GORE DUALMESH® BIOMATERIAL
Report
- Report Number
- 2017233-2019-00768
- Event Type
- Injury
- Date Received
- August 29, 2019
- Date of Event
- June 13, 2001
- Report Date
- March 22, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600977
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 2011: [FACILITY NI]. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS. INDICATIONS: EVALUATE FOR RECURRENT ABDOMINAL WALL HERNIA. CONCLUSION: STATUS POST CHOLECYSTECTOMY AND GASTRIC SURGERY. THERE HAS BEEN REPAIR OF THE VENTRAL WALL HERNIA. CURRENTLY THERE IS NO ABDOMINAL WALL HERNIA. ON (B)(6) 2001:CHW CENTRAL CALIFORNIA. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. OPERATION PERFORMED: LAPAROSCOPIC REPAIR OF RECURRENT VENTRAL HERNIA. INDICATIONS: THIS IS A 45-YEAR-OLD WOMAN WHO IS STATUS POST LAPAROSCOPIC CHOLECYSTECTOMY. SHE DEVELOPED AN INCISIONAL HERNIA AT HER SUPRAUMBILICAL CANNULA SITE. AT THE TIME OF HER REPAIR, SHE WAS ALSO FOUND TO HAVE AN UMBILICAL HERNIA. SHE HAD UNDERGONE PRIMARY REPAIR OF THESE HERNIA. SHE HAS NOW DEVELOPED A RECURRENCE. SHE IS NOW TAKEN TO THE OPERATING ROOM FOR REPAIR. FINDINGS AT THE TIME OF OPERATION: ¿HERNIA DEFECT MEASURING APPROXIMATELY 4 CM IN TOTAL DIAMETER. IMPLANTS: DUAL MESH GORE-TEX PATCH.¿ DESCRIPTION OF PROCEDURE: ¿AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM. THE SITE OF THE HERNIA AND THE PROCEDURES WERE AGAIN DISCUSSED AND VERIFIED WITH THE PATIENT. SHE WAS PLACED SUPINE ON THE OPERATING ROOM TABLE. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED BY THE ANESTHESIA DEPARTMENT. ANTIBIOTICS WERE ADMINISTERED INTRAVENOUSLY. USING AN OPTI-VIEW PORT, A 12 MM CANNULA WAS PLACED AT ABOUT THE LEVEL OF THE UMBILICUS LATERAL TO THE RECTUS SHEATH. THIS WAS QUITE DIFFICULT OWING TO THE PATIENT¿S SIZE. ONCE ENTRY WAS MADE, PNEUMOPERITONEUM WAS DEVELOPED. UNDER DIRECT VISION, 5 MM CANNULAS WERE PLACED IN THE LEFT UPPER QUADRANT AND LEFT LOWER QUADRANT LATERAL TO THE RECTUS SHEATH. THERE WAS SOME ADHESIONS PRIMARILY OF OMENTUM THAT WERE TAKEN DOWN USING SHARP DISSECTION AND ELECTROCAUTERY. THE HERNIA WAS THEN REDUCED AND THE ENTIRE HERNIA DEFECT WAS IDENTIFIED AND MOBILIZED. THIS WAS QUITE DIFFICULT OWING TO THE PATIENT¿S ADHESIONS AND HER SIZE. THIS REQUIRED PLACEMENT OF AN ADDITIONAL CAMERA PORT ON THE RIGHT AND ADDITIONAL WORKING PORTS IN THE RIGHT UPPER QUADRANT AND RIGHT LOWER QUADRANT. THE HERNIA DEFECT WAS MEASURED USING A SPINAL NEEDLE AND WAS NOTED TO BE 4 CM IN DIAMETER. MESH WAS THEN USED THAT WAS 3 CM LARGER THAN THE HERNIA DEFECT. PROLENE AND GORE-TEX SUTURES WERE PLACED AT THE 12:00, 3:00, 6:00 AND 9:00 POSITIONS OF THE MESH ALTERNATING THE SUTURES. THE MESH WAS THEN DELIVERED INTO THE PERITONEAL CAVITY. USING THE SUTURE PASSER DEVICE, THE SUTURES WERE BROUGHT THROUGH THE FULL THICKNESS OF THE ABDOMINAL WALL. THESE WERE THEN TIED. THE LEFT MOST LATERAL STITCH HAD FRAYED AND BROKEN BUT WAS STILL SECURE. THEN USING THE SPIRAL TACKER, THE MESH WAS SECURED TO THE ABDOMINAL WALL. THE ABDOMINAL [SIC] WAS IRRIGATED AND THE IRRIGANT WAS WITHDRAWN. THE REDUCED CONTENT OF THE HERNIA AS WELL AS THE AREAS OF ADHESIOLYSIS WERE INSPECTED AND HEMOSTASIS WAS NOTED TO BE GOOD. THE CANNULA WAS WITHDRAWN UNDER DIRECT VISION AND THE ABDOMEN WAS DESUFFLATED. THE SKIN WAS THEN CLOSED USING SKIN STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION.¿ ON (B)(6) 2001: BAKERSFIELD MEMORIAL HOSPITAL. IMPLANT STICKER. GORE-TEX DUALMESH. BIOMATERIAL ITEM#: 1DLMC04. LOT#: 00715807. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC04/00715807) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2001:KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-ABDOMEN. EXAM: ABDOMEN. INDICATION: RUPTURED UMBILICAL HERNIA REPAIR. INTERPRETATION OF THIS CASE IS VERY LIMITED DUE TO THE PATIENT¿S BODY HABITUS. THERE IS, HOWEVER, NO EVIDENCE OF INTESTINAL OBSTRUCTION. ALSO NO CRITERIA FOR ADYNAMIC ILEUS. ON (B)(6) 2001:KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS. INDICATION: LEFT SIDED ABDOMINAL PAIN. FINDINGS: THE PATIENT IS STATUS POST SURGERY FOR ANTERIOR ABDOMINAL WALL HERNIA AS THERE IS MESH DEMONSTRATED IN THE ANTERIOR ABDOMINAL WALL. IN THE LEFT PARACENTRAL REGION, THERE IS RECURRENCE OF ANTERIOR ABDOMINAL WALL HERNIA. THE CONTENTS OF HERNIA ARE MAINLY OMENTUM BUT THE OMENTAL FAT IN THE REGION OF THE HERNIA IS VERY STRIATED AND ALSO THERE IS SOME FLUID SEEN IN THE HERNIAL SAC, SUGGESTIVE OF INFLAMMATORY CHANGES. NO BOWEL LOOPS ARE SEEN WITHIN THE HERNIA. IMPRESSION: THE FINDINGS ARE SUGGESTIVE OF RECURRENCE OF ANTERIOR ABDOMINAL WALL HERNIA ON THE LEFT SIDE IN THE PARACENTRAL PORTION. THE HERNIAL SAC MAINLY CONTAINS OMENTAL FAT. THE OMENTAL FAT HAS EXTENSIVE STRIATIONS, REPRESENTING INFLAMMATORY CHANGES. ALSO, THERE IS FLUID PRESENT WITHIN THE HERNIAL SAC. THESE FINDINGS ARE SUGGESTIVE OF POSSIBILITY OF INCARCERATED HERNIA. OVERALL, THE HERNIAL SAC MEASURES ABOUT 11 CM. NO EVIDENCE OF ANY BOWEL CONTENTS WITHIN THE HERNIAL SAC. POST-OPERATIVE CHANGES OF ANTERIOR ABDOMINAL WALL HERNIA REPAIR. MILD FATTY INFILTRATION OF LIVER. ON (B)(6) 2001:CHW CENTRAL CALIFORNIA. (B)(6), MD. OPERATIVE REPORT. ASSISTANT: SHIRLEY HOM, PA. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. OPERATION PERFORMED: REPAIR OF RECURRENT VENTRAL HERNIA WITH MESH. REMOVAL OF OLD GORE-TEX MESH. INDICATIONS: THIS IS A 45-YEAR-OLD WOMAN STATUS POST LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA. SHE CONTINUED TO HAVE PAIN IN THE LOWER PORTION OF HER ABDOMEN. A CT OF HER ABDOMEN SUGGESTED A CHRONIC INCARCERATION OF FAT. AFTER DISCUSSION OF THE OPTIONS, SHE IS NOW TAKEN TO THE OPERATING ROOM FOR LAPAROTOMY AND REPAIR OF VENTRAL HERNIA. FINDINGS AT TIME OF OPERATION: A WELL-INCORPORATED GORE-TEX DUAL MESH. EVIDENCE OF INCARCERATED OMENTAL SAC BELOW THE LEFT LOWER PORTION OF THE MESH. NO EVIDENCE OF BOWEL INCARCERATION. SPECIMENS: NONE. IMPLANTS: A 15 X 19 CM OVAL GORE-TEX DUAL MESH. DESCRIPTION OF PROCEDURE: ¿AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM. ANTIBIOTICS WERE ADMINISTERED INTRAVENOUSLY. THE PATIENT WAS PLACED SUPINE ON THE OPERATING TABLE AND GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED BY THE ANESTHESIA DEPARTMENT. THE ABDOMEN WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A MIDLINE INCISION WAS MADE AROUND THE UMBILICUS. USING SHARP DISSECTION, THE FASCIA WAS INCISED. THERE WAS SOME EDEMATOUS-APPEARING TISSUE BELOW THE FASCIA. THIS WAS BLUNTLY MOBILIZED UNTIL THE MESH WAS IDENTIFIED. THE SUPERIOR PORTION OF THE MESH WAS IDENTIFIED. IT WAS FREED FROM ITS ATTACHMENTS TO THE FASCIA. THE MESH WAS THEN INCISED SHARPLY USING MAYO SCISSORS. THERE WERE NO ADHESIONS OF BOWEL OR OMENTUM TO THE MIDLINE PORTION OF THE MESH. THE MESH WAS COMPLETELY DIVIDED IN THE MIDLINE. THE MESH WAS THEN MOBILIZED LATERALLY. THE OMENTUM WAS ADHERENT TO THE SITES OF SOME OF THE SPIRAL TACKS. VERY CAREFULLY THESE WERE EXCISED. THERE WAS NO EVIDENCE OF ATTACHMENT OF BOWEL TO THE MESH OR THE TACKS. ONCE THE UNDERLYING OMENTUM WAS MOBILIZED OFF THE MESH, IT BECAME CLEAR THAT THERE WAS SOME OMENTUM THAT HAD BECOME TRAPPED UNDER THE MESH AT ITS INFERIOR LEFT PORTION. THIS WAS REDUCED. THE MESH WAS THEN REMOVED FROM THE UNDERSURFACE OF THE FASCIA. ALL THE SPIRAL TACKS WERE REMOVED. SIMILARLY, THE RIGHT SIDE OF THE MESH WAS MOBILIZED AND THEN REMOVED. THE UNDERSURFACE WAS PALPATED AND THE REMAINING PACKS WERE REMOVED. THE ANTERIOR SURFACE OF THE FASCIA WAS THEN CLEARED. THE HERNIA SAC AT THE UMBILICUS WAS IDENTIFIED, MOBILIZED AND EXCISED. THE FASCIA WAS CLEARED CIRCUMFERENTIALLY FOR A DISTANCE OF APPROXIMATELY 3 CM. A 15 BY 19 CM OVAL GORE-TEX DUAL MESH WAS THEN DELIVERED INTO THE FIELD AND SOAKED IN ANTIBIOTIC SOLUTION. THE MESH WAS SECURED TO THE UNDERSURFACE OF THE FASCIA USING INTERRUPTED # 0 PROLENE SUTURE IN A HORIZONTAL MATTRESS STITCH. SUTURES WERE PLACED PRIOR TO TRYING THEM. BEFORE THE SUTURES WERE SECURED, THE MESH WAS INSPECTED AND THERE WERE NO GAPS AT THE MESH INTERFACE. THE MESH WAS THEN SECURED. THE WOUND WAS THEN IRRIGATED. SCARPA¿S FASCIA WAS THEN CLOSED OVER THE MESH ATTEMPTING TO CLOSE THE DEAD SPACE OVER THE MESH. INTERRUPTED # 2-0 VICRYL SUTURES WERE USED. SEVERAL SUBDURAL # 2-0 VICRYL WERE USED TO REAPPROXIMATE THE SKIN. THE SKIN WAS THEN CLOSED USING SKIN STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE WAS TAKEN TO THE RECOVERY ROOM WHERE AND [SIC] ABDOMINAL BINDER WAS APPLIED.¿ ON (B)(6) 2001:BAKERSFIELD MEMORIAL HOSPITAL. IMPLANT STICKER. GORE-TEX DUALMESH BIOMATERIAL. ITEM #: 1DLMC04. LOT#: 00651144. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC04/00651144) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2001:CHW CENTRAL CALIFORNIA. (B)(6), MD. DISCHARGE SUMMARY. ADMITTING DIAGNOSIS: RECURRENT VENTRAL HERNIA. DISCHARGE DIAGNOSIS: RECURRENT VENTRAL HERNIA. PROCEDURE PERFORMED: REPAIR OF VENTRAL HERNIA WITH REMOVAL OF GORE-TEX MESH. REPLACEMENT OF MESH. CONDITION AT DISCHARGE: GOOD. FOLLOW UP IN ONE WEEK. ON (B)(6) 2002: KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-ABDOMEN SINGLE VIEW. INDICATION: SMALL BOWEL OBSTRUCTION. SURGICAL CLIP IS SEEN IN THE RIGHT UPPER QUADRANT. METALLIC RINGS AND CLIPS ARE SEEN AND APPARENTLY THESE WERE USED AS PART OF A VENTRAL HERNIA REPAIR WITH MESH. THERE IS NO OBSTRUCTION, PERFORATION, OR ASCITES. IMPRESSION: POSTOPERATIVE CHANGES. SUGGESTION OF SLIGHT ENLARGEMENT OF THE RIGHT LOBE OF THE LIVER. NO ACUTE ABDOMINAL PROCESS. ON (B)(6) 2003: CHW CENTRAL CALIFORNIA. ROGER ALMKLOZ. EMERGENCY DEPARTMENT VISIT. SAYS, ¿MY HERNIA IS HURTING¿. ABDOMEN: MIDLINE SCARS PRESENT WITH MILD TENDERNESS, NO EVIDENCE OF INCARCERATED HERNIA. THREE WAY ABDOMINAL SERIES WAS UNREMARKABLE. ABDOMINAL EVALUATION. FOLLOW UP WITH HER DOCTOR. ON (B)(6) 2003: KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS. INDICATIONS: RECURRENT VENTRAL HERNIA, NOW WITH RECURRENT ABDOMINAL PAIN. SINCE THE PREVIOUS EXAMINATION OF THE PATIENT IS STATUS POST OF VENTRAL HERNIA WITH MESH. THERE IS DEHISCENCE OF ANTERIOR ABDOMINAL WALL AGAIN WITH RECURRENCE OF LARGE VENTRAL HERNIA. THE CONTENTS OF HERNIA INCLUDE SMALL AND LARGE BOWEL LOOPS. THERE IS NO EVIDENCE OF ANY HERNIA INCARCERATION. CONCLUSION: 1. SINCE THE PREVIOUS EXAMINATION, THE PATIENT HAS UNDERGONE REPAIR OF VENTRAL HERNIA WITH MESH. HOWEVER, THERE IS DEHISCENCE OF THE MESH WITH RECURRENCE OF HERNIA. THE CONTENTS OF HERNIA INCLUDE SMALL AND LARGE BOWEL LOOPS. PRIOR CHOLECYSTECTOMY. ON (B)(6) 2004:CHW CENTRAL CALIFORNIA. (B)(6), MD. EMERGENCY DEPARTMENT VISIT. SCHEDULED FOR RECURRENT VENTRAL HERNIA REPAIR ON MONDAY. PATIENT STATES SHE CANNOT WAIT THAT LONG BECAUSE HER PAIN HAS GOTTEN TO SEVERE. SHE IS STATUS POST HERNIA REPAIR IN MARCH 2001, I BELIEVE SHE HAD A REDO PROCEDURE WITH SOME MESH PLACEMENT WITH RECURRENCE HERNIA. DR. SALES DID HERNIA REPAIR TIMES TWO. PATIENT REPORTS PAIN IN LOWER ABDOMINAL AREA WHERE THE HERNIA IS AND SHE THINKS IT IS STRANGULATED. NAUSEATED AND CONSTIPATED. WEIGHT 300 POUNDS. DIFFICULT TO ASSESS THE HERNIA BECAUSE OF THE PATIENT¿S VERY LARGE SIZE. DIFFICULT TO DETERMINE WHAT AREA IS HERNIATED. DOES NOT APPEAR TO BE ANY INCARCERATED OR STRANGULATED HERNIA PRESENT AND THERE IS NO SIGNIFICANT TENDERNESS TO PALPATION OVER THE AREA OF HERNIA. DIAGNOSIS: VENTRAL HERNIA WITH CONSTIPATION. ON (B)(6) 2004: CHW CENTRAL CALIFORNIA. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. OPERATION PERFORMED: REMOVAL OF HERNIA MESH WITH INCISIONAL HERNIA REPAIR. INDICATIONS: THIS IS A 48 YEAR-OLD LADY WITH RECURRENT INCISIONAL HERNIA. SHE MADE ATTEMPTS AT WEIGHT LOSS THAT WERE UNSUCCESSFUL. SHE IS NOW HAVING INCREASING PAIN. SHE IS NOW TAKEN TO THE OPERATING ROOM FOR HERNIA REPAIR. FINDINGS: 1. FREE-FLOATING GORE-TEX MESH. 2. INCISIONAL HERNIA DEFECT MEASURING 12 X 16 CM. IMPLANTS: BARD KUGEL COMPOSIX HERNIA MESH 13.8 X 17.8 CM X 2. DRAINS: A 10-MM FLAT JACKSON-PRATT DRAIN X 2. DESCRIPTION OF PROCEDURE: ¿AFTER INFORMED CONSENT WAS OBTAINED, SITE AND PROCEDURE VERIFICATION WERE PERFORMED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED ON THE OPERATING ROOM TABLE. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED BY THE ANESTHESIA DEPARTMENT. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. FOLEY CATHETER WAS INSERTED AND SEQUENTIAL COMPRESSION STOCKINGS WERE PLACED ON BOTH LOWER EXTREMITIES. IOBAN DRAPE WAS USED TO PROTECT THE SKIN. THE PREVIOUS MIDLINE INCISION WAS USED. THE HERNIA SAC WAS IDENTIFIED AND CIRCUMFERENTIALLY MOBILIZED. THE HERNIA WAS ENTERED. THE PREVIOUSLY PLACED GORE-TEX MESH WAS IDENTIFIED. IT HAD SEPARATED FROM THE FASCIAL CONNECTIONS ALMOST CIRCUMFERENTIALLY EXCEPT FOR ITS MOST INFERIOR PORTION. THE MESH WAS MOBILIZED AND EXCISED OFF THE UNDERLYING OMENTUM. THE ABDOMINAL WALL WAS THEN CLEARED ON ITS PERITONEAL SURFACE OF ADHESIONS. THE FALCIFORM LIGAMENT WAS MOBILIZED OFF THE ABDOMINAL WALL FOR A SHORT DISTANCE ABOVE THE INCISION. ONCE THE ENTIRE HERNIA HAD BEEN MOBILIZED, THE DEFECT MEASURED APPROXIMATELY 16 CM IN LENGTH X 12 CM IN WIDTH. TWO 13.8 X 17.8-CM BARD KUGEL COMPOSIX MESH WERE DELIVERED ONTO THE FIELD. THEY WERE THEN SEWN TOGETHER ALONG THE LONGITUDINAL AXIS SO THAT THE TOTAL LENGTH WOULD MEASURE APPROXIMATELY 22 CM. THE MESH WAS THEN INSERTED WITH BOTH MESH LYING TRANSVERSELY IN THE WOUND. IT APPEARED TO GIVE ADEQUATE FASCIAL OVERLAP OF GREATER THAN 3-4 CM AROUND THE DEFECT. THE MESH WAS THEN SOAKED IN ANTIBIOTIC SOLUTION AND # 0 PDS SUTURES WERE PLACED CIRCUMFERENTIALLY AROUND THE MESH ALONG THE SUTURE RING. THE MESH WAS PLACED IN THE SUBFASCIAL POSITION AND THEN SECURED TO THE UNDERSURFACE OF THE FASCIA WITH THE PREVIOUSLY PLACED SUTURES. THE MESH WAS INSPECTED AND IT CAME TO LIE NICELY. SEVERAL SMALL GAPS WERE REPAIRED WITH PDS SUTURE. THE WOUND WAS IRRIGATED AND HERNIA SAC WAS THEN MOBILIZED FROM THE SOFT TISSUE AND USED TO COVER THE MESH. THE WOUND WAS THEN MOBILIZED FROM THE SOFT TISSUE AND USED TO COVER THE MESH. THE WOUND WAS IRRIGATED. TWO FLAT 10-MM DRAINS WERE THEN BROUGHT IN THROUGH SEPARATE STAB INCISIONS TO THE LOWER PORTION OF THE INCISION. THEY WERE SECURED WITH NYLON SUTURES. THE UMBILICUS AND SCARPA¿S FASCIA WERE THEN RE-APPROXIMATED WITH PDS SUTURES AND THE WOUND WAS IRRIGATED AND THE SKIN CLOSED USING SKIN STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. AN ABDOMINAL BINDER WAS PLACED.¿ ON (B)(6) 2004: CHW CENTRAL CALIFORNIA. (B)(6), MD. DISCHARGE SUMMARY. ADMISSION DIAGNOSIS: VENTRAL HERNIA. DISCHARGE DIAGNOSIS: VENTRAL HERNIA. OPERATION: VENTRAL HERNIA REPAIR WITH MESH. POSTOPERATIVELY PATIENT DID WELL. PATIENT HAS BEEN INSTRUCTED ON DRAIN CARE AND WOUND CARE. DISCHARGED IN STABLE CONDITION. ON (B)(6) 2005 :KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS. INDICATIONS: ABDOMINAL WALL PAIN. CONCLUSION: THERE IS A VENTRAL HERNIA CONTAINING HERNIATED LOOPS OF BOWEL. STATUS POST CHOLECYSTECTOMY. ON (B)(6) 2006: CHW CENTRAL CALIFORNIA. (B)(6), MD. HISTORY & PHYSICAL. ADMITTING DIAGNOSIS: RECURRENT INCISIONAL HERNIA. STATUS POST MULTIPLE HERNIA REPAIRS, LAST ONE IN 2002 DONE WITH KUGEL COMPOSITE MESH WHICH HAS NOW RECURRED. HAVING ABDOMINAL PAIN AND UNABLE TO BEND OVER AT WORK BECAUSE OF DISCOMFORT FROM HER INCISIONAL HERNIA AND SHE IS COMING IN FOR REPEAT ELECTIVE REPAIR OF HER INCISIONAL HERNIA. PAST SURGERY: 5 CESAREAN SECTION, LAPAROSCOPIC CHOLECYSTECTOMY AND 3 HERNIA REPAIRS. WEIGHT 290 POUNDS. ABDOMEN: VERY OBESE WITH A LARGE UPPER MIDLINE HERNIA WHICH IS REDUCIBLE. ASSESSMENT: RECURRENT INCISIONAL HERNIA. TAKE TO OPERATING ROOM TO REATTEMPT REPAIR WITH MESH. I CANNOT GUARANTEE HER THAT THIS HERNIA WILL STAY REPAIRED AND PART OF THE PROBLEM IS HER SEVERE OBESITY. WE ARE GOING TO KEEP HER OFF OF WORK FOR 2 MONTHS AFTER HERNIA REPAIR TO GIVE IT A CHANCE TO HEAL. ON (B)(6) 2006:CHW CENTRAL CALIFORNIA. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. OPERATION PERFORMED: INCISIONAL HERNIORRHAPHY WITH MESH. THE PATIENT IS A 50-YEAR-OLD FEMALE WHO HAS HAD MULTIPLE HERNIA REPAIRS. SHE HAS HAD A TOTAL OF THREE HERNIA REPAIRS, THE LAST ONE IN 2002. SHE HAS RECENTLY HAD ANOTHER RECURRENCE AND IS HAVING ABDOMINAL PAIN. SHE IS UNABLE TO WORK BECAUSE OF HER DISCOMFORT FROM HER HERNIA. A CT SCAN HAS BEEN OBTAINED AND IT SHOWS THAT THE LEFT SIDE OF THE MESH PREVIOUSLY PLACED- A COMPOSIX KUGEL MESH ¿HAS PULLED AWAY FROM THE LEFT SIDE OF THE ABDOMINAL WALL. THE PATIENT IS BEING RETURNED TO SURGERY FOR REPAIR-EITHER TO RE-TACK THE SAME MESH INTO PLACE OR TO REMOVE IT AND PLACE WITH A NEW MESH. THE RISKS AND BENEFITS OF SURGERY INCLUDING BLEEDING, INFECTION, RECURRENT HERNIA, ETC HAVE BEEN EXPLAINED TO THE PATIENT. THE FACT THAT I CANNOT GUARANTEE THAT SHE WILL NOT GET ANOTHER HERNIA WAS EXPLAINED TO THE PATIENT. PART OF THE REASON FOR HER RECURRENT HERNIAS ARE SECONDARY TO HER MORBID OBESITY WHICH SHE UNDERSTANDS, BUT WE DO NOT HAVE TIME FOR HER TO LOSE A LOT OF WEIGHT BEFORE FIXING THIS HERNIA BECAUSE SHE CANNOT BE ACTIVE RIGHT NOW BECAUSE OF PAIN AND DISCOMFORT FROM THE HERNIA. DESCRIPTION OF PROCEDURE: ¿THE PATIENT IS BROUGHT TO THE OPERATING ROOM AND PLACED ON THE OPERATING TABLE IN SUPINE POSITION. AFTER INDUCTION OF GENERAL ANESTHESIA, HER ABDOMEN WAS PREPPED AND DRAPED IN ROUTINE, STANDARD, STERILE FASHION. A MIDLINE INCISION WAS MADE AND DISSECTION WAS CARRIED DOWN, ABOVE THE UMBILICUS. A LARGE HERNIA SAC WAS IDENTIFIED WHICH WAS OPENED. OMENTUM ADHERENT WITHIN THE HERNIA SAC WAS FREED. A PORTION OF THE HERNIA SAC WAS EXCISED. WE IDENTIFIED ON THE RIGHT SIDE OF HERNIA SAC THE MESH AND ON THE LEFT SIDE OF THE HERNIA SAC THE LEFT RECTUS MUSCLE. THE ANTERIOR AND POSTERIOR SURFACES OF THE RECTUS MUSCLE WERE COMPLETELY EXPOSED. THE MESH WAS ALSO CLEARED OF OMENTAL ADHESIONS. PALPATION INTRA-ABDOMINALLY REVEALED NO OTHER EVIDENCE OF ABDOMINAL WALL HERNIAS. ONCE WE CLEARED EVERYTHING OFF, IT APPEARED THAT WE COULD RE-TACK THIS MESH TO THE MUSCLE AND HAVE GOOD CLOSURE OF THE DEFECT. HOW WE CHOSE TO DO THIS WAS WITH 8 FULL THICKNESS, HORIZONTAL MATTRESS SUTURES PLACED SEVERAL CENTIMETERS BACK FROM THE RIM OF THE FASCIAL DEFECT, THROUGH THE EDGE OF THE MESH AND THEN ONCE TACKED AND SUTURED DOWN, 4 MORE ADDITIONAL SIMPLE SUTURES FROM THE RIM OF THE FASCIAL DEFECT THROUGH THE MARLEX LAYER OF THE MESH, PLACED TO HOLD THAT MESH BACK IN PLACE. THE RIGHT SIDE OF THE MESH WAS NOT RE-TACKED BECAUSE IT HAD ALREADY INGROWN AND WAS IN PLACE ON THE ABDOMINAL WALL SINCE 2002 WHEN IT WAS PLACED. AT COMPLETION WE HAD WHAT APPEARED TO BE A VERY STRONG REPAIR. THE WOUND WAS IRRIGATED WITH BACITRACIN SOLUTION. THE HERNIA SAC WAS CLOSED USING RUNNING 2-0 VICRYL. A JACKSON-PRATT DRAIN WAS PLACED IN THE SUBCUTANEOUS TISSUE AND SUTURED IN PLACE USING 2-0 NYLON AND THEN 2-0 VICRYL WAS USED TO CLOSE THE SUBQ. THE SKIN WAS APPROXIMATED USING SKIN STAPLES. A DRY STERILE BANDAGE WAS APPLIED. AN ABDOMINAL BINDER WAS APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ ON (B)(6) 2006: CHW CENTRAL CALIFORNIA. (B)(6), MD. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. MORBID OBESITY. PROCEDURES PERFORMED: REPEAT REPAIR OF INCISIONAL HERNIA. UNDERWENT HERNIA REPAIR WITH MESH. OLD MESH HAD PULLED AWAY FROM THE MUSCLE, WAS CLEARED OFF, AND WAS ABLE TO BE RETACKED TO THE MUSCLE. DRAIN CARE INSTRUCTION GIVEN. FOLLOW UP NEXT WEEK TO REMOVE DRAIN. NO HEAVY LIFTING. ABDOMINAL BINDER TO WEAR AT ALL TIMES. ON (B)(6) 2006: KERN RADIOLOGY MEDICAL GROUP, INC. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS. FINDINGS: ABDOMEN: SINCE THE PRIOR CT ABDOMEN AND PELVIS STUDY DATED 12/09/05, THE PATIENT HAS HAD INTERVAL REPAIR OF THE VENTRAL HERNIA. ALTHOUGH THERE IS NO EVIDENCE FOR A NEW ABDOMINAL WALL HERNIA, THERE IS NEW INCREASED DENSITY WITHIN THE SUBCUTANEOUS FAT OF THE MIDLINE ANTERIOR ABDOMINAL WALL. ALTHOUGH SOME OF THE INCREASED DENSITY MOST LIKELY REPRESENTS SCARRING FROM SURGERY, THERE IS AN OVOID SHAPED REGION OF INCREASED DENSITY MEASURING 6.3 CM TRANSVERSE X 2.5 CM AP, WHICH HAS FLUID DENSITY AND IS LOCATED JUST ANTERIOR TO THE ANTERIOR ABDOMINAL WALL MUSCULATURE. EVALUATION IS SOMEWHAT LIMITED DUE TO LACK OF INTRAVENOUS CONTRAST, BUT THIS COULD CERTAINLY REPRESENT AN ABSCESS OR SEROMA. CONCLUSION: 1. SINCE THE PRIOR CT ABDOMEN AND PELVIS STUDY DATES 12/09/05, THE PATIENT HAS HAD AN INTERVAL REPAIR OF THE VENTRAL WALL HERNIA. 2. AT THE POSTOPERATIVE SITE WITHIN THE MIDLINE ANTERIOR ABDOMINAL WALL, THERE IS FLUID COLLECTION, WHICH IS MOST CONCERNING FOR AN ABSCESS; LESS LIKELY, THIS COULD REPRESENT A SEROMA. EVALUATION OF THIS FLUID COLLECTION IS SOMEWHAT LIMITED DUE TO LACK OF INTRAVENOUS CONTRAST. SURROUNDING THIS FLUID COLLECTION WITHIN THE SUBCUTANEOUS FAT, THERE ARE STREAKY DENSITIES THAT COULD REPRESENT EITHER SOFT TISSUE STRANDING OR POST SURGICAL SCARRING. 3. STATUS POST CHOLECYSTECTOMY. 4. MULTILEVEL SPONDYLOSIS. ??/??