GORE DUALMESH BIOMATERIAL
Report
- Report Number
- 2017233-2019-00290
- Event Type
- Injury
- Date Received
- April 30, 2019
- Date of Event
- August 17, 2006
- Report Date
- July 12, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600960
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 2007: (B)(6). IMPLANT RECORD. IMPLANT STICKER. GORE® DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER: (B)(4). LOT BATCH CODE: 04406466. W.L. GORE & ASSOCIATES. SITE: ABDOMEN. SIZE: 15 CM X 19 CM X 1.0 MM. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC04/04406466) WAS IMPLANTED DURING THE PROCEDURE. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
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: [MISSING RECORDS: RECORDS FOR HERNIA REPAIR WITH MESH DURING CHOLECYSTECTOMY IN CANONSBURG BY DR. (B)(6) WERE NOT PROVIDED.] RECORDS PRIOR TO (B)(6) 2006 WERE NOT PROVIDED. (B)(6) 2006: THE (B)(6) HOSPITAL. (B)(6) MD. OPERATIVE REPORT. PREOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA WITH DENSE ADHESIONS. OPERATION: REPAIR OF RECURRENT INCISIONAL HERNIA (VENTRAL WALL) WITH GORE-TEX PATCH DUAL MESH. ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA. INDICATIONS FOR PROCEDURE AND CONSENT: THE PATIENT IS A PLEASANT 40-YEAR-OLD FEMALE WHO HAD A HERNIA REPAIRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY IN CANONSBURG BY DR. (B)(6). SUBSEQUENTLY, THE HERNIA RECURRED. SHE WENT BACK TO HIM, HE SAID HE WOULD NOT FIX AND SUBSEQUENTLY CAME TO ME TO BE EVALUATED FOR IT. SHE WAS SUBSEQUENTLY CONSENTED FOR REPAIR. I DID EXPLAIN THE PROCEDURE, RISKS, ALTERNATIVES AND BENEFITS, AND SHE DECIDED TO PROCEED. FINDINGS: MOST IMPRESSIVE WAS EXTENSIVE ADHESIONS FROM THE TYPE OF MESH THAT WAS USED OF OMENTUM TO THE MESH AS WELL AS SMALL BOWEL. PROCEDURE: ¿WITH THE PATIENT IN THE SUPINE POSITION UNDER GENERAL ANESTHESIA, SHE WAS DRAPED AND PREPPED IN THE USUAL STERILE FASHION. THE OLD INCISION WAS THEN OPENED, CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE TO THE HERNIA SAC. WE THEN GOT INTO THE HERNIA SAC, WHICH AS MENTIONED WAS A SIGNIFICANT SAC, INCLUDING THE MESH, WHICH WAS STRONGLY ADHERENT TO THE UNDERLYING OMENTUM AND BOWEL. FROM HERE ON IN, IT WAS JUST LYSIS OF ADHESIONS FROM THE FASCIA CIRCUMFERENTIALLY ALL THE WAY AROUND THE HERNIA. WE DID REMOVE A FAIR PORTION OF THE OLD MESH PLACED AT CANONSBURG, HOWEVER, SOME OF IT WAS LEFT WHERE IT WAS STILL INTACT SUPERIORLY AND ON THE RIGHT SIDE. AT THIS POINT, WE GOT A 10 BY 15-CM DUAL MESH GORE-TEX GRAFT PUT IN WITH THE SMOOTH SIDE DOWN AND SET IN WITH A RUNNING #1 PROLENE SUTURE LIGATURE IN A MATTRESS FASHION. WE DID IT WITH A SPONGE IN UNTIL THERE WAS JUST A LITTLE OPENING A COUPLE CENTIMETERS, APPROXIMATELY 4, REMOVED THE MESH, CHECKED THE REPAIR ALL THE WAY AROUND, IT WAS GOOD AND COMPLETED OUR CLOSURE. WE THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, CLOSED THE SUBCUTANEOUS FASCIA WITH A #1 MAXON SUTURE LIGATURE, IT WAS ANESTHETIZED WITH 0.25% MARCAINE AND THE SKIN WAS REAPPROXIMATED WITH THE SKIN STAPLER. SPONGE AND NEEDLE COUNTS WERE CORRECT. ESTIMATED BLOOD LOSS WAS MAYBE 50 TO 75 CC AT MAX. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ (B)(6) 2006: (B)(6) HOSPITAL. IMPLANT RECORD. IMPLANT STICKER. GORE DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMC03. LOT BATCH CODE: 04117042. W.L. GORE & ASSOCIATES. SITE: ABDOMEN. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC03/04117042) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2006: (B)(6) HOSPITAL. (B)(6) MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: RECURRENT INCISIONAL (VENTRAL WALL) HERNIA. OPERATION: RESUTURE OF MESH TO FASCIA. ANESTHESIA: GENERAL. INDICATIONS/CONSENT: THE PATIENT IS A VERY PLEASANT 41-YEAR-OLD FEMALE WHO SOMETIME AGO HAD A HERNIA REPAIRED BY DR. (B)(6) AT CANONSBURG. IT CAME BACK. HE SAID HE COULD NOT OR WOULD NOT FIX IT AGAIN. SHE SUBSEQUENTLY CAME TO MY OFFICE AND WE REPAIRED IT FOUR MONTH AGO AND DID FINE. I HAD SEEN HER POSTOPERATIVELY AND WAS DOING FINE. ALL THE SUDDEN SUBSEQUENTLY IT HAS RECURRED PRETTY MUCH ON THE RIGHT LATERAL SIDE. SHE HAS A BULGE AND IS HAVING DISCOMFORT, SUBSEQUENTLY CONSENTED FOR RE-REPAIR OF THE HERNIA. AFTER EXPLAINING THE PROCEDURE, RISKS, ALTERNATIVES, BENEFITS, SHE DECIDED TO PROCEED. FINDINGS MOST SIGNIFICANT WAS PROBABLY ON THE RIGHT SIDE OF THE DUALMESH GORE-TEX GRAFT ABOUT HALF OF IT THE SUTURES HAD PULLED AWAY FROM THE FASCIA AND THERE WERE ALSO A FAIR AMOUNT OF ADHESIONS TO THE FASCIA OF OMENTUM AND SMALL BOWEL UNDERNEATH TO THE GORE-TEX PATCH EVEN THOUGH THE SMOOTH SIDE WAS DOWN. PROCEDURE: ¿THE PATIENT WAS IN THE SUPINE POSITION UNDER GENERAL ANESTHESIA SHE WAS DRAPED AND PREPPED IN THE USUAL STERILE FASHION. THE OLD INCISION WAS OPENED, CARRIED DOWN TO THE FASCIA INTO THE HERNIA. WE SUBSEQUENTLY DISSECTED THE FASCIA FREE INFERIORLY EASILY. WE THEN DISSECTED THE ADHESIONS OFF THE TOP OF THE DUALMESH GORE-TEX PATCH. ONCE THIS WAS FREE WE DISSECTED THE UNDER SURFACE OF A PIECE OF SMALL BOWEL SEVERAL CENTIMETERS. WITH THIS DONE WE THEN PUT OUR CORNER STITCHES IN AND WHAT WE DID DIFFERENT THIS TIME WAS WE USED INTERRUPTED STITCHES TO #1 PROLENE SUTURE LIGATURE. WITH THAT SEWN IN, EACH ONE TIED, WE THEN PLACED A SMALL SPONGE UNDERNEATH, PLACED ALL OF OUR OTHER STITCHES IN, ONCE THEY WERE ALL IN AND PUT SNAPS ON THEM WE SUBSEQUENTLY REMOVED THE SPONGE AND THEN ONE BY ONE TIED THEM FROM A CRADIAD TO CAUDAL DIRECTION MAKING SURE NOTHING GOT IN BETWEEN. WE THEN IRRIGATED, EVERYTHING NOTED TO BE HEMOSTATIC SHE WAS ANESTHETIZED WITH A ¼% OF MARCAINE. SUBCUTANEOUS FASCIA CLOSED WITH A RUNNING #1 MAXON SUTURE LIGATURE AND THE SKIN WAS CLOSED WITH A SKIN STAPLER. SPONGE, NEEDLE COUNTS WERE CORRECT. THERE WAS NO SIGNIFICANT BLOOD LOSS. THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.¿ THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. (B)(6) 2007: (B)(6) HOSPITAL. (B)(6). OPERATIVE REPORT. PREOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOP DIAGNOSIS: SAME, ALONG WITH DENSE ADHESIONS. OPERATION: REPAIR OF HERNIA WITH LYSIS OF VERY DENSE ADHESIONS AND REMOVAL OF OLD MESH. ANESTHESIA: GENERAL. INDICATIONS/CONSENT: PATIENT IS A VERY PLEASANT 41 YEAR-OLD FEMALE, THE WHOLE EVENT STARTED YEARS AGO WITH DR. (B)(6) WHEN SHE HAD A HERNIA REPAIR, DID HAVE THEM [ILLEGIBLE]. WAS RE-DONE HERE TWICE ACTUALLY AND IS BACK AGAIN AND SHE IS HAVING PAIN AND SYMPTOMS AND SUBSEQUENTLY CONSENTED FOR REPAIR, AFTER BEING EXPLAINED THE PROCEDURE RISKS, ALTERNATIVES AND BENEFITS. FINDINGS: MOST SIGNIFICANT WERE VERY DENSE ADHESIONS AND THREE HERNIAS DESCRIBED ON THE CT. PROCEDURE: ¿WITH THE PATIENT IN THE SUPINE POSITION AND UNDER GENERAL ANESTHESIA, SHE WAS DRAPED AND PREPPED IN THE USUAL STERILE FASHION. BEGAN BY OPENING THE OLD EXCISION AND ACTUALLY EXTENDING IT CRANIAD AND CAUDALLY SLIGHTLY GREATER, THEN DISSECTING DOWN INTO THE SUBCUTANEOUS TISSUE DIRECTLY TO THE GORE-TEX PATCH. ONCE WE HAD THAT, WE THEN COULD IDENTIFY OUR HERNIAS AND WE GOT INTO THE PERITONEAL CAVITY AND THEN JUST CONTINUED CIRCUMFERENTIALLY GOING AROUND AND FREEING UP THE FASCIA COMPLETELY AND REMOVING THE OLD GORE-TEX. ACTUALLY THERE STILL IS MESH THOUGH FROM DR. (B)(6) THAT IS REALLY ADHERENT IN THERE SO I DIDN¿T REMOVE IT. AT THIS POINT WITH EVERYTHING FREED AND REMOVED, AND HEMOSTATIC, WE BROUGHT IN A PIECE OF DUEL [SIC] MESH GORE-TEX GRAFT, CUT IT APPROPRIATELY SO IT WOULD OVERLAP FOR 3 OR 4 CENTIMETERS AT LEAST WITH THE FASCIA AND SUTURED IT IN WITH A #1 PROLENE SUTURE LIGATURE USING MATTRESS SUTURES AND JUST PRIOR TO COMPLETING IT, HAVING A FINGER GO DOWN, FEELING ALL AROUND MAKING SURE IT WAS LYING FLAT, WHICH IT WAS AND SMOOTH SIDE, OF COURSE, WAS DOWN, WITH ROUGH SIDE UP AND, IN ADDITION, NO BOWEL IN BETWEEN ANY SUTURES WHICH THERE WEREN¿T AND IT WAS SUBSEQUENTLY COMPLETED. IT WAS THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, A #19 BLAKE DRAIN WAS BROUGHT THROUGH A SEPARATE STAB WOUND, SECURED WITH 2-0 SILK SUTURE LIGATURE. FASCIA WAS THEN CLOSED WITH RUNNING #1 MAXON SUTURE LIGATURE AND IT WAS ANESTHETIZED WITH 0.25% MARCAINE. SKIN CLOSED WITH A SKIN STAPLER. SPONGE AND NEEDLE COUNTS WERE CORRECT. NO SIGNIFICANT BLOOD LOSS. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WERE NOT PROVIDED. [MISSING RECORDS: RECORDS FOR THE CT WERE NOT PROVIDED.] [MISSING RECORDS: RECORDS FOR THE (B)(6) 2008, (B)(6) 2008, (B)(6) 2009,(B)(6) 2010 SURGERIES WERE NOT PROVIDED.] 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.
