MESH THAT IS FIRMLY EMBEDDED IN THE ABDOMINAL WALL IN THE RIGHT SIDE OF THE WOUND THAT I AM NOT GOING TO REMOVE. THE EXTRA-LARGE PIECE OF DUAL MESH PLUS IS USED. IT IS CUT IN HALF AND THEN FASHIONED SO THAT IT IS 20 CM OR THEREABOUTS IN LENGTH AND PROBABLY 15 CM IN WIDTH, IN AN OVAL. ONE PIECE OF MESH IS PLACED BELOW THE FASCIA WITH THE SLICK SIDE FACING THE SMALL BOWEL. THE OTHER PIECE OF MESH IS PLACED ABOVE THE FASCIA WITH THE ROUGH SIDE FACING THE SUBCUTANEOUS FAT. THE SUTURES THAT ARE USED ARE VERTICAL MATTRESS SUTURES OF # 0 ETHIBOND. THEY ARE INITIALLY USED TO AFFIX THE PIECE OF MESH THAT IS BELOW THE FASCIA. THEN, USING FRENCH-EYE NEEDLES AND THE SAME SUTURES, A SANDWICH IS NOW CREATED, TAKING THE SUPERFICIAL PIECE OF MESH AND PLACING IT ON TOP OF THE DEFECT. THE SUTURES ARE NOW TIED TO CREATED THIS TWO LAYER MESH REPAIR. TWO DRAINS ARE PLACED ON TOP OF THE MESH. THE WOUND IS CLOSED WITH # 0 VICRYL AND SKIN STAPLES. A STERILE DRESSING IS APPLIED.¿ ON (B)(6) 2011: IMPLANT RECORD. DUAL MESH. SITE, ABDOMEN. CATALOG # 1DLMCP08. VENDER: GORE. LOT # 7828732. EXP 2013-01. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP08/7828732) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2011: PATHOLOGY REPORT. ¿ACCESSION # (SPECIMEN #) S-17-11. HISTORY/DIAGNOSIS: INCARCERATED VENTRAL HERNIA. SPECIMEN: HERNIA SAC, VENTRAL. GROSS DESCRIPTION: THE SPECIMEN IS LABELED MENDELSON, RIC, VENTRAL HERNIA CONTENTS. IT IS SUBMITTED IN FORMALIN AND CONSISTS OF MULTIPLE FRAGMENTS OF REDDISH-PURPLE AND YELLOW RUBBERY TISSUE MEASURING, IN AGGREGATE, APPROXIMATELY 13.0 X 13.0 X 4.5 CM. ALSO IN THE SAME SPECIMEN CONTAINER THERE IS ONE PORTION OF REDDISH-PINK FOREIGN BODY IDENTIFIED AS MESH MEASURING APPROXIMATELY 8.5 X 3.5 X 1.5 CM. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO BLOCKS. MICROSCOPIC DESCRIPTION: MICROSCOPIC SLIDES EXAMINED. DIAGNOSIS: VENTRAL HERNIA SAC: MEMBRANOUS FRAGMENTS OF FIBROUS TISSUE WITH SCLEROSIS, PATCHY CHRONIC INFLAMMATORY CELL INFILTRATE AND PATCHY HEMOSIDERIN LADEN MACROPHAGES.¿ ON (B)(6) 2011: DISCHARGE SUMMARY. ¿DISPOSITION: HOME. PRINCIPAL DIAGNOSIS: INCISIONAL HERNIA WITH OBSTRUCTION. SECONDARY DIAGNOSIS: SYMPTOMS INVOLVING THE RESPIRATORY SYSTEM & CHEST. ASTHMA. PROCEDURE: OTHER LYSIS OF PERITONEAL ADHESIONS. OTHER OPEN INCISIONAL HERNIA REPAIR WITH GRAFT OR PROSTHESIS.¿ RECORDS BETWEEN 2011 AND 2017 WERE NOT PROVIDED. ON (B)(6) 2017: OPERATIVE REPORT. ¿PRE/POSTOP DIAGNOSIS: INCARCERATED RECURRENT VENTRAL HERNIA. OPERATION: REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA WITH ATRIUM PROLITE MESH.