/??:[MISSING RECORDS: RECORDS FOR THE ¿GASTRIC BYPASS AND HERNIA REPAIR PROCEDURE¿ WERE NOT PROVIDED.] ON (B)(6) 2007: PASADENA MEDICAL OFFICES UPASU. RON OSTROM. CONSULTATION. STATUS POST VENTRAL HERNIA REPAIR AND GASTRIC BYPASS SURGERY, COMPLAINING OF MAROON STOOLS INCREASING OVER THE PAST TWO DAYS. CLINICAL IMPRESSION: ACTIVE GASTROINTESTINAL BLEED. STATUS POST GASTRIC BYPASS. VENTRAL HERNIA REPAIR AND ANEMIA. ADMIT FOR GASTROINTESTINAL CONSULTATION PENDING ESOPHAGOGASTRODUODENOSCOPY AND COLONOSCOPY. ON (B)(6) 2008: CHW CENTRAL CALIFORNIA. (B)(6), MD. EMERGENCY DEPARTMENT VISIT. ABDOMINAL PAIN. HAS HAD THIS PAIN BEFORE AND SHE SAYS SHE HAS A VENTRAL HERNIA. PAST SURGICAL HISTORY: GASTRIC BYPASS 2007 AND 4 HERNIA REPAIRS. ABDOMEN: TENDER AND FIRM FEELING IN THE 1 O¿CLOCK AND 2 O¿CLOCK POSITION OF THE UMBILICUS. CT OF ABDOMEN AND PELVIS, SHOWED A LARGE VENTRAL HERNIA WITHOUT OBSTRUCTION. WILL ADMIT PATIENT. ADMITTING DIAGNOSIS: SEVERE ABDOMINAL PAIN, PROBABLY INCARCERATED VENTRAL HERNIA. ON (B)(6) 2008: CHW CENTRAL CALIFORNIA. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. OPERATION PERFORMED: REMOVAL OF OLD MESH AND INCISIONAL HERNIORRHAPHY WITH MESH. ESTIMATED BLOOD LOSS: 200 ML. SPECIMENS: NONE. FLUIDS: CRYSTALLOID. REASON FOR PROCEDURE: THE PATIENT IS A 53-YEAR-OLD FEMALE WHO HAD A LAPAROSCOPIC CHOLECYSTECTOMY IN THE LATE 1990S AND DEVELOPED INCISIONAL HERNIA AFTER THAT, HAD A LAPAROSCOPIC REPAIR WHICH FAILED, HAD ACTUALLY 3 OPEN REPAIRS THAT FAILED, AND THEN UNDERWENT GASTRIC BYPASS WITH REPAIR AGAIN DURING THE GASTRIC BYPASS THAT FAILED, AND NOW PRESENTS WITH A STRANGULATED INCISIONAL HERNIA THAT WAS ABLE TO BE REDUCED AND IS NO LONGER STRANGULATED, BUT IT IS FELT REPAIR IS NECESSARY NOW BECAUSE OF THE BOUT OF STRANGULATION. THE RISK AND BENEFITS OF SURGERY, INCLUDING BLEEDING, INFECTION, AND AGAIN THE POSSIBILITY OF RECURRENT HERNIA, THE FACT THAT THIS WOULD BE A QUITE LARGE PIECE OF MESH, AND RISK OF BOWEL INJURY EXPLAINED, ETC., BUT ALSO THE FACT THAT WE FEEL IT NEEDS TO BE DONE BECAUSE OF HER BOUT OF STRANGULATION, AND THE PATIENT UNDERSTANDS AND CONSENTS TO PROCEED. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED ON THE OPERATING TABLE IN SUPINE POSITION. AFTER INDUCTION OF GENERAL ANESTHESIA, HER ABDOMEN WAS PREPPED AND DRAPED IN ROUTINE STANDARD STERILE FASHION. THE PREVIOUS MIDLINE INCISION WAS OPENED AND DISSECTION CARRIED OUT. THE HERNIA SAC WAS IDENTIFIED AND OPENED. THERE WAS NO BOWEL STUCK IN THE HERNIA SAC AT THE TIME OF OPENING. THERE WERE A FEW OMENTAL ADHESIONS THAT WERE TAKEN DOWN. THERE WERE ACTUALLY 2 FASCIAL DEFECTS DIVIDED BY THE PREVIOUS MESH. THIS WAS A BARD KUGEL COMPOSIX MESH THAT WAS WELL INCORPORATED ON THE PATIENT¿S RIDE SIDE. ON THE LEFT SIDE, IT WAS INCORPORATED IN 1 PLACE, AND ABOVE AND BELOW THIS, IT HAD BECOME UNINCORPORATED WITH HERNIAS ABOVE AND BELOW. IT WAS FIRST TAKEN OFF THE LEFT SIDE OF THE ABDOMEN WHERE IT WAS STILL ADHERENT, AND THEN IT WAS CAREFULLY DISSECTED OFF THE RIGHT SIDE OF THE ABDOMEN. THERE WERE NO BOWEL ADHESIONS TO THE MESH OR THE ABDOMINAL WALL, BUT THERE WERE OMENTAL ADHESIONS THAT WERE TAKEN DOWN WITH A COMBINATION OF BLUNT, SHARP, AND ELECTROCAUTERY DISSECTION. BLEEDING VESSELS FROM THE OMENTUM WERE CLAMPED AND TIED OFF WITH 2-0 VICRYL TIES. ONCE WE COMPLETELY REMOVED THE MESH, THE FALCIFORM LIGAMENT HAD TO ALSO BE CLAMPED AND DIVIDED AND TIED OFF IN ORDER TO GET PROPER MOBILIZATION SUPERIORLY FOR PLACEMENT OF THE NEW MESH. BECAUSE SHE HAD A GASTRIC BYPASS, WE WENT AHEAD AND EXAMINED THE ROUX-Y ANASTOMOSIS AND THE ROUX LIMB GOING UP THROUGH THE TRANSVERSE COLON MESENTERY TO MAKE SURE THERE WERE NO INTERNAL HERNIAS, AND THERE WERE NONE. THE BOWEL WAS RETURNED TO ITS NORMAL POSITION. MEASURING OUT THE SIZE OF THE DEFECT, WE ENDED UP USING AN 8 X 10 INCH PROCEED MESH. THIS WAS INITIALLY SECURED BY PLACING 8 SUTURES AROUND THE EDGE OF THE MESH, EQUALLY SPACED. THEN, STAB INCISIONS WERE MADE THROUGH THE ABDOMINAL WALL, AND A SUTURE PASSER WAS USED TO GRAB THE STITCHES AND PULL THEM THROUGH THE ABDOMINAL WALL TO HOLD THE MESH IN PLACE WITH 8 TRANSFASCIAL SUTURES. WE ENDED UP USING AN ADDITIONAL 8 SUTURES IN BETWEEN THESE THAT WERE PLACED ALSO TRASNFASCIALLY, BUT THESE WERE PLACED NOT THROUGH THE SKIN ALSO BUT FROM ANTERIOR FASCIA THROUGH POSTERIOR FASCIA AND THROUGH THE MESH. ONCE ALL THESE WERE TIED DOWN, WE HAD EXCELLENT COVERAGE AND HAD THE MESH WELL SECURED CIRCUMFERENTIALLY SO THAT BOWEL COULD NOT SNEAK IN AROUND THE MESH SUTURES. THE MESH HAD BEEN SOAKED IN BACITRACIN SOLUTION PRIOR TO PLACEMENT. THE WOUND WAS THEN COPIOUSLY IRRIGATED WITH BACITRACIN SOLUTION. ALL SPONGE, INSTRUMENT, AND NEEDLE COUNTS WERE CORRECT. A 19-FRENCH ROUND FLUTED BLAKE DRAIN WAS PLACED OVER THE TOP OF THE MESH AND BROUGHT OUT THROUGH A SEPARATE STAB INCISION. THE SUBCUTANEOUS TISSUE WAS CLOSED WITH 2-0 VICRYL, AND THEN THE SKIN WAS APPROXIMATED USING SKIN STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS EXTUBATED IN THE OPERATING ROOM, AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.¿ A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE 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: CODES 3221/11 THE MANUFACTURING RECORDS FOR DEVICE LOT NUMBER 00715807 ARE UNAVAILABLE FOR REVIEW. BASED ON AN IMPLANT DATE OF (B)(6) 2001, THE REQUIRED RECORD RETENTION PERIOD OF 10 YEARS WOULD HAVE BEEN EXCEEDED, AT THE LATEST, ON (B)(6) 2011. ALTHOUGH DOCUMENTS ARE UNAVAILABLE, STANDARD MANUFACTURING PROCEDURES REQUIRE LOT HISTORY REVIEW BEFORE RELEASE OF THE DEVICE TO ENSURE COMPLIANCE WITH DEVICE SPECIFICATIONS. CONCLUSION CODE REMAINS UNCHANGED.
