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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant: dlmcp (b)(6) 2008 explant: (b)(6) 2018, (b)(6) 2019 allegations: hernia recurrence, infection, abscess, dense adhesions, wound vac.Implant preoperative complaints: ¿ (b)(6) 2008: (b)(6).Gregory t.Jarrin, md.Indications: ¿this is a 46-year-old female who presents with a midline ventral hernia wound.The patient had a paraesophageal hernia repair about a year and a half ago.She has now developed a ventral hernia.She is obese with pulmonary problems.The patient had cardiac evaluation by dr.(b)(6).He states that she is at low risk for this moderate risk procedure.The patient is 46 years old and, otherwise, only has hypertension.Consent was obtained for the procedure.All risks and benefits were described to the patient preoperatively.¿ implant procedure: laparoscopic ventral hernia with dual gore-tex mesh 20 x 30-cm.[implant: gore® dualmesh® plus biomaterial, 1dlmcp07/05179385, 20cm x 30cm x 1mm thick.] implant date: (b)(6), 2008 [hospitalization dates not provided.] ¿ (b)(6) 2008: (b)(6) center.Gregory t.Jarrin, md.Operative report.Preoperative diagnosis: ventral hernia, 20 x 10-cm.Postoperative diagnosis: ventral hernia, 20 x 10-cm.Anesthesia: general.Estimated blood loss: 150cc.Specimens: none.Complications: none.¿ wound classification: clean.¿ findings: ¿multiple defects in an old midline incision that measured 20-cm superior to inferior and 10-cm lateral to lateral.¿ ¿ procedure: ¿the patient was intubated without difficulty.A foley catheter was placed.The abdomen was prepped and draped using a sterile manner for a laparoscopic ventral hernia repair which includes having entire abdomen prepped from the nipple line to the mid thighs and having both arms tucked.Care was taken to make sure that the prep extended all the way lateral on both sides.Loban was placed over the abdomen after the drapes were placed.A left-sided abdominal incision was made lateral to the umbilicus.I carefully dissected through the subcutaneous tissue and scarpus fascia.External oblique fascia was identified and incised along the direction of its fibers.I then made an incision in the internal oblique fascia.Along each fascial incision, a figure-of-eight 0-pds suture was placed.L then bluntly entered the abdomen using my finger.A hasson trocar was inserted.The abdomen was insufflated.Under direct vision, a total of four additional trocars were inserted size 5; one in the right lower quadrant, one in the left lower quadrant, one in the left upper quadrant, and one in the right upper quadrant.Using a 10 scope, i identified multiple adhesions to the anterior abdominal wall.L carefully dissected free all the adhesions to the anterior abdominal wall.Multiple hernia defects were identified.The stomach was adherent to the anterior abdominal wall, and it was left in place as it was in the left upper quadrant away from the hernia.I then measured the edges of the hernia.Superiorly, the beginning of the hernia was 6-cm away from the most superior aspect of the incision.I measured superior to inferior and the patient had the hernia extended to 10-cm from the right side to the left side.I then measured the mesh to be approximately 28 x 18-cm; 28-cm from superior to inferior and then 18-cm from right side to left side.I then measured out the size of the mesh and placed gore-tex sutures in the mesh.I correlated the markings on the mesh to the anterior abdominal wall.I then proceeded to roll the mesh up and place it into the abdomen.I rolled it out so that the white mesh part was up against the anterior abdominal wall and the brown nonadherent side was against the bowel.I then sequentially pulled the gore-tex sutures, after unrolling the mesh, through the anterior abdominal wall using the gore-tex suture passer.The goretex suture transfascial incisions were at 12 o'clock, 2 o'clock, 3 o¿clock, 4 o'clock.6 o'clock, 8 o'clock, 9 o'clock, and 10 o'clock.Once the mesh was in place, i secured the edges of the mesh to the anterior abdominal wall using the pro-tacker.Copious irrigation ensued.There was no bleeding from the anterior abdominal wall nor the omentum.I then inspected all the sites for the trocars.They were not bleeding.All the trocars were removed.I then removed as much insufflation as possible.I then had to remove the figure-of-eight 0-pds sutures i placed.I had to close the internal oblique fascia with a running 0-pds suture.I closed the external oblique fascia with a running 0-pds suture.Scarpus fascia was closed with subcutaneous 3-0 vicryl.I then closed all the incisions with subcuticular 4-0 monocryl, steri-strips, telfa, and tegaderm.There were a total of 13 incisions.The patient was extubated in the operating room.Foley catheter was left in place.All laparotomy pads, sponge, and instrument counts were correct postoperatively.¿ ¿ (b)(6) 2008: (b)(6).Implant sticker.Gore® dualmesh® plus biomaterial.Cat #: 1dlmcp07.Lot #: 05179385.Size: 20cm x 30cm x 1mm thick.¿ pathology: not provided.Revision preoperative complaints: ¿ (b)(6) 2018: (b)(6).Brian bucina, do.Indications: ¿bertha benally is a 56-year-old female initially seen at the ihs urgent care here in winslow, arizona, secondary to a lower midline anterior abdominal wall abscess.Relayed a history of multiple abdominal surgeries with previous ventral incisional hernia repairs x2 performed in 2009.States that she was doing fairly well, but recently developed firmness and redness at the lower aspect of her abdomen with subjective fevers.Ct performed at the ihs urgent care demonstrating an abscess and concern for the abscess being near the previous hernia mesh.The patient was directly admitted to little colorado medical center from the ihs urgent care by myself and underwent incision and drainage with surgical excisional debridement, thorough irrigation, and wet-to-dry dressing as mentioned above.Wound cultures also taken during the procedure.¿ revision procedure: lower midline anterior abdominal wall abscess incision and drainage with wound cultures and surgical excisional debridement of skin, surgical scar, as well as necrotic subcutaneous fat.Wound thoroughly irrigated after abscess drainage, and wet-to-dry dressing applied.Post debridement wound measurements include a 15 x 10 x 10 cm open lower midline abdominal wound.Revision date: (b)(6), 2018 [hospitalization (b)(6) 2018].¿ (b)(6) 2018: (b)(6).(b)(6), do.Operative report.Preoperative diagnosis: 1.Lower midline anterior abdominal wall abscess.2.History of multiple abdominal surgeries including 2 ventral incisional hernia repairs performed in 2009.3.History of diabetes type 2 and hypertension, as well as osteoarthritis.Postoperative diagnosis: 1.Lower midline anterior abdominal wall abscess.2.History of multiple abdominal surgeries including 2 ventral incisional hernia repairs performed in 2009.3.History of diabetes type 2 and hypertension, as well as osteoarthritis.Anesthesia: general.Estimated blood loss: 15 ml.Specimens: wound cultures.Complications: none.¿ wound classification: not provided.¿ findings: ¿lower midline anterior abdominal wall abscess superficial to previous mesh from ventral incisional hernia.Mesh appeared to be intact and folded.However, did not see any evidence of recurrent hernia on exploration.The previous surgical scar was excised, as well as surgical excisional debridement performed of necrotic subcutaneous fat after abscess drainage.There was copious frank pus from the wound.Wound cultures were also taken.Post debridement wound measurements included a 15 x 10 x 10 cm area.A wet-to-dry dressing was placed after thorough and extensive irrigation with saline.¿ ¿ procedure: ¿prior to the procedure, informed consent was obtained.The patient was then taken to the preoperative holding area where seen by the anesthesia department and cleared for the procedure.Ancef 2 g was administered as a preoperative antibiotic before taking the patient back to the operating room.The area was marked with marking pen with the patient awake before taking the patient to the operating room as well.Once in the operating room, the patient was positioned supine.General endotracheal anesthesia was administered via the anesthesia department.Please see anesthesia record.Once the patient was anesthetized, scds were applied to the patient's bilateral lower extremities for dvt prophylaxis.The patient's abdomen was prepped and draped in a sterile and routine manner.Next, a 15-blade scalpel was then used to excise the previous surgical scar at the lower aspect of the midline of the abdomen.The subcutaneous fat was then opened with boyle electrocautery very carefully into the abscessed cavity.Frank pus was then drained from the wound.Wound cultures were then taken.Surgical excisional debridement was performed of necrotic subcutaneous fat using bovie electrocautery.The area was thoroughly irrigated with saline solution.Minimal bovie electrocautery was necessary for hemostasis.There was an area in the subcutaneous fat that was suture ligated to obtained hemostasis using a 3-0 vicryl suture in a figure-of-eight manner.Hemostasis controlled with this vicryl suture.Post debridement wound measurements included a 15 x 10 x 10 cm open lower midline abdominal wound.The fascia appeared folded, however, intact.There was no evidence of recurrent hernia appreciated.The abscess appeared to be anterior to the mesh itself.Wet-to-dry dressing placed with a kerlix roll soaked in saline, dry 4 x 4¿s, abd, and mefix tape.The patient tolerated the procedure well.There were no known complications at this time.She was transported to the pacu in stable condition with an anticipated continued hospital admission for wound care, iv antibiotics.I also discussed the case with the on-call ihs medicine provider, dr.(b)(6) regarding medical management.The patient relayed only osteoarthritis and taking over-the-counter medications for her osteoarthritis.However, after reviewing the medical record through the indian health service, it appeared that she had more medical problems than what she relayed, including hypertension and diabetes.Medical consultation sought for this purpose.I will continue iv clindamycin 600 mg every 8 hours until wound culture and sensitivity results are available.Iv morphine for pain control.Instructed the nurse to leave the wet-to-dry dressing in place, to notify if there is any strikethrough on the dressing.I spoke with the patient, relayed the results and the procedure performed, once she recovered from the anesthesia.There was no family available after surgery.I will start a clear liquid diet and make the patient n.P.O.After midnight for recommended dressing change in the operating room tomorrow morning for pain control and also to reexplore the wound for possible need for further surgical debridement.Also discussed pulsatile lavage with suction and eventual negative pressure wound therapy.¿ ¿ (b)(6) 2018: (b)(6).(b)(6), do.Operative report.Assistant # 1/# 2.Procedure: removal of postoperative wet-to-dry dressing from her initial surgery in the operating room for pain control.Pulsatile lavage with suction performed, and negative pressure wound therapy (wound vacuum assisted closure placement in the operating room).Wound vacuum assisted closure machine set at 125 mmhg negative pressure.Wound dimensions intraoperatively included a 15 x 10 x 10 cm open wound.No further signs of necrosis or pus/abscess.Folded intact hernia mesh [implants: black wound vac sponge cut to the dimensions of the wound bed.Standard wound vac adhesive tubing, and hospital wound vac machine set at 125 mmhg negative pressure.] preoperative diagnosis: 1.Status post lower midline anterior abdominal wail abscess and drainage with wound cultures, surgical excisional debridement of skin and subcutaneous fat, saline irrigation, and initial wet-to-dry dressing placement.2.History of multiple abdominal surgeries including a ventral incisional hernia repair x2 in 2009.3.History of diabetes mellitus type 2, as well as hypertension and osteoarthritis.Postoperative diagnosis: 1.Status post lower midline anterior abdominal wall abscess and drainage with wound cultures, surgical excisional debridement of skin and subcutaneous fat, saline irrigation, and initial wet-to-dry dressing placement.2.History of multiple abdominal surgeries including a ventral incisional hernia repair x2 in 2009.3.History of diabetes mellitus type 2, as well as hypertension and osteoarthritis.Anesthesia: general.Estimated blood loss: 10 ml.Specimens: none.Complications. indications: ¿bertha benally is a 56-year-old female who was initially directly admitted from the ihs urgent care in (b)(6), arizona, to (b)(6) secondary to a lower midline abdominal wall abscess.History of multiple abdominal surgeries including 2 ventral incisional hernia repairs performed in 2009.History of diabetes mellitus type 2, hypertension, and osteoarthritis.The patient underwent initial incision and drainage with wound cultures and surgical excisional debridement of skin and subcutaneous fat.Wound irrigated with saline solution and initial wet-to-dry dressing placed.Recommendation for wet-to-dry dressing removal in the operating room for pain control, as well as for possible need for further surgical excisional debridement and any other indicated procedure.Also discussed with the patient the use of pulsatile lavage with suction and negative pressure wound therapy.¿ wound classification: not provided. findings: ¿lower midline anterior abdominal wall open wound measuring 15 x 10 x 10 cm.No further tissue necrosis appreciated.No further pus or residual abscess.Hernia mesh folded but appears to be intact without wound exploration evidence of recurrent hernia.Pulsatile lavage with suction performed.Negative pressure wound dressing with black wound vac sponge, standard adhesive tubing, and hospital wound vac machine set at 125 mmhg negative pressure.¿ procedure: ¿prior to the procedure, informed consent was obtained.The patient was then taken from the floor to the operating room.Preoperative scheduled clindamycin continued.The patient was placed in the supine position.General endotracheal anesthesia was administered via the anesthesia department.Please see anesthesia record.Once the patient was anesthetized, scds were applied to the patient's bilateral lower extremities for dvt prophylaxis.The lower midline wet-to-dry dressing was then removed.The abdomen was then prepped and draped in a sterile and routine manner.Next, the wound was then measured and described as above it measured 15 x 10 x 10 cm.Pulsatile lavage with suction was then used to thoroughly clean the wound.There was no evidence of further necrotic tissue or infection/abscess.Wound mesh palpated and appeared to be folded, however intact.No evidence of recurrent hernia.Please note that the wound mesh was felt.The abscess was anterior to the mesh itself.Minimal bovie electrocautery was necessary for hemostasis prior to negative pressure wound therapy applied.Black wound vac sponge cut to the dimensions of the wound bed and placed.Standard wound vac adhesive was then placed over the sponge and secured to the peri-wound skin.A small hole was then cut in the center of the sponge, and standard wound vac tubing as well as hospital wound vac machine was connected.Negative pressure applied at 125 mmhg negative pressure.Negative pressure applied without air leak or tubing obstruction.The patient tolerated the procedure well.There were no known complications at this time.She was transported to the pacu in stable condition with an anticipated continued hospital admission for continuation of iv clindamycin pending initial wound culture and sensitivity results.Further recommendations will be made once these results are available.Recommending continuing negative pressure wound therapy.Next wound vac change anticipated at the bedside on friday, (b)(6), 2018.Discussed with social services the need for a home wound vac and negative pressure wound therapy.Paperwork filled out, and plan is for home wound vac machine and supplies to be available by friday for anticipated discharge date.Also discussed the case with ihs medicine for medical management regarding diabetes, hypertension, etc.We will restart clear liquid diet as tolerated and resume orders as previously ordered prior to the procedure.I discussed the procedure and findings with the patient after surgery once recovered from anesthesia.There were no family members available right after surgery.¿ ¿ pathology: not provided.Explant preoperative complaints: ¿ (b)(6) 2019: (b)(6), md.¿pt seen and examined.Discussed need for possible mesh explantation and the risk of subsequent hernia if we have to remove the mesh.¿ ¿ (b)(6) 2019: (b)(6), md.Indications: ¿persistent draining sinus in the abdominal wall and concern for mesh infection.¿ explant procedure: 1.Exploratory laparotomy.2.Mesh explantation.3.Drainage of peritoneal abscess.4.Debridement abdominal wall skin, sq tissue and fascia 40 cm2.5.Vac placement < 50 cm2.Explant date: (b)(6) 2019 [hospitalization dates not provided.].¿ (b)(6) 2019: (b)(6), md.Operative report.Assistant: dr.(b)(6).Preoperative diagnosis: cutaneous abscess, abdominal wall, possible mesh infection.Postoperative diagnosis: mesh infection with peritoneal abscess; cutaneous abscess of abdominal wall.Anesthesia: general.Estimated blood loss: 50 ml.Specimens: 1.Mesh, gross examination only.2.Abdominal wall tissue culture for gram stain, c&s.Complications: none.¿ wound classification: not provided.¿ findings: ¿peritoneal abscess surrounding old mesh which was explanted.Inflammatory tissue surrounding the cavity containing the mesh and peritoneal abscess.¿ ¿ procedure: ¿the patient was prepped and draped in standard fashion.A time-out was performed using the patient's name and date of birth.An incision was then made over the draining sinus in the lower midline of the abdomen using a 15 blade scalpel.Cautery was then used to carry this incision down to the fascia and the mesh was explanted using blunt dissection as well as sharp dissection.A peritoneal abscess was surrounding the mesh and was drained with suction and irrigation.Fibrotic areas of the abscess cavity were removed using scissors and cautery.Cautery was used to create flaps overlying the fascia for improved identification of the fascia.The wound was thoroughly irrigated with saline.Hemostasis was achieved.A jp drain was placed within the abscess cavity.The fascial edges were closed using 1.0 vicryl in interrupted figure-of-eight and single sutures.A wound vac was placed in the subcutaneous space overlying the closed fascia and was placed to suction.The patient tolerated the procedure well and there were no complications.She was taken to pacu and will be admitted to the floor postoperatively.Dr.Aldridge was present for the entire case and assisted with the critical portions of the procedure.¿ ¿ pathology: not provided.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 have not 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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