¿ PROCEDURE/FINDINGS: ¿IN THE OPERATING ROOM, AFTER THE PATIENT WAS PREPPED AND DRAPED, SURGICAL TIME-OUT WAS TAKEN. THE PATIENT WAS IDENTIFIED AS THE CORRECT PATIENT AND AGREED-UPON PROCEDURE WAS REPAIR OF VENTRAL HERNIA. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. SPONGE AND NEEDLE COUNTS WERE REPORTED AS CORRECT. GENERAL ANESTHETIC WAS INDUCED. THE ABDOMEN WAS PREPPED AND DRAPED IN ROUTINE FASHION. THE PREVIOUS MIDLINE INCISION WAS OPENED. THE FIRST PART OF THE SURGERY WAS DESIGNED TO IDENTIFY THE HERNIA SAC, WHICH WAS RIGHT LATERAL. THE SAC WAS HUGE, IT WAS DISSECTED FREE CIRCUMFERENTIALLY, AND THE INCARCERATED CONTENTS WERE LARGELY REDUCED. IT WAS RECOGNIZED THAT THERE WAS FLUID BETWEEN THE TWO LAYERS OF MESH. SO, THE MESH WAS MOBILIZED ANTERIORLY, INCISIONS MADE IN THE MESH. THIS FLUID WAS EVACUATED AND CULTURED. NOW, THE NEXT THING THAT WAS DONE WAS AN EXTRAORDINARILY TEDIOUS LYSIS OF ADHESIONS SEPARATING THE SMALL BOWEL FROM THE MARGINS OF THE HERNIA DEFECT THAT WAS IN THE RIGHT LATERAL ASPECT OF THE ABDOMINAL WALL. ONCE THIS WAS COMPLETED, THEN THE REPAIR WAS ACCOMPLISHED SUTURING A PIECE OF ATRIUM PROLITE MESH WITH INTERRUPTED MATTRESS SUTURES OF 0 ETHIBOND. THE TISSUE THAT WAS UTILIZED IS FASCIA, SUPERIORLY, INFERIORLY, LATERALLY AND MEDIALLY, THE OLD MESH WAS SUTURED TO THE NEW MESH. THE FASCIA WAS THEN CLOSED OVER THE ATRIUM PROLITE MESH WITH NUMBER # 1 VICRYL. A PORTION OF THE ANTERIOR WALL OF THE MESH THAT HAD THE FLUID BETWEEN THE TWO LAYERS OF MESH WAS EXCISED SO AS TO PLICATE AND REDUCE THIS POTENTIAL SPACE FOR FURTHER FLUID DEVELOP. THIS EXCISION WAS THEN CLOSED WITH RUNNING # 1 PROLENE. A SINGLE JACKSON-PRATT DRAIN WAS BROUGHT IN SUPERIORLY AND LEFT IN THE SOFT TISSUE DEFECT, LEFT BEHIND BY THE REDUCTION OF THIS HUGE HERNIA. THE ABDOMINAL WOUND WAS CLOSED WITH 3-0 VICRYL AND SKIN WITH STAPLES. STERILE DRESSINGS APPLIED.¿ ON (B)(6) 2017: OR CASE REPORT. ASA: III. IMPLANTS: MESH. CATALOG # 1000306-00. ATRIUM. LOT # 411106. SERIAL # (B)(6). MICROBIOLOGY: AEROBIC, ANAEROBIC. SITE, PERITONEAL FLUID. SPECIMEN: HERNIA SAC. REMOVED MESH. ON (B)(6) 2017: PATHOLOGY REPORT. ¿ACCESSION # (SPECIMEN #) SE-4112-17. HISTORY/DIAGNOSIS: VENTRAL HERNIA. SPECIMEN: HERNIA SAC. TISSUE, MESH. GROSS DESCRIPTION: THE SPECIMEN IS LABELED WITH THE PATIENTS¿ NAME, MEDICAL RECORD NUMBER, AND IDENTIFIED AS HERNIA SAC. IT IS RECEIVED IN FORMALIN AND CONSISTS OF A PORTION OF PURPLISH TAN MEMBRANOUS TISSUE MEASURING APPROXIMATELY 21 X 7 X 0.3 CM. NO DISCRETE LESIONS GROSSLY IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. THE SPECIMEN IS LABELED WITH THE PATIENT¿S NAME, MEDICAL RECORD NUMBER, AND CLINICALLY IDENTIFIED AS MESH. IT IS RECEIVED IN FORMALIN. IT CONSISTS OF A PORTION OF TAN TISSUE MEASURING 10 X 5 X 0.4 CM. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. MICROSCOPIC DESCRIPTION: MICROSCOPIC SLIDES EXAMINED ON ALL NON GROSS ONLY SPECIMENS. DIAGNOSIS: VENTRAL HERNIA SAC EXCISION-HERNIA SAC AND ADIPOSE TISSUE. MESH, EXCISION-DENSE FIBROUS TISSUE AND ADIPOSE TISSUE.¿ ON (B)(6) 2017: PATHOLOGY REPORT. ¿ACCESSION # (SPECIMEN #) PE-194-17. HISTORY/DIAGNOSIS: SBO, HERNIA. SPECIMEN: BLOOD SMEAR FOR REVIEW FROM HEMATOLOGY, M0180015. CONSULTATION REPORT: RECEIVED ONE STAINED PERIPHERAL BLOOD SMEAR SLIDE LABELED WITH PATIENT¿S NAME. IMPRESSION: PERIPHERAL BLOOD SMEAR REVIEW-GRANULOCYTE LEFT SHIFT IS SUGGESTIVE OF A REACTIVE/INFLAMMATORY PROCESS.¿ ON (B)(6) 2017: HISTORY AND PHYSICAL. ¿7 WEEKS AGO OPEN VENTRAL HERNIA REPAIR WITH MESH. PRESENTS TO ED FROM DR. MUELLER¿S OFFICE WITH POSSIBLE INFECTION INVOLVING ABDOMINAL MESH. LUMP AT SITE OF SURGERY, DID NOT GO AWAY, OVER LAST COUPLE DAYS IT WAS LARGE AND BECAME MORE TENDER, WITH EARLY SIGNS OF CELLULITIS WITH REDDENED SKIN WARM TO TOUCH. DR. MUELLER SAW HIS SURGICAL SITE, WAS INCISED AND DRAINED, AGAIN SUSPICIOUS FOR COLLECTION. PATIENT SENT TO ED FOR ADMISSION FOR FURTHER RADIOLOGIC IMAGING, ID CONSULTATIONS AND FOR PROPER IV ANTIBIOTIC THERAPY. CULTURES WERE TAKEN IN OFFICE. PMH: ASTHMA, DIABETES MELLITUS. EXAM: ABDOMEN- INCISION COVERED BY CLEAN, DRY, INTACT GAUZE DRESSING AND OPSITE COVERING THAT. REDNESS TO SKIN SURROUNDING. INCISION SITE WARM TO TOUCH. LAB: WBC 10.7. IMPRESSION AND PLAN: PRESENTS WITH MESH INFECTION. AWAITING ID CONSULTATION.¿ ON (B)(6) 2017: BETHESDA HEALTH. LABORATORY RESULTS. WBC 12.2 H. ON (B)(6) 2017: MICROBIOLOGY. ¿WOUND/SURGICAL. GRAM STAIN: RARE WBCS, NO ORGANISMS SEEN. WOUND CULTURE WITH ANAE: NO GROWTH AT THIS TIME, CULTURE IN PROGRESS. FINAL REPORT: NO GROWTH NO ANAEROBES ISOLATED.¿ ON (B)(6) 2017: CT ABDOMEN AND PELVIS WITH CONTRAST. ¿INDICATION: ABDOMINAL PAIN. RECENT VENTRAL HERNIA REPAIR. EVALUATE FLUID WITHIN THE HERNIA MESH. IMPRESSION: PERSISTENT 13 CM AREA OF FLUID WITHIN THE VENTRAL HERNIA MESH AND IN THE LOWER VENTRAL ABDOMINAL WALL WITH MULTIPLE FOCI OF AIR. FLUID IS OVERALL LESS LOCULATED AND DECREASED IN SIZE COMPARED TO PRIOR.