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 CODE (3190) WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND IS NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2001 THROUGH (B)(6) 2008 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE TWO GORE® DUALMESH® BIOMATERIAL DEVICES. MEDICAL HISTORY: OBESITY (B)(6) 2001: ¿THIS WAS QUITE DIFFICULT OWING TO THE PATIENT¿S SIZE.¿, (B)(6) 2001: ¿INTERPRETATION OF THIS CASE IS VERY LIMITED DUE TO THE PATIENT¿S BODY HABITUS.¿, (B)(6) 2004: 300 LBS, FORMER SMOKER, HYPERTENSION, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE (GERD), RECURRENT INCISIONAL HERNIA, (B)(6) 2004: VENTRAL HERNIA WITH CONSTIPATION. SURGICAL PROCEDURES: UNKNOWN DATES: CESAREAN SECTION X5, UNKNOWN DATE: LAPAROSCOPIC CHOLECYSTECTOMY, UNKNOWN DATE: UNKNOWN GASTRIC SURGERY, UNKNOWN DATE: PRIMARY REPAIR TO VENTRAL WALL HERNIA, (B)(6) 2001: LAPAROSCOPIC REPAIR OF RECURRENT VENTRAL HERNIA. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2001: REPAIR OF RECURRENT VENTRAL HERNIA WITH MESH. REMOVAL OF OLD GORE-TEX MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL, (B)(6) 2004: REMOVAL OF HERNIA MESH WITH INCISIONAL HERNIA REPAIR. IMPLANT: BARD KUGEL COMPOSIX, (B)(6) 2006: INCISIONAL HERNIORRHAPHY WITH MESH, 2007: GASTRIC BYPASS, HERNIA REPAIR, (B)(6) 2008: REMOVAL OF OLD MESH AND INCISIONAL HERNIORRHAPHY WITH MESH. RELEVANT MEDICAL INFORMATION: (B)(6) 2001: CT ABDOMEN/PELVIS (A/P). ¿EVALUATE FOR RECURRENT ABDOMINAL WALL HERNIA. CONCLUSION: STATUS POST CHOLECYSTECTOMY AND GASTRIC SURGERY. THERE HAS BEEN REPAIR OF THE VENTRAL WALL HERNIA. CURRENTLY THERE IS NO ABDOMINAL WALL HERNIA.¿ IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2001: INDICATIONS: ¿THIS IS A 45-YEAR-OLD WOMAN WHO IS STATUS POST LAPAROSCOPIC CHOLECYSTECTOMY. SHE DEVELOPED AN INCISIONAL HERNIA AT HER SUPRAUMBILICAL CANNULA SITE. AT THE TIME OF HER REPAIR, SHE WAS ALSO FOUND TO HAVE AN UMBILICAL HERNIA. SHE HAD UNDERGONE PRIMARY REPAIR OF THESE HERNIA. SHE HAS NOW DEVELOPED A RECURRENCE.¿ IMPLANT #1 PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT VENTRAL HERNIA. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC04/00715807, 15CM X 19CM X 1MM THICK, OVAL] IMPLANT #1 DATE: (B)(6) 2001 [HOSPITALIZATION DATES NOT PROVIDED] . WOUND CLASSIFICATION: NOT PROVIDED. FINDINGS: ¿HERNIA DEFECT MEASURING APPROXIMATELY 4 CM IN TOTAL DIAMETER. IMPLANTS: DUAL MESH GORE-TEX PATCH.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿USING AN OPTI-VIEW PORT, A 12 MM CANNULA WAS PLACED AT ABOUT THE LEVEL OF THE UMBILICUS LATERAL TO THE RECTUS SHEATH. THIS WAS QUITE DIFFICULT OWING TO THE PATIENT¿S SIZE. ONCE ENTRY WAS MADE, PNEUMOPERITONEUM WAS DEVELOPED. UNDER DIRECT VISION, 5 MM CANNULAS WERE PLACED IN THE LEFT UPPER QUADRANT AND LEFT LOWER QUADRANT LATERAL TO THE RECTUS SHEATH. THERE WAS SOME ADHESIONS PRIMARILY OF OMENTUM THAT WERE TAKEN DOWN USING SHARP DISSECTION AND ELECTROCAUTERY. THE HERNIA WAS THEN REDUCED AND THE ENTIRE HERNIA DEFECT WAS IDENTIFIED AND MOBILIZED. THIS WAS QUITE DIFFICULT OWING TO THE PATIENT¿S ADHESIONS AND HER SIZE. THIS REQUIRED PLACEMENT OF AN ADDITIONAL CAMERA PORT ON THE RIGHT AND ADDITIONAL WORKING PORTS IN THE RIGHT UPPER QUADRANT AND RIGHT LOWER QUADRANT. THE HERNIA DEFECT WAS MEASURED USING A SPINAL NEEDLE AND WAS NOTED TO BE 4 CM IN DIAMETER.¿ IMPLANT SIZE AND FIXATION: ¿MESH WAS THEN USED THAT WAS 3 CM LARGER THAN THE HERNIA DEFECT. PROLENE AND GORE-TEX SUTURES WERE PLACED AT THE 12:00, 3:00, 6:00 AND 9:00 POSITIONS OF THE MESH ALTERNATING THE SUTURES. THE MESH WAS THEN DELIVERED INTO THE PERITONEAL CAVITY. USING THE SUTURE PASSER DEVICE, THE SUTURES WERE BROUGHT THROUGH THE FULL THICKNESS OF THE ABDOMINAL WALL. THESE WERE THEN TIED. THE LEFT MOST LATERAL STITCH HAD FRAYED AND BROKEN BUT WAS STILL SECURE. THEN USING THE SPIRAL TACKER, THE MESH WAS SECURED TO THE ABDOMINAL WALL. THE ABDOMINAL [SIC] WAS IRRIGATED AND THE IRRIGANT WAS WITHDRAWN. THE REDUCED CONTENT OF THE HERNIA AS WELL AS THE AREAS OF ADHESIOLYSIS WERE INSPECTED AND HEMOSTASIS WAS NOTED TO BE GOOD. THE CANNULA WAS WITHDRAWN UNDER DIRECT VISION AND THE ABDOMEN WAS DESUFFLATED. THE SKIN WAS THEN CLOSED USING SKIN STAPLES.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2001: RADIOLOGY ABDOMEN. ¿INDICATION: RUPTURED UMBILICAL HERNIA REPAIR. INTERPRETATION OF THIS CASE IS VERY LIMITED DUE TO THE PATIENT¿S BODY HABITUS. THERE IS, HOWEVER, NO EVIDENCE OF INTESTINAL OBSTRUCTION. ALSO NO CRITERIA FOR ADYNAMIC ILEUS.