H6: UPDATED HEALTH EFFECT- CLINICAL CODE. H6: UPDATED INVESTIGATION FINDINGS. H6: UPDATED INVESTIGATION CONCLUSIONS. HEALTH IMPACT CODES: F26: NO HEALTH CONSEQUENCES OR IMPACT. 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, 2240) 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 MARCH 17, 2006 THROUGH JULY 16, 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIALS. PATIENT INFORMATION: MEDICAL HISTORY: MORBID OBESITY, ON (B)(6) 10: 304 LBS., BMI 55.6, SMOKING, ON (B)(6) 2008: TOBACCO ADDICTION AND ABUSE, ON (B)(6) 2009: CHRONIC TOBACCO USE, ON (B)(6) 2006: RECURRENT INCISIONAL HERNIA WITH DENSE ADHESIONS, ON (B)(6) 2006: RECURRENT INCISIONAL (VENTRAL WALL) HERNIA, ON (B)(6) 2007: RECURRENT INCISIONAL HERNIA, ON (B)(6) 2008: CHRONIC INCARCERATED INCISIONAL HERNIA, ON (B)(6) 2008: SYMPTOMATIC RECURRENT ABDOMINAL WALL (INCISIONAL) HERNIA, DIABETES MELLITUS, ON (B)(6) 2009: INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA, ON (B)(6) 2010: RECURRENT INCISIONAL HERNIA. SURGICAL PROCEDURES: ON (B)(6) : HERNIA REPAIR WITH MESH, LAPAROSCOPIC CHOLECYSTECTOMY. ON (B)(6) 2006: REPAIR OF RECURRENT INCISIONAL HERNIA (VENTRAL WALL) WITH GORE-TEX PATCH DUAL MESH. IMPLANT #1: GORE® DUALMESH® BIOMATERIAL. ON (B)(6) 2006: RESUTURE OF MESH TO FASCIA. ON (B)(6) 2007: REPAIR OF HERNIA WITH LYSIS OF VERY DENSE ADHESIONS AND REMOVAL OF OLD MESH [IMPLANT #1]. IMPLANT #2: GORE® DUALMESH® BIOMATERIAL. ON (B)(6) 2008: INCISIONAL HERNIORRHAPHY. ON (B)(6) 2008: REPAIR OF HERNIA, LYSIS OF ADHESIONS. IMPLANT: PROCEED VENTRAL PATCH. ON (B)(6) 2009: REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA, LYSIS OF ADHESIONS. IMPLANT: COMPOSIX.. ON (B)(6) 2010: RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. IMPLANT: PROCEED. IMPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 2006: CT ABDOMEN. ¿IMPRESSION: VENTRAL HERNIA MIDLINE. SMALL BOWEL SEGMENTS PRESENT WITHIN THE HERNIA. HERNIA HANGS IN A PENDULOUS FASHION LEFT OF MIDLINE OVER LOWER ABDOMEN, UNDER PELVIS. EVIDENCE OF PRIOR REPAIR TO ANTERIOR ABDOMINAL WALL. SMALL HIATAL HERNIA.¿ ON (B)(6) 2006: ¿HAD A HERNIA REPAIRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. SUBSEQUENTLY, THE HERNIA RECURRED. SHE WENT BACK TO HIM, HE SAID HE WOULD NOT FIX AND SUBSEQUENTLY CAME TO ME TO BE EVALUATED FOR IT. SHE WAS SUBSEQUENTLY CONSENTED FOR REPAIR. I DID EXPLAIN THE PROCEDURE, RISKS, ALTERNATIVES AND BENEFITS, AND SHE DECIDED TO PROCEED.¿ IMPLANT #1 PROCEDURE: REPAIR OF RECURRENT INCISIONAL HERNIA (VENTRAL WALL) WITH GORE-TEX PATCH DUAL MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL (1DLMC03/04117042, 10CM X 15CM X 1MM THICK, OVAL). IMPLANT #1 DATE: ON (B)(6) 2006. FINDINGS: ¿MOST IMPRESSIVE WAS EXTENSIVE ADHESIONS FROM THE TYPE OF MESH THAT WAS USED OF OMENTUM TO THE MESH AS WELL AS SMALL BOWEL.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿THE OLD INCISION WAS THEN OPENED, CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE TO THE HERNIA SAC. WE THEN GOT INTO THE HERNIA SAC, WHICH AS MENTIONED WAS A SIGNIFICANT SAC, INCLUDING THE MESH, WHICH WAS STRONGLY ADHERENT TO THE UNDERLYING OMENTUM AND BOWEL. FROM HERE ON IN, IT WAS JUST LYSIS OF ADHESIONS FROM THE FASCIA CIRCUMFERENTIALLY ALL THE WAY AROUND THE HERNIA. WE DID REMOVE A FAIR PORTION OF THE OLD MESH, HOWEVER, SOME OF IT WAS LEFT WHERE IT WAS STILL INTACT SUPERIORLY AND ON THE RIGHT SIDE.¿ IMPLANT SIZE AND FIXATION: ¿AT THIS POINT, WE GOT A 10 BY 15-CM DUAL MESH GORE-TEX GRAFT PUT IN WITH THE SMOOTH SIDE DOWN AND SET IN WITH A RUNNING #1 PROLENE SUTURE LIGATURE IN A MATTRESS FASHION. WE DID IT WITH A SPONGE IN UNTIL THERE WAS JUST A LITTLE OPENING A COUPLE CENTIMETERS, APPROXIMATELY 4, REMOVED THE MESH, CHECKED THE REPAIR ALL THE WAY AROUND, IT WAS GOOD AND COMPLETED OUR CLOSURE. WE THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, CLOSED THE SUBCUTANEOUS FASCIA WITH A #1 MAXON SUTURE LIGATURE, IT WAS ANESTHETIZED WITH 0.25% MARCAINE AND THE SKIN WAS REAPPROXIMATED WITH THE SKIN STAPLER.¿ ON (B)(6) 2006: PATHOLOGY REPORT. ¿FINAL DIAGNOSIS: CONGESTED FIBROFATTY TISSUE REMOVED FROM HERNIA SAC. MESH NOT SECTIONED. FOREIGN BODY REACTION. SPECIMEN RECEIVED: HERNIA SAC/MESH. GROSS DESCRIPTION: THE SPECIMEN CONSISTS OF MULTIPLE, LARGE SEGMENTS OF INFLAMED TISSUE AND MESH. REPRESENTATIVE SECTIONS OF TISSUE ARE TAKEN. TOTAL VOLUME IS APPROXIMATELY 70CC.¿ RELEVANT MEDICAL INFORMATION: ON (B)(6) 2006: CT ABDOMEN/PELVIS [A/P]. ¿IMPRESSION: DIASTASIS OF RECTUS ABDOMINAL MUSCULATURE WITH PRIOR HERNIA REPAIR WITH SMALL VENTRAL ABDOMINAL WALL HERNIA SUPERIOR TO UMBILICUS TO RIGHT OF MIDLINE CONTAINING LARGE BOWEL AND FAT WITHOUT EVIDENCE OF BOWEL OBSTRUCTION.¿ REVISION #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 2006: INDICATIONS: ¿SOMETIME AGO HAD A HERNIA REPAIRED. IT CAME BACK. HE SAID HE COULD NOT OR WOULD NOT FIX IT AGAIN. SHE SUBSEQUENTLY CAME TO MY OFFICE AND WE REPAIRED IT FOUR MONTH [SIC] AGO AND DID FINE. I HAD SEEN HER POSTOPERATIVELY AND WAS DOING FINE. ALL THE SUDDEN SUBSEQUENTLY IT HAS RECURRED PRETTY MUCH ON THE RIGHT LATERAL SIDE. SHE HAS A BULGE AND IS HAVING DISCOMFORT, SUBSEQUENTLY CONSENTED FOR RE-REPAIR OF THE HERNIA. AFTER EXPLAINING THE PROCEDURE, RISKS, ALTERNATIVES, BENEFITS, SHE DECIDED TO PROCEED.¿ REVISION #1 PROCEDURE: RESUTURE OF MESH TO FASCIA. REVISION #1 DATE: ON (B)(6) 2006. FINDINGS: ¿MOST SIGNIFICANT WAS PROBABLY ON THE RIGHT SIDE OF THE DUALMESH GORE-TEX GRAFT ABOUT HALF OF IT THE SUTURES HAD PULLED AWAY FROM THE FASCIA AND THERE WERE ALSO A FAIR AMOUNT OF ADHESIONS TO THE FASCIA OF OMENTUM AND SMALL BOWEL UNDERNEATH TO THE GORE-TEX PATCH EVEN THOUGH THE SMOOTH SIDE WAS DOWN.