¿ ON (B)(6) 2017: CONSULTATION. ¿REASON FOR CONSULTATION: ABDOMINAL WALL INFECTION. PLAN: DUE TO CONCERN FOR INTRAABDOMINAL ABSCESS WITH UNDERLYING MESH, WE WILL NEED BROAD IV ANTIBIOTIC COVERAGE. CONTINUE IV VANCOMYCIN, ADD IV ZOSYN TO COVER BOTH GRAM-POSITIVE AND GRAM-NEGATIVE. AGREE WITH SURGICAL INTERVENTION WITH POSSIBLE MESH REMOVAL.¿ ON (B)(6) 2017: CONSULTATION. ¿GENERAL SURGERY. WT. 107.955 KG, HT. 70 INCH, BODY MASS INDEX 34.15. IMPRESSION: SURGICAL SITE INFECTION WHICH APPEARS TO INVOLVE THE NEWLY PLACED MESH. PLAN: IV ABX, F/U CULTURES, NO SURGICAL INTERVENTION AT THIS TIME.¿ ON (B)(6) 2017: OPERATIVE REPORT. ¿PRE/POSTOP DIAGNOSIS: ABDOMINAL WALL FLUID COLLECTION. OPERATION: DRAINAGE OF ABDOMINAL WALL FLUID COLLECTION.¿ DESCRIPTION OF PROCEDURE/FINDINGS: ¿THE INCISION WAS MADE IN THE OFFICE IS ENLARGED WITH THE CEPHALAD AND CAUDAD. SOFT MATERIAL IS EVACUATED. THERE WAS NO GROSS PURULENCE PRESENT. MESH WAS EXPOSED; HOWEVER, THE MESH THAT WAS EXPOSED IS THE DUAL MESH. THE ATRIUM MESH WAS NOT EXPOSED. THE 3000 ML WERE USED FROM THE SURGICAL LAVAGE SYSTEM TO FORCEFULLY WASH DOWN THE ENTIRE AREA. TWO DRAINS WERE PLACED. THERE WAS A 10 MM DRAIN, ONE CEPHALAD TO CAUDAD AND OTHER CAUDAD TO CEPHALAD. THE WOUND WAS CLOSED WITH 2-0 NYLON. STERILE DRESSINGS APPLIED. THE PLAN WILL BE TO SEE WITH CULTURES THAT WERE DONE YESTERDAY PRIOR TO PATIENT ON ANTIBIOTICS.¿ ON (B)(6) 2017: OR CASE RECORD REPORT. ¿ABDOMINAL WALL ABSCESS. WOUND CLASS: III-CONTAMINATED.¿ ON (B)(6) 2017: DISCHARGE SUMMARY. ¿ REASON FOR ADMISSION: SURGICAL SITE INFECTION, STATUS POST I AND D. HOSPITAL COURSE: ADMITTED WITH A SEVEN-WEEK POST VENTRAL HERNIA REPAIR WITH MESH WITH SURGICAL SITE INFECTION. UNDERWENT SUCCESSFUL SURGERY. STARTED ON IV ANTIBIOTICS PER ID. ALL CULTURES WERE ESSENTIALLY NEGATIVE EXCEPT FOR CORYNEBACTERIUM IN THE SKIN, WHICH HAS COLONIZATION. WILL NEED 2 MORE WEEKS OF IV ANTIBIOTICS, WILL BE ARRANGED WITH HOME HEALTHCARE. HAS PICC LINE IN PLACE. WILL NEED IV VANCOMYCIN 1 G TWICE A DAY FOR 14 DAYS. WILL NEED TO HAVE FOLLOWUP OF LABS WEEKLY. INSTRUCTED TO FOLLOW UP WITH INFECTIOUS DISEASE AND SURGERY. TO RESUME HOME MEDICATIONS, INCLUDING METFORMIN.¿ ON (B)(6) 2017: OPERATIVE REPORT. ¿PRE/POSTOP DIAGNOSIS: ABDOMINAL WALL COMPLICATED ABSCESS. OPERATION: INCISION AND DRAINAGE OF COMPLICATED ABSCESS.