Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2007: (b)(6) health center.(b)(6), md.Indications: ¿this 39-year-old female underwent a repair of an incisional hernia with mesh about a year ago and has developed a recurrence in the left lateral aspect.The procedure, risks, benefits, and indication were explained to the patient, and she understands and gives her consent.She was evaluated prior to procedure and felt to be stable to tolerate the procedure.¿ implant procedure: 1.Laparoscopic repair of incisional hernia with dual mesh.2.Adhesiolysis, 90 minutes.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/(b)(4), 15cm x 19cm x 1mm thick].Implant date: (b)(6) 2007 [medical record states date of surgery(b)(6) 2007] [outpatient surgery].(b)(6) 2007: (b)(6) health center.(b)(6), md.Operative report.Preoperative diagnosis: 1.Incisional hernia.Postoperative diagnosis: 1.Incisional hernia.2.Dense intra-abdominal adhesions.Anesthesia: general.Estimated blood loss: minimal.Wound classification: not provided.Procedure: ¿after adequate levels of general endotracheal anesthesia, the patient's abdomen was prepped and draped in a sterile fashion.An incision was made in the right upper quadrant through which a 5 port was passed into the peritoneal cavity.The laparoscope was inserted, and the entire anterior abdominal wall was obliterated with adhesions between bowel and omentum and abdominal wall.I was able to clear small amounts of the left lower quadrant in order to place a 5 port.I sequentially cleared adhesions and placed ports as i went along such that i had had five 5 ports in the right mid abdomen and lower quadrant at the completion.I was then ultimately able to dissect all adhesions off the anterior abdominal wall.A left upper quadrant 10 port and a left anterior axillary 5 port were passed into the peritoneal cavity as well.With all the adhesions cleared, the fascial defect of approximately 10 x 15 cm as appreciated.The 15 x 19 cm dual mesh was selected and six stay sutures placed circumferentially about the mesh.The mesh was rolled and placed in the peritoneal cavity through the 10 port.The mesh was then unrolled and corresponding sutures withdrawn through the abdominal wall through stab wounds.The sutures were secured and the mesh completed with spiral tackers in order to pex it to the abdominal wall.The defect was well covered with significant overlap of mesh.The insufflation pressure was cut to 10 mmhg during this portion of the procedure.Hemostasis was assured.Mild amounts of blood was evacuated with a suction catheter.The ports were then removed and skin incisions closed and dressings applied.The patient tolerated the procedure well and was extubated and taken in stable condition to the recovery room.¿ (b)(6) 2007: (b)(6) health center.Implant sticker.¿gore® dualmesh® plus biomaterial¿.Cat #: 1dlmcp04.Lot #: (b)(4).Pathology: pathology report was not provided.Relevant medical information: (b)(6) 2007: (b)(6) health center.Inpatient hospitalization.(b)(6) 2007: phillip m.Hornbostel, md.Operative report.Laparoscopic incisional hernia repair.Preoperative diagnosis: abdominal wall herniation with incarceration.Postoperative diagnosis: abdominal wall herniation with incarceration.Anesthesia: general.Estimated blood loss: 100 cc.Indications: ¿this 40-year-old female presents now with a history of having undergone multiple previous attempts at repairing incisional hernias.She has developed acute incarceration and possible strangulation of hernia in her anterior abdominal wall once again and is taken to the operating room now for emergent laparoscopy.¿ wound classification: not provided.Procedure: ¿risks and benefits of the procedure were explained to the patient and consent was obtained.She was assessed prior to induction of anesthesia and felt to be clinically stable for the anticipated procedure.On that basis she was taken to the operating room.She was prepped and draped in the usual fashion in supine position.Under satisfactory general anesthesia, a transverse incision was made out in the left flank of the abdomen and veress needle was inserted.The abdomen was insufflated to 15 mmhg.An 11 mm trocar was placed at this level and diagnostic laparoscope was inserted.Following this, free areas could be identified out in the left flank and 5 mm ports were placed both above and below the site of the primary port and adhesiolysis was initiated to clear up the anterior abdominal wall.The total adhesiolysis time to get this accomplished was approximately one hour.Once this was accomplished, the hernia defect could be clearly identified and a couple of loops of bowel and incarcerated omentum were retrieved out of the site.The bowel appeared quite viable, as did the omentum, but there was quite a bit of fluid in the area as well.This was suctioned out of the abdominal cavity.Once this had been accomplished, the defect could be clearly identified circumferentially.On that basis operating ports x 2 were placed out in the right flank.Subsequently a piece of parietex was inserted into the abdominal cavity and fixed to the anterior abdominal wall using interrupted tacks circumferentially to provide a very generous overlap to the entire defect.Subsequently 30 cc of ¼% marcaine was injected into the right subdiaphragmatic space and all instruments were removed.Skin incisions were reapproximated with a 4-0 polysorb interauricular closure.Sterile dressings were applied.Sponge and needle counts were correct x2.The patient was sent to the recovery room in stable condition.¿ pathology: pathology report was not provided.Explant preoperative complaints: (b)(6) 2017:(b)(6) health center.(b)(6), md.Indication: ¿this 49-year-old had multiple abdominal hernia repairs and presents with swiss-cheese abdomen and complete failure of the abdominal wall.The procedure, risks, benefits and indications were explained to the patient.She understands and gives her consent.She has [sic] evaluated prior to procedure, felt to be stable to tolerate the procedure.