¿ PROCEDURE: ¿THE OLD INCISION WAS OPENED, CARRIED DOWN TO THE FASCIA INTO THE HERNIA. WE SUBSEQUENTLY DISSECTED THE FASCIA FREE INFERIORLY EASILY. WE THEN DISSECTED THE ADHESIONS OFF THE TOP OF THE DUALMESH GORE-TEX PATCH. ONCE THIS WAS FREE WE DISSECTED THE UNDER SURFACE OF A PIECE OF SMALL BOWEL SEVERAL CENTIMETERS. WITH THIS DONE WE THEN PUT OUR CORNER STITCHES IN AND WHAT WE DID DIFFERENT THIS TIME WAS WE USED INTERRUPTED STITCHES TO #1 PROLENE SUTURE LIGATURE. WITH THAT SEWN IN, EACH ONE TIED, WE THEN PLACED A SMALL SPONGE UNDERNEATH, PLACED ALL OF OUR OTHER STITCHES IN, ONCE THEY WERE ALL IN AND PUT SNAPS ON THEM WE SUBSEQUENTLY REMOVED THE SPONGE AND THEN ONE BY ONE TIED THEM FROM A CRADIAD [SIC] TO CAUDAL DIRECTION MAKING SURE NOTHING GOT IN BETWEEN. WE THEN IRRIGATED, EVERYTHING NOTED TO BE HEMOSTATIC SHE WAS ANESTHETIZED WITH A ¼% OF MARCAINE. SUBCUTANEOUS FASCIA CLOSED WITH A RUNNING #1 MAXON SUTURE LIGATURE AND THE SKIN WAS CLOSED WITH A SKIN STAPLER.¿ RELEVANT MEDICAL INFORMATION: ON (B)(6) 2006: CT A/P. ¿INDICATION: MULTIPLE ABDOMINAL HERNIA REPAIRS, ABDOMINAL PAIN. IMPRESSION: STATUS POST HERNIA REPAIR OF VENTRAL HERNIA FOR WHICH INFERIOR LATERAL ASPECT OF MESH, THERE ARE SMALL FAT CONTAINING HERNIAS. A 3RD FAT CONTAINING HERNIA SEEN SUPERIOR AND LATERAL TO MESH. SMALL BOWEL LOOPS APPROXIMATED MESH, HOWEVER THERE IS NO HERNIATION.¿ EXPLANT #1, IMPLANT #2 PREOPERATIVE COMPLAINTS: ON (B)(6) 2007: INDICATIONS: ¿SHE HAD A HERNIA REPAIR, DID HAVE THEM [ILLEGIBLE]. WAS RE-DONE HERE TWICE ACTUALLY AND IS BACK AGAIN AND SHE IS HAVING PAIN AND SYMPTOMS AND SUBSEQUENTLY CONSENTED FOR REPAIR.¿ EXPLANT #1, IMPLANT #2 PROCEDURE: REPAIR OF HERNIA WITH LYSIS OF VERY DENSE ADHESIONS AND REMOVAL OF OLD MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL (1DLMC04/04406466, 15CM X 19CM X 1MM THICK, OVAL). EXPLANT #1, IMPLANT #2 DATE: ON (B)(6) 2007, (HOSPITALIZATION ON (B)(6) 2007. FINDINGS: ¿MOST SIGNIFICANT WERE VERY DENSE ADHESIONS AND THREE HERNIAS DESCRIBED ON THE CT.¿ PROCEDURE: ¿BEGAN BY OPENING THE OLD EXCISION AND ACTUALLY EXTENDING IT CRANIAD AND CAUDALLY SLIGHTLY GREATER, THEN DISSECTING DOWN INTO THE SUBCUTANEOUS TISSUE DIRECTLY TO THE GORE-TEX PATCH. ONCE WE HAD THAT, WE THEN COULD IDENTIFY OUR HERNIAS AND WE GOT INTO THE PERITONEAL CAVITY AND THEN JUST CONTINUED CIRCUMFERENTIALLY GOING AROUND AND FREEING UP THE FASCIA COMPLETELY AND REMOVING THE OLD GORE-TEX. ACTUALLY THERE STILL IS MESH THOUGH THAT IS REALLY ADHERENT IN THERE SO I DIDN'T REMOVE IT. AT THIS POINT WITH EVERYTHING FREED AND REMOVED, AND HEMOSTATIC, WE BROUGHT IN A PIECE OF DUEL [SIC] MESH GORE-TEX GRAFT, CUT IT APPROPRIATELY SO IT WOULD OVERLAP FOR 3 OR 4 CENTIMETERS AT LEAST WITH THE FASCIA AND SUTURED IT IN WITH A #1 PROLENE SUTURE LIGATURE USING MATTRESS SUTURES AND JUST PRIOR TO COMPLETING IT, HAVING A FINGER GO DOWN, FEELING ALL AROUND MAKING SURE IT WAS LYING FLAT, WHICH IT WAS AND SMOOTH SIDE, OF COURSE, WAS DOWN, WITH ROUGH SIDE UP AND, IN ADDITION, NO BOWEL IN BETWEEN ANY SUTURES WHICH THERE WEREN'T AND IT WAS SUBSEQUENTLY COMPLETED. IT WAS THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, A #19 BLAKE DRAIN WAS BROUGHT THROUGH A SEPARATE STAB WOUND, SECURED WITH 2-0 SILK SUTURE LIGATURE. FASCIA WAS THEN CLOSED WITH RUNNING #1 MAXON SUTURE LIGATURE AND IT WAS ANESTHETIZED WITH 0.25% MARCAINE. SKIN CLOSED WITH A SKIN STAPLER.¿ ON (B)(6) 2007: DISCHARGE SUMMARY. ¿WOUND LOOKED GOOD. DISCHARGED HOME WITH SPECIFIC ORDERS AND INSTRUCTIONS: DO NO HEAVY LIFTING, NO STRENUOUS ACTIVITY.¿ RELEVANT MEDICAL INFORMATION: ON (B)(6) 2008: CT A/P. ¿INDICATION: SEVERE ABDOMINAL PAIN. IMPRESSION: MID ANTERIOR ABDOMINAL WALL, MIDLINE, MODERATE SIZE HERNIA MEASURING APPROXIMATELY 4.3 CM IN DEPTH, 12.9 CM IN WIDTH, INCREASED IN SIZE FROM ON (B)(6) 2006. HERNIA CONTAINS AN 8 CM WIDE AREA OF RADIOPAQUE HERNIA MESH WHICH ONLY PARTIALLY BRIDGES THE HERNIA DEFECT. MULTIPLE HERNIATIONS OF FAT ALONG RIGHT LATERAL, LEFT LATERAL, INFERIOR MARGINS OF THE MESH, THERE IS ALSO HERNIATED SMALL BOWEL LOOP AT LEFT LATERAL MARGIN OF HERNIA MESH AND A PARTIALLY HERNIATED SMALL BOWEL LOOP AT RIGHT LATERAL MARGIN OF HERNIA MESH. IN EFFECT, THESE ARE MULTIPLE SMALL HERNIAS ALONG THE MARGINS OF HERNIA MESH, THAT HAVE INCORPORATED INTO ONE MODERATE SIZE HERNIA. A SEGMENT OF TRANSVERSE COLON IS IMMEDIATELY DEEP TO THE HERNIA MESH.¿ ON (B)(6) 2008: OPERATIVE REPORT. INCISIONAL HERNIORRHAPHY. PROCEDURE: ¿THE PREVIOUS UPPER MIDLINE INCISION WAS REOPENED AND THE SKIN AND SUBCUTANEOUS TISSUE WAS INCISED. WITHIN THE SUBCU [SIC] WERE MULTIPLE POCKETS OF INCARCERATED INCISIONAL HERNIAS WITH FAT PRESENT WITHIN THEM. NO PORTIONS OF BOWEL OR SMALL BOWEL WERE SEEN. THE MULTIPLE DEFECTS WHICH NUMBERED ABOUT 5 WERE OPENED AND HERNIA SAC WAS REMOVED FROM EACH ONE AND ALL THE DEFECTS WERE CONVERTED INTO ONE LARGE DEFECT WITH A DIAMETER OF ABOUT 6 CM. THE PREVIOUSLY PLACED GORE-TEX PATCHES COULD BE SEEN ON THE LEFT EDGE OF THE DEFECT. THE EDGES APPEARED TO BE SOLID AND SECURE. THEREFORE, IT WAS FELT THAT A SUTURE COURSE WOULD BE ADEQUATE, EVEN THOUGH THERE WOULD BE A HIGH CHANCE OF A RECURRENCE DUE TO HER MASSIVE MORBID OBESITY. SUTURES OF O ETHIBOND WERE SELECTED AND THESE WERE PLACED UNDER DIRECT VISION IN A FIGURE-OF-EIGHT FASHION. THESE WERE PULLED UP TO CLOSE THE DEFECT IN A VERTICAL FASHION IN THE MIDLINE. EACH ONE WAS TIED SEPARATELY WHILE HOLDING THE OTHER ONES UP TO PREVENT ANY BOWEL FROM GETTING UP INTO THE HERNIA REPAIR. AFTER THE ETHIBOND SUTURES WERE TIED, THE SKIN WAS CLOSED WITH INTERRUPTED SUTURES OF 3-O PROLENE.¿ ON (B)(6) 2008: DISCHARGE SUMMARY. ¿POSTOPERATIVELY DID WELL, NO COMPLICATIONS. MORBID OBESITY, TOBACCO ADDICTION AND ABUSE.¿ ON (B)(6) 2008: MRI ABDOMEN. ¿IMPRESSION: MODERATE SIZED LEFT PARASAGITTAL ANTERIOR ABDOMINAL WALL HERNIA CONTAINING SMALL BOWEL AND FAT, NO EVIDENCE OF OBSTRUCTION. PRIOR POSTOPERATIVE FINDINGS WITH DIASTASIS OF RECTUS ABDOMINAL MUSCLES, PROTUBERANCE OF ABDOMINAL CONTENTS THROUGH THE DEFECT, VERY SMALL FAT CONTAINING AND ABDOMINAL WALL HERNIA COMPONENTS AT INFERIOR EXTENT OF PRIOR SURGERY, AT ABOUT UMBILICAL LEVEL.¿ REVISION #2 PREOPERATIVE COMPLAINTS: ON (B)(6) 2008: INDICATION: ¿SUBSEQUENTLY CAME BACK WITH A HERNIA AGAIN PRIMARILY ON HER LEFT SIDE, CAUSING HER A LOT OF DISCOMFORT AND DESIRED SOMETHING DONE. SHE WAS SUBSEQUENTLY CONSENTED FOR REPAIR.¿ REVISION #2 PROCEDURE: REPAIR OF HERNIA, LYSIS OF ADHESIONS. IMPLANT: PROCEED VENTRAL PATCH. REVISION #2 DATE: ON (B)(6) 2008 (HOSPITALIZATION DATES UNKNOWN). FINDINGS: ¿MOST SIGNIFICANT WAS THIS LEFT PARA-SAGITTAL HERNIA, HAD A LOT OF INCARCERATED OMENTUM AND SMALL BOWEL IN IT. SHE ALSO HAD ANOTHER TWO ABDOMINAL WALL HERNIAS IN THE MIDLINE JUST ABOVE THE UMBILICUS AND AROUND THE UMBILICUS.¿ PROCEDURE: ¿OLD INCISION WAS THEN OPEN [SIC], HEMOSTASIS CONTROLLED WITH ELECTROCAUTERY. WAS CARRIED DOWN TO THE HERNIA SAC IN THE MIDLINE, INCISION WHICH WE ENTERED, FREED UP A LOT OF OMENTUM ADHERENT TO IT, FOUND ANOTHER ONE JUST SLIGHTLY BELOW IT WHICH WE EXTENDED INTO ONE. WE THEN PALPATED THIS LEFT PARA-SAGITTAL ONE WHICH WAS BOTHERING HER AND BEGAN TO DISSECT OVER TO IT AND FREED IT UP WITHOUT ANY DIFFICULTY REMOVING THE SMALL BOWEL AND OMENTUM FROM IT. WE ACTUALLY THEN REMOVED SOME OF THE OMENTUM AS IT JUST APPEARED TO BE KIND OF THROMBOSED FROM BEING CHRONICALLY INCARCERATED. HERNIA WAS THEN CLOSED WITH A RUNNING #1 PROLENE SUTURE LIGATURE, SEWING IT TO GORE-TEX MESH. WITH THIS DONE WE THEN BROUGHT A 6 CENTIMETER PROCEED OF VENTRAL PATCH INTO THE FIELD AND THIS, I FIGURED, WOULD DECREASE THE TENSION BY PUTTING A LOWER PORTION WHERE IT WAS THE SAME LEVEL AS THIS. WE SEWED IT IN WITH #1 PROLENE MATTRESS SUTURE LIGATURES, CIRCUMFERENTIALLY AROUND IT. ONCE WE HAD THEM ALL IN, WE PARACHUTED AND SECURED THEM, FEELING UNDERNEATH TO MAKE SURE EVERYTHING FELT WELL. ONCE IT WAS IN THE STRAPS WERE THEN SUTURED TO THE ANTERIOR FASCIA, WAS THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, ANESTHETIZED WITH 0.25% MARCAINE. SUB Q FASCIA WAS THEN CLOSED WITH A RUNNING 2-0 VICRYL SUTURE LIGATURE AND THE SKIN WAS REAPPROXIMATED WITH SKIN STAPLES¿ RELEVANT MEDICAL INFORMATION: ON (B)(6) 2009: CT A/P: ¿INCISIONAL HERNIA. UMBILICAL REGION PAIN SINCE ON (B)(6) 2009, PAIN INCREASED X 2 DAYS. IMPRESSION: EXPANDING VENTRAL HERNIA CONTAINING LOOPS OF BOTH SMALL AND LARGE BOWEL. HERNIA IS AT LEVEL OF UMBILICUS AND ABOVE IT. SOME STRANDING OF FAT COULD REPRESENT THE MANIFESTATION OF STRANGULATION, NO OBSTRUCTION OR NECROSIS IS SEEN.¿ ON (B)(6) 2009: OPERATIVE REPORT. REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA. LYSIS OF ADHESIONS. IMPLANT: COMPOSIX. INDICATIONS: ¿HAS HAD MULTIPLE ABDOMINAL SURGERIES IN THE PAST. SHE WAS ADMITTED DIRECTLY FROM THE CLINIC YESTERDAY WITH AN INCARCERATED VENTRAL INCISIONAL HERNIA. THE PATIENT HAS HAD MULTIPLE RECURRENT HERNIAS WITH MESH IN THE PAST. SHE HAD A CT SCAN OF THE ABDOMEN AND PELVIS DONE WHICH SHOWED MULTIPLE SMALL HERNIA DEFECTS, AS WELL AS A LARGE HERNIA DEFECT WITH LARGE INTESTINE AND SMALL BOWEL STUCK WITHIN THE HERNIA.¿ FINDINGS: ¿DENSE ADHESIONS IN THE LEFT UPPER QUADRANT WITH SMALL PIECE OF OLD MESH WHICH WAS WELL INCORPORATED AND NOT REMOVED. NO ADHESIONS IN THE REST OF THE ABDOMINAL CAVITY. BOWEL WAS COMPLETELY VIABLE. HERNIA WAS REPAIRED WITH 27 X 22 CENTIMETER BARD COMPOSIX.¿ PROCEDURE: ¿A MIDLINE INCISION WAS MADE THROUGH THE OLD SCAR WITH A 10 BLADE SCALPEL. THIS WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUE DOWN TO THE AREA OF THE HERNIA. THE HERNIA SAC WAS THEN OPENED CIRCUMFERENTIALLY AND DISSECTED DOWN TO THE AREA OF THE FASCIA. IN THE LEFT UPPER QUADRANT, THERE WERE DENSE ADHESIONS WHICH WERE TAKEN DOWN WITH A COMBINATION OF BOVIE ELECTROCAUTERY AND SHARP DISSECTION WITH METZENBAUM SCISSORS. DURING THIS PORTION OF THE DISSECTION, IT WAS NOTED THAT THERE WERE TWO OTHER HERNIAS WITHIN THE LEFT LATERAL ABDOMINAL WALL. THE CONTENTS OF THESE APPEARED TO BE OMENTUM WHICH WAS REDUCED. ONCE THE LYSIS OF ADHESIONS WAS COMPLETE AND THE BOWEL AND OMENTUM WERE FREED FROM THE ANTERIOR ABDOMINAL WALL, THE BOWEL WAS INSPECTED. IT APPEARED TO BE COMPLETELY VIABLE. A SMALL PIECE OF MESH WAS WELL INCORPORATED WITHIN THE LEFT UPPER QUADRANT. THIS WAS LEFT IN PLACE. A 27 X 22 CENTIMETER BARD COMPOSIX MESH WAS THEN PLACED IN AN ANTIBIOTIC SOLUTION AND WAS THEN PLACED INTO THE INCISION AFTER #1 PROLENE SUTURES WERE PLACED AT THE FOUR CORNERS. IT WAS PLACED INTO THE ABDOMINAL CAVITY. IT WAS PLACED FLAT OVER TOP OF THE BOWEL. AN 11 BLADE SCALPEL WAS USED TO MAKE SKIN INCISIONS ON BOTH LATERAL SIDES OF THE ABDOMEN INFRAUMBILICALLY AND IN THE EPIGASTRIC AREA. A LAPAROSCOPIC ENDO CLOSURE DEVICE WAS USED TO GRASP THE PROLENE SUTURES UP TO THE ABDOMINAL WALL. ONCE ALL OF THESE SUTURES HAD BEEN PASSED THROUGH, THEY WERE TIED DOWN. AN ABSORBABLE TACKING DEVICE WAS THEN USED TO TACK THE MESH TO THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY. ONCE THIS WAS DONE, THE MESH WAS INSPECTED. THERE APPEARED TO BE GOOD ADHERENCE OF THE MESH TO THE ANTERIOR ABDOMINAL WALL. THE WOUND WAS IRRIGATED COPIOUSLY. THE DEEP TISSUES WERE THEN CLOSED OVER THE MESH WITH A 2-0 VICRYL SUTURE IN A RUNNING FASHION. HEMOSTASIS WAS OBTAINED WITH THE BOVIE ELECTROCAUTERY. THE SKIN WAS CLOSED WITH STAPLES.¿ ON (B)(6) 2009: DISCHARGE SUMMARY. ¿POSTOPERATIVELY DID WELL. DID HAVE SOME SEROUS DRAINAGE FROM AREA OF WOUND WHICH EVENTUALLY DECREASED BEFORE DISCHARGE.¿ ON (B)(6) 2009: CT A/P. IMPRESSION: INTERVAL DEVELOPMENT OF PROMINENT ABSCESS COLLECTION IN AREA OF PRIOR VENTRAL HERNIA ADJACENT TO MESH AND THE MAJORITY OF THE HERNIA SEEN ON PRIOR EXAM NOW IS ABSCESS COLLECTION WITH AIR BUBBLES, FLUID WITHIN IT. EXTENDS FROM POSTERIOR SURGICAL SKIN STAPLES DOWN TO LEVEL OF UMBILICUS IN ANTERIOR ABDOMINAL WALL.¿ ON (B)(6) 2010: CT A/P. ¿IMPRESSION: VENTRAL HERNIA REPAIR DOES APPEAR INTACT ALTHOUGH THERE IS BULGING OF PERITONEAL CONTENTS BETWEEN TRANSVERSELY DISPLACED RECTUS MUSCLES OF ANTERIOR ABDOMINAL WALL.¿ ON (B)(6) 2010: CT A/P. ¿IMPRESSION: PROMINENT LAXITY AND RECTUS DIASTASIS INVOLVING ANTERIOR ABDOMINAL WALL. THERE MAY BE A SMALL DISCRETE HERNIA DEFECT AT LEVEL OF UPPER ABDOMEN.¿ ON (B)(6) 2010: OPERATIVE REPORT. RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. IMPLANT: PROCEED. INDICATIONS: ¿MIDDLE-AGED OBESE FEMALE WITH ABDOMINAL PAIN AND BULGE OVER THE AREA OF HER PREVIOUS HERNIA REPAIR, AS WELL AS A CT SCAN THAT SHOWS A SMALL HERNIA AROUND HER PREVIOUS MESH. THE PATIENT HAS HAD EIGHT VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE WAS CONSENTED FOR A RECURRENT VENTRAL INCISIONAL HERNIA REPAIR.¿ FINDINGS: ¿OLD MESH FOLDED OVER AND ONE SIDE OF THE SMALL BOWEL STUCK TO IT. HERNIA ABOVE THE SUPERIOR ASPECT OF THE MESH.¿ PROCEDURE: ¿AN INCISION WAS MADE THROUGH THE OLD SCAR IN THE EPIGASTRIC AREA OF THE ABDOMEN. IT WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUE DOWN TO THE AREA OF THE OLD MESH. THE SUBCUTANEOUS TISSUE WAS THEN DISSECTED FREE FROM THE MESH ON THE ANTERIOR SURFACE OF THE MESH. THERE WAS NOTED TO BE A SMALL HERNIA AT THE SUPERIOR ASPECT OF THE MESH. THESE SUTURES WERE CUT TO EXPOSE THE UNDERSURFACE OF THE MESH. THE MESH WAS THEN REMOVED CIRCUMFERENTIALLY FROM THE INCISION. ON THE LEFT LATERAL SIDE, THE MESH HAD TURNED UNDER AND THERE WAS SMALL BOWEL STUCK TO THE UPPER PORTION OF THE MESH. THIS WAS TAKEN OFF WITH METZENBAUM SCISSORS. ONCE THE MESH WAS COMPLETELY REMOVED, ANY REMAINING PROLENE SUTURES WERE PULLED FROM THE WOUND. THE OLD MESH WAS PASSED OFF THE TABLE. ADHESIONS WERE TAKEN DOWN CIRCUMFERENTIALLY WITH METZENBAUM SCISSORS AND BLUNT DISSECTION. ONCE AN ADEQUATE AREA WAS FREED UP ON THE UNDERSURFACE OF THE FASCIA, THE HERNIA DEFECT WAS MEASURED. IT WAS NOTED TO BE 10 X 10 CENTIMETERS. A 15 X 20 CENTIMETERS LIGHT WEIGHT MESH WAS THEN PLACED INTO THE INCISION AND WAS SUTURED TO THE FASCIA WITH A U STITCHES OF #1 PROLENE. IT WAS FIRST TACKED AT THE 12 O¿CLOCK, 6 O¿CLOCK, 3 O¿CLOCK, AND 9 O¿CLOCK POSITIONS MAKING SURE THAT THE MESH WAS TAUT. SUTURES WERE THEN PLACED IN AN INTERRUPTED U STITCH BETWEEN EACH OF THESE ANCHORING SUTURES. ONCE THIS WAS ACCOMPLISHED, THE FASCIA WAS CLOSED OVER TOP OF THE MESH WITH A RUNNING 2-0 VICRYL SUTURE. THE DEEP SUBCUTANEOUS TISSUE WAS REAPPROXIMATED WITH A 3-0 VICRYL IN A RUNNING FASHION. THE SKIN WAS CLOSED WITH STAPLES.¿ ON (B)(6) 2010: PATHOLOGY REPORT NOT PROVIDED. ON (B)(6) 2010: DISCHARGE SUMMARY. ¿DISCHARGED HOME WITHOUT THE SEROMA BEING DRAINED.¿ ON (B)(6) 2010: US ABDOMEN. ¿INDICATION: INCREASING ABDOMINAL GIRTH/RECENT SURGERY. IMPRESSION: MAY BE DUE TO HEMATOMA DEEP TO INCISION LINE.¿ ON (B)(6) 2010: US GUIDED ASPIRATION SUBCUTANEOUS RIGHT LOWER QUADRANT. ¿IMPRESSION: SUCCESSFUL ASPIRATION OF A SUBCUTANEOUS COLLECTION.¿ ON (B)(6) 2010: US GUIDED DRAIN PLACEMENT RIGHT LOWER QUADRANT SUBCUTANEOUS FLUID COLLECTION. ¿INDICATION: PERSISTENT LOCULATED RIGHT LOWER QUADRANT FLUID COLLECTION FOLLOWING RECENT SURGERY.¿ ON (B)(6) 2010: HISTORY AND PHYSICAL. ¿STATUS POST HERNIA REPAIR WITH DRAIN PLACED IN ABDOMINAL CAVITY, DRAINING AROUND IT. DR. (B)(6) FELT WOUND WAS INFECTED. ADMITTED HER FOR IV ANTIBIOTICS, CHANGED DRAIN TO LARGER SIZE. IMPRESSION: PROBABLE INFECTED FLUID SUBCUTANEOUS, UNFORTUNATELY NOT IN CONTACT WITH MESH AT THIS TIME.¿ ON (B)(6) 2010: CT A/P. ¿INDICATION: SUBCUTANEOUS MID LINE COLLECTION FOLLOWING HERNIA REPAIR. IMPRESSION: 5 X 10 CM SUBCUTANEOUS ABDOMINAL WALL ABSCESS WITH INFLAMMATORY CHANGES SEEN WITHIN ADJACENT SUBCUTANEOUS FAT.¿ ON (B)(6) 2010: ¿MOST RECENT SURGERY ON (B)(6) 2010. AT THAT TIME OLD MESH WAS REMOVED AND NEW MESH PLACE. FOLLOW UP CT: MIGHT HAVE DEVELOPED SOME RIM ENHANCEMENT, LOCULATION SUGGESTIVE OF POSSIBLE ABSCESS FORMATION.¿ ON (B)(6) 2010: CT A/P. ¿IMPRESSION: THE TREATED SUBCUTANEOUS ABDOMINAL WALL ABSCESS WITH INFLAMMATORY CHANGE HAS SIGNIFICANTLY DECREASED IN SIZE.¿ ON (B)(6) 2010: CT A/P. ¿IMPRESSION: FAIRLY THICK WALLED, PERIPHERALLY LOCULATED FLUID COLLECTION WITHIN MIDLINE LOWER ABDOMEN, UPPER PELVIS MEASURING APPROXIMATELY 7 X 5.2 X 2.9 CM IN SIZE.¿ ON (B)(6) 2011: US ABDOMEN. ¿INDICATION: ABDOMINAL PAIN, RULE OUT RECURRENT HERNIA VERSUS FLUID COLLECTION. IMPRESSION: PERSISTENT MIDLINE SUBCUTANEOUS COMPLEX FLUID COLLECTION. NOT SIGNIFICANTLY CHANGED SINCE PRIOR CT.¿ CONCLUSION: #1 GORE® DUALMESH® BIOMATERIAL ¿ 04117042. 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 MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. 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.
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2006 WERE NOT PROVIDED ON (B)(6) 2006: [FACILITY NI]. (B)(6). RADIOLOGY ¿ CT ABDOMEN. INDICATION: VENTRAL HERNIA, ABDOMINAL PAIN. IMPRESSION: VENTRAL HERNIA MIDLINE. SMALL BOWEL SEGMENTS PRESENT WITHIN THE HERNIA. HERNIA HANGS IN A PENDULOUS FASHION LEFT OF MIDLINE OVER LOWER ABDOMEN, UNDER PELVIS. EVIDENCE OF PRIOR REPAIR TO ANTERIOR ABDOMINAL WALL. SMALL HIATAL HERNIA. ON (B)(6) 2006: THE (B)(6) HOSPITAL. (B)(6), MD. PATHOLOGY REPORT. ACCESSION #: (B)(4). FINAL DIAGNOSIS: CONGESTED FIBROFATTY TISSUE REMOVED FROM HERNIA SAC. MESH NOT SECTIONED. FOREIGN BODY REACTION. SPECIMEN RECEIVED: HERNIA SAC/MESH. GROSS DESCRIPTION: THE SPECIMEN CONSISTS OF MULTIPLE, LARGE SEGMENTS OF INFLAMED TISSUE AND MESH. REPRESENTATIVE SECTIONS OF TISSUE ARE TAKEN. TOTAL VOLUME IS APPROXIMATELY 70CC. CLINICAL HISTORY: NOT GIVEN. PRE-OPERATIVE DIAGNOSIS: INCISIONAL HERNIA. POST-OPERATIVE DIAGNOSIS: NOT GIVEN. ON (B)(6) 2006: [FACILITY NI]. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: ABDOMEN PAIN, RULE OUT HERNIA. IMPRESSION: DIASTASIS OF RECTUS ABDOMINAL MUSCULATURE WITH PRIOR HERNIA REPAIR WITH SMALL VENTRAL ABDOMINAL WALL HERNIA SUPERIOR TO UMBILICUS TO RIGHT OF MIDLINE CONTAINING LARGE BOWEL AND FAT WITHOUT EVIDENCE OF BOWEL OBSTRUCTION. ON (B)(6) 2006: [FACILITY NI]. (B)(6), DO. RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: MULTIPLE ABDOMINAL HERNIA REPAIRS, ABDOMINAL PAIN. IMPRESSION: STATUS POST HERNIA REPAIR OF VENTRAL HERNIA FOR WHICH INFERIOR LATERAL ASPECT OF MESH, THERE ARE SMALL FAT CONTAINING HERNIAS. A 3RD FAT CONTAINING HERNIA SEEN SUPERIOR AND LATERAL TO MESH. SMALL BOWEL LOOPS APPROXIMATED MESH, HOWEVER THERE IS NO HERNIATION. ON (B)(6) 2007: THE (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: ON (B)(6) 2007. DIAGNOSIS: RECURRENT INCISIONAL HERNIAS, PERITONEAL ADHESIONS, MORBID OBESITY. PROBLEM STARTED YEARS AGO WITH DR. (B)(6) WHEN SHE HAD A HERNIA REPAIR AND HE SUBSEQUENTLY REFUSED TO DO IT. I SUBSEQUENTLY REPAIRED IT. HOSPITAL COURSE: WAS COMPLAINING OF CONSTIPATION, WE GAVE HER SUPPOSITORIES, LAXATIVES WITHOUT MUCH SUCCESS, FINALLY HAD RESULTS ON FIFTH POSTOPERATIVE DAY, WOUND LOOKED GOOD. DISCHARGED HOME WITH SPECIFIC ORDERS AND INSTRUCTIONS: DO NO HEAVY LIFTING, NO STRENUOUS ACTIVITY. ON (B)(6) 2008: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: SEVERE ABDOMINAL PAIN. IMPRESSION: MID ANTERIOR ABDOMINAL WALL, MIDLINE, MODERATE SIZE HERNIA MEASURING APPROXIMATELY 4.3 CM IN DEPTH, 12.9 CM IN WIDTH, INCREASED IN SIZE FROM (B)(6) 2006. HERNIA CONTAINS AN 8 CM WIDE AREA OF RADIOPAQUE HERNIA MESH WHICH ONLY PARTIALLY BRIDGES THE HERNIA DEFECT. MULTIPLE HERNIATIONS OF FAT ALONG RIGHT LATERAL, LEFT LATERAL, INFERIOR MARGINS OF THE MESH, THERE IS ALSO HERNIATED SMALL BOWEL LOOP AT LEFT LATERAL MARGIN OF HERNIA MESH AND A PARTIALLY HERNIATED SMALL BOWEL LOOP AT RIGHT LATERAL MARGIN OF HERNIA MESH. IN EFFECT, THESE ARE MULTIPLE SMALL HERNIAS ALONG THE MARGINS OF HERNIA MESH, THAT HAVE INCORPORATED INTO ONE MODERATE SIZE HERNIA. A SEGMENT OF TRANSVERSE COLON IS IMMEDIATELY DEEP TO THE HERNIA MESH. ON (B)(6) 2008: THE (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: CHRONIC INCARCERATED INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. OPERATION: INCISIONAL HERNIORRHAPHY. PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND ADMINISTERED GENERAL ANESTHETIC VIA ENDOTRACHEAL TUBE. THE ABDOMEN WAS PREPPED AND DRAPED IN THE ROUTINE FASHION. THE PREVIOUS UPPER MIDLINE INCISION WAS REOPENED AND THE SKIN AND SUBCUTANEOUS TISSUE WAS INCISED. WITHIN THE SUBCU WERE MULTIPLE POCKETS OF INCARCERATED INCISIONAL HERNIAS WITH FAT PRESENT WITHIN THEM. NO PORTIONS OF BOWEL OR SMALL BOWEL WERE SEEN. THE MULTIPLE DEFECTS WHICH NUMBERED ABOUT 5 WERE OPENED AND HERNIA SAC WAS REMOVED FROM EACH ONE AND ALL THE DEFECTS WERE CONVERTED INTO ONE LARGE DEFECT WITH A DIAMETER OF ABOUT 6 CM. THE PREVIOUSLY PLACED GORE-TEX PATCHES COULD BE SEEN ON THE LEFT EDGE OF THE DEFECT. THE EDGES APPEARED TO BE SOLID AND SECURE. THEREFORE, IT WAS FELT THAT A SUTURE COURSE WOULD BE ADEQUATE, EVEN THOUGH THERE WOULD BE A HIGH CHANCE OF A RECURRENCE DUE TO HER MASSIVE MORBID OBESITY. SUTURES OF O ETHIBOND WERE SELECTED AND THESE WERE PLACED UNDER DIRECT VISION IN A FIGURE-OF-EIGHT FASHION. THESE WERE PULLED UP TO CLOSE THE DEFECT IN A VERTICAL FASHION IN THE MIDLINE. EACH ONE WAS TIED SEPARATELY WHILE HOLDING THE OTHER ONES UP TO PREVENT ANY BOWEL FROM GETTING UP INTO THE HERNIA REPAIR. AFTER THE ETHIBOND SUTURES WERE TIED, THE SKIN WAS CLOSED WITH INTERRUPTED SUTURES OF 3-O PROLENE. A STERILE DRESSING WAS APPLIED.¿ ON (B)(6) 2008: THE (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. ADMIT DATE: ON (B)(6) 2008. CT SCAN SHOWED PROBABLE INCISIONAL HERNIA WITH SMALL BOWEL CAUGHT IN IT AND OBSTRUCTION. EXAM: RECURRENT INCISIONAL HERNIA CENTRAL MIDLINE. HOSPITAL COURSE: POSTOPERATIVELY DID WELL, NO COMPLICATIONS. MORBID OBESITY, TOBACCO ADDICTION AND ABUSE. ON (B)(6) 2008: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ MRI ABDOMEN. INDICATION: VENTRAL HERNIA. IMPRESSION: MODERATE SIZED LEFT PARASAGITTAL ANTERIOR ABDOMINAL WALL HERNIA CONTAINING SMALL BOWEL AND FAT, NO EVIDENCE OF OBSTRUCTION. PRIOR POSTOPERATIVE FINDINGS WITH DIASTASIS OF RECTUS ABDOMINAL MUSCLES, PROTUBERANCE OF ABDOMINAL CONTENTS THROUGH THE DEFECT, VERY SMALL FAT CONTAINING AND ABDOMINAL WALL HERNIA COMPONENTS AT INFERIOR EXTENT OF PRIOR SURGERY, AT ABOUT UMBILICAL LEVEL. ON (B)(6) 2008: THE (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: SYMPTOMATIC RECURRENT ABDOMINAL WALL (INCISIONAL) HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. OPERATION: REPAIR OF HERNIA, LYSIS OF ADHESIONS. INDICATIONS: PATIENT IS A PLEASANT 43 YEAR-OLD FEMALE, ACTUALLY ABOUT 3-4 MONTHS AGO UNDERWENT EMERGENT HERNIA REPAIR BY DR. (B)(6). SHE HAD SEVERAL IN THE PAST BEFORE. SUBSEQUENTLY CAME BACK WITH A HERNIA AGAIN PRIMARILY ON HER LEFT SIDE, CAUSING HER A LOT OF DISCOMFORT AND DESIRED SOMETHING DONE. SHE WAS SUBSEQUENTLY CONSENTED FOR REPAIR AFTER BEING EXPLAINED PROCEDURE, RISKS, ALTERNATIVES AND BENEFITS. FINDINGS: ¿MOST SIGNIFICANT WAS THIS LEFT PARA-SAGITTAL HERNIA, HAD A LOT OF INCARCERATED OMENTUM AND SMALL BOWEL IN IT. SHE ALSO HAD ANOTHER TWO ABDOMINAL WALL HERNIAS IN THE MIDLINE JUST ABOVE THE UMBILICUS AND AROUND THE UMBILICUS.¿ PROCEDURE: ¿PATIENT IN THE SUPINE POSITION UNDER GENERAL ANESTHESIA, SHE WAS DRAPED AND PREPPED IN THE USUAL STERILE FASHION. OLD INCISION WAS THEN OPEN, HEMOSTASIS CONTROLLED WITH ELECTROCAUTERY. WAS CARRIED DOWN TO THE HERNIA SAC IN THE MIDLINE, INCISION WHICH WE ENTERED, FREED UP A LOT OF OMENTUM ADHERENT TO IT, FOUND ANOTHER ONE JUST SLIGHTLY BELOW IT WHICH WE EXTENDED INTO ONE. WE THEN PALPATED THIS LEFT PARA-SAGITTAL ONE WHICH WAS BOTHERING HER AND BEGAN TO DISSECT OVER TO IT AND FREED IT UP WITHOUT ANY DIFFICULTY REMOVING THE SMALL BOWEL AND OMENTUM FROM IT. WE ACTUALLY THEN REMOVED SOME OF THE OMENTUM AS IT JUST APPEARED TO BE KIND OF THROMBOSED FROM BEING CHRONICALLY INCARCERATED. HERNIA WAS THEN CLOSED WITH A RUNNING #1 PROLENE SUTURE LIGATURE, SEWING IT TO GORE-TEX MESH. WITH THIS DONE WE THEN BROUGHT A 6 CENTIMETER PROCEED OF VENTRAL PATCH INTO THE FIELD AND THIS, I FIGURED, WOULD DECREASE THE TENSION BY PUTTING A LOWER PORTION WHERE IT WAS THE SAME LEVEL AS THIS. WE SEWED IT IN WITH #1 PROLENE MATTRESS SUTURE LIGATURES, CIRCUMFERENTIALLY AROUND IT. ONCE WE HAD THEM ALL IN, WE PARACHUTED AND SECURED THEM, FEELING UNDERNEATH TO MAKE SURE EVERYTHING FELT WELL. ONCE IT WAS IN THE STRAPS WERE THEN SUTURED TO THE ANTERIOR FASCIA, WAS THEN IRRIGATED WITH ANTIBIOTIC IMPREGNATED SALINE, ANESTHETIZED WITH 0.25% MARCAINE. SUB Q FASCIA WAS THEN CLOSED WITH A RUNNING 2-0 VICRYL SUTURE LIGATURE AND THE SKIN WAS REAPPROXIMATED WITH SKIN STAPLES. SPONGE AND NEEDLE COUNTS WERE CORRECT. NO SIGNIFICANT BLOOD LOSS. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ ON (B)(6) 2008: THE (B)(6) HOSPITAL. IMPLANT STICKER. PROCEED VENTRAL PATCH. ETHICON. SITE: ABDOMEN. ON (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: INCISIONAL HERNIA. UMBILICAL REGION PAIN SINCE (B)(6) 2009, PAIN INCREASED X 2 DAYS. IMPRESSION: EXPANDING VENTRAL HERNIA CONTAINING LOOPS OF BOTH SMALL AND LARGE BOWEL. HERNIA IS AT LEVEL OF UMBILICUS AND ABOVE IT. SOME STRANDING OF FAT COULD REPRESENT THE MANIFESTATION OF STRANGULATION, NO OBSTRUCTION OR NECROSIS IS SEEN. ON (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6), DO. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA. OPERATION: REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA. LYSIS OF ADHESIONS. INDICATIONS: THIS IS A 44-YEAR-OLD FEMALE WHO HAS HAD MULTIPLE ABDOMINAL SURGERIES IN THE PAST. SHE WAS ADMITTED DIRECTLY FROM THE CLINIC YESTERDAY WITH AN INCARCERATED VENTRAL INCISIONAL HERNIA. THE PATIENT HAS HAD MULTIPLE RECURRENT HERNIAS WITH MESH IN THE PAST. SHE HAD A CT SCAN OF THE ABDOMEN AND PELVIS DONE WHICH SHOWED MULTIPLE SMALL HERNIA DEFECTS, AS WELL AS A LARGE HERNIA DEFECT WITH LARGE INTESTINE AND SMALL BOWEL STUCK WITHIN THE HERNIA. THERE WERE NO SIGNS OF OBSTRUCTION. THE PATIENT WAS CONSENTED FOR VENTRAL INCISIONAL HERNIA REPAIR WITH POSSIBLE MESH, POSSIBLE BOWEL RESECTION. RISKS AND BENEFITS WERE DISCUSSED WITH THE PATIENT BEFORE BRINGING HER INTO THE OPERATING ROOM. DESCRIPTION OF FINDINGS: ¿DENSE ADHESIONS IN THE LEFT UPPER QUADRANT WITH SMALL PIECE OF OLD MESH WHICH WAS WELL INCORPORATED AND NOT REMOVED. NO ADHESIONS IN THE REST OF THE ABDOMINAL CAVITY. BOWEL WAS COMPLETELY VIABLE. HERNIA WAS REPAIRED WITH 27 X 22 CENTIMETER BARD COMPOSIX.¿ PROCEDURE: ¿THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM AND PLACED IN THE SUPPING POSITION ON THE OPERATING TABLE. THE PATIENT WAS GIVEN PREOPERATIVE ANTIBIOTICS. SCDS WERE PLACED. GENERAL ANESTHESIA WAS INTRODUCED. THE PATIENT WAS INTUBATED. THE ABDOMEN WAS PREPARED AND DRAPED IN THE USUAL STANDARD SURGICAL FASHION. A MIDLINE INCISION WAS MADE THROUGH THE OLD SCAR WITH A 10 BLADE SCALPEL. THIS WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUE DOWN TO THE AREA OF THE HERNIA. THE HERNIA SAC WAS THEN OPENED CIRCUMFERENTIALLY AND DISSECTED DOWN TO THE AREA OF THE FASCIA. IN THE LEFT UPPER QUADRANT, THERE WERE DENSE ADHESIONS WHICH WERE TAKEN DOWN WITH A COMBINATION OF BOVIE ELECTROCAUTERY AND SHARP DISSECTION WITH METZENBAUM SCISSORS. DURING THIS PORTION OF THE DISSECTION, IT WAS NOTED THAT THERE WERE TWO OTHER HERNIAS WITHIN THE LEFT LATERAL ABDOMINAL WALL. THE CONTENTS OF THESE APPEARED TO BE OMENTUM WHICH WAS REDUCED. ONCE THE LYSIS OF ADHESIONS WAS COMPLETE AND THE BOWEL AND OMENTUM WERE FREED FROM THE ANTERIOR ABDOMINAL WALL, THE BOWEL WAS INSPECTED. IT APPEARED TO BE COMPLETELY VIABLE. A SMALL PIECE OF MESH WAS WELL INCORPORATED WITHIN THE LEFT UPPER QUADRANT. THIS WAS LEFT IN PLACE. A 27 X 22 CENTIMETER BARD COMPOSIX MESH WAS THEN PLACED IN AN ANTIBIOTIC SOLUTION AND WAS THEN PLACED INTO THE INCISION AFTER #1 PROLENE SUTURES WERE PLACED AT THE FOUR CORNERS. IT WAS PLACED INTO THE ABDOMINAL CAVITY. IT WAS PLACED FLAT OVER TOP OF THE BOWEL. AN 11 BLADE SCALPEL WAS USED TO MAKE SKIN INCISIONS ON BOTH LATERAL SIDES OF THE ABDOMEN INFRAUMBILICAL AND IN THE EPIGASTRIC AREA. A LAPAROSCOPIC ENDO CLOSURE DEVICE WAS USED TO GRASP THE PROLENE SUTURES UP TO THE ABDOMINAL WALL. ONCE ALL OF THESE SUTURES HAD BEEN PASSED THROUGH, THEY WERE TIED DOWN. AN ABSORBABLE TACKING DEVICE WAS THEN USED TO TACK THE MESH TO THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY. ONCE THIS WAS DONE, THE MESH WAS INSPECTED. THERE APPEARED TO BE GOOD ADHERENCE OF THE MESH TO THE ANTERIOR ABDOMINAL WALL. THE WOUND WAS IRRIGATED COPIOUSLY. THE DEEP TISSUES WERE THEN CLOSED OVER THE MESH WITH A 2-0 VICRYL SUTURE IN A RUNNING FASHION. HEMOSTASIS WAS OBTAINED WITH THE BOVIE ELECTROCAUTERY. THE SKIN WAS CLOSED WITH STAPLES. DRY GAUZE DRESSINGS WERE THEN PLACED OVER THE LAPAROTOMY INCISION. THE STAB INCISIONS FOR PASSAGE OF THE SUTURE WERE CLOSED WITH BENZOIN AND STERI-STRIPS. SPONGE, NEEDLE, AND INSTRUMENT COUNTS WERE CORRECT AT THE END OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL, EXTUBATED, AND TRANSFERRED TO THE POST ANESTHESIA CARE UNIT.¿ COMPLICATIONS: NONE. SPECIMEN DESCRIPTIONS: NONE. POSTOPERATIVE CONDITION: SATISFACTORY. ON (B)(6) 2009: THE (B)(6) HOSPITAL. IMPLANT STICKER. BARD COMPOSIX KUGEL HERNIA PATCH. SITE: ABDOMEN. ON (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6), MD. CONSULTATION. HISTORY OF DIABETES MELLITUS, OBESITY COMPLICATED BY VENTRAL HERNIAS, CHRONIC ABDOMINAL PAIN, CHRONIC TOBACCO USE. ON (B)(6) 2009: (B)(6) HEATH SYSTEM. (B)(6), DO. DISCHARGE SUMMARY. HOSPITAL COURSE: POSTOPERATIVELY DID WELL. DID HAVE SOME SEROUS DRAINAGE FROM AREA OF WOUND WHICH EVENTUALLY DECREASED BEFORE DISCHARGE. DISCHARGED HOME. ON (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: PAIN AT ABDOMEN, ABSCESS. IMPRESSION: INTERVAL DEVELOPMENT OF PROMINENT ABSCESS COLLECTION IN AREA OF PRIOR VENTRAL HERNIA ADJACENT TO MESH AND THE MAJORITY OF THE HERNIA SEEN ON PRIOR EXAM NOW IS ABSCESS COLLECTION WITH AIR BUBBLES, FLUID WITHIN IT. EXTENDS FROM POSTERIOR SURGICAL SKIN STAPLES DOWN TO LEVEL OF UMBILICUS IN ANTERIOR ABDOMINAL WALL. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: MID ABDOMINAL PAIN. IMPRESSION: VENTRAL HERNIA REPAIR DOES APPEAR INTACT ALTHOUGH THERE IS BULGING OF PERITONEAL CONTENTS BETWEEN TRANSVERSELY DISPLACED RECTUS MUSCLES OF ANTERIOR ABDOMINAL WALL. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: REOCCURRING HERNIA. IMPRESSION: PROMINENT LAXITY AND RECTUS DIASTASIS INVOLVING ANTERIOR ABDOMINAL WALL. THERE MAY BE A SMALL DISCRETE HERNIA DEFECT AT LEVEL OF UPPER ABDOMEN. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6), DO. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. INDICATIONS: MIDDLE-AGED OBESE FEMALE WITH ABDOMINAL PAIN AND BULGE OVER THE AREA OF HER PREVIOUS HERNIA REPAIR, AS WELL AS A CT SCAN THAT SHOWS A SMALL HERNIA AROUND HER PREVIOUS MESH. THE PATIENT HAS HAD EIGHT VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE WAS CONSENTED FOR A RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. PROCEDURE: RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. FINDINGS: ¿OLD MESH FOLDED OVER AND ONE SIDE OF THE SMALL BOWEL STUCK TO IT. HERNIA ABOVE THE SUPERIOR ASPECT OF THE MESH.¿ PROCEDURE DETAIL: ¿THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION ON THE OPERATING TABLE. SHE IS INTUBATED. GENERAL ANESTHESIA WAS INTRODUCED. PREOPERATIVE ANTIBIOTICS WERE GIVEN. THE ABDOMEN WAS PREPPED AND DRAPED IN USUAL STANDARD STERILE SURGICAL FASHION. AN INCISION WAS MADE THROUGH THE OLD SCAR IN THE EPIGASTRIC AREA OF THE ABDOMEN. IT WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUE DOWN TO THE AREA OF THE OLD MESH. THE SUBCUTANEOUS TISSUE WAS THEN DISSECTED FREE FROM THE MESH ON THE ANTERIOR SURFACE OF THE MESH. THERE WAS NOTED TO BE A SMALL HERNIA AT THE SUPERIOR ASPECT OF THE MESH. THESE SUTURES WERE CUT TO EXPOSE THE UNDERSURFACE OF THE MESH. THE MESH WAS THEN REMOVED CIRCUMFERENTIALLY FROM THE INCISION. ON THE LEFT LATERAL SIDE, THE MESH HAD TURNED UNDER AND THERE WAS SMALL BOWEL STUCK TO THE UPPER PORTION OF THE MESH. THIS WAS TAKEN OFF WITH METZENBAUM SCISSORS. ONCE THE MESH WAS COMPLETELY REMOVED, ANY REMAINING PROLENE SUTURES WERE PULLED FROM THE WOUND. THE OLD MESH WAS PASSED OFF THE TABLE. ADHESIONS WERE TAKEN DOWN CIRCUMFERENTIALLY WITH METZENBAUM SCISSORS AND BLUNT DISSECTION. ONCE AN ADEQUATE AREA WAS FREED UP ON THE UNDERSURFACE OF THE FASCIA, THE HERNIA DEFECT WAS MEASURED. IT WAS NOTED TO BE 10 X 10 CENTIMETERS. A 15 X 20 CENTIMETERS LIGHT WEIGHT MESH WAS THEN PLACED INTO THE INCISION AND WAS SUTURED TO THE FASCIA WITH A U STITCHES OF #1 PROLENE. IT WAS FIRST TACKED AT THE 12 O¿CLOCK, 6 O¿CLOCK, 3 O¿CLOCK, AND 9 O¿CLOCK POSITIONS MAKING SURE THAT THE MESH WAS TAUT. SUTURES WERE THEN PLACED IN AN INTERRUPTED U STITCH BETWEEN EACH OF THESE ANCHORING SUTURES. ONCE THIS WAS ACCOMPLISHED, THE FASCIA WAS CLOSED OVER TOP OF THE MESH WITH A RUNNING 2-0 VICRYL SUTURE. THE DEEP SUBCUTANEOUS TISSUE WAS REAPPROXIMATED WITH A 3-0 VICRYL IN A RUNNING FASHION. THE SKIN WAS CLOSED WITH STAPLES. DRY GAUZE DRESSINGS WERE PLACED. SPONGE, NEEDLE, AND INSTRUMENT COUNTS WERE CORRECT AT THE END OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT.¿ INTRAOPERATIVE COMPLICATIONS: NONE. SPECIMEN DESCRIPTION: OLD MESH. ON (B)(6) 2010: THE (B)(6) HOSPITAL. IMPLANT STICKER. PROCEED SURGICAL MESH. SITE: ABDOMEN. ON (B)(6) 2010: [MISSING RECORDS: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE (B)(6) 2010 PROCEDURE WAS NOT PROVIDED.] ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6), DO. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: ABDOMINAL WALL SEROMA. HOSPITAL COURSE: DISCHARGED HOME WITHOUT THE SEROMA BEING DRAINED. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. NURSE NOTES. WEIGHT 304 POUNDS. BMI 55.6. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ US ABDOMEN. INDICATION: INCREASING ABDOMINAL GIRTH/RECENT SURGERY. IMPRESSION: MAY BE DUE TO HEMATOMA DEEP TO INCISION LINE. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ US GUIDED ASPIRATION SUBCUTANEOUS RIGHT LOWER QUADRANT. IMPRESSION: SUCCESSFUL ASPIRATION OF A SUBCUTANEOUS COLLECTION. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ US GUIDED DRAIN PLACEMENT RIGHT LOWER QUADRANT SUBCUTANEOUS FLUID COLLECTION. INDICATION: PERSISTENT LOCULATED RIGHT LOWER QUADRANT FLUID COLLECTION FOLLOWING RECENT SURGERY. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6), MD. HISTORY AND PHYSICAL. STATUS POST HERNIA REPAIR WITH DRAIN PLACED IN ABDOMINAL CAVITY, DRAINING AROUND IT. DR. (B)(6) FELT WOUND WAS INFECTED. ADMITTED HER FOR IV ANTIBIOTICS, CHANGED DRAIN TO LARGER SIZE. IMPRESSION: PROBABLE INFECTED FLUID SUBCUTANEOUS, UNFORTUNATELY NOT IN CONTACT WITH MESH AT THIS TIME. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: SUBCUTANEOUS MID LINE COLLECTION FOLLOWING HERNIA REPAIR. IMPRESSION: 5 X 10 CM SUBCUTANEOUS ABDOMINAL WALL ABSCESS WITH INFLAMMATORY CHANGES SEEN WITHIN ADJACENT SUBCUTANEOUS FAT. ON (B)(6) 2010: (B)(6)HEALTH SYSTEM. (B)(6), MD. CONSULTATION. MOST RECENT SURGERY ON (B)(6) 2010. AT THAT TIME OLD MESH WAS REMOVED AND NEW MESH PLACE. FOLLOW UP CT: MIGHT HAVE DEVELOPED SOME RIM ENHANCEMENT, LOCULATION SUGGESTIVE OF POSSIBLE ABSCESS FORMATION. ON (B)(6) 2010: WASHINGTON HEALTH SYSTEM. (B)(6), MD. CONSULTATION. HISTORY OF VENTRAL ABDOMINAL WALL HERNIA WITH INCISIONAL REPAIR, RELEASE OF SMALL-BOWEL OBSTRUCTION (B)(6) 2008 AND (B)(6) 2008, VENTRAL HERNIA REPAIR (B)(6) 2007, LAPAROSCOPIC CHOLECYSTECTOMY AND HERNIA REPAIR (B)(6) 2005. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: SUBCUTANEOUS ABSCESS. IMPRESSION: THE TREATED SUBCUTANEOUS ABDOMINAL WALL ABSCESS WITH INFLAMMATORY CHANGE HAS SIGNIFICANTLY DECREASED IN SIZE. ON (B)(6) 2010: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. INDICATION: PAIN ENTIRE ABDOMINAL WALL. IMPRESSION: FAIRLY THICK WALLED, PERIPHERALLY LOCULATED FLUID COLLECTION WITHIN MIDLINE LOWER ABDOMEN, UPPER PELVIS MEASURING APPROXIMATELY 7 X 5.2 X 2.9 CM IN SIZE. ON (B)(6) 2011: (B)(6) HEALTH SYSTEM. (B)(6). RADIOLOGY ¿ US ABDOMEN. INDICATION: ABDOMINAL PAIN, RULE OUT RECURRENT HERNIA VERSUS FLUID COLLECTION. IMPRESSION: PERSISTENT MIDLINE SUBCUTANEOUS COMPLEX FLUID COLLECTION. NOT SIGNIFICANTLY CHANGED SINCE PRIOR CT. ON (B)(6) 2015: (B)(6) HEALTH SYSTEM. NURSE NOTES. HISTORY OF ABDOMINAL INFECTION AFTER HERNIA REPAIR (B)(6) 2010. ON (B)(6) 2015: (B)(6) HEALTH SYSTEM. (B)(6), CRNP. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: CLOSTRIDIUM DIFFICILE COLITIS, ABDOMINAL PAIN, MORBID OBESITY. RECORDS SPAN (B)(6) 2006 TO (B)(6) 2015 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.
UPDATED RESULT CODE. CONCLUSION CODE REMAINS UNCHANGED.
(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 THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, AND (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, ADHESIONS TO THE FASCIA OF OMENTUM AND SMALL BOWEL UNDERNEATH, ADHESIONS TO THE SMALL BOWEL, SURGERY TO REMOVE MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360108 | GORE DUALMESH BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC03 | 04117042 | 00733132600960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R |