¿ PROCEDURE/FINDINGS: ¿PATIENT¿S WOUND WAS OPENED AND A SIGNIFICANT AMOUNT OF ABSCESS FLUID WAS SUCTIONED OUT, IT WAS CULTURED. THERE WAS EXCESSIVE AMOUNT OF NECROTIC TISSUE IN THE SUBCUTANEOUS AREA THAT WAS EXCISED AND THEN THE AREA WAS FULLY IRRIGATED. THE PATIENT¿S MESH WAS NOT REMOVED BECAUSE I FELT THAT THERE WAS TOO MUCH INFLAMMATION GOING ON AT THE TIME TO REMOVE THIS MESH THAT WAS SECURE AND KEEPING HIS BOWELS FROM EVISCERATING. FOLLOWING THIS, THE AREA WAS THEN PACKED WITH WET-TO-DRY DRESSING.¿ POSTPROCEDURE PLAN: ¿THE PATIENT IS GOING TO REQUIRE EXCISION OF THIS MESH AND THIS WILL BE PLANNED ONCE THE PATIENT¿S INFECTION PROCESS IMPROVES.¿ ON (B)(6) 2017: MICROBIOLOGY. ¿ABDOMINAL WOUND FOR CULTURE # 1. GRAM STAIN: MODERATE WBCS, NO ORGANISMS SEEN. WOUND CULTURE WITH ANAE: CULTURE IN PROGRESS. NO GROWTH AT THIS TIME, CULTURE IN PROGRESS. NO ANAEROBES ISOLATED. FINAL REPORT: NO GROWTH. ABDOMINAL WOUND FOR CULTURE # 2. GRAM STAIN: MODERATE WBCS, NO ORGANISMS SEEN. WOUND CULTURE WITH ANAE: NO GROWTH AT THIS TIME, CULTURE IN PROGRESS. NO ANAEROBES ISOLATED. FINAL REPORT: NO GROWTH.¿ ON (B)(6) 2017: MICROBIOLOGY. ¿ABDOMINAL FLUID ABSCESS. DIRECT FUNGAL SMEAR: NO FUNGAL ELEMENTS SEEN. FUNGUS CULTURE: NO FUNGUS PRESENT AT 4 WEEKS, FINAL REPORT. ACID FAST BACILLUS STAIN: NO ACID FAST BACILLI SEEN ON DIRECT KINYOUN SMEAR. ACID FAST BACILLUS CULTURE: CANCELLED ON 07/09/17, INADEQUATE SPECIMEN/AEROBIC SWAB ONLY SUBMITTED.¿ ON (B)(6) 2017: MICROBIOLOGY. ¿WOUND: ABDOMINAL FLUID. ACID FAST BACILLUS STAIN: NO ACID-FAST BACILLI SEEN ON CONCENTRATED SMEAR. ACID FAST BACILLUS CULTURE: NO ACID FAST BACILLI ISOLATED AT 6 WEEKS, FINAL REPORT.¿ ON (B)(6) 2017: LABORATORY RESULTS. WBC 17.0 H. ON (B)(6) 2017: OPERATIVE REPORT. ¿PREOPERATIVE DIAGNOSIS: FOREIGN BODY REACTION TO PREVIOUSLY IMPLANTED MESH. VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: FOREIGN BODY REACTION TO PREVIOUSLY IMPLANTED MESH. VENTRAL HERNIA. EXTENSIVE INTRAPERITONEAL ADHESIONS. OPERATION: LAPAROTOMY AND LYSIS OF ADHESIONS (TOTAL TIME DOING LYSIS OF ADHESIONS 1 TO 1-1/2 HOURS). EXCISION OF PREVIOUSLY PLACED MESH. VENTRAL HERNIA REPAIR. IMPLANTATION OF 15 CM X 20 CM XENMATRIX PORCINE DERMAL MATRIX.¿ PROCEDURE/FINDINGS: ¿AN ELLIPTICAL SKIN INCISION WAS MADE TO ENCOMPASS THE OPEN WOUND AND THE INCISION WAS EXTENDED PROXIMALLY TO NORMAL FASHION IN THE UPPER MIDLINE AND DISTALLY INTO NORMAL FASCIA IN THE MIDLINE BELOW THE PREVIOUSLY IMPLANTED MESH. THE ABDOMINAL CAVITY WAS ENTERED CEPHALAD AND THEN WHAT ENSUED WAS A 3-HOUR LYSIS OF ADHESIONS TO SEPARATE THE SMALL BOWEL FROM THE PREVIOUSLY IMPLANTED MESH. THIS WAS DONE IN A SLOW AND DELIBERATE FASHION WITH EXTRAORDINARY CARE TAKEN TO AVOID A