¿ (B)(6) 2001: CT A/P. ¿INDICATION: LEFT SIDED ABDOMINAL PAIN . FINDINGS: THE PATIENT IS STATUS POST SURGERY FOR ANTERIOR ABDOMINAL WALL HERNIA AS THERE IS MESH DEMONSTRATED IN THE ANTERIOR ABDOMINAL WALL. IN THE LEFT PARACENTRAL REGION, THERE IS RECURRENCE OF ANTERIOR ABDOMINAL WALL HERNIA. THE CONTENTS OF HERNIA ARE MAINLY OMENTUM BUT THE OMENTAL FAT IN THE REGION OF THE HERNIA IS VERY STRIATED AND ALSO THERE IS SOME FLUID SEEN IN THE HERNIAL SAC, SUGGESTIVE OF INFLAMMATORY CHANGES. NO BOWEL LOOPS ARE SEEN WITHIN THE HERNIA. IMPRESSION: THE FINDINGS ARE SUGGESTIVE OF RECURRENCE OF ANTERIOR ABDOMINAL WALL HERNIA ON THE LEFT SIDE IN THE PARACENTRAL PORTION . THE HERNIAL SAC MAINLY CONTAINS OMENTAL FAT. THE OMENTAL FAT HAS EXTENSIVE STRIATIONS, REPRESENTING INFLAMMATORY CHANGES. ALSO, THERE IS FLUID PRESENT WITHIN THE HERNIAL SAC. THESE FINDINGS ARE SUGGESTIVE OF POSSIBILITY OF INCARCERATED HERNIA. OVERALL, THE HERNIAL SAC MEASURES ABOUT 11 CM. NO EVIDENCE OF ANY BOWEL CONTENTS WITHIN THE HERNIAL SAC. POST-OPERATIVE CHANGES OF ANTERIOR ABDOMINAL WALL HERNIA REPAIR. MILD FATTY INFILTRATION OF LIVER.¿ EXPLANT #1 AND IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2001: INDICATIONS: ¿THIS IS A 45-YEAR-OLD WOMAN STATUS POST LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA. SHE CONTINUED TO HAVE PAIN IN THE LOWER PORTION OF HER ABDOMEN. A CT OF HER ABDOMEN SUGGESTED A CHRONIC INCARCERATION OF FAT.¿ EXPLANT #1 AND IMPLANT #2 PROCEDURE: REPAIR OF RECURRENT VENTRAL HERNIA WITH MESH. REMOVAL OF OLD GORE-TEX MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL 1DLMC04/00651144, 15CM X 19CM X 1MM THICK, OVAL]. EXPLANT #1 AND IMPLANT #2 DATE: (B)(6) 2001 [HOSPITALIZATION DATES (B)(6) 2001]. WOUND CLASSIFICATION: ¿CLEAN¿. FINDINGS: ¿A WELL-INCORPORATED GORE-TEX DUAL MESH. EVIDENCE OF INCARCERATED OMENTAL SAC BELOW THE LEFT LOWER PORTION OF THE MESH. NO EVIDENCE OF BOWEL INCARCERATION. SPECIMENS: NONE.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿A MIDLINE INCISION WAS MADE AROUND THE UMBILICUS. USING SHARP DISSECTION, THE FASCIA WAS INCISED. THERE WAS SOME EDEMATOUS-APPEARING TISSUE BELOW THE FASCIA. THIS WAS BLUNTLY MOBILIZED UNTIL THE MESH WAS IDENTIFIED. THE SUPERIOR PORTION OF THE MESH WAS IDENTIFIED. IT WAS FREED FROM ITS ATTACHMENTS TO THE FASCIA. THE MESH WAS THEN INCISED SHARPLY USING MAYO SCISSORS. THERE WERE NO ADHESIONS OF BOWEL OR OMENTUM TO THE MIDLINE PORTION OF THE MESH. THE MESH WAS COMPLETELY DIVIDED IN THE MIDLINE. THE MESH WAS THEN MOBILIZED LATERALLY. THE OMENTUM WAS ADHERENT TO THE SITES OF SOME OF THE SPIRAL TACKS. VERY CAREFULLY THESE WERE EXCISED. THERE WAS NO EVIDENCE OF ATTACHMENT OF BOWEL TO THE MESH OR THE TACKS. ONCE THE UNDERLYING OMENTUM WAS MOBILIZED OFF THE MESH, IT BECAME CLEAR THAT THERE WAS SOME OMENTUM THAT HAD BECOME TRAPPED UNDER THE MESH AT ITS INFERIOR LEFT PORTION. THIS WAS REDUCED. THE MESH WAS THEN REMOVED FROM THE UNDERSURFACE OF THE FASCIA. ALL THE SPIRAL TACKS WERE REMOVED. SIMILARLY, THE RIGHT SIDE OF THE MESH WAS MOBILIZED AND THEN REMOVED. THE UNDERSURFACE WAS PALPATED AND THE REMAINING PACKS [SIC] WERE REMOVED. THE ANTERIOR SURFACE OF THE FASCIA WAS THEN CLEARED. THE HERNIA SAC AT THE UMBILICUS WAS IDENTIFIED, MOBILIZED AND EXCISED. THE FASCIA WAS CLEARED CIRCUMFERENTIALLY FOR A DISTANCE OF APPROXIMATELY 3 CM.¿ IMPLANT SIZE AND FIXATION: ¿A 15 BY 19 CM OVAL GORE-TEX DUAL MESH WAS THEN DELIVERED INTO THE FIELD AND SOAKED IN ANTIBIOTIC SOLUTION. THE MESH WAS SECURED TO THE UNDERSURFACE OF THE FASCIA USING INTERRUPTED # 0 PROLENE SUTURE IN A HORIZONTAL MATTRESS STITCH. SUTURES WERE PLACED PRIOR TO TRYING [SIC] THEM. BEFORE THE SUTURES WERE SECURED, THE MESH WAS INSPECTED AND THERE WERE NO GAPS AT THE MESH INTERFACE. THE MESH WAS THEN SECURED. THE WOUND WAS THEN IRRIGATED. SCARPA¿S FASCIA WAS THEN CLOSED OVER THE MESH ATTEMPTING TO CLOSE THE DEAD SPACE OVER THE MESH. INTERRUPTED # 2-0 VICRYL SUTURES WERE USED. SEVERAL SUBDURAL # 2-0 VICRYL WERE USED TO REAPPROXIMATE THE SKIN. THE SKIN WAS THEN CLOSED USING SKIN STAPLES. AND [SIC] ABDOMINAL BINDER WAS APPLIED.¿ PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE (B)(6) 2001 PROCEDURE WAS NOT PROVIDED. (B)(6) 2001: DISCHARGE SUMMARY. ¿CONDITION AT DISCHARGE: GOOD. FOLLOW UP IN ONE WEEK.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2002: X-RAY ABDOMEN. ¿INDICATION: SMALL BOWEL OBSTRUCTION. SURGICAL CLIP IS SEEN IN THE RIGHT UPPER QUADRANT. METALLIC RINGS AND CLIPS ARE SEEN AND APPARENTLY THESE WERE USED AS PART OF A VENTRAL HERNIA REPAIR WITH MESH. THERE IS NO OBSTRUCTION, PERFORATION, OR ASCITES. IMPRESSION: POSTOPERATIVE CHANGES. SUGGESTION OF SLIGHT ENLARGEMENT OF THE RIGHT LOBE OF THE LIVER. NO ACUTE ABDOMINAL PROCESS.¿ (B)(6) 2003: EMERGENCY ROOM. ¿SAYS, ¿MY HERNIA IS HURTING .¿¿ ABDOMEN: ¿MIDLINE SCARS PRESENT WITH MILD TENDERNESS, NO EVIDENCE OF INCARCERATED HERNIA. THREE-WAY ABDOMINAL SERIES WAS UNREMARKABLE. ABDOMINAL EVALUATION. FOLLOW UP WITH HER DOCTOR.¿ (B)(6) 2003: CT A/P. INDICATIONS: ¿RECURRENT VENTRAL HERNIA, NOW WITH RECURRENT ABDOMINAL PAIN. SINCE THE PREVIOUS EXAMINATION OF THE PATIENT IS STATUS POST OF VENTRAL HERNIA WITH MESH. THERE IS DEHISCENCE OF ANTERIOR ABDOMINAL WALL AGAIN WITH RECURRENCE OF LARGE VENTRAL HERNIA. THE CONTENTS OF HERNIA INCLUDE SMALL AND LARGE BOWEL LOOPS. THERE IS NO EVIDENCE OF ANY HERNIA INCARCERATION. CONCLUSION: 1. SINCE THE PREVIOUS EXAMINATION, THE PATIENT HAS UNDERGONE REPAIR OF VENTRAL HERNIA WITH MESH. HOWEVER, THERE IS DEHISCENCE OF THE MESH WITH RECURRENCE OF HERNIA. THE CONTENTS OF HERNIA INCLUDE SMALL AND LARGE BOWEL LOOPS. PRIOR CHOLECYSTECTOMY.¿ EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2004: EMERGENCY ROOM. ¿SCHEDULED FOR RECURRENT VENTRAL HERNIA REPAIR ON MONDAY. PATIENT STATES SHE CANNOT WAIT THAT LONG BECAUSE HER PAIN HAS GOTTEN TOO SEVERE. SHE IS STATUS POST HERNIA REPAIR IN (B)(6) 2001, I BELIEVE SHE HAD A REDO PROCEDURE WITH SOME MESH PLACEMENT WITH RECURRENCE HERNIA. PATIENT REPORTS PAIN IN LOWER ABDOMINAL AREA WHERE THE HERNIA IS AND SHE THINKS IT IS STRANGULATED. NAUSEATED AND CONSTIPATED. WEIGHT 300 POUNDS. DIFFICULT TO ASSESS THE HERNIA BECAUSE OF THE PATIENT¿S VERY LARGE SIZE. DIFFICULT TO DETERMINE WHAT AREA IS HERNIATED. DOES NOT APPEAR TO BE ANY INCARCERATED OR STRANGULATED HERNIA PRESENT AND THERE IS NO SIGNIFICANT TENDERNESS TO PALPATION OVER THE AREA OF HERNIA. DIAGNOSIS: VENTRAL HERNIA WITH CONSTIPATION.¿ (B)(6) 2004: INDICATIONS: ¿THIS IS A 48-YEAR-OLD LADY WITH RECURRENT INCISIONAL HERNIA. SHE MADE ATTEMPTS AT WEIGHT LOSS THAT WERE UNSUCCESSFUL. SHE IS NOW HAVING INCREASING PAIN.¿ EXPLANT #2 PROCEDURE: REMOVAL OF HERNIA MESH WITH INCISIONAL HERNIA REPAIR. [IMPLANT: BARD KUGEL COMPOSIX] EXPLANT #2 DATE: (B)(6) 2004 [HOSPITALIZATION DATES (B)(6) 2004]. WOUND CLASSIFICATION: ¿CLEAN¿ . FINDINGS: ¿FINDINGS: 1. FREE-FLOATING GORE-TEX MESH. 2. INCISIONAL HERNIA DEFECT MEASURING 12 X 16 CM.¿ PROCEDURE: ¿THE PREVIOUS MIDLINE INCISION WAS USED. THE HERNIA SAC WAS IDENTIFIED AND CIRCUMFERENTIALLY MOBILIZED. THE HERNIA WAS ENTERED. THE PREVIOUSLY PLACED GORE-TEX MESH WAS IDENTIFIED. IT HAD SEPARATED FROM THE FASCIAL CONNECTIONS ALMOST CIRCUMFERENTIALLY EXCEPT FOR ITS MOST INFERIOR PORTION. THE MESH WAS MOBILIZED AND EXCISED OFF THE UNDERLYING OMENTUM. T HE ABDOMINAL WALL WAS THEN CLEARED ON ITS PERITONEAL SURFACE OF ADHESIONS. THE FALCIFORM LIGAMENT WAS MOBILIZED OFF THE ABDOMINAL WALL FOR A SHORT DISTANCE ABOVE THE INCISION. ONCE THE ENTIRE HERNIA HAD BEEN MOBILIZED, THE DEFECT MEASURED APPROXIMATELY 16 CM IN LENGTH X 12 CM IN WIDTH. TWO 13.8 X 17.8-CM BARD KUGEL COMPOSIX MESH WERE DELIVERED ONTO THE FIELD. THEY WERE THEN SEWN TOGETHER ALONG THE LONGITUDINAL AXIS SO THAT THE TOTAL LENGTH WOULD MEASURE APPROXIMATELY 22 CM. THE MESH WAS THEN INSERTED WITH BOTH MESH LYING TRANSVERSELY IN THE WOUND. IT APPEARED TO GIVE ADEQUATE FASCIAL OVERLAP OF GREATER THAN 3-4 CM AROUND THE DEFECT. THE MESH WAS THEN SOAKED IN ANTIBIOTIC SOLUTION AND # 0 PDS SUTURES WERE PLACED CIRCUMFERENTIALLY AROUND THE MESH ALONG THE SUTURE RING. THE MESH WAS PLACED IN THE SUBFASCIAL POSITION AND THEN SECURED TO THE UNDERSURFACE OF THE FASCIA WITH THE PREVIOUSLY PLACED SUTURES. THE MESH WAS INSPECTED AND IT CAME TO LIE NICELY. SEVERAL SMALL GAPS WERE REPAIRED WITH PDS SUTURE. THE WOUND WAS IRRIGATED AND HERNIA SAC WAS THEN MOBILIZED FROM THE SOFT TISSUE AND USED TO COVER THE MESH. THE WOUND WAS THEN MOBILIZED FROM THE SOFT TISSUE AND USED TO COVER THE MESH. THE WOUND WAS IRRIGATED. TWO FLAT 10-MM DRAINS WERE THEN BROUGHT IN THROUGH SEPARATE STAB INCISIONS TO THE LOWER PORTION OF THE INCISION. THEY WERE SECURED WITH NYLON SUTURES. THE UMBILICUS AND SCARPA¿S FASCIA WERE THEN RE-APPROXIMATED WITH PDS SUTURES AND THE WOUND WAS IRRIGATED AND THE SKIN CLOSED USING SKIN STAPLES. AN ABDOMINAL BINDER WAS PLACED.¿ PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE(B)(6) 2004 PROCEDURE WAS NOT PROVIDED. (B)(6) 2004: DISCHARGE. ¿POSTOPERATIVELY PATIENT DID WELL. PATIENT HAS BEEN INSTRUCTED ON DRAIN CARE AND WOUND CARE. DISCHARGED IN STABLE CONDITION.¿ CONCLUSION: #1 GORE® DUALMESH® BIOMATERIAL, 00715807. 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.¿ AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(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 LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2001, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL REQUIRING TWO ADDITIONAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741323 | GORE DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC04 | 00715807 | 00733132600977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Hospitalization| R |