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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 2005; including appendectomy, right herniorrhaphy, left inguinal herniorrhaphy and sigmoid resection with anastomosis were not provided.(b)(6) 2003: [missing records: records for the ¿incisional hernia repair¿ were not provided.] (b)(6) 2005: (b)(6), md.Office note.Developed recurrent incisional hernia.Hernia has increased in size over past year.History: incisional hernia repair (b)(6) 2003; appendectomy as a child; right herniorrhaphy about 25 years ago, left inguinal herniorrhaphy 1998, sigmoid colon resection with anastomosis 1999 for colon cancer; colonoscopy (b)(6) 2000; excision of stitch abscess (b)(6) 2002.Has occasional beer.Abdomen: normal bowel sounds; has recurrent incisional hernia upper midline incision.(b)(6) 2005: (b)(6), md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Procedure performed: recurrent incisional herniorrhaphy with mesh repair.First assistant: (b)(6), md.Second assistant: (b)(6), md.Anesthesia: general.Indications for surgery: mr.(b)(6) is a 69-year-old caucasian male who has had a previous incisional hernia repair.The patient has had a recurrence and so therefore he is undergoing a repeat repair.Description of procedure: ¿the patient received ancef 1 gm intravenously preoperatively.He was prepped and draped in the usual manner.An incision was made over the hernia sac.Dissection was carried down to the hernia sac.The hernia sac was then sharply dissected from the surrounding tissues down to the fascia circumferentially around the opening.The sac was opened and then amputated.Examination revealed that there were several other smaller holes in the fascia and these were all connected to make one large hole.After this was completed, the dual mesh was then cut to shape and sutured in place using interrupted 0 prolene sutures.The patch was sewn underneath the fascial layer.The operative area was thoroughly irrigated.Hemostasis was complete.The incision was then injected with 0.5% marcaine with epinephrine.A jackson-pratt drain was then placed in the operative area and sutured in place using a 3-0 nylon suture.The incision was then closed in layers using a running 3-0 vicryl for the deep and superficial layers.The skin was closed with 4-0 vicryl subcuticular stitch.Steri-strips were applied.The patient tolerated the operation and returned to recovery in stable condition.¿ (b)(6) 2005: altru health system.Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp02.Lot batch code: 03650018.W.L.Gore & associates.# implant 1.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp02/03650018) was implanted during the procedure.(b)(6) 2005: (b)(6), md.Pathology report.Case: (b)(6).Clinical history: hernia increased in size, history of incisional hernia repair 2003.Specimen received: hernia sac/lipoma.Gross description: submitted in formalin, labeled with the patient¿s name and ¿hernia sac¿ are irregularly pieces of lobulated yellow and hemorrhagic soft tissue measuring 9 x 6.5 x 2.5 cm in aggregate.Some of the fragments demonstrate attached fibromembranous tissue.Representative sections in 1 cassette.Microscopic description: the slides show cross sections of mature adipose tissue and fibrous tissue.Adipose tissue component shows a normal vascular pattern.Fibrous component shows a focal flat surface lined by gland mesothelial cells.Diagnosis: soft tissue, abdominal region, incisional hernia repair: fibrous hernia sac and attached benign adipose tissue.(b)(6) 2007: (b)(6), md.Office note.Seen for recurrent incisional hernia.Symptomatic in that it¿s tender especially when he lifts anything.Denies any incarceration or overlying skin changes.Abdomen: soft; recurrent incisional hernia easily reducible.Discussed fact that we would need to use mesh, the risks and benefits of using mesh, and the fact that this may recur even with mesh.He understands and wishes to proceed.(b)(6) 2007: (b)(6), np.Office note.Wearing abdominal belt to keep hernia from protruding.States when he has significant protrusion, there is an amount of pain associated with it.Denies any incarceration symptoms.Medications: aspirin (stopped (b)(6) 2007).Weight 234 lbs.