TRANSMURAL INJURY TO THE BOWEL. AT THE COMPLETION OF THE 1 TO 1-1/2 HOUR LYSIS OF ADHESIONS, THE SMALL BOWEL HAD BEEN SUCCESSFULLY SEPARATED FROM THE PREVIOUSLY IMPLANTED MESH AND THERE WAS NOT EVIDENCE OF TRANSMURAL INJURY TO SMALL BOWEL. AT THIS POINT, THEN FLAPS WERE ELEVATED BETWEEN THE SUBCUTANEOUS TISSUE AND THE ANTERIOR RECTUS FASCIA, AS WELL AS THE EXTERNAL OBLIQUE FASCIA. THESE FLAPS WERE ELEVATED LATERALLY TO THE ANTERIOR SUPERIOR ILIAC SPINES BILATERALLY WITH THE INTENT OF DOING LONG RELAXING INCISIONS. SUPERIORLY, THE FLAPS WERE ELEVATED WELL TO THE COSTAL MARGIN, WHICH VERTICALLY COINCIDED WITH THE LEVEL OF THE ANTERIOR SUPERIOR ILIAC SPINE. THIS WAS DONE BILATERALLY. NOW, THE PREVIOUSLY IMPLANTED MESH WAS EXCISED COMPLETELY TAKING BOTH THE GORE-TEX SILVER IMPREGNATED DUAL MESH, WHICH APPEARED TO HAVE THE FOREIGN BODY REACTION, AS WELL AS THE PREVIOUSLY IMPLANTED ATRIUM PROLITE MESH, WHICH REALLY DID NOT SEEM TO HAVE A FOREIGN BODY REACTION, NOW RELAXING INCISIONS WERE PERFORMED LATERALLY. THESE GO FROM THE ANTERIOR SUPERIOR ILIAC SPINE VERTICALLY TO THE COSTAL MARGIN AT THE POINT OF THE LATERAL ASPECT OF THE RECTUS SHEATH EXPOSING THE EXTERNAL OBLIQUE MUSCULATURE. THESE RELAXING INCISIONS WERE PERFORMED SYMMETRICALLY BILATERALLY. NOW, A STRATEGY HAS TO BE DEVELOPED TO CLOSE THE ABDOMINAL WALL. MY HOPE WOULD BE TO CLOSE THE ABDOMINAL WALL PRIMARILY AND THEN REINFORCE IT WITH BIOLOGIC MESH. MY HOPE THEY ARE NOT TO HAVE TO IMPLANT ANY PROSTHETIC MESH. WITH THIS IN MIND, A SLOW AND DELIBERATE CLOSURE OF THE ABDOMINAL WALL WAS INITIATED WITH ALTERNATING INTERRUPTED SUTURES OF # 1 VICRYL AND # 1 PROLENE, WORKING ALTERNATELY FROM THE CEPHALAD PORTION OF THE WOUND AND THEN THE CAUDAD PORTION OF THE WOUND. EVENTUALLY, IT BECOMES APPARENT THAT PRIMARY CLOSURE IS GOING TO BE ACHIEVED ALTHOUGH IT IS CLEAR THAT IT IS UNDER TENSION. ONCE THIS PRIMARY CLOSURE WAS ACHIEVED, THEN A 15 CM X 20 CM PIECE OF PORCINE DERMAL MATRIX WAS PROCURED AND THEN IT WAS SUTURED TO THE ANTERIOR FASCIA CIRCUMFERENTIALLY WITH INTERRUPTED SUTURES OF #1 VICRYL. MY HOPE IS THAT THIS WILL PROVIDE SOME REINFORCEMENT FOR THE REPAIR. TWO JACKSON-PRATT DRAINS WERE PLACED UNDER THE FLAPS. THE SUBCUTANEOUS FAT WAS THEN CLOSED WITH 0 VICRYL. THE SKIN WAS CLOSED WITH RUNNING 3-0 NYLON. STERILE DRESSING AND A BINDER WERE APPLIED.THE PATIENT TOLERATED THE PROCEDURE WELL. IT SHOULD BE NOTED THAT THE ENTIRE DURATION OF THIS OPERATION SLIGHTLY IN EXCESS OF 3 HOURS, WHICH GIVES SOME ESTIMATION OF THE COMPLEXITY OF THE SERVICE RENDERED.