¿ explant procedure: 1.Laparoscopic adhesiolysis, converted to open.2.Removal of infected abdominal mesh.3.Drainage of abdominal wall abscess.4.Adhesiolysis, 90 minutes.Explant date: (b)(6) 2017 [outpatient surgery] (b)(6) 2017: (b)(6) health center.(b)(6), md.Operative report.Preoperative diagnosis: incisional hernias.Postoperative diagnosis: multiple incisional hernias with infected abdominal mesh, dense intraabdominal adhesions.Anesthesia: general.Estimated blood loss: 150 cc.Specimens: 1.Skin.2.Hernia sac.3.Infected mesh.Wound classification: not provided.Procedure: ¿after adequate general anesthesia, the patient¿s abdomen was prepped and draped in sterile fashion.A left upper quadrant incision was made, through which a veress needle was inserted into the peritoneal cavity.The peritoneum was insufflated with co2 to 14 mmhg.The needle was removed and replaced with a 5 port.Laparoscope was inserted and under direct visualization a left lower quadrant 5 port, left midabdominal 5 port and epigastric 5 port were all passed into the peritoneal cavity after considerable adhesiolysis with scissors and harmonic scalpel to allow placement of extra ports.I was taking adhesions down from the epigastrium toward the umbilicus, taking omentum out of hernia sacs as i went.Everything was going well until i dissected dense adhesions and got into what looked like cecal contents.I converted the incision to a long midline, went into the abdomen, and then found there was in fact a significant abdominal wall abscess with infected mesh.I cut out all the prior mesh that i could see and sent it to pathology.About 90 minutes of adhesiolysis ensued.I made no enterotomies.There was certainly no way that this abdomen was going to be closed primarily.I selected a xenograft biologic mesh 20 x 25 cm in size, and i cut it the appropriate dimensions, and then sewed it in as an underlay mesh with 0-pds suture.The peritoneum was copiously irrigated prior to closure, then placed a jp through a stab wound inferiorly over the mesh and secured the drain to the skin.The skin on the left side was a little thin, i removed it, and then closed the incision primarily with staples.A dressing was applied.The patient tolerated the procedure well, was extubated and taken in stable condition to the recovery room.¿ pathology: pathology report was not provided.Relevant medical information: (b)(6) 2017: (b)(6) health center.(b)(6), md.Operative report.Irrigation and re closure of abdominal wound.Preoperative diagnosis: wound infection.Postoperative diagnosis: wound infection.Anesthesia: general.Estimated blood loss: minimal. indications: ¿this 49-year-old underwent a complicated abdominal wall reconstruction with biologic mesh, only to have the wound become infected.Outpatient management with drainage and antibiotics has failed.She is now admitted for irrigation and washout.The procedure, risks, benefits, and indications were explained [sic] the patient.She understands and gives her consent.She was evaluated prior to procedure, felt to be stable to tolerate the procedure.¿ wound classification: not provided.Procedure: ¿after adequate general anesthesia, the patient's abdomen is prepped and draped in sterile fashion.The previous incision was opened.The mesh repair was intact.The wound was copiously irrigated with antibiotic solution.The stab wounds were made in both lower quadrants through which 10 flat jp drains were drawn.The drains were secured to the skin with sutures.The skin was stapled and dressings were applied.The patient tolerated the procedure well, was extubated and taken in stable condition to the recovery room.¿ (b)(6) 2017: (b)(6) health center.(b)(6), md.Operative report.Irrigation and debridement of abdominal wall with closure over a drain.Preoperative diagnosis: abdominal wall dehiscence with mesh exposure.Postoperative diagnosis: abdominal wall dehiscence with mesh exposure.Anesthesia: general.Estimated blood loss: minimal.Specimens: skin and subcu.Indications: ¿this 49-year-old female underwent a biologic mesh repair of her abdominal wall hernia with infected synthetic mesh.She has a skin dehiscence with mesh exposed.Unfortunately, she could not keep her referral to the abdominal wall specialist at barnes and she is continuing to smoke, which has resulted in wound complications.The procedure, risks, benefits and indication were explained to the patient.She understands and gives her consent.She has evaluated prior to procedure, felt to be stable to tolerate the procedure.¿ wound classification: not provided.Procedure: ¿after adequate lma anesthesia, the patient's abdomen was prepped and draped in sterile fashion.The prior sutures and staples were removed and the skin edges were excised about 1.5 cm back on each edge using cautery.The mesh was intact circumferentially with no herniation and no disillusion of the mesh.The wound was copiously irrigated with antibiotic solution, and then the skin incision closed with interrupted #2 horizontal mattress nylon futures.The skin edges were then approximated with running 2-0 nylon.This allowed a good seal.Prior to the closure, a stab wound was made in the right mid abdomen and a jp was placed over the fascia.The drain was secured to the skin.A dressing was applied.She tolerated the procedure well, was extubated and taken in stable condition to the recovery room.¿ 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® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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H6: conclusion code remains unchanged.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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