(b)(6) 2007: (b)(6), md.Operative report.Preoperative diagnosis: recurrent ventral incisional hernia.Postoperative diagnosis: recurrent ventral incisional hernia.Procedure performed: repair of ventral incisional hernia with 6 x 6 prolene soft mesh.Assistant: nathaniel p.Reuter, md, pgyv.Anesthesia: general.Indication: (b)(6) is a 71-year-old who presents with asymptomatic recurrent incisional hernia for repair.We have discussed the surgery and the risks, benefits, and alternatives of surgery.He understands and wishes to proceed.Procedure: ¿the patient was brought to the operating room, placed under general anesthesia, and prepped and draped sterilely with betadine solution.Midline incision was made with a #10 blade and dissection was carried down through the subcutaneous tissues using electrocautery.We encountered the hernia sac.Then we dissected flaps free superiorly, inferiorly, medially, and laterally, all with electrocautery.We carried this down to the fascia.We found 3 hernias, all in the same area; one 2 cm in size and two 1 cm hernias.We removed some old ethibond sutures and some old prolene sutures and then began our repair.We placed a 6 x 6 piece of prolene soft mesh over the top of the entire area with a good 3 cm around each side to aid our repair.We then tacked it to the surrounding fascia with interrupted 0 prolene and interrupted 0 vicryl.The area was then anesthetized with 30 ml of 0.5% sensorcaine with epinephrine solution.The umbilicus was tacked back down to the fascia with 3-0 undyed vicryl and the skin was then closed with skin clips.All sponge and needle counts were correct.He tolerated this well and was taken to recovery in stable condition.¿ records between (b)(6) 2007 and (b)(6) 2010 were not provided.(b)(6) 2010: (b)(6), md.Operative report.Preoperative diagnoses: small bowel obstruction.Recurrent ventral hernia.Postoperative diagnosis: small-bowel obstruction secondary to adhesions with a small ventral wall hernia.Procedures performed: exploratory laparotomy.Lysis of adhesions.Repair of a ventral wall hernia.Assistant: (b)(6), md, pgyv.Anesthesia: general.Estimated blood loss: 200 ml.Findings: ¿this 74-year-old male has been followed most of the week with what was thought to be a partial small-bowel obstruction.After initially improving with an ng tube and iv fluids, his x-ray over the last 48 hours began to get worse and he developed recurrent nausea.He has had a colon resection for cancer in 1999 and had 4 hernia repairs in the past.Op notes were reviewed and 1 surgeon reports putting in a 6 x 6-inch piece of prolene mesh.Another surgeon at an earlier date had put in a dualmesh of unknown size.¿ the patient [remaining pages missing].Records between (b)(6) 2010 and (b)(6) 2017 were not provided.(b)(6) 2017 (b)(6), md.Operative report.Preop diagnosis: recurrent ventral incisional hernia with cholelithiasis, history of acute cholecystitis.Preop indication: prevent future episodes of cholecystitis, prepare for abdominal wall ventral hernia repair, prevent infection.Assistant: (b)(6), mbbs.Postop diagnosis: recurrent ventral incisional hernia with cholelithiasis.History of acute cholecystitis.Chronic cholecystitis.Procedure: exploratory laparotomy.Lysis of adhesions of 45 minutes.Open cholecystectomy.Bilateral transversus abdominis plane blocks with liposomal bupivacaine.Temporary abdominal closure with abthera device.Anesthesia: general endotracheal, liposomal bupivacaine 20 cc or 266 mg, 0.25% bupivacaine 50 cc of 125 mg.Blood loss: 37 cc.Fluids receive: 1 l of crystalloid.Complication: none.Procedure: ¿the patient was brought to the operating room where he was successfully induced under a general anesthetic.The abdomen was prepped with chloraprep and draped in the usual sterile fashion.He has a midline laparotomy incision with two dominant hernias.We came through the skin with a scalpel and subcutaneous tissues with bovie electrocautery.We entered the upper hernia sac.He had numerous adhesions of bowel and omentum into the hernia.These were sharply taken down with bovie electrocautery.He has many small vessels through scar, and we had to achieve meticulous hemostasis with the cautery.We continued to divide a fascial band between the upper hernia defect and lower defect and continued with our extensive adhesiolysis.We then took omentum and small bowel off the anterior abdominal wall, extending to right, extending inferiorly, and extending to the left.After approximately 45 minutes of lysis of adhesions, we were able to see the gallbladder.It was chronically inflamed.We packed over the liver for exposure and placed a bookwalter retractor.We were able to performed [sic] a retrograde dissection of the gallbladder.We skeletonized the cystic artery and divided it.I was trying to skeletonize the cystic duct when i punctured the gallbladder.We had spillage of bile and small stones.All of these were recovered.We then divided the cystic duct with ligature of 0 vicryl.We then thoroughly irrigated out the right upper quadrant and checked for hemostasis.At the gallbladder, there we some bleeding form the peritoneal edge which was easily controlled with cautery.We rinsed out with suction irrigation.We then spent a lot of time looking for additional small bleeding vessels from omentum and adhesions.These were cauterized or suture ligated.Once we were happy with hemostasis, we examined the hernias themselves.The lower hernia defect was associated with a large sac, extending to the left.However, the fascial edges were approximately 11 cm apart for the lower defect and 11 cm apart for the upper defect.With traction on the fascial edges, i felt that we could get them within 2 or 3 cm of midline, making the patient a candidate for anterior component separation.Because of chronic cholecystitis and spillage of bile, we opted to perform temporary abdominal closure to allow him to get two days of antibiotics to reduce the risk of infection.We placed an abthera vacuum dressing with a grandma nellie¿s type closure.The octopus portion of the dressing was placed against the viscera and a small blue sponge placed over this and then interrupted 0 vicryl sutures from hernia sac on the left side to fascial edge on the right side followed by a third sponge in the subcutaneous space.Our occlusive dressing was hooked up to this to 125 mm continuous suction.The plan is for the patient to return to the operating in 48 hours for abdominal reconstruction and antibiotics bead implantation.¿ wound type: type iii ¿ contaminated.(b)(6) 2017 (b)(6), md.Operative report.Preop diagnosis: giant ventral incisional hernia status post exploration and cholecystectomy, temporary abdominal closure.Preop indication: restore abdominal wall integrity, relieve pain, suppress infection, promote healing.Assistant: (b)(6), md; (b)(6), md; (b)(6), md.Postop diagnosis: giant ventral incisional hernia status post exploration and cholecystectomy, temporary abdominal closure.Procedure: removal of temporary abdominal closure.Ventral hernia repair with bilateral cutaneous advancement flaps of 25 x 10 cm on the left, 25 x 10 cm on the right.Surgimend 3.0 onlay measuring 20 x 30 cm.Antibiotic bead implantation of 30 beads.Incisional vac dressing.Drainage: 2 jackson-pratt drains.Graft/ implant information: lot/ serial #: (b)(6); catalog/ model #: 606-300-017; implant name: surgimend rectangle 3.0 20 cm x 30 cm; manufacturer: integra lifesciences corp; implant placement: abdominal; fluid: normal saline; lot/ serial #: (b)(6), expiration date: 07/03/2017.Anesthesia: general endotracheal.Blood loss: 133 cc.Fluids received: 2.3 l of crystalloid, 500 cc albumin.Drains: left jackson-pratt 15 french, right jackson-pratt 19 french.Complications: none.Procedure: ¿patient was brought to the operating room where was successfully induced under a general anesthetic.His temporary abdominal dressing of abthera was removed with the top dressing and one piece of sponge, and the abdomen was prepped with hibiclens and draped in the usual sterile fashion.After a surgical pause, we removed the gramma nellie¿s closure and the two remaining pieces of abthera.We explored the abdomen.There was a small amount of blood clot which was evacuated.Otherwise, finding ins [sic] in the abdomen were unremarkable.Omentum was already scarred down around the gallbladder fossa.Patient had retraction of his external oblique fascia.We began to mobilize hernia sac first on the left side and then on the right side.We did not amputate hernia sac until we were sure that we could get omentum together.We did encounter two pieces of retained polypropylene mesh from his previous mesh infection.One was in the left midabdomen, and one was at the lower midline.We performed meticulous dissection to expose external oblique.We marked the lateral extent of the rectus muscle near midline.Dissection was very difficult because of extensive fibrofatty tissue, and it was a very tedious dissection.We had to divide several perforators.We ultimately developed flap 25 cm in length and 10 cm in width on the left side.We repeated the process on the right side and dissected a majority of the hernia sac out from the subcutaneous space.We felt that we could get fascia to midline.Up around to the xiphoid process, it was difficult to say whether there was hernia sac here or whether this represented diastasis recti.The rectus muscles were separated a bit, and the xiphoid process was rather prominent.We did clear off skin flaps superior to the xiphoid process extending up on to the sternum and below the lower point of the inferior aspect of the hernia defect on towards the pubis.We then noted that the defect measured approximately 8 x 22 cm, but we were able to get the fascia together.We amputated the sac from the edge of the rectus muscles.We closed rectus muscles with interrupted 0 pds sutures.We did imbricate diastasis up at the level of the xiphoid process.We then took a 20- x 30-cm piece of surgimend 3.0 and began tacking this into the wound with interrupted pds sutures.We started on the left side with an outer-most line of interrupted pds sutures as an onlay onto the external oblique.These were advanced.We then did three lines of advancement sutures on the left side of our midline fascia closure and three lines of interrupted pds advancement sutures on the right side.We tacked the mesh up to sternum above the xiphoid process onto rib cage and down toward pubis.There was excellent tension on the mesh throughout.We brought a 15-french round jp drain under the surgimend out through a left stab wound.This was sewn in place with 2-0 prolene.We brought a 19-french round jp drain out through a stab wound in the right.This was left on the surgimend.We then mixed antibiotic beads with a full dose of bone cement mixed with 2 g of vancomycin and 2.4 g gentamicin, b diameters approximately 1.5 cm.We had two stringers and 15b zetron prolene for a total of 30 beads which were placed in midline wound.We irrigated with pulse irrigation and achieved final hemostasis.We did excise scarred skin edges for skin incision of approximately 50 cm2 total body surface area.We then closed the skin incision with vertical mattress sutures of 0 prolene followed by numerous interrupted staples following by an incisional vac dressing.The patient tolerated the procedure well.There were no complications.¿ wound type: type iii ¿ contaminated.(b)(6) 2017: (b)(6), md.Hospital summary.Additional diagnoses: history of enterocutaneous fistula with mesh infection status post explantation of infected mesh and fistula takedown; moderate copd; bilateral iliac artery aneurysms, stable; benign prostatic hypertrophy status post turp [transurethral resection of prostate]; gastroesophageal reflux disease; ascending aorta dilatation; history of nicotine dependence, 50 pack year history.Brief hospital course: tolerated both procedures.Progressed without complications.Jackson-pratt drain instructions, open cholecystectomy wound care instructions printed.[missing records: records regarding the patient¿s ¿enterocutaneous fistula with mesh infection status post explantation of infected mesh and fistula takedown¿ were not provided.] (b)(6) 2017 (b)(6), md.Operative report.Preop diagnosis: status post ventral hernia repair with surgimend onlay, antibiotic bead implantation of 30 beads.Preop indication: suppress infection, promote healing.Assistant: (b)(6), md.Visit type: outpatient.Postop diagnosis: status post ventral hernia repair with surgimend onlay; antibiotic bead implantation of 30 beads.Procedure: midline abdominal incision.Explantation of 30 antibiotic beads.Irrigation, debridement.Implantation of eight beads (five upper incision, three lower incision).Drainage: 1 15-french jp drain.Anesthesia: general endotracheal and 6 cc of 0.25% bupivacaine.Fluids received 600 cc.Ebl [estimated blood loss] 27 cc.Procedure: ¿the patient was brought to the operating room where he was successfully induced under general anesthetic.The abdomen was prepped with chloraprep and draped in the usual sterile fashion.After a surgical pause, we first made our lower midline incision.It was approximately 6 cm in length and over what i could feel through skin as antibiotic beads.I came through the skin with a scalpel and subcutaneous tissue with bovie electrocautery.The beads were well-incorporated in the scar.There were only two areas of visible surgimend, each measuring approximately 5 x 2 cm on either side of midline.Fifteen beads were recovered with the lower stringer.We then made a counterincision at the upper pocket.This had more of a cavity over the surgimend, which measured approximately 15 x 8 cm.Fifteen beads were recovered on a second stringer.We irrigated, used kashiwagi, and checked for hemostasis, which was excellent.We placed a single 15-french jp drain from a stab wound in the left abdomen and threaded first through the superior cavity and then through scar into the inferior cavity.We fashioned antibiotic beads at half-dose of bone cement mixed with 1 g of vancomycin, 1.2 g of gentamicin.We made approximately 20 beads, 1.5 cm in diameter.Of these, we used three beads on a single stringer to place on the lower wound and five beads on a single stringer to place in the upper wound.The skin was closed with vertical mattress sutures of prolene followed by numerous staples.Sterile dressing was applied.The drain was sewn in place with prolene.The patient tolerated the procedure well.There were no signs of infection, and everything appeared healthy.The plan is for beads to remain in place for another six months, at which time i think he can probably have complete explantation.¿ wound type: type iii ¿ contaminated.(b)(6) 2017: (b)(6), md.Operative report.Prep diagnosis: status post ventral herniorrhaphy with surgimend onlay, antibiotic bead implantation, skin separation.Preop indication: prevent infection, promote healing.Assistant: (b)(6), md.Visit type: outpatient.Postop diagnosis: status post ventral herniorrhaphy with surgimend onlay, antibiotic bead implantation, skin separation.Procedure: abdominal wall incision and debridement.Antibiotic bead exchange of five beads out and five beads in.Repeat skin closure over 9 cm.Drainage: 1 jackson-pratt drain.Anesthesia: general endotracheal and 60 cc of 0.25% bupivacaine.Procedure: ¿patient was brought to the operating room where he was successfully induced under a general endotracheal anesthetic.He had two suture and staple lines.At the upper one, there was a very small skin separation with fluid emanating from it.We removed staples and sutures and excised the very edge of epidermis.We retrieved five antibiotic beads from the upper wound; three antibiotic beads from prior bead implantation were left in the lower wound as the skin appeared quite healthy here.The surgimend appeared healthy.We debrided with a kashiwagi and irrigated with 3 l of saline solution.Skin flap to the left of midline had sealed down, and so we opted to bring the drain out of a right-sided skin stab wound.We used a 15-french jp drain which was continued through the upper wound cavity of the surgimend, and we found a small communication to the inferior collection of three retained antibiotic beads.We fashioned new antibiotic beads out of a half dose of bone cement using 1 g of vancomycin and 1.2 g of gentamicin, making beads 1.5 cm in diameter.We placed five of these beads on a prolene stringer and placed them in the wound.We infiltrated the wound edges with a total of 60 cc of 0.25% bupivacaine and closed our incision of 9 cm with vertical mattress sutures of 0 prolene followed skin staples.Sterile dressings were applied.The patient tolerated the procedure well.There were no complications.¿ wound type: type iii ¿ contaminated.There is no mention of gore device removal in the records.Records after (b)(6) 2017 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 gore® dualmesh® plus biomaterial 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.
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