¿ ON (B)(6) 2017: IMMEDIATE POST-OP POST PROCEDURE NOTE. ¿POST OP DIAGNOSIS: S/P MESH EXPLANT AND ABDOMINAL WALL RECONSTRUCTION WITH SEPARATION OF EXTERNAL OBLIQUE FASCIA, PRIMARY CLOSURE AND APPLICATION OF XENOGRAFT MESH IN ONLAY FASHION. PROCEDURE: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESION. EXPLANT OF REJECTED MESH. SEPARATION OF EXTERNAL OBLIQUE FASCIA TILL ANTERIOR SUPERIOR ILIAC CREST AND BILATERAL COASTAL MARGINS. PRIMARY CLOSURE OF ABDOMINAL WALL DEFECT WITH PROLENE AND VICRYL AND APPLICATION OF XENMATRIX MESH IN AN ONLAY FASHION. FINDINGS: ¿SMALL BOWEL ADHERED DENSELY TO FASCIA AND MESH, LYSIS OF ADHESIONS PERFORMED. ABDOMINAL MESH EXPLANTED AND EXTERNAL OBLIQUE FASCIA SEPARATED; PRIMARY CLOSURE ACHIEVED. XENOGRAFT MESH PLACED IN ONLAY FASHION, JP DRAINS X 2 PLACED IN WOUND BED.¿ SPECIMENS: EXPLANTED MESH.¿ ON (B)(6) 2017: OR CASE RECORD REPORT. ¿PRE-OP AND POST-OP DIAGNOSIS: INFECTED ABDOMINAL MESH. WOUND CLASS: IV-INFECTED. ASA: III-EMERGENCY. IMPLANT: XENMAT. BARD. SPECIMEN: INFECTED ABDOMINAL MESH. DRESSING: DRY STERILE DRESSING, XEROFORM, ABDOMINAL BINDER. TRANSPORTED TO: PACU.¿ ON (B)(6) 2017: PATHOLOGY REPORT. ¿ACCESSION # (SPECIMEN #): SE-7261-17. HISTORY/DIAGNOSIS: INFECTED ABDOMINAL MESH. SPECIMEN: HARDWARE, INFECTED ABDOMINAL MESH. OPERATING ROOM CONSULTATION/FROZEN SECTION: SPECIMEN REVIEWED INTRAOPERATIVELY WITH DR. G. MUELLER FOR DOCUMENTATION PURPOSES. GROSS DESCRIPTION: RECEIVED FRESH FOR INTRAOPERATIVE EVALUATION AND DOCUMENTATION, LABELED WITH PATIENT¿S NAME, MEDICAL RECORD NUMBER, AND DESIGNATED AS ¿INFECTED ABDOMINAL MESH¿, TWO PORTIONS OF SYNTHETIC MESH MATERIAL MEASURING 15 X 15 X 0.3 CM, WITH PARTIAL SKIN AND SOFT TISSUE COMPONENTS THAT ARE ATTACHED TO THE MESH MATERIAL. FIBRINOPURULENT MATERIAL IS PRESENT. REPRESENTATIVE SECTIONS ARE SUBMITTED IN THREE CASSETTES. MICROSCOPIC DESCRIPTION: MICROSCOPIC SLIDES EXAMINED ON ALL NON GROSS ONLY SPECIMENS. DIAGNOSIS: INFECTED ABDOMINAL MESH, REMOVAL: SKIN AND UNDERLYING CONNECTIVE TISSUE WITH AREAS OF ACUTE AND CHRONIC INFLAMMATION, NECROSIS, AND GIANT CELL REACTION, ASSOCIATED WITH MESH MATERIAL. COMMENT: THIS CASE WAS SUBJECT TO INTRADEPARTMENTAL REVIEW WITH CONCORDANCE. CLINICOPATHOLOGIC CORRELATION IS RECOMMENDED.¿ ON (B)(6) 2017: LABORATORY RESULTS. WBC 15.3 H. ON (B)(6) 2017: DISCHARGE SUMMARY. ¿HOSPITAL COURSE: HISTORY OF VENTRAL HERNIA REQUIRING MULTIPLE SURGERIES, NOW ABDOMINAL DEHISCENCE WITH SEROUS DRAINAGE FOR 24 HOURS. JUST FINISHED A COURSE OF ANTIBIOTICS LAST WEEK. S/P INCISION, DRAINAGE, IRRIGATION AND PACKING OF ABDOMINAL WALL. LAST BOWEL WAS THIS MORNING WHICH WAS REPORTED TO BE NORMAL, HE HAS BEEN PASSING GAS. DIAGNOSIS/COURSE/PROCEDURE: INFECTED VENTRAL HERNIA, I&D, MESH REMOVAL. ANTIBX PER ID VANCO/ROCEPHIN AT LEAST TWO WEEKS. DISCHARGE INSTRUCTIONS: DISCHARGED TO HOME. ADDENDUM. ANEMIA DUE TO ACUTE BLOOD LOSS ANEMIA FROM SURGERY AS WELL AS CHRONIC DISEASE IN PATIENT S/P MULTIPLE SURGERIES AND LIMITED NUTRITION FOR SOME TIME POST OPERATIVELY.¿ 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® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING WARNING AMONG OTHERS: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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: 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: (B)(6) 2017: [NI]. (B)(6), PA. OFFICE VISIT. HPI: F/U. ABDOMEN: WELL HEALING MIDLINE WOUND WITH STAPLES IN PLACE. MINIMAL SWELLING. ALL STAPLES REMOVED AND STERI STRIPS PLACED. JP DRAINING MINIMAL, REMOVED. IMPRESSION/PLAN: NO HEAVY LIFTING 4 WEEKS. (B)(6) 2017 MODERATE WBCS. NO ORGANISMS SEEN. (B)(6) 2017 1 SCANT GROWTH OF CORYNEBACTERIUM SPECIES. (B)(6) 2017: [NI]. (B)(6), MD. OFFICE VISIT. HPI: F/U I&D ANTERIOR ABDOMINAL WALL COLLECTION. ABDOMEN: WELL HEALING MIDLINE SCAR. STAPLES REMOVED; STERI-STRIPS PLACED. (B)(6) 2017: [NI]. (B)(6), MD. OFFICE VISIT. HPI: ABDOMINAL PAIN. ABDOMEN: WELL HEALING SCAR. STAPLES REMOVED; STERI-STRIPS PLACED. SUPERFICIAL SEROMA ABOUT 6 X 5. IMPRESSION/PLAN. CONTINUE WEARING BINDER DAILY, NO HEAVY LIFTING. (B)(6) 2017: [NI]. (B)(6), MD. OFFICE VISIT. HPI: WEARING BINDER DAILY. ABDOMEN: WELL HEALING MIDLINE SCAR. SUPERFICIAL SEROMA NOTED ABOUT 6 X 5 CM. IMPRESSION/PLAN. CONTINUE WEARING BINDER DAILY. NO HEAVY LIFTING. 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® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING WARNING AMONG OTHERS: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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. 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)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING WARNING AMONG OTHERS: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FLUID COLLECTION, ABDOMINAL ABSCESS, MESH INFECTION, MESH REVISION, ADDITIONAL SURGERIES, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302557 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP08 | 7828732 | 00733132601158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |