GORE DUALMESH BIOMATERIAL
Report
- Report Number
- 3003910212-2018-00114
- Event Type
- Injury
- Date Received
- November 20, 2018
- Date of Event
- July 24, 2018
- Report Date
- August 30, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600977
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- 003
Narratives
H6: HEALTH EFFECT ¿ CLINICAL CODE. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSION. 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, 1994, 2061, 2091, 2240, AND 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR ¿THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN¿; ¿THE GORE DUALMESH CONTRACTED¿; ¿SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PHYSICAL DISABILITY, AND PAST, PRESENT, AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE, AND PHARMACEUTICAL EXPENSES, AND OTHER RELATED DAMAGES¿; ¿[THE PATIENT] HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, ECONOMIC LOSS, AND OTHER DAMAGES INCLUDING, BUT NOT LIMITED TO, COST OF MEDICAL CARE, REHABILITATION, LOST INCOME AND EARNING CAPACITY, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, DIMINISHED QUALITY OF LIFE, AND PAIN AND SUFFERING...¿), WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION.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), 2010 THROUGH (B)(6), 2019 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. MEDICAL RECORDS FROM (B)(6), 2010 THROUGH (B)(6), 2013, (B)(6), 2015 THROUGH (B)(6), 2016 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: SMOKER: (B)(6) 2013: ¿FORMER SMOKER FOR APPROXIMATELY 35-PACK YEAR HISTORY, QUIT 2000.¿ OBESITY: (B)(6) 2013: ¿OBESE¿ .(B)(6) 2014: 207.9 LBS., BMI: 33.4. (B)(6) 2018: 208 LBS., BMI 33.65. (B)(6) 2010: RIGHT INGUINAL HERNIA. HEPATITIS C HEPATITIS C CIRRHOSIS WITH REFRACTORY ASCITES (B)(6) 2013: WEEKLY PARACENTESIS BACTERIAL PERITONITIS HYPERTENSION GASTROESOPHAGEAL REFLUX DISEASE [GERD] POLYSUBSTANCE ABUSE DIVERTICULOSIS CHRONIC KIDNEY DISEASE, STAGE III SURGICAL PROCEDURES: 2003: LAPAROSCOPIC CHOLECYSTECTOMY (B)(6) 2013: ORTHOTOPIC LIVER TRANSPLANT, DUCT-TO-DUCT ANASTOMOSIS, STANDARD BACK BENCH PREPARATION, PORTAL VEIN THROMBECTOMY AND RECONSTRUCTION OF DIVIDED RIGHT HEPATIC ARTERY ON THE BACK TABLE (B)(6) 2013: EXPLORATORY LAPAROTOMY STATUS POST LIVER TRANSPLANT FOR POSSIBLE ARTERIAL THROMBOSIS WITH ARTERIAL RECONSTRUCTION (B)(6) 2014: INCISIONAL HERNIA REPAIR WITH GORE TEX DUAL MESH PLACEMENT. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2014: REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH (B)(6) 2017: RIGHT INCISIONAL HERNIA PRIMARY REPAIR (B)(6) 2018: MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE RIGHT. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE LEFT. REPAIR OF RECURRENT, INCARCERATED INCISIONAL HERNIA (15X30 CM). IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH). TRANSVERSUS ABDOMINIS PLANE BLOCK. RELEVANT MEDICAL INFORMATION: (B)(6) 2010: CT ABDOMEN/PELVIS [A/P] ¿FINDINGS: MILD DIVERTICULOSIS OF THE COLON IS PRESENT. RIGHT INGUINAL HERNIA WITH OMENTAL FAT WITHOUT BOWEL LOOPS IS NOTED.¿ MEDICAL RECORDS FROM APRIL 16, 2010 THROUGH AUGUST 13, 2013 WERE NOT PROVIDED. (B)(6) 2013: ABDOMINAL MRI. ¿FINDINGS: THERE IS A SMALL VENTRAL ABDOMINAL HERNIA THAT CONTAINS SOME ASCITES.¿ INPATIENT HOSPITALIZATION [HOSPITALIZATION DATES (B)(6), 2013] (B)(6) 2013: ORTHOTOPIC LIVER TRANSPLANT, DUCT-TO-DUCT ANASTOMOSIS, STANDARD BACK BENCH PREPARATION, PORTAL VEIN THROMBECTOMY AND RECONSTRUCTION OF DIVIDED RIGHT HEPATIC ARTERY ON THE BACK TABLE. (B)(6) 2013: EXPLORATORY LAPAROTOMY STATUS POST LIVER TRANSPLANT FOR POSSIBLE ARTERIAL THROMBOSIS WITH ARTERIAL RECONSTRUCTION. ¿THE PATIENT HAD A LIVER TRANSPLANT YESTERDAY. HE HAD AN ULTRASOUND TODAY. THE ARTERY WAS NOT VISUALIZED. WE TOOK HIM TO THE OPERATING ROOM IN LIGHT OF THE RIGHT HEPATIC ARTERY RECONSTRUCTION YESTERDAY TO CHECK AND SEE IF THE ARTERY WAS OPEN.¿ (B)(6) 2013: DISCHARGE SUMMARY. ¿¿ WITH A HISTORY OF HEPATITIS C CIRRHOSIS COMPLICATED BY HEPATIC ENCEPHALOPATHY, ASCITES, AND ESOPHAGEAL VARICES STATUS POST BANDING WHO NOW PRESENTS FOR POSSIBLE ORTHOTOPIC LIVER TRANSPLANT. THE PATIENT WAS INITIALLY DIAGNOSED WITH HEPATITIS C IN [ILLEGIBLE] ON ROUTINE SCREENING LABORATORY EXAMINATION. HIS DISEASE WAS THOUGHT TO ARRIVE FROM PRIOR IV DRUG USE IN THE 1960¿S. HE WAS BRIEFLY TREATED WITH INTERFERON AND RIBAVIRIN¿BUT HE WAS UNABLE TO TOLERATE HIS TREATMENT, AND IT WAS STOPPED. THE PATIENT¿S END-STAGE LIVER DISEASE HAS BEEN FURTHER COMPLICATED WITH RESISTANT ASCITES REQUIRING MULTIPLE THERAPEUTIC PARACENTESES, WHICH HAS ALSO RESULTED IN INTERMITTENT EPISODES OF SPONTANEOUS BACTERIAL PERITONITIS. THE PATIENT WAS MOST RECENTLY TREATED FOR PERITONITIS IN (B)(6) 2013. HIS MOST RECENT THERAPEUTIC PARACENTESIS WAS PERFORMED¿ ON (B)(6) 2013. AT THAT TIME, 6500 ML WAS REMOVED. THE PATIENT ALSO HAD COMPLICATIONS OF HEPATIC ENCEPHALOPATHY AND WAS MOST RECENTLY ADMITTED FROM (B)(6) 2013 TO (B)(6), 2013¿FOR PROGRESSIVE CONFUSION AND FORGETFULNESS. THIS EPISODE RESOLVED...¿ ¿THE PATIENT¿S MOST RECENT UPPER ENDOSCOPY WAS PERFORMED ON (B)(6), 2013, WHICH DEMONSTRATED ESOPHAGEAL VARICES AND GASTROPATHY. HE WAS MOST RECENTLY BANDED IN (B)(6) 2012 WITH THREE BANDS PLACED. THE PATIENT DENIES ANY RECENT UPPER GASTROINTESTINAL BLEEDING OR HEMATEMESIS.¿ (B)(6) 2014: ¿DONE WELL FOLLOWING THIS PROCEDURE, DEVELOPED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH BOTHERS HIM PRIMARILY IF COUGHING OR OTHER EXERTION. EASILY REDUCIBLE APPROXIMATELY 3-4 CM DEFECT ALONG THE LEFT SUBCOSTAL INCISION. IMPRESSION: REDUCIBLE INCISIONAL HERNIA ALONG THE LEFT SUBCOSTAL INCISION. PLAN: WE HAVE ADVISED THE PATIENT TO AGGRESSIVELY ATTEMPT 10-15 LB. WEIGHT LOSS TO FACILITATE SUCCESSFULLY HERNIA REPAIR.¿ IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2014: ¿HAS DONE EXCEEDINGLY WELL SINCE PROCEDURE [LIVER TRANSPLANT], EXCELLENT GRAFT FUNCTION. HAVE BEEN FOLLOWING HIM OVER THE PAST FEW MONTHS FOR BOTH TITRATION AND MANAGEMENT OF IMMUNOSUPPRESSION AND ALSO FOR INCIDENTALLY NOTED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH OVER THE PAST MONTH HAS STARTED TO BOTHER HIM SIGNIFICANTLY MORE...¿ ¿BULGE HAS INCREASED IN SIZE OVER THE PAST MONTH. CAUSING DISCOMFORT WITH MOVING EXERTION AND COUGHING, CAN NO LONGER LIE ON THAT SIDE. NOTES BURNING, TINGLING IN THE AREA. HE WOULD LIKE THIS FIXED. WE HAVE MENTIONED TO HIM WEIGHT LOSS. HIS WEIGHT IS ESSENTIALLY STABLE OVER THE PAST MONTH DESPITE EFFORTS TO TRY AND LOSE WEIGHT. EASILY REDUCIBLE APPROXIMATELY 4 CM DEFECT ALONG LEFT SUBCOSTAL INCISION. THE BULGE INCREASES SIGNIFICANTLY WITH ELEVATION OF HIS LOWER EXTREMITIES. IMPRESSION/PLAN: ...PRESENTING FOR GROWING AND SYMPTOMATIC INCISIONAL HERNIA. DUE TO THE FACT THAT THIS IS GROWING IN SIZE AND IS CAUSING SYMPTOMS WE HAVE AGREED TO REPAIR ELECTIVELY AT THIS TIME. WITH REGARD TO THE RISKS, WE SPECIFICALLY DISCUSSED WITH HIM THE RISK OF RECURRENT HERNIA AND INFECTION. WE DID DISCUSS WITH HIM THAT IF HIS MESH DOES BECOME INFECTION (SIC) HE WOULD REQUIRE MESH REMOVAL. WE ENCOURAGED CONTINUING TO ATTEMPT TO LOSE WEIGHT IN THE INTERIM AS THIS WILL HELP WITH THE INTENDED PROCEDURE.¿ (B)(6) 2014: ¿HE PRESENTED TO THE CLINIC WITH COMPLAINTS OF A SYMPTOMATIC HERNIA ALONG THE LEFT LATERAL ASPECT OF HIS MERCEDES INCISION. HE WAS WITHOUT SYMPTOMS OF INCARCERATION. HE IS CURRENTLY ON IMMUNE SUPPRESSION...¿ IMPLANT PROCEDURE: INCISIONAL HERNIA REPAIR WITH GORE TEX DUAL MESH PLACEMENT. [IMPLANT: GORE®DUALMESH® BIOMATERIAL, 1DLMC04/12553724, 15CM X 19CM X 1MM THICK, OVAL] IMPLANT DATE: (B)(6), 2014 [HOSPITALIZATION DATES (B)(6), 2014] FINDINGS: ¿10 BY 4-CENTIMETER FASCIAL DEFECT WITH ADJACENT ATTENUATED FASCIA. NO INCARCERATED HERNIA CONTENTS.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿THE PREVIOUS SCAR ALONG THE LEFT LATERAL ASPECT OF HIS INCISION WAS REOPENED AND DISSECTED DOWN TO THE LEVEL OF THE HERNIA SAC WHICH WAS OPENED AND EXCISED. THE FASCIA WAS IDENTIFIED AND FLAPS APPROXIMATELY 3 CENTIMETERS WERE DISSECTED CIRCUMFERENTIALLY AROUND THE HERNIA DEFECT.¿ IMPLANT SIZE AND FIXATION: ¿A MESH UNDERLAY USING GORE TEX DUAL MESH WAS THEN TACKED CIRCUMFERENTIALLY TO THE FASCIA USING #1 PROLENE SUTURE. SCAR TISSUE, BUT NOT THE TRUE FASCIA OVERLYING THE DEFECT, WAS CLOSED USING 3-0 VICRYL. THE WOUND WAS IRRIGATED AND HEMOSTASIS WAS ACHIEVED. THE DEEP DERMAL TISSUE WAS REAPPROXIMATED USING VICRYL SUTURE AND THE SKIN WAS CLOSED USING MONOCRYL IN A SUBCUTICULAR FASHION.¿ REVISION #1 PREOPERATIVE COMPLAINTS: [SAME HOSPITALIZATION (B)(6), 2014] (B)(6) 2014: CT A/P. ¿POSTOPERATIVE COURSE HAS BEEN COMPLICATED BY HEMATOMA AND GAS. IMPRESSION: POSTSURGICAL CHANGES OF LEFT INCISIONAL HERNIA REPAIR WITH MESH AT THE SUPERIOR ASPECT OF THE VENTRAL WALL DEFECT. THERE IS A PERSISTENT INCISIONAL HERNIA AT THE INFERIOR ASPECT WHICH CONTAINS NONOBSTRUCTED LOOPS OF SMALL BOWEL. EXTRALUMINAL GAS WITHIN THIS HERNIA SAC IS LIKELY POSTSURGICAL IN NATURE. NO ASSOCIATED SMALL BOWEL OBSTRUCTION. FAT CONTAINING RIGHT INGUINAL HERNIA.¿ (B)(6) 2014: INDICATIONS. ¿... NOW ABOUT FIVE DAYS STATUS POST REPAIR OF AN INCISIONAL VENTRAL HERNIA WITH DUALMESH. ON POSTOPERATIVE DAY TWO, HE DEVELOPED SWELLING UNDERNEATH HIS INCISION. THIS WAS EVALUATED WITH A CT SCAN WHICH DEMONSTRATED A FAILURE OF THE MESH AND RECURRENCE OF THE HERNIA. HE HAS NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTION. HE IS BROUGHT TO THE OPERATING ROOM AT THIS TIME FOR URGENT REPAIR OF THIS RECURRENT INCISIONAL VENTRAL HERNIA.¿ REVISION #1 PROCEDURE: REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH REVISION #1 DATE: (B)(6), 2014 [SAME HOSPITALIZATION (B)(6), 2014] ¿HIS INCISION WAS REOPENED. WE IDENTIFIED THAT THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN. THE BOWEL WAS ALL VIABLE AND WAS NON-OBSTRUCTED. THE BOWEL WAS THEN RETURNED TO THE ABDOMEN. THE SAME MESH GRAFT WAS USED AND IT WAS SEWN CIRCUMFERENTIALLY TO THE FASCIA USING A SERIES OF INTERRUPTED FIGURE-OF-EIGHT 0 PROLENE SUTURE. THERE WAS NO TENSION ON THE MESH. THE SUBCUTANEOUS TISSUE WAS IRRIGATED AND REAPPROXIMATED WITH 3-0 VICRYL AND THE SKIN WITH 4-0 MONOCRYL SUBCUTICULAR SUTURES. DERMABOND WAS THEN APPLIED.¿ DISCHARGE SUMMARY. ¿HERNIA REPAIR INCISION IS CLEAN, DRY, INTACT. HE HAS A BINDER IN PLACE.¿ ¿ON( B)(6) HE WAS DISCHARGED IN STABLE CONDITION. HE WILL COMPLETE A TOTAL OF 5 DAYS OF AUGMENTIN FOR WOUND ERYTHEMA.¿ RELEVANT MEDICAL INFORMATION: MEDICAL RECORDS FROM (B)(6), 2015 THROUGH (B)(6) 2016 WERE NOT PROVIDED. (B)(6) 2016: CT A/P: ¿IMPRESSION: SEVERAL ANTERIOR AND RIGHT LATERAL WALL HERNIAS WITH PROTRUDING SMALL BOWEL LOOPS THROUGH THE RIGHT LATERAL WALL. NO EVIDENCE OF INTESTINAL OBSTRUCTION. MODERATE DIVERTICULOSIS.¿ (B)(6) 2017: SURGERY CONSULT. ¿PRESENTS WITH BILATERAL INCISIONAL FLANK HERNIAS AT HIS TRANSPLANT INCISION SITE. PATIENT REPORTS THAT THE HERNIAS HAVE BEEN PRESENT SINCE 2015. THEY ARE ALWAYS REDUCIBLE BUT ARE VERY PAINFUL. HE DID PREVIOUSLY HAVE ANOTHER INCISIONAL HERNIA AT THE CENTER OF THE INCISION THAT WAS REAPIRED [SIC] IN 2014 AT BARNES. EXAM: ABDOMEN: LARGE HORIZONTAL SCAR FROM PREVIOUS SURGERY, BILATERAL FLANK INCISIONAL HERNIAS PRESENT, BOTH HERNIAS ARE REDUCIBLE AND TENDER. PATIENT IS A CANDIDATE FOR OPEN HERNIA REPAIR WITH MESH.¿ (B)(6) 2017: BRIEF HISTORY: ¿LIVER TRANSPLANT 2013, DEVELOPED BILATERAL INCISIONAL FLANK HERNIAS AT TRANSPLANT INCISION SITE. THESE HAVE BEEN PRESENT IN THE PAST, THEY WERE REPAIRED IN 2014, HOWEVER, THAT WAS COMPLICATED BY WOUND DEHISCENCE AND THE INCISIONAL HERNIA HAS RECURRED. AT THIS TIME, HE NOTES THAT THE RIGHT HERNIA CAUSES HIM PAIN WHILE WALKING AND DOING ACTIVITY. AGAIN, OF NOTE, THERE WERE SEVERAL HERNIAS ON THE LEFT AND CENTRAL PORTION OF HIS PREVIOUS INCISION, WHICH WERE NOT ADDRESSED TODAY.¿ INPATIENT HOSPITALIZATION (HOSPITALIZATION DATES (B)(6), 2017) (B)(6) 2017: RIGHT INCISIONAL HERNIA PRIMARY REPAIR ¿AFTER AN APPROPRIATE TIME OUT, THE RIGHT LATERAL INCISION WAS OPENED. IT WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE AND CAUTERIZED. IT WAS OPENED TO THE FULL EXTENT USING GENTLE BLUNT DISSECTION TO PROTECT THE UNDERLYING VISCERA. SEVERAL FASCIAL DEFECTS WERE ENCOUNTERED ON THE RIGHT SIDE OF THE INCISION. THE RIGHT LATERAL ASPECT WAS OPENED AND ALL FASCIAL DEFECTS WERE COMBINED INTO ONE, THIS RESULTED IN AN APPROXIMATELY 8 CM FASCIAL DEFECT IN TOTAL. METZENBAUM SCISSORS WERE THEN USED TO OPEN THE HERNIA SAC. WE ENCOUNTERED OMENTUM. SUBSEQUENTLY, A PRIMARY CLOSURE WITH 1-0 LOOPED PDS RUNNING WAS DONE. DUE TO A PUSTULE NEAR THE INCISION, WE OPTED NOT TO USE THE MESH FOR FEAR OF INFECTION. SUBSEQUENTLY, THE SUPERFICIAL LAYER WAS CLOSED WITH 3-0 INTERRUPTED VICRYL AND THE SKIN WAS CLOSED WITH STAPLES.¿ (B)(6) 2017: DISCHARGE SUMMARY. ¿HOSPITAL COURSE: RIGHT INCISIONAL HERNIA REPAIR. TOLERATED PROCEDURE WELL, TRANSFERRED TO THE FLOOR IN STABLE CONDITION AFTER MONITORING IN THE PACU. THE PATIENT¿S POSTOP COURSE WAS UNCOMPLICATED.¿ (B)(6) 2017: ¿HERE FOR POSTOP VISIT. PT STATES THIS HAS BEEN A VERY PAINFUL SURGERY FOR HIM MORE SO THAN HIS LIVER TRANSPLANT SURGERY. ALSO, C/O [COMPLAINING OF] PAIN AT UMBILICUS SINCE THE SURGERY, NO BULGE OR REDNESS, AS WELL AS VERY LOW-MID ABDOMINAL PAIN. ABD [ABDOMEN]: INCISION TO RT [RIGHT] ABDOMEN INTACT WITH STAPLES, NO REDNEESS [SIC] OR DRAINAGE. VERY TENDER AT UMBILICUS WITHOUT SURROUNDING TENDERNESS OR REDNESS, UNABLE TO DISCERN IF HE HAS A DEFECT AT UMBILICUS, BUT VERY TENDER. TENDERNESS VERY LOW MID-ABDOMEN. ALSO HAS REDUCIBLE RIH [RIGHT INGUINAL HERNIA], AS WELL AS LT [LEFT] SIDED INCISIONAL HERNIA. A&P: POSSIBLE RECURRENT UMBILICAL HERNIA REPAIR.¿ (B)(6) 2017: CT A/P. ¿POST-SURGICAL CHANGES IN THE ANTERIOR ABDOMINAL WALL, SOME RESIDUAL HERNIATED FAT. FAT-CONTAINING RIGHT INTERNAL HERNIA.¿ (B)(6) 2018: ¿... BECAUSE HE HAD A PUSTULE ON HIS SKIN AT THE TIME OF [HIS LAST] SURGERY NO MESH WAS USED AND WE ONLY REPAIRED THE RIGHT SIDE. HE IS NOW HERE TO DISCUSS REPAIR OF THE LEFT SIDE. HE HAS PAIN WITH MOVEMENT AND STRAINING ALONG HIS LEFT SUBCOSTAL INCISION. OCCASIONALLY HE HAS TISSUE THAT POPS OUT AND HE IS ABLE TO SELF REDUCE IT BUT HAS SIGNIFICANT SORENESS. CT SCAN (B)(6) 2017 SHOWS EPIGASTRIC HERNIA AS WELL AS HERNIA ALONG HIS BILATERAL SUBCOSTAL INCISION. ABDOMEN: PALPABLE FASCIAL DEFECT AND CENTER OF CHEVRON INCISION WITH LAXITY ALONG LEFT SIDE, NO DISCRETE DEFECT PALPABLE. GROIN: BILATERAL INGUINAL HERNIA EASILY REDUCIBLE. ASSESSMENT: PRESENTS WITH COMPLICATED VENTRAL HERNIA WITH MULTIPLE PRIOR REPAIRS INCLUDING WITH MESH. GIVEN THE COMPLEXITY OF HIS HERNIA AND THE LOCATION OF THE INCISION CLOSE TO THE RIB CAGE, HE WOULD BENEFIT FROM CONSULTATION WITH A HERNIA SPECIALIST. HE WILL REQUIRE A TOTAL ABDOMINAL WALL RECONSTRUCTION. WE WILL REFER HIM TO BARNES TO SEE DR. XX. ADDENDUM: HE COMPLAINS OF LEFT SIDED INCISIONAL HERNIA, WITH SENSATION OF HERNIA ¿POPPING OUT¿ WHEN HE TURNS TO THE LEFT OR LIFTS ONE OF HIS GRANDCHILDREN. NO OBSTRUCTIVE SYMPTOMS. IS AWARE OF HERNIA AT APEX OF CHEVRON INCISION BUT SAYS IT IS LARGELY ASYMPTOMATIC. CT SCAN DONE (B)(6)2017, AFTER THE RIGHT SIDED INCISIONAL HERNIA WAS REPAIRED SHOWS HERNIAS ON RIGHT AND LEFT, AS WELL AS AT APEX. INTACT DUAL MESH SEEN ON LEFT, WITH HERNIA LATERAL TO THAT. GIVEN COMPLEXITY OF REPAIR BASED ON MULTIPLE LOCATIONS AND RECURRENCE SO SOON AFTER RIGHT SIDED REPAIR, I RECOMMEND HE BE REFERRED TO DR. XX HERNIA SPECIALIST AT BARNES, WHO COULD PERHAPS OFFER A COMPONENT SEPARATION (ALTHOUGH THAT MAY BE IMPOSSIBLE IN SETTING OF PRIOR MESH).¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2018: SURGERY CONSULT. ¿I PERSONALLY REVIEWED HIS MOST RECENT CT OF ABDOMEN AND PELVIS THAT SHOWS THE MODERATE-SIZED MID ABDOMINAL INCISIONAL HERNIA WITH SIGNIFICANT MUSCLE ATROPHY IN BOTH THE LEFT AND RIGHT SIDE. ASSESSMENT AND PLAN: HISTORY OF HCV [HEPATITIS C VIRUS] CIRRHOSIS S/P [STATUS POST] LIVER TRANSPLANT WHO DEVELOPED INCISIONAL HERNIAS AFTER HIS PROCEDURE. HE HAS HAD 3 REPAIRS AND NOW A RECURRENCE. WE THINK HE IS A GOOD CANDIDATE FOR AN ABDOMINAL WALL RECONSTRUCTION AND REPAIR WITH MESH REINFORCEMENT. WE WILL PLAN ON DOING IT WITH AN OPEN APPROACH.¿ (B)(6) 2018: ¿¿WITH [PRIOR MEDICAL HISTORY] OF LIVER TXP [TRANSPLANT] C/B [COMPLICATED BY] INCISIONAL HERNIA THAT HAS REQUIRED THREE PREVIOUS OPERATIONS.¿ EXPLANT PROCEDURE: MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE RIGHT. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE LEFT. REPAIR OF RECURRENT, INCARCERATED INCISIONAL HERNIA (15X30 CM). IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH). TRANSVERSUS ABDOMINIS PLANE BLOCK. EXPLANT DATE: (B)(6) 2018 [HOSPITALIZATION DATES (B)(6) 2018] FINDINGS: ¿LARGE, RECURRENT INCISIONAL HERNIA INVOLVING HIS ENTIRE LIVER TRANSPLANT INCISION WITH SIGNIFICANT OMENTAL SCARRING TO TOLD [SIC] MESH.¿ ¿THE PATIENT HAD A 15X30 CM DEFECT WITH SIGNIFICANT AMOUNT OF ADHESIONS. AFTER COMPLETING THE ADHESIOLYSIS GIVEN THE SIZE OF THE DEFECT AND HIS COMPLEX SURGICAL HISTORY WE ELECTED TO PROCEED WITH AN INCISIONAL HERNIA REPAIR AND ABDOMINAL WALL RECONSTRUCTION. HE HAD MULTIPLE DENSE ADHESIONS OF OMENTUM TO HIS ABDOMINAL WALL AND OLD MESH. HE ALSO HAD ADHESIONS OF HIS TRANSVERSE COLON TO THE ANTERIOR ABDOMINAL WALL. AFTER FREEING UP THE ADHESIONS, WE REMOVED HIS OLD MESH, AND THEN PROCEEDED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS TO RECONSTRUCT THE ABDOMEN AND ALLOW FOR ADEQUATE MESH OVERLAP.¿ ¿WE BEGAN BY REOPENING HIS MIDLINE INCISION AND DISSECTING DOWN THROUGH THE SUBCUTANEOUS TISSUE UNTIL WE ENCOUNTER THE REMAINDER OF THE LINEA ALBA. THIS WAS THEN OPEN [SIC] SHARPLY TO ENTER THE ABDOMINAL CAVITY. WE ENCOUNTERED A SIGNIFICANT AMOUNT OF ADHESIONS OF OMENTUM AND COLON TO THE ANTERIOR ABDOMINAL WALL AND OLD MESH. THESE WERE ALL TAKEN DOWN WITH SHARP DISSECTION AND MINIMAL ELECTROCAUTERY. DURING ADHESIOLYSIS WE ENCOUNTERED NO BOWEL INJURIES. TOTAL ADHESIOLYSIS TIME WAS GREATER THAN 1 HOUR. AFTER WE WERE SATISFIED WITH ALL OF THE BOWEL WORK, WE PLACED A COUNTABLE TOWEL INTO THE ABDOMEN TO PROTECT THE VISCERA AND TURNED OUR ATTENTION TO REPAIRING THE HERNIA DEFECT. WE MEASURED THE HERNIA DEFECT TO BE 15X30 CM. WE THEN ATTEMPTED TO BRING THE ABDOMINAL WALL MUSCLES BACK TOGETHER AND IT WAS UNDER SIGNIFICANT TENSION. GIVEN THE LARGE SIZE OF THE HERNIA DEFECT, ITS LOCATION AND HIS PREVIOUS SURGICAL HISTORY IN ADDITION THE INCREASED ABDOMINAL TENSION WE ELECTED TO PROCEED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE IN ORDER TO ALLOW FOR ADEQUATE MESH OVERLAP AND MIDLINE MEDIALIZATION OF THE RECTUS MUSCLES. WE BEGAN ON THE PATIENT'S RIGHT SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS. THIS WAS AN INCREDIBLY DIFFICULT DISSECTION GIVEN THE PATIENTS SURGICAL HISTORY, PREVIOUS REPAIRS AND PREVIOUS MESH. ULTIMATELY, WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY. WE WERE LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH WHERE HIS PREVIOUS INCISION AND MESH HAD BEEN PLACED IN THE SUBCOSTAL REGION. BY SEPARATING THE FASCIA, IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. HOWEVER, IT WAS STILL FELT THERE WAS INCREASED TENSION ON THE MIDLINE SO WE TURNED OUR ATTENTION TO PERFORMING A SIMILAR RELEASE ON THE OPPOSITE SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. AGAIN, THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS. WE WERE AGAIN LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH FROM HIS PREVIOUS MESH REPAIR AND SUBCOSTAL INCISION. THIS WAS AN INCREDIBLY DIFFICULT DISSECTION. ULTIMATELY, WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY. BY SEPARATING THE FASCIA IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. TO COMPLETE THE PELVIC DISSECTION, WE WERE ABLE PASS A FINGER THROUGH THE SPACE OF RETZIUS, ALONG THE PUBIC SYMPHYSIS TO CONNECT THE PRE-PERITONEAL DISSECTION OF THE LEFT AND RIGHT SIDE. THE BLADDER COMPLEX WAS THEN FREED FROM THE OVERLYING ABDOMINAL WALL PRESERVING THE LINEA ALBA INTACT. THIS EXPOSED BELOW THE PUBIC SYMPHYSIS TO ALLOW FOR ADEQUATE INFERIOR MESH OVERLAP. FOR THE CRANIAL DISSECTION THE FALCIFORM LIGAMENT HAD BEEN PREVIOUSLY REMOVED, BUT WE WERE ABLE TO UTILIZE THE PRE-PERITONEAL FAT PAD TO ESTABLISH A PLANE UNDER THE XIPHOID BONE. THIS WAS THEN CONNECTED WITH THE LEFT AND RIGHT PRE-PERITONEAL DISSECTION THAT HAD BEEN PERFORMED BY DIVIDING THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE. THIS WAS THEN CONTINUED CRANIALLY BY FREEING THE PERITONEUM OFF THE DIAPHRAGM TO ALLOW FOR ADEQUATE CRANIAL OVERLAP. ONCE WE WERE SATISFIED WITH THE AREA OF DISSECTION, WE THEN TURNED OUR ATTENTION TO CLOSING THE POSTERIOR RECTUS SHEATH IN THE MIDLINE. THERE WERE A FEW HOLES IN THE PERITONEUM AND POSTERIOR SHEATH. THE HOLES WERE CLOSED WITH 2-0 & 3-0 VICRYL SUTURES. WE THEN PERFORMED A SPONGE, INSTRUMENT, NEEDLE COUNT THAT WAS CORRECT. THE POSTERIOR RECTUS SHEATH WAS THEN CLOSED IN THE MIDLINE PRIMARILY AFTER REMOVING THE COUNTABLE TOWEL. WE THEN PERFORMED A TRANSVERSUS ABDOMINIS PLANE BLOCK BY INJECTION 60CC OF 0.25% MARCAINE DIVIDED BETWEEN THE LEFT AND RIGHT TRANSVERSUS ABDOMINIS MUSCLE UNDER DIRECT VISUALIZATION. WE THEN PLACED A 50X50CM PIECE OF ETHICON PROLENE SOFT MESH PLACED IN A SQUARE FASHION. THIS NICELY COVERED FROM THE BELOW THE PUBIC SYMPHYSIS TO THE XIPHOID BONE. THERE LATERAL EDGES OF THE MESH WERE TRIMMED TO ALLOW THE MESH TO LAY FLAT. WE ELECTED TO CLOSE THE LATERAL PORTIONS OF HIS INCISIONAL DEFECT WITH INTERRUPTED FIGURE OF 8 #1 PDS SUTURES IN A TRANSVERSE FASHION. WE THEN PLACED TWO 19 FRENCH BLAKE DRAINS TO DRAIN THE SPACE ABOVE THE MESH. THE ANTERIOR FASCIA WAS THEN CLOSED WITH RUNNING #1 PDS SUTURES. WE CLOSED THE SUBCUTANEOUS TISSUE WITH INTERRUPTED 3-0 VICRYL SUTURE. SKIN WAS CLOSED WITH 4-0 MONOCRYL AND EXOFIN WAS APPLIED.¿ (B)(6) 2018: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE PROCEDURE WAS NOT PROVIDED. (B)(6) 2018: DISCHARGE SUMMARY. ¿HOSPITAL COURSE: ¿ ONCE THE PATIENT WAS TOLERATING DIET, HAD RETURN OF BOWEL FUNCTION, AMBULATING IN HALLWAY, PAIN CONTROLLED THE PATIENT WAS STABLE FOR DISCHARGE ON POSTOPERATIVE DAY 3. LEFT ABDOMINAL JP DRAIN WAS REMOVED PRIOR TO DISCHARGE.¿ 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.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. 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 MY 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.
H6: HEALTH EFFECT ¿ CLINICAL CODE. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSION. 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, 1994, 2061, 2091, 2240, AND 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR ¿THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN¿; ¿THE GORE DUALMESH CONTRACTED¿; ¿SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PHYSICAL DISABILITY, AND PAST, PRESENT, AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE, AND PHARMACEUTICAL EXPENSES, AND OTHER RELATED DAMAGES¿; ¿[THE PATIENT] HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, ECONOMIC LOSS, AND OTHER DAMAGES INCLUDING, BUT NOT LIMITED TO, COST OF MEDICAL CARE, REHABILITATION, LOST INCOME AND EARNING CAPACITY, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, DIMINISHED QUALITY OF LIFE, AND PAIN AND SUFFERING...¿), 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), 2010 THROUGH (B)(6), 2019 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. MEDICAL RECORDS FROM (B)(6) 2010 THROUGH (B)(6) 2013, AND (B)(6), 2015 THROUGH (B)(6), 2016 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: SMOKER: (B)(6) 2013: ¿FORMER SMOKER FOR APPROXIMATELY 35-PACK YEAR HISTORY, QUIT 2000.¿ ¿ OBESITY: (B)(6) 2013: ¿OBESE¿ (B)(6) 2014: 207.9 LBS., BMI: 33.4 (B)(6) 2018: 208 LBS., BMI 33.65 (B)(6) 2010: RIGHT INGUINAL HERNIA HEPATITIS C HEPATITIS C CIRRHOSIS WITH REFRACTORY ASCITES (B)(6) 2013: WEEKLY PARACENTESIS BACTERIAL PERITONITIS HYPERTENSION GASTROESOPHAGEAL REFLUX DISEASE [GERD] POLYSUBSTANCE ABUSE DIVERTICULOSIS CHRONIC KIDNEY DISEASE, STAGE III SURGICAL PROCEDURES: 2003: LAPAROSCOPIC CHOLECYSTECTOMY (B)(6) 2013: ORTHOTOPIC LIVER TRANSPLANT, DUCT-TO-DUCT ANASTOMOSIS, STANDARD BACK BENCH PREPARATION, PORTAL VEIN THROMBECTOMY AND RECONSTRUCTION OF DIVIDED RIGHT HEPATIC ARTERY ON THE BACK TABLE (B)(6) 2013: EXPLORATORY LAPAROTOMY STATUS POST LIVER TRANSPLANT FOR POSSIBLE ARTERIAL THROMBOSIS WITH ARTERIAL RECONSTRUCTION (B)(6) 2014: INCISIONAL HERNIA REPAIR WITH GORE TEX DUAL MESH PLACEMENT. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2014: REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH (B)(6) 2017: RIGHT INCISIONAL HERNIA PRIMARY REPAIR (B)(6) 2018: MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE RIGHT. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE LEFT. REPAIR OF RECURRENT, INCARCERATED INCISIONAL HERNIA (15X30 CM). IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH). TRANSVERSUS ABDOMINIS PLANE BLOCK. RELEVANT MEDICAL INFORMATION: (B)(6) 2010: CT ABDOMEN/PELVIS [A/P] ¿FINDINGS: MILD DIVERTICULOSIS OF THE COLON IS PRESENT. RIGHT INGUINAL HERNIA WITH OMENTAL FAT WITHOUT BOWEL LOOPS IS NOTED.¿ MEDICAL RECORDS FROM (B)(6), 2010 THROUGH (B)(6), 2013 WERE NOT PROVIDED. (B)(6) 2013: ABDOMINAL MRI. ¿FINDINGS: THERE IS A SMALL VENTRAL ABDOMINAL HERNIA THAT CONTAINS SOME ASCITES.¿ INPATIENT HOSPITALIZATION [HOSPITALIZATION DATES (B)(6), 2013] (B)(6) 2013: ORTHOTOPIC LIVER TRANSPLANT, DUCT-TO-DUCT ANASTOMOSIS, STANDARD BACK BENCH PREPARATION, PORTAL VEIN THROMBECTOMY AND RECONSTRUCTION OF DIVIDED RIGHT HEPATIC ARTERY ON THE BACK TABLE. (B)(6) 2013: EXPLORATORY LAPAROTOMY STATUS POST LIVER TRANSPLANT FOR POSSIBLE ARTERIAL THROMBOSIS WITH ARTERIAL RECONSTRUCTION. ¿THE PATIENT HAD A LIVER TRANSPLANT YESTERDAY. HE HAD AN ULTRASOUND TODAY. THE ARTERY WAS NOT VISUALIZED. WE TOOK HIM TO THE OPERATING ROOM IN LIGHT OF THE RIGHT HEPATIC ARTERY RECONSTRUCTION YESTERDAY TO CHECK AND SEE IF THE ARTERY WAS OPEN.¿ (B)(6) 2013: DISCHARGE SUMMARY. ¿¿ WITH A HISTORY OF HEPATITIS C CIRRHOSIS COMPLICATED BY HEPATIC ENCEPHALOPATHY, ASCITES, AND ESOPHAGEAL VARICES STATUS POST BANDING WHO NOW PRESENTS FOR POSSIBLE ORTHOTOPIC LIVER TRANSPLANT. THE PATIENT WAS INITIALLY DIAGNOSED WITH HEPATITIS C IN [ILLEGIBLE] ON ROUTINE SCREENING LABORATORY EXAMINATION. HIS DISEASE WAS THOUGHT TO ARRIVE FROM PRIOR IV DRUG USE IN THE 1960¿S. HE WAS BRIEFLY TREATED WITH INTERFERON AND RIBAVIRIN¿BUT HE WAS UNABLE TO TOLERATE HIS TREATMENT, AND IT WAS STOPPED. THE PATIENT¿S END-STAGE LIVER DISEASE HAS BEEN FURTHER COMPLICATED WITH RESISTANT ASCITES REQUIRING MULTIPLE THERAPEUTIC PARACENTESES, WHICH HAS ALSO RESULTED IN INTERMITTENT EPISODES OF SPONTANEOUS BACTERIAL PERITONITIS. THE PATIENT WAS MOST RECENTLY TREATED FOR PERITONITIS IN (B)(6) 2013. HIS MOST RECENT THERAPEUTIC PARACENTESIS WAS PERFORMED¿ ON (B)(6), 2013. AT THAT TIME, 6500 ML WAS REMOVED. THE PATIENT ALSO HAD COMPLICATIONS OF HEPATIC ENCEPHALOPATHY AND WAS MOST RECENTLY ADMITTED FROM (B)(6), 2013 TO (B)(6), 2013¿FOR PROGRESSIVE CONFUSION AND FORGETFULNESS. THIS EPISODE RESOLVED...¿ ¿THE PATIENT¿S MOST RECENT UPPER ENDOSCOPY WAS PERFORMED ON (B)(6), 2013, WHICH DEMONSTRATED ESOPHAGEAL VARICES AND GASTROPATHY. HE WAS MOST RECENTLY BANDED IN (B)(6) 2012 WITH THREE BANDS PLACED. THE PATIENT DENIES ANY RECENT UPPER GASTROINTESTINAL BLEEDING OR HEMATEMESIS.¿ (B)(6) 2014: ¿DONE WELL FOLLOWING THIS PROCEDURE, DEVELOPED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH BOTHERS HIM PRIMARILY IF COUGHING OR OTHER EXERTION. EASILY REDUCIBLE APPROXIMATELY 3-4 CM DEFECT ALONG THE LEFT SUBCOSTAL INCISION. IMPRESSION: REDUCIBLE INCISIONAL HERNIA ALONG THE LEFT SUBCOSTAL INCISION. PLAN: WE HAVE ADVISED THE PATIENT TO AGGRESSIVELY ATTEMPT 10-15 LB. WEIGHT LOSS TO FACILITATE SUCCESSFULLY HERNIA REPAIR.¿ IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2014: ¿HAS DONE EXCEEDINGLY WELL SINCE PROCEDURE [LIVER TRANSPLANT], EXCELLENT GRAFT FUNCTION. HAVE BEEN FOLLOWING HIM OVER THE PAST FEW MONTHS FOR BOTH TITRATION AND MANAGEMENT OF IMMUNOSUPPRESSION AND ALSO FOR INCIDENTALLY NOTED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH OVER THE PAST MONTH HAS STARTED TO BOTHER HIM SIGNIFICANTLY MORE...¿ ¿BULGE HAS INCREASED IN SIZE OVER THE PAST MONTH. CAUSING DISCOMFORT WITH MOVING EXERTION AND COUGHING, CAN NO LONGER LIE ON THAT SIDE. NOTES BURNING, TINGLING IN THE AREA. HE WOULD LIKE THIS FIXED. WE HAVE MENTIONED TO HIM WEIGHT LOSS. HIS WEIGHT IS ESSENTIALLY STABLE OVER THE PAST MONTH DESPITE EFFORTS TO TRY AND LOSE WEIGHT. EASILY REDUCIBLE APPROXIMATELY 4 CM DEFECT ALONG LEFT SUBCOSTAL INCISION. THE BULGE INCREASES SIGNIFICANTLY WITH ELEVATION OF HIS LOWER EXTREMITIES. IMPRESSION/PLAN: ...PRESENTING FOR GROWING AND SYMPTOMATIC INCISIONAL HERNIA. DUE TO THE FACT THAT THIS IS GROWING IN SIZE AND IS CAUSING SYMPTOMS WE HAVE AGREED TO REPAIR ELECTIVELY AT THIS TIME. WITH REGARD TO THE RISKS, WE SPECIFICALLY DISCUSSED WITH HIM THE RISK OF RECURRENT HERNIA AND INFECTION. WE DID DISCUSS WITH HIM THAT IF HIS MESH DOES BECOME INFECTION (SIC) HE WOULD REQUIRE MESH REMOVAL. WE ENCOURAGED CONTINUING TO ATTEMPT TO LOSE WEIGHT IN THE INTERIM AS THIS WILL HELP WITH THE INTENDED PROCEDURE.¿ (B)(6) 2014: ¿HE PRESENTED TO THE CLINIC WITH COMPLAINTS OF A SYMPTOMATIC HERNIA ALONG THE LEFT LATERAL ASPECT OF HIS MERCEDES INCISION. HE WAS WITHOUT SYMPTOMS OF INCARCERATION. HE IS CURRENTLY ON IMMUNE SUPPRESSION...¿ IMPLANT PROCEDURE: INCISIONAL HERNIA REPAIR WITH GORE TEX DUAL MESH PLACEMENT. [IMPLANT: GORE®DUALMESH® BIOMATERIAL, 1DLMC04/12553724, 15CM X 19CM X 1MM THICK, OVAL] IMPLANT DATE: (B)(6), 2014 [HOSPITALIZATION DATES (B)(6), 2014] FINDINGS: ¿10 BY 4-CENTIMETER FASCIAL DEFECT WITH ADJACENT ATTENUATED FASCIA. NO INCARCERATED HERNIA CONTENTS.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿THE PREVIOUS SCAR ALONG THE LEFT LATERAL ASPECT OF HIS INCISION WAS REOPENED AND DISSECTED DOWN TO THE LEVEL OF THE HERNIA SAC WHICH WAS OPENED AND EXCISED. THE FASCIA WAS IDENTIFIED AND FLAPS APPROXIMATELY 3 CENTIMETERS WERE DISSECTED CIRCUMFERENTIALLY AROUND THE HERNIA DEFECT.¿ IMPLANT SIZE AND FIXATION: ¿A MESH UNDERLAY USING GORE TEX DUAL MESH WAS THEN TACKED CIRCUMFERENTIALLY TO THE FASCIA USING #1 PROLENE SUTURE. SCAR TISSUE, BUT NOT THE TRUE FASCIA OVERLYING THE DEFECT, WAS CLOSED USING 3-0 VICRYL. THE WOUND WAS IRRIGATED AND HEMOSTASIS WAS ACHIEVED. THE DEEP DERMAL TISSUE WAS REAPPROXIMATED USING VICRYL SUTURE AND THE SKIN WAS CLOSED USING MONOCRYL IN A SUBCUTICULAR FASHION.¿ REVISION #1 PREOPERATIVE COMPLAINTS: [SAME HOSPITALIZATION (B)(6), 2014] (B)(6) 2014: CT A/P. ¿POSTOPERATIVE COURSE HAS BEEN COMPLICATED BY HEMATOMA AND GAS. IMPRESSION: POSTSURGICAL CHANGES OF LEFT INCISIONAL HERNIA REPAIR WITH MESH AT THE SUPERIOR ASPECT OF THE VENTRAL WALL DEFECT. THERE IS A PERSISTENT INCISIONAL HERNIA AT THE INFERIOR ASPECT WHICH CONTAINS NONOBSTRUCTED LOOPS OF SMALL BOWEL. EXTRALUMINAL GAS WITHIN THIS HERNIA SAC IS LIKELY POSTSURGICAL IN NATURE. NO ASSOCIATED SMALL BOWEL OBSTRUCTION. FAT CONTAINING RIGHT INGUINAL HERNIA.¿ (B)(6) 2014: INDICATIONS. ¿... NOW ABOUT FIVE DAYS STATUS POST REPAIR OF AN INCISIONAL VENTRAL HERNIA WITH DUALMESH. ON POSTOPERATIVE DAY TWO, HE DEVELOPED SWELLING UNDERNEATH HIS INCISION. THIS WAS EVALUATED WITH A CT SCAN WHICH DEMONSTRATED A FAILURE OF THE MESH AND RECURRENCE OF THE HERNIA. HE HAS NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTION. HE IS BROUGHT TO THE OPERATING ROOM AT THIS TIME FOR URGENT REPAIR OF THIS RECURRENT INCISIONAL VENTRAL HERNIA.¿ REVISION #1 PROCEDURE: REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH REVISION #1 DATE: (B)(6), 2014 [SAME HOSPITALIZATION (B)(6), 2014] ¿HIS INCISION WAS REOPENED. WE IDENTIFIED THAT THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN. THE BOWEL WAS ALL VIABLE AND WAS NON-OBSTRUCTED. THE BOWEL WAS THEN RETURNED TO THE ABDOMEN. THE SAME MESH GRAFT WAS USED AND IT WAS SEWN CIRCUMFERENTIALLY TO THE FASCIA USING A SERIES OF INTERRUPTED FIGURE-OF-EIGHT 0 PROLENE SUTURE. THERE WAS NO TENSION ON THE MESH. THE SUBCUTANEOUS TISSUE WAS IRRIGATED AND REAPPROXIMATED WITH 3-0 VICRYL AND THE SKIN WITH 4-0 MONOCRYL SUBCUTICULAR SUTURES. DERMABOND WAS THEN APPLIED.¿ DISCHARGE SUMMARY. ¿HERNIA REPAIR INCISION IS CLEAN, DRY, INTACT. HE HAS A BINDER IN PLACE.¿ ¿ON (B)(6) HE WAS DISCHARGED IN STABLE CONDITION. HE WILL COMPLETE A TOTAL OF 5 DAYS OF AUGMENTIN FOR WOUND ERYTHEMA.¿ RELEVANT MEDICAL INFORMATION: MEDICAL RECORDS FROM (B)(6), 2015 THROUGH (B)(6), 2016 WERE NOT PROVIDED. (B)(6) 2016: CT A/P: ¿IMPRESSION: SEVERAL ANTERIOR AND RIGHT LATERAL WALL HERNIAS WITH PROTRUDING SMALL BOWEL LOOPS THROUGH THE RIGHT LATERAL WALL. NO EVIDENCE OF INTESTINAL OBSTRUCTION. MODERATE DIVERTICULOSIS.¿ (B)(6) 2017: SURGERY CONSULT. ¿PRESENTS WITH BILATERAL INCISIONAL FLANK HERNIAS AT HIS TRANSPLANT INCISION SITE. PATIENT REPORTS THAT THE HERNIAS HAVE BEEN PRESENT SINCE 2015. THEY ARE ALWAYS REDUCIBLE BUT ARE VERY PAINFUL. HE DID PREVIOUSLY HAVE ANOTHER INCISIONAL HERNIA AT THE CENTER OF THE INCISION THAT WAS REAPIRED [SIC] IN 2014 AT BARNES. EXAM: ABDOMEN: LARGE HORIZONTAL SCAR FROM PREVIOUS SURGERY, BILATERAL FLANK INCISIONAL HERNIAS PRESENT, BOTH HERNIAS ARE REDUCIBLE AND TENDER. PATIENT IS A CANDIDATE FOR OPEN HERNIA REPAIR WITH MESH.¿ (B)(6) 2017: BRIEF HISTORY: ¿LIVER TRANSPLANT 2013, DEVELOPED BILATERAL INCISIONAL FLANK HERNIAS AT TRANSPLANT INCISION SITE. THESE HAVE BEEN PRESENT IN THE PAST, THEY WERE REPAIRED IN 2014, HOWEVER, THAT WAS COMPLICATED BY WOUND DEHISCENCE AND THE INCISIONAL HERNIA HAS RECURRED. AT THIS TIME, HE NOTES THAT THE RIGHT HERNIA CAUSES HIM PAIN WHILE WALKING AND DOING ACTIVITY. AGAIN, OF NOTE, THERE WERE SEVERAL HERNIAS ON THE LEFT AND CENTRAL PORTION OF HIS PREVIOUS INCISION, WHICH WERE NOT ADDRESSED TODAY.¿ INPATIENT HOSPITALIZATION (HOSPITALIZATION DATES (B)(6), 2017) (B)(6) 2017: RIGHT INCISIONAL HERNIA PRIMARY REPAIR ¿AFTER AN APPROPRIATE TIME OUT, THE RIGHT LATERAL INCISION WAS OPENED. IT WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE AND CAUTERIZED. IT WAS OPENED TO THE FULL EXTENT USING GENTLE BLUNT DISSECTION TO PROTECT THE UNDERLYING VISCERA. SEVERAL FASCIAL DEFECTS WERE ENCOUNTERED ON THE RIGHT SIDE OF THE INCISION. THE RIGHT LATERAL ASPECT WAS OPENED AND ALL FASCIAL DEFECTS WERE COMBINED INTO ONE, THIS RESULTED IN AN APPROXIMATELY 8 CM FASCIAL DEFECT IN TOTAL. METZENBAUM SCISSORS WERE THEN USED TO OPEN THE HERNIA SAC. WE ENCOUNTERED OMENTUM. SUBSEQUENTLY, A PRIMARY CLOSURE WITH 1-0 LOOPED PDS RUNNING WAS DONE. DUE TO A PUSTULE NEAR THE INCISION, WE OPTED NOT TO USE THE MESH FOR FEAR OF INFECTION. SUBSEQUENTLY, THE SUPERFICIAL LAYER WAS CLOSED WITH 3-0 INTERRUPTED VICRYL AND THE SKIN WAS CLOSED WITH STAPLES.¿ (B)(6) 2017: DISCHARGE SUMMARY. ¿HOSPITAL COURSE: RIGHT INCISIONAL HERNIA REPAIR. TOLERATED PROCEDURE WELL, TRANSFERRED TO THE FLOOR IN STABLE CONDITION AFTER MONITORING IN THE PACU. THE PATIENT¿S POSTOP COURSE WAS UNCOMPLICATED.¿ (B)(6) 2017: ¿HERE FOR POSTOP VISIT. PT STATES THIS HAS BEEN A VERY PAINFUL SURGERY FOR HIM MORE SO THAN HIS LIVER TRANSPLANT SURGERY. ALSO, C/O [COMPLAINING OF] PAIN AT UMBILICUS SINCE THE SURGERY, NO BULGE OR REDNESS, AS WELL AS VERY LOW-MID ABDOMINAL PAIN. ABD [ABDOMEN]: INCISION TO RT [RIGHT] ABDOMEN INTACT WITH STAPLES, NO REDNEESS [SIC] OR DRAINAGE. VERY TENDER AT UMBILICUS WITHOUT SURROUNDING TENDERNESS OR REDNESS, UNABLE TO DISCERN IF HE HAS A DEFECT AT UMBILICUS, BUT VERY TENDER. TENDERNESS VERY LOW MID-ABDOMEN. ALSO HAS REDUCIBLE RIH [RIGHT INGUINAL HERNIA], AS WELL AS LT [LEFT] SIDED INCISIONAL HERNIA. A&P: POSSIBLE RECURRENT UMBILICAL HERNIA REPAIR.¿ (B)(6) 2017: CT A/P. ¿POST-SURGICAL CHANGES IN THE ANTERIOR ABDOMINAL WALL, SOME RESIDUAL HERNIATED FAT. FAT-CONTAINING RIGHT INTERNAL HERNIA.¿ (B)(6) 2018: ¿... BECAUSE HE HAD A PUSTULE ON HIS SKIN AT THE TIME OF [HIS LAST] SURGERY NO MESH WAS USED AND WE ONLY REPAIRED THE RIGHT SIDE. HE IS NOW HERE TO DISCUSS REPAIR OF THE LEFT SIDE. HE HAS PAIN WITH MOVEMENT AND STRAINING ALONG HIS LEFT SUBCOSTAL INCISION. OCCASIONALLY HE HAS TISSUE THAT POPS OUT AND HE IS ABLE TO SELF REDUCE IT BUT HAS SIGNIFICANT SORENESS. CT SCAN (B)(6) 2017 SHOWS EPIGASTRIC HERNIA AS WELL AS HERNIA ALONG HIS BILATERAL SUBCOSTAL INCISION. ABDOMEN: PALPABLE FASCIAL DEFECT AND CENTER OF CHEVRON INCISION WITH LAXITY ALONG LEFT SIDE, NO DISCRETE DEFECT PALPABLE. GROIN: BILATERAL INGUINAL HERNIA EASILY REDUCIBLE. ASSESSMENT: PRESENTS WITH COMPLICATED VENTRAL HERNIA WITH MULTIPLE PRIOR REPAIRS INCLUDING WITH MESH. GIVEN THE COMPLEXITY OF HIS HERNIA AND THE LOCATION OF THE INCISION CLOSE TO THE RIB CAGE, HE WOULD BENEFIT FROM CONSULTATION WITH A HERNIA SPECIALIST. HE WILL REQUIRE A TOTAL ABDOMINAL WALL RECONSTRUCTION. WE WILL REFER HIM TO BARNES TO SEE DR. XX. ADDENDUM: HE COMPLAINS OF LEFT SIDED INCISIONAL HERNIA, WITH SENSATION OF HERNIA ¿POPPING OUT¿ WHEN HE TURNS TO THE LEFT OR LIFTS ONE OF HIS GRANDCHILDREN. NO OBSTRUCTIVE SYMPTOMS. IS AWARE OF HERNIA AT APEX OF CHEVRON INCISION BUT SAYS IT IS LARGELY ASYMPTOMATIC. CT SCAN DONE (B)(6) 2017, AFTER THE RIGHT SIDED INCISIONAL HERNIA WAS REPAIRED SHOWS HERNIAS ON RIGHT AND LEFT, AS WELL AS AT APEX. INTACT DUAL MESH SEEN ON LEFT, WITH HERNIA LATERAL TO THAT. GIVEN COMPLEXITY OF REPAIR BASED ON MULTIPLE LOCATIONS AND RECURRENCE SO SOON AFTER RIGHT SIDED REPAIR, I RECOMMEND HE BE REFERRED TO DR. XX HERNIA SPECIALIST AT BARNES, WHO COULD PERHAPS OFFER A COMPONENT SEPARATION (ALTHOUGH THAT MAY BE IMPOSSIBLE IN SETTING OF PRIOR MESH).¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2018: SURGERY CONSULT. ¿I PERSONALLY REVIEWED HIS MOST RECENT CT OF ABDOMEN AND PELVIS THAT SHOWS THE MODERATE-SIZED MID ABDOMINAL INCISIONAL HERNIA WITH SIGNIFICANT MUSCLE ATROPHY IN BOTH THE LEFT AND RIGHT SIDE. ASSESSMENT AND PLAN: HISTORY OF HCV [HEPATITIS C VIRUS] CIRRHOSIS S/P [STATUS POST] LIVER TRANSPLANT WHO DEVELOPED INCISIONAL HERNIAS AFTER HIS PROCEDURE. HE HAS HAD 3 REPAIRS AND NOW A RECURRENCE. WE THINK HE IS A GOOD CANDIDATE FOR AN ABDOMINAL WALL RECONSTRUCTION AND REPAIR WITH MESH REINFORCEMENT. WE WILL PLAN ON DOING IT WITH AN OPEN APPROACH.¿ (B)(6) 2018: ¿¿WITH [PRIOR MEDICAL HISTORY] OF LIVER TXP [TRANSPLANT] C/B [COMPLICATED BY] INCISIONAL HERNIA THAT HAS REQUIRED THREE PREVIOUS OPERATIONS.¿ EXPLANT PROCEDURE: MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE RIGHT. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE LEFT. REPAIR OF RECURRENT, INCARCERATED INCISIONAL HERNIA (15X30 CM). IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH). TRANSVERSUS ABDOMINIS PLANE BLOCK. EXPLANT DATE: (B)(6), 2018 [HOSPITALIZATION DATES (B)(6), 2018] FINDINGS: ¿LARGE, RECURRENT INCISIONAL HERNIA INVOLVING HIS ENTIRE LIVER TRANSPLANT INCISION WITH SIGNIFICANT OMENTAL SCARRING TO TOLD [SIC] MESH.¿ ¿THE PATIENT HAD A 15X30 CM DEFECT WITH SIGNIFICANT AMOUNT OF ADHESIONS. AFTER COMPLETING THE ADHESIOLYSIS GIVEN THE SIZE OF THE DEFECT AND HIS COMPLEX SURGICAL HISTORY WE ELECTED TO PROCEED WITH AN INCISIONAL HERNIA REPAIR AND ABDOMINAL WALL RECONSTRUCTION. HE HAD MULTIPLE DENSE ADHESIONS OF OMENTUM TO HIS ABDOMINAL WALL AND OLD MESH. HE ALSO HAD ADHESIONS OF HIS TRANSVERSE COLON TO THE ANTERIOR ABDOMINAL WALL. AFTER FREEING UP THE ADHESIONS, WE REMOVED HIS OLD MESH, AND THEN PROCEEDED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS TO RECONSTRUCT THE ABDOMEN AND ALLOW FOR ADEQUATE MESH OVERLAP.¿ ¿WE BEGAN BY REOPENING HIS MIDLINE INCISION AND DISSECTING DOWN THROUGH THE SUBCUTANEOUS TISSUE UNTIL WE ENCOUNTER THE REMAINDER OF THE LINEA ALBA. THIS WAS THEN OPEN [SIC] SHARPLY TO ENTER THE ABDOMINAL CAVITY. WE ENCOUNTERED A SIGNIFICANT AMOUNT OF ADHESIONS OF OMENTUM AND COLON TO THE ANTERIOR ABDOMINAL WALL AND OLD MESH. THESE WERE ALL TAKEN DOWN WITH SHARP DISSECTION AND MINIMAL ELECTROCAUTERY. DURING ADHESIOLYSIS WE ENCOUNTERED NO BOWEL INJURIES. TOTAL ADHESIOLYSIS TIME WAS GREATER THAN 1 HOUR. AFTER WE WERE SATISFIED WITH ALL OF THE BOWEL WORK, WE PLACED A COUNTABLE TOWEL INTO THE ABDOMEN TO PROTECT THE VISCERA AND TURNED OUR ATTENTION TO REPAIRING THE HERNIA DEFECT. WE MEASURED THE HERNIA DEFECT TO BE 15X30 CM. WE THEN ATTEMPTED TO BRING THE ABDOMINAL WALL MUSCLES BACK TOGETHER AND IT WAS UNDER SIGNIFICANT TENSION. GIVEN THE LARGE SIZE OF THE HERNIA DEFECT, ITS LOCATION AND HIS PREVIOUS SURGICAL HISTORY IN ADDITION THE INCREASED ABDOMINAL TENSION WE ELECTED TO PROCEED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE IN ORDER TO ALLOW FOR ADEQUATE MESH OVERLAP AND MIDLINE MEDIALIZATION OF THE RECTUS MUSCLES. WE BEGAN ON THE PATIENT'S RIGHT SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS. THIS WAS AN INCREDIBLY DIFFICULT DISSECTION GIVEN THE PATIENTS SURGICAL HISTORY, PREVIOUS REPAIRS AND PREVIOUS MESH. ULTIMATELY, WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY. WE WERE LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH WHERE HIS PREVIOUS INCISION AND MESH HAD BEEN PLACED IN THE SUBCOSTAL REGION. BY SEPARATING THE FASCIA, IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. HOWEVER, IT WAS STILL FELT THERE WAS INCREASED TENSION ON THE MIDLINE SO WE TURNED OUR ATTENTION TO PERFORMING A SIMILAR RELEASE ON THE OPPOSITE SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. AGAIN, THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS. WE WERE AGAIN LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH FROM HIS PREVIOUS MESH REPAIR AND SUBCOSTAL INCISION. THIS WAS AN INCREDIBLY DIFFICULT DISSECTION. ULTIMATELY, WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY. BY SEPARATING THE FASCIA IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. TO COMPLETE THE PELVIC DISSECTION, WE WERE ABLE PASS A FINGER THROUGH THE SPACE OF RETZIUS, ALONG THE PUBIC SYMPHYSIS TO CONNECT THE PRE-PERITONEAL DISSECTION OF THE LEFT AND RIGHT SIDE. THE BLADDER COMPLEX WAS THEN FREED FROM THE OVERLYING ABDOMINAL WALL PRESERVING THE LINEA ALBA INTACT. THIS EXPOSED BELOW THE PUBIC SYMPHYSIS TO ALLOW FOR ADEQUATE INFERIOR MESH OVERLAP. FOR THE CRANIAL DISSECTION THE FALCIFORM LIGAMENT HAD BEEN PREVIOUSLY REMOVED, BUT WE WERE ABLE TO UTILIZE THE PRE-PERITONEAL FAT PAD TO ESTABLISH A PLANE UNDER THE XIPHOID BONE. THIS WAS THEN CONNECTED WITH THE LEFT AND RIGHT PRE-PERITONEAL DISSECTION THAT HAD BEEN PERFORMED BY DIVIDING THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE. THIS WAS THEN CONTINUED CRANIALLY BY FREEING THE PERITONEUM OFF THE DIAPHRAGM TO ALLOW FOR ADEQUATE CRANIAL OVERLAP. ONCE WE WERE SATISFIED WITH THE AREA OF DISSECTION, WE THEN TURNED OUR ATTENTION TO CLOSING THE POSTERIOR RECTUS SHEATH IN THE MIDLINE. THERE WERE A FEW HOLES IN THE PERITONEUM AND POSTERIOR SHEATH. THE HOLES WERE CLOSED WITH 2-0 & 3-0 VICRYL SUTURES. WE THEN PERFORMED A SPONGE, INSTRUMENT, NEEDLE COUNT THAT WAS CORRECT. THE POSTERIOR RECTUS SHEATH WAS THEN CLOSED IN THE MIDLINE PRIMARILY AFTER REMOVING THE COUNTABLE TOWEL. WE THEN PERFORMED A TRANSVERSUS ABDOMINIS PLANE BLOCK BY INJECTION 60CC OF 0.25% MARCAINE DIVIDED BETWEEN THE LEFT AND RIGHT TRANSVERSUS ABDOMINIS MUSCLE UNDER DIRECT VISUALIZATION. WE THEN PLACED A 50X50CM PIECE OF ETHICON PROLENE SOFT MESH PLACED IN A SQUARE FASHION. THIS NICELY COVERED FROM THE BELOW THE PUBIC SYMPHYSIS TO THE XIPHOID BONE. THERE LATERAL EDGES OF THE MESH WERE TRIMMED TO ALLOW THE MESH TO LAY FLAT. WE ELECTED TO CLOSE THE LATERAL PORTIONS OF HIS INCISIONAL DEFECT WITH INTERRUPTED FIGURE OF 8 #1 PDS SUTURES IN A TRANSVERSE FASHION. WE THEN PLACED TWO 19 FRENCH BLAKE DRAINS TO DRAIN THE SPACE ABOVE THE MESH. THE ANTERIOR FASCIA WAS THEN CLOSED WITH RUNNING #1 PDS SUTURES. WE CLOSED THE SUBCUTANEOUS TISSUE WITH INTERRUPTED 3-0 VICRYL SUTURE. SKIN WAS CLOSED WITH 4-0 MONOCRYL AND EXOFIN WAS APPLIED.¿ (B)(6) 2018: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE PROCEDURE WAS NOT PROVIDED. (B)(6) 2018: DISCHARGE SUMMARY. ¿HOSPITAL COURSE: ¿ ONCE THE PATIENT WAS TOLERATING DIET, HAD RETURN OF BOWEL FUNCTION, AMBULATING IN HALLWAY, PAIN CONTROLLED THE PATIENT WAS STABLE FOR DISCHARGE ON POSTOPERATIVE DAY 3. LEFT ABDOMINAL JP DRAIN WAS REMOVED PRIOR TO DISCHARGE.¿ 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.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. 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 MY 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.
ADDED PATIENT WEIGHT. ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. 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 4/15/2010 WERE NOT PROVIDED. ON (B)(6) 2010: (B)(6) DIVISION. RADIOLOGY-CT ABDOMEN/PELVIS W/O CONTRAST. FINDINGS: MILD DIVERTICULOSIS OF THE COLON IS PRESENT. RIGHT INGUINAL HERNIA WITH OMENTAL FAT WITHOUT BOWEL LOOPS IS NOTED. ON (B)(6) 2014: (B)(6), MD, FACS. OFFICE VISIT. HPI: DONE WELL FOLLOWING THIS PROCEDURE, DEVELOPED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH BOTHERS HIM PRIMARILY IF COUGHING OR OTHER EXERTION. EXAM: ABDOMEN: SOFT NONTENDER, NONDISTENDED. EASILY REDUCIBLE APPROXIMATELY 3-4 CM DEFECT ALONG THE LEFT SUBCOSTAL INCISION. IMPRESSION: REDUCIBLE INCISIONAL HERNIA ALONG THE LEFT SUBCOSTAL INCISION. PLAN: CONTINUE ADJUSTMENTS IN IMMUNOSUPPRESSION AS NEEDED. WE HAVE ADVISED THE PATIENT TO AGGRESSIVELY ATTEMPT 10-15 LBS WEIGHT LOSS TO FACILITATE SUCCESSFULLY HERNIA REPAIR. ON (B)(6) 2014: (B)(6) ST. LOUIS. OFFICE VISIT. HPI: UNDERWENT ORTHOTROPIC LIVER TRANSPLANT IN NOVEMBER 2013 FOR HCV. HAS DONE EXCEEDING WELL SINCE PROCEDURE, EXCELLENT GRAFT FUNCTION. HAVE BEEN FOLLOWING HIM OVER THE PAST FEW MONTHS FOR BOTH TITRATION AND MANAGEMENT OF IMMUNOSUPPRESSION AND ALSO FOR INCIDENTALLY NOTED LEFT SUBCOSTAL INCISIONAL HERNIA WHICH OVER THE PAST MONTH HAS STARTED TO BOTHER HIM SIGNIFICANTLY MORE. NO OBSTRUCTIVE SYMPTOMS, TOLERATING ORAL INTAKE, REGULAR MOVEMENTS. BULGE HAS INCREASED IN SIZE OVER THE PAST MONTH. CAUSING DISCOMFORT WITH MOVING EXERTION AND COUGHING, CAN NO LONGER LIE ON THAT SIDE. NOTES BURNING, TINGLING IN THE AREA. HE WOULD LIKE THIS FIXED. WE HAVE MENTIONED TO HIM WEIGHT LOSS. HIS WEIGHT IS ESSENTIALLY STABLE OVER THE PAST MONTH DESPITE EFFORTS TO TRY AND LOSE WEIGHT. ABDOMEN: SOFT NONTENDER, NONDISTENDED. EASILY REDUCIBLE APPROXIMATELY 4 CM DEFECT ALONG LEFT SUBCOSTAL INCISION. NO TENDERNESS TO PALPATION. THE BULGE INCREASES SIGNIFICANTLY WITH ELEVATION OF HIS LOWER EXTREMITIES. IMPRESSION/PLAN: POST OLT SIX MONTHS AGO DOING WELL POSTOP PRESENTING FOR GROWING AND SYMPTOMATIC INCISIONAL HERNIA. DUE TO THE FACT THAT THIS IS GROWING IN SIZE AND IS CAUSING SYMPTOMS WE HAVE AGREED TO REPAIR ELECTIVELY AT THIS TIME. WE EXPLAINED TO HIM THE PROCEDURE AND THE RISKS BENEFITS AND ANTICIPATED CONVALESCENCE. WITH REGARD TO THE RISKS WE SPECIFICALLY DISCUSSED WITH HIM THE RISK OF RECURRENT HERNIA AND INFECTION. WE DID DISCUSS WITH HIM THAT IF HIS MESH DOES BECOME INFECTION HE WOULD REQUIRE MESH REMOVAL. HE UNDERSTANDS THE PROCEDURE AND RISKS AND BENEFITS AND WOULD LIKE TO PROCEED AT THIS TIME. WE ENCOURAGED CONTINUING TO ATTEMPT TO LOSE WEIGHT IN THE INTERIM AS THIS WILL HELP WITH THE INTENDED PROCEDURE. ON (B)(6) 2016: (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS W/O CONTRAST. IMPRESSION: SEVERAL ANTERIOR AND RIGHT LATERAL WALL HERNIAS WITH PROTRUDING SMALL BOWEL LOOPS THROUGH THE RIGHT LATERAL WALL. NO EVIDENCE OF INTESTINAL OBSTRUCTION. MODERATE DIVERTICULOSIS. ON (B)(6) 2017: (B)(6). CONSULT REQUEST. PROVISIONAL DIAGNOSIS: OTHER SPECIFIED ABDOMINAL HERNIA WITHOUT OBSTRUCTION OR GANGRENE. LARGE TRANSVERSE ABDOMINAL HERNIAS, REDUCIBLE, PRESENT FOR YEARS. ON (B)(6) 2017: (B)(6), MD. GENERAL SURGERY CONSULT. HPI: PRESENTS WITH BILATERAL INCISIONAL FLANK HERNIAS AT HIS TRANSPLANT INCISION SITE. PATIENT REPORTS THAT THE HERNIAS HAVE BEEN PRESENT SINCE 2015. THEY ARE ALWAYS REDUCIBLE BUT ARE VERY PAINFUL. HE DID PREVIOUSLY HAVE ANOTHER INCISIONAL HERNIA AT THE CENTER OF THE INCISION THAT WAS REAPIRED [SIC] IN 2014 AT (B)(6). EXAM: ABDOMEN: LARGE HORIZONTAL SCAR FROM PREVIOUS SURGERY, BILATERAL FLANK INCISIONAL HERNIAS PRESENT, BOTH HERNIAS ARE REDUCIBLE AND TENDER. ASSESSMENT/PLAN: TENDER BILATERAL FLANK INCISIONAL HERNIAS. PATIENT IS A CANDIDATE FOR OPEN HERNIA REPAIR WITH MESH. ON (B)(6) 2017: (B)(6). OPERATIVE REPORT. FIRST ASSISTANT: (B)(6). SECOND ASSISTANT: (B)(6), MD. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. PROCEDURE: RIGHT INCISIONAL HERNIA PRIMARY REPAIR. BRIEF HISTORY: LIVER TRANSPLANT 2013, DEVELOPED BILATERAL INCISIONAL FLANK HERNIAS AT TRANSPLANT INCISION SITE. THESE HAVE BEEN PRESENT IN THE PAST, THEY WERE REPAIRED IN 2014, HOWEVER, THAT WAS COMPLICATED BY WOUND DEHISCENCE AND THE INCISIONAL HERNIA HAS RECURRED. AT THIS TIME, HE NOTES THAT THE RIGHT HERNIA CAUSES HIM PAIN WHILE WALKING AND DOING ACTIVITY. AGAIN, OF NOTE, THERE WERE SEVERAL HERNIAS ON THE LEFT AND CENTRAL PORTION OF HIS PREVIOUS INCISION, WHICH WERE NOT ADDRESSED TODAY. INDICATIONS FOR SURGERY/PROCEDURE: HERNIA. DESCRIPTION OF SURGERY/PROCEDURE: ¿AFTER AN APPROPRIATE TIME OUT, THE RIGHT LATERAL INCISION WAS OPENED. IT WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE AND CAUTERIZED. IT WAS OPENED TO THE FULL EXTENT USING GENTLE BLUNT DISSECTION TO PROTECT THE UNDERLYING VISCERA. SEVERAL FASCIAL DEFECTS WERE ENCOUNTERED ON THE RIGHT SIDE OF THE INCISION. THE RIGHT LATERAL ASPECT WAS OPENED AND ALL FASCIAL DEFECTS WERE COMBINED INTO ONE, THIS RESULTED IN AN APPROXIMATELY 8 CM FASCIAL DEFECT IN TOTAL. METZENBAUM SCISSORS WERE THEN USED TO OPEN THE HERNIA SAC. WE ENCOUNTERED OMENTUM. SUBSEQUENTLY, A PRIMARY CLOSURE WITH 1-0 LOOPED PDS RUNNING WAS DONE. DUE TO A PUSTULE NEAR THE INCISION, WE OPTED NOT TO USE THE MESH FOR FEAR OF INFECTION. SUBSEQUENTLY, THE SUPERFICIAL LAYER WAS CLOSED WITH 3-0 INTERRUPTED VICRYL AND THE SKIN WAS CLOSED WITH STAPLES.¿ SPECIMENS: NONE. COMPLICATIONS: NONE. IMPLANTS: NONE. CONDITION AT DISCHARGE: STABLE. THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. ON (B)(6) 2017: (B)(6), MD. DISCHARGE SUMMARY. PRINCIPAL DIAGNOSIS: INCISIONAL HERNIA. HOSPITAL COURSE: RIGHT INCISIONAL HERNIA REPAIR. TOLERATED PROCEDURE WELL, TRANSFERRED TO THE FLOOR IN STABLE CONDITION AFTER MONITORING IN THE PACU. THE PATIENT¿S POSTOP COURSE WAS UNCOMPLICATED. ON (B)(6) 2017: (B)(6), PA-C. PROGRESS NOTES. HERE FOR POSTOP VISIT. PT STATES THIS HAS BEEN A VERY PAINFUL SURGERY FOR HIM MORE SO THAN HIS LIVER TRANSPLANT SURGERY. ALSO C/O PAIN AT UMBILICUS SINCE THE SURGERY, NO BULGE OR REDNESS, AS WELL AS VERY LOW-MID ABDOMINAL PAIN. HAS BEEN WEARING ABDOMINAL BINDER 24/7. ABD: INCISION TO RT ABDOMEN INTACT WITH STAPLES, NO REDNEESS [SIC] OR DRAINAGE. VERY TENDER AT UMBILICUS WITHOUT SURROUNDING TENDERNESS OR REDNESS, UNABLE TO DISCERN IF HE HAS A DEFECT AT UMBILICUS, BUT VERY TENDER. TENDERNESS VERY LOW MID-ABDOMEN. ALSO HAS REDUCIBLE RIH, AS WELL AS LT SIDED INCISIONAL HERNIA. A&P: POSSIBLE RECURRENT UMBILICAL HERNIA REPAIR: WILL GET CT ABD PELVIS TO FURTHER EVALUATE THIS AND HIS OTHER ABDOMINAL HERNIAS. ON (B)(6) 2017: (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS W/O CONTRAST. HISTORY: S/P INCISIONAL HERNIA REPAIR; HX LIVER TRANSPLANT WITH UMBILICAL HERNIA REPAIR IN 2013; C/O PAIN AND EXQUISITE TENDERNESS IN UMBILICUS, NEED TO R/O RECURRENT HERNIA VS FAT HERNIATION; ALSO HAS RT INGUINAL HERNIA GETTING LARGER, ALSO C/O LOW MID-ABDOMINAL PAIN. IMPRESSION: POST-SURGICAL CHANGES IN THE ANTERIOR ABDOMINAL WALL, SOME RESIDUAL HERNIATED FAT. FAT-CONTAINING RIGHT INTERNAL HERNIA. ON(B)(6) 2018: (B)(6), MD. PROGRESS NOTES. PATIENT DEVELOPED HERNIA AT MIDPOINT OF CHEVRON INCISION A FEW MONTHS AFTER HIS LIVER SURGERY. RECURRED WITHIN A FEW DAYS WAS FOUND TO HAVE INCARCERATED BOWEL IN THE HERNIA, THE SAME MESH WAS REAPPROXIMATED. HE THEN DEVELOPED BILATERAL HERNIAS AND WE TOOK HIM FOR PRIMARY REPAIR. BECAUSE HE HAD A PUSTULE ON HIS SKIN AT THE TIME OF SURGERY NO MESH WAS USED AND WE ONLY REPAIRED THE RIGHT SIDE. HE IS NOW HERE TO DISCUSS REPAIR OF THE LEFT SIDE. HE HAS PAIN WITH MOVEMENT AND STRAINING ALONG HIS LEFT SUBCOSTAL INCISION. OCCASIONALLY HE HAS TISSUE THAT POPS OUT AND HE IS ABLE TO SELF REDUCE IT BUT HAS SIGNIFICANT SORENESS. CT SCAN 7/2017 SHOWS EPIGASTRIC HERNIA AS WELL AS HERNIA ALONG HIS BILATERAL SUBCOSTAL INCISION. PHYSICAL EXAM: ABDOMEN: PALPABLE FASCIAL DEFECT AND CENTER OF CHEVRON INCISION WITH LAXITY ALONG LEFT SIDE, NO DISCRETE DEFECT PALPABLE. GROIN: BILATERAL INGUINAL HERNIA EASILY REDUCIBLE. ASSESSMENT: PRESENTS WITH COMPLICATED VENTRAL HERNIA WITH MULTIPLE PRIOR REPAIRS INCLUDING WITH MESH. GIVEN THE COMPLEXITY OF HIS HERNIA AND THE LOCATION OF THE INCISION CLOSE TO THE RIB CAGE, HE WOULD BENEFIT FROM CONSULTATION WITH A HERNIA SPECIALIST. HE WILL REQUIRE A TOTAL ABDOMINAL WALL RECONSTRUCTION. WE WILL REFER HIM TO (B)(6) TO SEE DR. (B)(6). ADDENDUM: HE COMPLAINS OF LEFT SIDED INCISIONAL HERNIA, WITH SENSATION OF HERNIA ¿POPPING OUT¿ WHEN HE TURNS TO THE LEFT OR LIFTS ONE OF HIS GRANDCHILDREN. NO OBSTRUCTIVE SYMPTOMS. IS AWARE OF HERNIA AT APEX OF CHEVRON INCISION BUT SAYS IT IS LARGELY ASYMPTOMATIC. CT SCAN DONE JULY 2017, AFTER THE RIGHT SIDED INCISIONAL HERNIA WAS REPAIRED SHOWS HERNIAS ON RIGHT AND LEFT, AS WELL AS AT APEX. INTACT DUAL MESH SEEN ON LEFT, WITH HERNIA LATERAL TO THAT. GIVEN COMPLEXITY OF REPAIR BASED ON MULTIPLE [SIC] LOCATIONS AND RECURRENCE SO SOON AFTER RIGHT SIDED REPAIR, I RECOMMEND HE BE REFERRED TO DR. (B)(6), HERNIA SPECIALIST AT (B)(6), WHO COULD PERHAPS OFFER A COMPONENT SEPARATION (ALTHOUGH THAT MAY BE IMPOSSIBLE IN SETTING OF PRIOR MESH). ON (B)(6) 2018: (B)(6), MD. OFFICE VISIT. HPI: HISTORY OF LIVER TRANSPLANT IN 2013, WHO DEVELOPED AN INCISIONAL HERNIA ONE YEAR AFTER HIS TRANSPLANT. HE HAD THIS HERNIA REPAIRED USING MESH IN THREE DIFFERENT OCCASIONS, AND IT HAS NOW RECURRED. HE DENIES EPISODES OF INCARCERATION, OR CHANGES IN THE COLOR OF THE SKIN ABOVE THE HERNIA. HE ENDORSES PAIN WITH VALSALVA MANEUVERS. HE IS HERE LOOKING FOR SURGICAL MANAGEMENT. PHYSICAL EXAM: ABDOMEN: MERCEDES BENZ SCAR WELL HEALED, HERNIA ALONG THE EXTENT OF THE SCAR. REVIEW OF STUDIES: I PERSONALLY REVIEWED HIS MOST RECENT CT OF ABDOMEN AND PELVIS THAT SHOWS THE MODERATE-SIZED MID ABDOMINAL INCISIONAL HERNIA WITH SIGNIFICANT MUSCLE ATROPHY IN BOTH THE LEFT AND RIGHT SIDE. ASSESSMENT AND PLAN: HISTORY OF HCV CIRRHOSIS S/P LIVER TRANSPLANT WHO DEVELOPED INCISIONAL HERNIAS AFTER HIS PROCEDURE. HE HAS HAD 3 REPAIRS AND NOW A RECURRENCE. WE THINK HE IS A GOOD CANDIDATE FOR AN ABDOMINAL WALL RECONSTRUCTION AND REPAIR WITH MESH REINFORCEMENT. WE WILL PLAN ON DOING IT WITH AN OPEN APPROACH. WE DESCRIBED THE SURGERY AND TALKED ABOUT POTENTIAL POST OPERATIVE COMPLICATIONS, POST OPERATIVE COURSE AND HOSPITAL STAY. TEACHING ATTESTATION: HE INITIALLY HAD THIS REPAIRED IN 2014 AND HAD A SHORT TERM RECURRENCE. HE DID HAVE ADDITIONAL REPAIR AT THE (B)(6) CENTER. HE NOW PRESENTS WITH A RECURRENCE ON BOTH THE LEFT AND RIGHT SIDE. I DO THINK GIVEN HIS COMPLEX HISTORY AND THE SIZE OF THE HERNIA HE WOULD BE BEST SERVED BY AN OPEN REPAIR WITH ABDOMINAL WALL RECONSTRUCTION. ON (B)(6) 2018: [MISSING RECORDS: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE ON (B)(6) 2018 PROCEDURE WAS NOT PROVIDED.] THERE IS NO MENTION OF INFECTION INVOLVING THE GORE DEVICE. ON (B)(6) 2018: (B)(6), MD. DISCHARGE SUMMARY. PRIMARY DISCHARGE DIAGNOSIS: VENTRAL HERNIA. SECONDARY DISCHARGE DIAGNOSIS: INCISIONAL HERNIA, WITHOUT OBSTRUCTION OR GANGRENE; HISTORY OF LIVER TRANSPLANT; OBESITY WITH BODY MASS INDEX 30 OR GREATER. HOSPITAL COURSE: UNDERWENT BILATERAL MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE, REPAIR OF RECURRENT AND INCARCERATED INCISIONAL HERNIA (15 X30 CM), IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH), TRANSVERSUS ABDOMINIS PLANE BLOCK. LIVER TRANSPLANT WAS CONSULTED AND FOLLOWED RECOMMENDATIONS FOR IMMUNOSUPPRESSIVE THERAPY. ONCE THE PATIENT WAS TOLERATING DIET, HAD RETURN OF BOWEL FUNCTION, AMBULATING IN HALLWAY, PAIN CONTROLLED THE PATIENT WAS STABLE FOR DISCHARGE ON POSTOPERATIVE DAY 3. LEFT ABDOMINAL JP DRAIN WAS REMOVED PRIOR TO DISCHARGE. ACTIVITY INSTRUCTIONS: DO NOT LIFT GREATER THAN 10 POUNDS FOR 4 WEEKS. ON (B)(6) 2019: (B)(6), MD. PROGRESS NOTES. S/P LIVER TRANSPLANT C/B MULTIPLE INCISIONAL HERNIA REPAIRS INITIALLY REPAIRED AT THE VA AND EVENTUALLY REFERRED TO DR. (B)(6) WHO PERFORMED A COMPONENT SEPARATION 5 MONTHS AGO THAT IS DOING WELL. HE IS HERE TODAY FOR A NEW RIGHT INGUINAL HERNIA. NOTICED RIGHT GROIN DISCOMFORT 2 YEARS AGO, PROGRESSIVELY WORSENED. NOW CONSTANT DULL ACHING PAIN IN RIGHT GROIN, BECOMES SHARP WITH COUGHING OR STRAINING. THE HERNIA IS SOFT AND EASILY REDUCIBLE WITH NO OVERLYING SKIN CHANGES. HE DENIES CONSTIPATION OR OTHER CHANGES IN BOWEL HABITS SINCE NOTICING THIS HERNIA. ABD: SOFT, NT, ND, NO CVAT, BS. WELL HEALED SURGICAL SCARS. R GROIN WITH SOFT ESILY [SIC] REDUCIBLE INGUINAL HERNIA. ON (B)(6) 2019: (B)(6), MD, PHD. OPERATIVE REPORT. PREOP DIAGNOSIS: RIGHT INGUINAL HERNIA. POSTOP DIAGNOSIS: RIGHT INGUINAL HERNIA. SURGERY/PROCEDURE PERFORMED: OPEN RIGHT INGUINAL HERNIA REPAIR WITH NO MESH BASSINI REPAIR. FINDINGS: LARGE INDIRECT HERNIA. INDICATIONS FOR SURGERY/PROCEDURE: S/P LIVER TRANSPLANT WITH A HISTORY OF MULTIPLE INCISIONAL HERNIAS WHO PRESENTED WITH SYMPTOMATIC RIGHT INGUINAL HERNIA THAT HAS BEEN BOTHERING HIM FOR MULTIPLE YEARS. THE PATIENT WAS SCHEDULED FOR ELECTIVE RIGHT INGUINAL HERNIA REPAIR. DESCRIPTION OF SURGERY/PROCEDURE: ¿AFTER AN APPROPRIATE TIMEOUT WAS PERFORMED AND THE VA CHECKLIST WAS COMPLETED, THE PATIENT WAS INTUBATED SUCCESSFULLY BY THE ANESTHESIA TEAM WITH NO COMPLICATION. THE PATIENT WAS THEN PREPPED AND DRAPED IN A STERILE FASHION. PRIOR TO THE INCISION, ANCEF WAS GIVEN FOR INFECTION PROPHYLAXIS. WE THEN STARTED THE PROCEDURE BY MAKING AN INCISION OVER THE APPROXIMATE LOCATION OF THE INGUINAL LIGAMENT. WE CARRIED THE INCISION DOWN PAST THE SUBCUTANEOUS TISSUE TO SCARPA FASCIA AND ALSO DOWN PAST THE EXTERNAL ABDOMINAL OBLIQUE MUSCLE FIBERS UNTIL WE GOT TO THE SPERMATIC CORD. WE THEN PROCEEDED TO ISOLATE THE SPERMATIC CORD. AFTER ISOLATING THE SPERMATIC CORD, WE PROCEEDED TO USE ELECTROCAUTERY TO DISSECT OFF THE PROSTATIC FASCIA BOTH LATERALLY AND ANTEROMEDIALLY. THE OBVIOUS SIGNIFICANT INDIRECT INGUINAL HERNIA WAS NOTICED IN THE SPERMATIC CORD. WE THEN PROCEEDED TO DISSECT OFF THE HERNIAL SAC FROM THE SPERMATIC CORD TAKING CARE TO ENSURE WE DID NOT DAMAGE ANY OF THE SPERMATIC CORD STRUCTURES. AFTER SAFELY DISSECTING OFF THE HERNIAL SAC FROM THE SPERMATIC CORD, WE THEN OPENED UP THE HERNIAL SAC USING METZENBAUM SCISSORS. WE TOOK A LOOK AT THE CONTENTS OF THE HERNIAL SAC AND NOTED THAT IT WAS JUST FATTY CONTENTS PRESENT IN THE HERNIAL SAC. WE SAFELY REDUCED THE CONTENTS OF THE HERNIAL SAC AND THEN PROCEEDED TO LIGATE THE HERNIAL SAC USING A 2-0 SILK IN A PURSESTRING FORMAT TO LIGATE THE HERNIAL SAC. WE THEN PROCEEDED TO USE ANOTHER 2-0 SILK TO TIE OFF/LIGATE THE HERNIAL SAC ABOVE THE INITIAL PURSESTRING SUTURE. THE HERNIAL SAC WAS SAFELY REDUCED. OF NOTE, WE DID NOTICE THE INFERIOR EPIGASTRIC VESSELS AND THEY WERE INTACT. AFTER REDUCTION OF THE HERNIAL SAC, WE THEN PROCEEDED TO APPROXIMATE THE CONJOINT TENDON TO THE SHELVING EDGE OF THE INGUINAL LIGAMENT USING 0 ETHIBOND SUTURES IN AN INTERRUPTED FORMAT. AT THE COMPLETION OF THIS REAPPROXIMATION, WE TIED ALL OUR SUTURES SEQUENTIALLY. THE INTERNAL RING WAS EXAMINED. IT WAS NOTED NOT TO BE TOO CONSTRICTING OF THE SPERMATIC CORD. WE THEN PROCEEDED TO CLOSE THE EXTERNAL ABDOMINAL OBLIQUE FIBERS USING 2-0 VICRYL SUTURE IN A CONTINUOUS FORMAT. AFTER APPROXIMATING THE EXTERNAL ABDOMINAL OBLIQUE MUSCLE FIBERS, WE THEN PROCEEDED TO APPROXIMATE SCARPA FASCIA ALSO USING 2-0 VICRYL SUTURES IN A RUNNING FORMAT. DURING ALL OUR STEPS, WE ENSURED WE ACHIEVED ADEQUATE HEMOSTASIS. WE THEN PROCEEDED TO CLOSE THE SKIN USING 4-0 MONOCRYL SUBCUTICULAR SUTURES IN A RUNNING FORMAT. DERMABOND WAS THEN APPLIED ON THE SKIN. THE PATIENT TOLERATED THE PROCEDURE ADEQUATELY AND WAS EXTUBATED WITH NO COMPLICATIONS. WE PALPATED THE TESTICLES AT THE BEGINNING AND END OF THE CASE, AND THEY WERE BOTH INTACT WITH NO NOTED CHANGES AFTER THE CASE.¿ SPECIMEN: HERNIAL SAC. COMPLICATIONS: NONE. IMPLANTS: NONE. CONDITION AT DISCHARGE: STABLE. PT DISPOSITION: PT WAS SENT TO THE PACU IN A STABLE FORMAT. ON (B)(6) 2019: (B)(6), PHD. SURGICAL PATHOLOGY. ACCESSION NO. SP 19 2225. SPECIMEN: A) RIGHT INGUINAL HERNIA SAC. PREOPERATIVE/POSTOPERATIVE DIAGNOSIS: INGUINAL HERNIA. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER LABELED WITH THE PATIENT¿S NAME, FULL SOCIAL SECURITY NUMBER, ¿RIGHT INGUINAL HERNIA SAC¿, AND CONSISTS OF ONE IRREGULARLY SHAPED FRAGMENT OF SOFT, PINK-TAN TISSUE MEASURING 4 X 3 X 0.5 CM. THE SPECIMEN IS SERIALLY SECTIONED TO SHOW SOFT, PINK-TAN TISSUE. NO LESIONS ARE SEEN. REPRESENTATIVE SECTIONS ARE SUBMITTED AS PATIENT IDENTIFIER. MICROSCOPIC EXAM: MICROSCOPIC EXAMINATION SUBSTANTIATES THE CITED DIAGNOSES. DIAGNOSIS: SOFT TISSUE, RIGHT INGUINAL ¿HERNIA¿ REPAIR: FEATURES CONSISTENT WITH HERNIA SAC. 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.
B7: ADDED PATIENT 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: OPERATIVE RECORDS DATED ON (B)(6) 2013 STATE THE PATIENT UNDERWENT ¿ORTHOTOPIC LIVER TRANSPLANT, DUCT-TO-DUCT ANASTOMOSIS, STANDARD BACK BENCH PREPARATION, PORTAL VEIN THROMBECTOMY AND RECONSTRUCTION OF DIVIDED RIGHT HEPATIC ARTERY ON THE BACK TABLE.¿ OPERATIVE RECORDS DATED ON (B)(6) 2013 STATE THE PATIENT UNDERWENT ¿EXPLORATORY LAPAROTOMY STATUS POST LIVER TRANSPLANT FOR POSSIBLE ARTERIAL THROMBOSIS WITH ARTERIAL RECONSTRUCTION.¿ THE RECORDS STATE: ¿THE PATIENT HAD A LIVER TRANSPLANT YESTERDAY. HE HAD AN ULTRASOUND TODAY. THE ARTERY WAS NOT VISUALIZED. WE TOOK HIM TO THE OPERATING ROOM IN LIGHT OF THE RIGHT HEPATIC ARTERY RECONSTRUCTION YESTERDAY TO CHECK AND SEE IF THE ARTERY WAS OPEN.¿ DISCHARGE SUMMARY RECORDS DATED ON (B)(6) 2013 STATE THE PATIENT ¿WITH A HISTORY OF HEPATITIS C CIRRHOSIS COMPLICATED BY HEPATIC ENCEPHALOPATHY, ASCITES, AND ESOPHAGEAL VARICES STATUS POST BANDING WHO NOW PRESENTS FOR POSSIBLE ORTHOTOPIC LIVER TRANSPLANT. THE PATIENT WAS INITIALLY DIAGNOSED WITH HEPATITIS C IN [ILLEGIBLE] ON ROUTINE SCREENING LABORATORY EXAMINATION. HIS DISEASE WAS THOUGHT TO ARRIVE FROM PRIOR IV DRUG USE IN THE 1960¿S. HE WAS BRIEFLY TREATED WITH INTERFERON AND RIBAVIRIN¿BUT HE WAS UNABLE TO TOLERATE HIS TREATMENT, AND IT WAS STOPPED. THE PATIENT¿S END-STAGE LIVER DISEASE HAS BEEN FURTHER COMPLICATED WITH RESISTANT ASCITES REQUIRING MULTIPLE THERAPEUTIC PARACENTESES, WHICH HAS ALSO RESULTED IN INTERMITTENT EPISODES OF SPONTANEOUS BACTERIAL PERITONITIS. THE PATIENT WAS MOST RECENTLY TREATED FOR PERITONITIS ON (B)(6) 2013. HIS MOST RECENT THERAPEUTIC PARACENTESIS WAS PERFORMED. ON (B)(6) 2013. AT THAT TIME, 6500 ML WAS REMOVED.¿ ON (B)(6) 2013, DISCHARGE SUMMARY RECORDS CONTINUE: ¿THE PATIENT ALSO HAD COMPLICATIONS OF HEPATIC ENCEPHALOPATHY AND WAS MOST RECENTLY ADMITTED FROM ON (B)(6) 2013. FOR PROGRESSIVE CONFUSION AND FORGETFULNESS. THIS EPISODE RESOLVED WITH LACTULOSE TREATMENT. HE HAS HAD NO PROBLEMS OVER THE LAST SEVERAL DAYS SINCE HIS DISCHARGE. THE PATIENT¿S MOST RECENT UPPER ENDOSCOPY WAS PERFORMED ON (B)(6) 2013, WHICH DEMONSTRATED ESOPHAGEAL VARICES AND GASTROPATHY. NO BANDING WAS PERFORMED AT THIS TIME. HE WAS MOST RECENTLY BANDED ON (B)(6) 2012 WITH THREE BANDS PLACED. THE PATIENT DENIES ANY RECENT UPPER GASTROINTESTINAL BLEEDING OR HEMATEMESIS.¿ OPERATIVE RECORDS DATED ON (B)(6) 2014 STATE THE PATIENT UNDERWENT ¿INCISIONAL HERNIA REPAIR WITH GORE TEX DUAL MESH PLACEMENT¿ FOR A DIAGNOSIS OF ¿SYMPTOMATIC INCISIONAL HERNIA. STATUS POST LIVER TRANSPLANT.¿ ¿[THE PATIENT] IS A 60-YEAR-OLD GENTLEMAN WHO IS STATUS POST ORTHOTOPIC LIVER TRANSPLANT ON (B)(6) 2013 FOR HEPATITIS C ASSOCIATED CIRRHOSIS. HE PRESENTED TO THE CLINIC WITH COMPLAINTS OF A SYMPTOMATIC HERNIA ALONG THE LEFT LATERAL ASPECT OF HIS MERCEDES INCISION. HE WAS WITHOUT SYMPTOMS OF INCARCERATION. HE IS CURRENTLY ON IMMUNE SUPPRESSION WITH PROGRAF AND MYFORTIC .¿ FINDINGS FROM THE PROCEDURE STATE: ¿10 BY 4 CENTIMETER FASCIAL DEFECT WITH ADJACENT ATTENUATED FASCIA. NO INCARCERATED HERNIA CONTENTS.¿ ON (B)(6) 2014, OPERATIVE REPORT STATES: ¿THE PREVIOUS SCAR ALONG THE LEFT LATERAL ASPECT OF HIS INCISION WAS REOPENED AND DISSECTED DOWN TO THE LEVEL OF THE HERNIA SAC WHICH WAS OPENED AND EXCISED. THE FASCIA WAS IDENTIFIED AND FLAPS APPROXIMATELY 3 CENTIMETERS WERE DISSECTED CIRCUMFERENTIALLY AROUND THE HERNIA DEFECT. A MESH UNDERLAY USING GORE TEX DUAL MESH WAS THEN TACKED CIRCUMFERENTIALLY TO THE FASCIA USING #1 PROLENE SUTURE. SCAR TISSUE, BUT NOT THE TRUE FASCIA OVERLYING THE DEFECT, WAS CLOSED USING 3-0 VICRYL. THE WOUND WAS IRRIGATED AND HEMOSTASIS WAS ACHIEVED. THE DEEP DERMAL TISSUE WAS REAPPROXIMATED USING VICRYL SUTURE AND THE SKIN WAS CLOSED USING MONOCRYL IN A SUBCUTICULAR FASHION.¿ THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC04/12553724) WAS IMPLANTED DURING THE PROCEDURE. OPERATIVE RECORDS DATED ON (B)(6) 2014 STATE THE PATIENT UNDERWENT ¿REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH.¿ POSTOPERATIVE DIAGNOSIS STATES: ¿IMMEDIATE RECURRENCE OF INCISIONAL VENTRAL HERNIA REPAIRED WITH MESH.¿ INDICATIONS STATE: ¿THE PATIENT IS A 60-YEAR-OLD MALE WHO IS NOW ABOUT FIVE DAYS STATUS POST REPAIR OF AN INCISIONAL VENTRAL HERNIA WITH DUALMESH. ON POSTOPERATIVE DAY TWO, HE DEVELOPED SWELLING UNDERNEATH HIS INCISION. THIS WAS EVALUATED WITH A CT SCAN WHICH DEMONSTRATED A FAILURE OF THE MESH AND RECURRENCE OF THE HERNIA. HE HAS NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTION. HE IS BROUGHT TO THE OPERATING ROOM AT THIS TIME FOR URGENT REPAIR OF THIS RECURRENT INCISIONAL VENTRAL HERNIA.¿ ON (B)(6) 2014, RECORDS STATE: ¿HIS INCISION WAS REOPENED. WE IDENTIFIED THAT THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN. THE BOWEL WAS ALL VIABLE AND WAS NON-OBSTRUCTED. THE BOWEL WAS THEN RETURNED TO THE ABDOMEN. THE SAME MESH GRAFT WAS USED AND IT WAS SEWN CIRCUMFERENTIALLY TO THE FASCIA USING A SERIES OF INTERRUPTED FIGURE-OF-EIGHT 0 PROLENE SUTURES . THERE WAS NO TENSION ON THE MESH. THE SUBCUTANEOUS TISSUE WAS IRRIGATED AND REAPPROXIMATED WITH 3-0 VICRYL AND THE SKIN WITH 4-0 MONOCRYL SUBCUTICULAR SUTURES. DERMABOND WAS THEN APPLIED.¿ DISCHARGE SUMMARY RECORDS DATED ON (B)(6) 2014 STATE THE PATIENT ¿UNDERWENT ORTHOTOPIC LIVER TRANSPLANT ON (B)(6) 2013 FOR HCV. HE HAS DONE EXCEEDINGLY WELL SINCE HIS PROCEDURE AND HAS EXCELLENT GRAFT FUNCTION. HOWEVER, WE HAVE BEEN FOLLOWING HIM OVER THE PAST FEW MONTHS FOR BOTH TITRATION AND MANAGEMENT OF HIS IMMUNOSUPPRESSION AND ALSO FOR "INCIDENTALLY" NOTED LEFT SUBCOSTAL INCISIONAL HERNIA, WHICH OVER THE PAST MONTH HAS STARTED TO BOTHER HIM SIGNIFICANTLY MORE. HE HAS NO OBSTRUCTIVE SYMPTOMS, HE IS TOLERATING ORAL INTAKE, AND IS HAVING REGULAR MOVEMENTS. HE NOTES THAT THE BULGE HAS INCREASED IN SIZE OVER THE PAST MONTH. THIS CAUSING HIS DISCOMFORT WITH MOVING, EXERTION, AND COUGHING, AND HE CAN NO LONGER LIE ON THAT SIDE ANY LONGER. HE STATES THAT ALL OF THESE SYMPTOMS HAVE GOTTEN WORSE. HE ALSO NOTES BURNING AND TINGLING IN THE AREA. HE WOULD LIKE THIS FIXED. WE HAVE MENTIONED TO HIM WEIGHT LOSS . HE WEIGHT IS ESSENTIALLY STABLE OVER THE PAST MONTH, DESPITE EFFORTS TO TRY AND LOSE WEIGHT. HE IS OTHERWISE DOING WELL AND IS WITHOUT COMPLAINT.¿ PHYSICAL EXAMINATION STATES: ¿HERNIA REPAIR INCISION IS CLEAN, DRY, INTACT. HE HAS A BINDER IN PLACE.¿ ON (B)(6) 2014 DISCHARGE SUMMARY CONTINUES: ¿UNFORTUNATELY, THE PATIENT¿S HERNIA WOULD RECUR IN THE IMMEDIATE POST-OPERATIVE PERIOD, AND HE WOULD REQUIRE A TAKE BACK TO THE OPERATING ROOM FOR A SECOND REPAIR WITH MESH. ON 8/14 HE WAS DISCHARGED IN STABLE CONDITION. HE WILL COMPLETE A TOTAL OF 5 DAYS OF AUGMENTA FOR WOUND ERYTHEMA.¿ RECORDS BETWEEN ON (B)(6) 2014 AND ON (B)(6) 2018 WERE NOT PROVIDED. HISTORY AND PHYSICAL RECORDS DATED ON (B)(6) 2018 STATE THE PATIENT ¿WITH [PRIOR MEDICAL HISTORY] OF LIVER TXP C/B INCISIONAL HERNIA THAT HAS REQUIRED THREE PREVIOUS OPERATIONS. THIS HERNIA HAS SINCE RECURRED, AND HE PRESENTS FOR DEFINITIVE REPAIR.¿ PAST SURGICAL HISTORY STATES HERNIA REPAIRS WERE PERFORMED ON (B)(6) 2014, ON (B)(6) 2014, AND IN 2017 WITH A NOTE STATING ¿FAILED INCISIONAL HERNIA REPAIR [WITH] MESH, INCISION FROM LIVER TXP¿. THERE ARE NO MEDICAL RECORDS DETAILING A HERNIA REPAIR IN 2017. OPERATIVE RECORDS DATED ON (B)(6) 2018 STATE THE PATIENT UNDERWENT: ¿1. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE RIGHT 2. MYOFASCIAL ADVANCEMENT FLAP OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE ON THE LEFT 3. REPAIR OF RECURRENT, INCARCERATED INCISIONAL HERNIA (15X30 CM) 4. IMPLANTATION OF MESH (50X50 ETHICON PROLENE SOFT MESH) 5. TRANSVERSUS ABDOMINIS PLANE BLOCK.¿ POSTOPERATIVE DIAGNOSIS STATES: ¿MULTIPLY [SIC] RECURRENT INCISIONAL HERNIA WITH INCARCERATION.¿ OPERATIVE FINDINGS FROM ON (B)(6) 2018 STATE: ¿LARGE, RECURRENT INCISIONAL HERNIA INVOLVING HIS ENTIRE LIVER TRANSPLANT INCISION WITH SIGNIFICANT OMENTAL SCARRING TO TOLD [SIC] MESH.¿ ¿THE PATIENT HAD A 15X30 CM DEFECT WITH SIGNIFICANT AMOUNT OF ADHESIONS. AFTER COMPLETING THE ADHESIOLYSIS GIVEN THE SIZE OF THE DEFECT AND HIS COMPLEX SURGICAL HISTORY WE ELECTED TO PROCEED WITH A INCISIONAL HERNIA REPAIR AND ABDOMINAL WALL RECONSTRUCTION. HE HAD MULTIPLE DENSE ADHESIONS OF OMENTUM TO HIS ABDOMINAL WALL AND OLD MESH. HE ALSO HAD ADHESIONS OF HIS TRANSVERSE COLON TO THE ANTERIOR ABDOMINAL WALL. AFTER FREEING UP THE ADHESIONS, WE REMOVED HIS OLD MESH , AND THEN PROCEEDED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS TO RECONSTRUCT THE ABDOMEN AND ALLOW FOR ADEQUATE MESH OVERLAP.¿ ON (B)(6) 2018 OPERATIVE REPORT PROVIDES THE FOLLOWING INDICATION: ¿[THE PATIENT] IS A 64 Y.O. MALE WHO WAS REFERRED FOR RECURRENT HERNIA. HE HAD UNDERGONE A LIVER TRANSPLANT SEVERAL YEARS AGO, AND DEVELOPED A HERNIA [A]LONG HIS INCISION. HE HAS HAD IT REPAIRED SEVERAL TIMES IN THE PAST, AND PRESENTS WITH ANOTHER SYMPTOMATIC RECURRENCE. THIS IS CAUSING HIM DISCOMFORT, ESPECIALLY WITH SIGNIFICANT ACTIVITY. GIVEN THE PATIENTS SURGICAL HISTORY, THE SIZE AND LOCATION OF THE DEFECT IT WAS FELT HE WOULD BE BEST SERVED WITH AN OPEN REPAIR.¿ ON (B)(6) 2018 OPERATIVE REPORT STATES: ¿WE BEGAN BY REOPENING HIS MIDLINE INCISION AND DISSECTING DOWN THROUGH THE SUBCUTANEOUS TISSUE UNTIL WE ENCOUNTER THE REMAINDER OF THE LINEA ALBA. THIS WAS THEN OPEN SHARPLY TO ENTER THE ABDOMINAL CAVITY. WE ENCOUNTERED A SIGNIFICANT AMOUNT OF ADHESIONS OF OMENTUM AND COLON TO THE ANTERIOR ABDOMINAL WALL AND OLD MESH. THESE WERE ALL TAKEN DOWN WITH SHARP DISSECTION AND MINIMAL ELECTROCAUTERY. DURING ADHESIOLYSIS WE ENCOUNTERED NO BOWEL INJURIES. TOTAL ADHESIOLYSIS TIME WAS GREATER THAN 1 HOUR. AFTER WE WERE SATISFIED WITH ALL OF THE BOWEL WORK WE PLACED A COUNTABLE TOWEL INTO THE ABDOMEN TO PROTECT THE VISCERA AND TURNED OUR ATTENTION TO REPAIRING THE HERNIA DEFECT. WE MEASURED THE HERNIA DEFECT TO BE 15X30 CM. WE THEN ATTEMPTED TO BRING THE ABDOMINAL WALL MUSCLES BACK TOGETHER AND IT WAS UNDER SIGNIFICANT TENSION. GIVEN THE LARGE SIZE OF THE HERNIA DEFECT, ITS LOCATION AND HIS PREVIOUS SURGICAL HISTORY IN ADDITION THE INCREASED ABDOMINAL TENSION WE ELECTED TO PROCEED WITH BILATERAL MYOFASCIAL ADVANCEMENT FLAPS OF THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE IN ORDER TO ALLOW FOR ADEQUATE MESH OVERLAP AND MIDLINE MEDIALIZATION OF THE RECTUS MUSCLES.¿ ON (B)(6) 2018 OPERATIVE REPORT CONTINUES: ¿WE BEGAN ON THE PATIENT'S RIGHT SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS. THIS WAS A INCREDIBLY DIFFICULT DISSECTION GIVEN THE PATIENTS SURGICAL HISTORY, PREVIOUS REPAIRS AND PREVIOUS MESH. ULTIMATELY WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY.¿ ON (B)(6) 2018, OPERATIVE REPORT STATES: ¿WE WERE LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH WHERE HIS PREVIOUS INCISION AND MESH HAD BEEN PLACED IN THE SUBCOSTAL REGION. BY SEPARATING THE FASCIA IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. HOWEVER, IT WAS STILL FELT THERE WAS INCREASED TENSION ON THE MIDLINE SO WE TURNED OUR ATTENTION TO PERFORMING A SIMILAR RELEASE ON THE OPPOSITE SIDE. AFTER PLACING KOCHER CLAMPS ON THE MEDIAL EDGE OF THE RECTUS MUSCLE, WE BEGAN BY INCISING THE POSTERIOR RECTUS SHEATH JUST LATERAL TO THE LINEA-ALBA. THIS PLANE WAS CONTINUED OUT LATERAL TOWARDS THE LINEA-SEMILUMINARIS AND THE NEUROVASCULAR PERFORATORS TO THE RECTUS MUSCLE WHICH WERE IDENTIFIED AND PRESERVED. WE THEN INCISED THE POSTERIOR SHEATH AND DIVIDED THE TRANSVERSUS ABDOMINIS MUSCLE TO ENTER INTO AN EXTRAPERITONEAL PLANE. AGAIN, THIS WAS NECESSARY TO ALLOW FOR ADEQUATE MIDLINE MEDIALIZATION OF THE RECTUS MUSCLE AND ADEQUATE MESH OVERLAP. THIS WAS CONTINUED OUT LATERALLY TOWARDS THE RETROPERITONEUM, UNDER THE COSTAL MARGIN AND DOWN TOWARDS THE PELVIS.¿ ON (B)(6) 2018 OPERATIVE REPORT CONTINUES: ¿WE WERE AGAIN LEFT WITH A MODERATE SIZED HOLE IN THE POSTERIOR SHEATH FROM HIS PREVIOUS MESH REPAIR AND SUBCOSTAL INCISION. THIS WAS A INCREDIBLY DIFFICULT DISSECTION. ULTIMATELY WE WERE ABLE TO COMPLETE THE DISSECTION OUT LATERALLY. BY SEPARATING THE FASCIA IT ALLOWED US TO ACHIEVE 15 X 15 CM OF ADVANCEMENT FROM THIS SIDE. TO COMPLETE THE PELVIC DISSECTION, WE WERE ABLE PASS A FINGER THROUGH THE SPACE OF RETZIUS, ALONG THE PUBIC SYMPHYSIS TO CONNECT THE PRE-PERITONEAL DISSECTION OF THE LEFT AND RIGHT SIDE. THE BLADDER COMPLEX WAS THEN FREED FROM THE OVERLYING ABDOMINAL WALL PRESERVING THE LINEA ALBA INTACT. THIS EXPOSED BELOW THE PUBIC SYMPHYSIS TO ALLOW FOR ADEQUATE INFERIOR MESH OVERLAP. FOR THE CRANIAL DISSECTION THE FALCIFORM LIGAMENT HAD BEEN PREVIOUSLY REMOVED, BUT WE WERE ABLE TO UTILIZE THE PRE-PERITONEAL FAT PAD TO ESTABLISH A PLANE UNDER THE XIPHOID BONE. THIS WAS THEN CONNECTED WITH THE LEFT AND RIGHT PRE-PERITONEAL DISSECTION THAT HAD BEEN PERFORMED BY DIVIDING THE POSTERIOR RECTUS SHEATH AND TRANSVERSUS ABDOMINIS MUSCLE. THIS WAS THEN CONTINUED CRANIALLY BY FREEING THE PERITONEUM OFF THE DIAPHRAGM TO ALLOW FOR ADEQUATE CRANIAL OVERLAP.¿ ON (B)(6) 2018 OPERATIVE REPORT STATES: ¿ONCE WE WERE SATISFIED WITH THE AREA OF DISSECTION, WE THEN TURNED OUR ATTENTION TO CLOSING THE POSTERIOR RECTUS SHEATH IN THE MIDLINE. THERE WERE A FEW HOLES IN THE PERITONEUM AND POSTERIOR SHEATH. THE HOLES WERE CLOSED WITH 2-0 & 3-0 VICRYL SUTURES. WE THEN PERFORMED A SPONGE, INSTRUMENT, NEEDLE COUNT THAT WAS CORRECT. THE POSTERIOR RECTUS SHEATH WAS THEN CLOSED IN THE MIDLINE PRIMARILY AFTER REMOVING THE COUNTABLE TOWEL. WE THEN PERFORMED A TRANSVERSUS ABDOMINIS PLANE BLOCK BY INJECTION 60CC OF 0.25% MARCAINE DIVIDED BETWEEN THE LEFT AND RIGHT TRANSVERSUS ABDOMINIS MUSCLE UNDER DIRECT VISUALIZATION. WE THEN PLACED A 50X50CM PIECE OF ETHICON PROLENE SOFT MESH PLACED IN A SQUARE FASHION. THIS NICELY COVERED FROM THE BELOW THE PUBIC SYMPHYSIS TO THE XIPHOID BONE. THERE LATERAL EDGES OF THE MESH WERE TRIMMED TO ALLOW THE MESH TO LAY FLAT. WE ELECTED TO CLOSE THE LATERAL PORTIONS OF HIS INCISIONAL DEFECT WITH INTERRUPTED FIGURE OF 8 #1 PDS SUTURES IN A TRANSVERSE FASHION. WE THEN PLACED TWO 19 FRENCH BLAKE DRAINS TO DRAIN THE SPACE ABOVE THE MESH. THE ANTERIOR FASCIA WAS THEN CLOSED WITH RUNNING #1 PDS SUTURES. WE CLOSED THE SUBCUTANEOUS TISSUE WITH INTERRUPTED 3-0 VICRYL SUTURE. SKIN WAS CLOSED WITH 4-0 MONOCRYL AND EXOFIN WAS APPLIED. A DRY STERILE DRESSING AS THEN PLACED OVER THE WOUND.¿ THE RECORDS INDICATE A NON-GORE DEVICE WAS IMPLANTED DURING THE PROCEDURE. 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.
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 BETWEEN (B)(6) 2010 AND (B)(6) 2013 WERE NOT PROVIDED. (B)(6) 2013: (B)(6).. RADIOLOGY ¿ ABDOMINAL MRI. FINDINGS: THERE IS A SMALL VENTRAL ABDOMINAL HERNIA THAT CONTAINS SOME ASCITES. (B)(6) 2014: (B)(6). NURSING OPERATIVE RECORD. IMPLANT RECORD. MATERIAL NAME: DUAL MESH 15 X 19 X 1 LF. MANUFACTURER: WL GORE & ASSOCIATES. QUANTITY 1. CATALOG #: 1DLMC04. BODY SITE: ABDOMEN, LUQ [LEFT UPPER QUADRANT]. SERIAL #: (B)(6). LOT #: 12553724. EXPIRATION DATE: 03/31/2019. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC04/12553724) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2014: (B)(6). RADIOLOGY ¿ CT ABDOMINAL/PELVIC. HISTORY: STATUS POST REPAIR OF SYMPTOMATIC INCISIONAL HERNIA. POSTOPERATIVE COURSE HAS BEEN COMPLICATED BY HEMATOMA AND GAS. IMPRESSION: POSTSURGICAL CHANGES OF LEFT INCISIONAL HERNIA REPAIR WITH MESH AT THE SUPERIOR ASPECT OF THE VENTRAL WALL DEFECT. THERE IS A PERSISTENT INCISIONAL HERNIA AT THE INFERIOR ASPECT WHICH CONTAINS NONOBSTRUCTED LOOPS OF SMALL BOWEL. EXTRALUMINAL GAS WITHIN THIS HERNIA SAC IS LIKELY POSTSURGICAL IN NATURE. NO ASSOCIATED SMALL BOWEL OBSTRUCTION. FAT CONTAINING RIGHT INGUINAL HERNIA. (B)(6) 2014: (B)(6). OPERATIVE REPORT. FIRST SURGICAL ASSISTANT: (B)(6). ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA. PREOPERATIVE DIAGNOSIS: IMMEDIATE RECURRENCE OF INCISIONAL VENTRAL HERNIA REPAIRED WITH MESH. POSTOPERATIVE DIAGNOSIS: IMMEDIATE RECURRENCE OF INCISIONAL VENTRAL HERNIA REPAIRED WITH MESH. OPERATION: REPAIR OF EARLY RECURRENT INCISIONAL VENTRAL HERNIA THAT HAD BEEN REPAIRED WITH MESH. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 60-YEAR-OLD MALE WHO IS NOW ABOUT FIVE DAYS STATUS POST REPAIR OF AN INCISIONAL VENTRAL HERNIA WITH DUALMESH. ON POSTOPERATIVE DAY TWO, HE DEVELOPED SWELLING UNDERNEATH HIS INCISION. THIS WAS EVALUATED WITH A CT SCAN WHICH DEMONSTRATED A FAILURE OF THE MESH AND RECURRENCE OF THE HERNIA. HE HAS NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTION. HE IS BROUGHT TO THE OPERATING ROOM AT THIS TIME FOR URGENT REPAIR OF THIS RECURRENT INCISIONAL VENTRAL HERNIA. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS IDENTIFIED, BROUGHT TO THE OPERATING ROOM AND PLACED SUPINE ON THE OPERATING TABLE AND STERILELY PREPPED AND DRAPED. HE HAD LOWER EXTREMITY COMPRESSION BOOTS ON FOR THE PROCEDURE. ALL PRESSURE POINTS WERE WELL PADDED. HE HAD EXTERNAL WARMING BLANKETS ON FOR THE PROCEDURE. HE RECEIVED 2 GRAMS OF ANCEF FOR PREOPERATIVE ANTIBIOTIC COVERAGE AND WILL RECEIVE NO ADDITIONAL DOSES. A TIMEOUT WAS COMPLETED. THE SKIN WAS STERILELY PREPPED AND DRAPED AND HE WAS STERILELY PREPPED AND DRAPED. HIS INCISION WAS REOPENED. WE IDENTIFIED THAT THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN. THE BOWEL WAS ALL VIABLE AND WAS NON-OBSTRUCTED. THE BOWEL WAS THEN RETURNED TO THE ABDOMEN. THE SAME MESH GRAFT WAS USED AND IT WAS SEWN CIRCUMFERENTIALLY TO THE FASCIA USING A SERIES OF INTERRUPTED FIGURE-OF-EIGHT 0 PROLENE SUTURE. THERE WAS NO TENSION ON THE MESH. THE SUBCUTANEOUS TISSUE WAS IRRIGATED AND REAPPROXIMATED WITH 3-0 VICRYL AND THE SKIN WITH 4-0 MONOCRYL SUBCUTICULAR SUTURES. DERMABOND WAS THEN APPLIED. HE TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ PRESENT STATEMENT: I WAS PRESENT AND SCRUBBED THROUGHOUT THE ENTIRE SURGICAL PROCEDURE, EXCEPT FOR THE FINAL STITCHES OF SKIN CLOSURE, DURING WHICH TIME I WAS IMMEDIATELY AVAILABLE. 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.
(B)(4). ¿THE GORE DUALMESH CONTRACTED¿; ¿SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PHYSICAL DISABILITY, AND PAST, PRESENT, AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE, AND PHARMACEUTICAL EXPENSES, AND OTHER RELATED DAMAGES¿; ¿[THE PATIENT] HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, ECONOMIC LOSS, AND OTHER DAMAGES INCLUDING, BUT NOT LIMITED TO, COST OF MEDICAL CARE, REHABILITATION, LOST INCOME AND EARNING CAPACITY, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, DIMINISHED QUALITY OF LIFE, AND PAIN AND SUFFERING...¿ (B)(6). 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.¿
IT WAS REPORTED TO GORE THAT A PATIENT ALLEGES TO HAVE UNDERWENT HERNIA REPAIR ON (B)(6) 2014 USING A GORE DUALMESH® BIOMATERIAL. IT WAS REPORTED THAT ¿ON OR ABOUT (B)(6) 2014, [THE PATIENT] DEVELOPED SWELLING UNDERNEATH HIS INCISION, AND THE CT SCAN REVEALED THAT THE GORE DUALMESH HAD FAILED, CAUSING A RECURRENCE OF THE HERNIA AND REQUIRING ANOTHER SURGERY. THE OPERATIVE REPORT NOTES THAT ¿THE MESH HAD FAILED ALONG THE INFERIOR PORTION OF THE REPAIR AND BOWEL WAS INCARCERATED UNDERNEATH THE SKIN.¿¿ THE COMPLAINT STATES: ¿ON OR ABOUT (B)(6) 2018, [THE PATIENT] UNDERWENT REMOVAL OF THE FAILED DUALMESH AT (B)(6) HOSPITAL. THE OPERATIVE FINDINGS DESCRIBE A LARGE, RECURRENT INCISIONAL HERNIA ALONG THE ENTIRE INCISION WITH SIGNIFICANT OMENTAL SCARRING TO THE GORE DUALMESH. THE GORE DUALMESH CONTRACTED AND CAUSED DENSE ADHESIONS, SCARRING, AND A LARGE RECURRENT INCISIONAL HERNIA WITH INCARCERATION. THE OPERATIVE REPORT ALSO NOTES ¿A SIGNIFICANT AMOUNT OF ADHESIONS OF OMENTUM AND COLON TO THE ANTERIOR ABDOMINAL WALL AND OLD MESH.¿ THE SYMPTOMATIC RECURRENCE AND FAILURE OF THE MESH WERE NOTED AS THE LIKELY CAUSE OF [THE PATIENT'S] PAIN.¿ THE COMPLAINT CONTINUES: ¿DUE TO THE LARGE SIZE OF THE RECURRENT HERNIA DEFECT, ITS LOCATION, HIS PRIOR SURGICAL HISTORY, AND THE INCREASED ABDOMINAL TENSION AS A RESULT OF THE GORE DUALMESH FAILURE, [THE PATIENT] WAS FORCED TO UNDERGO A DIFFICULT SURGICAL PROCEDURE RESULTING IN BILATERAL MYOFASCIAL ADVANCEMENT FLAPS AND AN ADDITION [SIC] HERNIA MESH IMPLANT.¿ IT WAS REPORTED THAT ¿...[THE PATIENT] SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PHYSICAL DISABILITY, AND PAST, PRESENT, AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE, AND PHARMACEUTICAL EXPENSES, AND OTHER RELATED DAMAGES.¿ THE COMPLAINT ALSO STATES: "[THE PATIENT] HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, ECONOMIC LOSS, AND OTHER DAMAGES INCLUDING, BUT NOT LIMITED TO, COST OF MEDICAL CARE, REHABILITATION, LOST INCOME AND EARNING CAPACITY, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, DIMINISHED QUALITY OF LIFE, AND PAIN AND SUFFERING...¿ ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 932733 | GORE DUALMESH BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC04 | 12553724 | 00733132600977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |