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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.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) 2003: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: ¿incarcerated incisional hernia.¿ implant procedure: repair of incarcerated incisional hernia with mesh (gore-tex dual mesh) with intermediate closure (10 cm).Implant: gore® dualmesh® plus biomaterial, 1dlmcp05/(b)(6), 8cm x 12cm x 1mm thick.Implant date: (b)(6) 2003 (hospitalization dates unknown) (b)(6) 2003: (b)(6) hospital.(b)(6) md.Operative report.Assistant #1: (b)(6), md.Pre- and postoperative diagnosis: incarcerated incisional hernia.Anesthesia: general.Drains: 10 mm jackson-pratt.Complications: none.Procedure: ¿under general anesthesia with lma in place the left lower quadrant of the abdomen was prepped and draped in the usual manner.Local anesthesia was infiltrated over the previous surgical scar which was transverse incision on the left lower quadrant.An incision was made and carried down into the subcutaneous tissue until the hernia sac was identified.The sac was opened, entered and contained small bowel.The edges of the hernia sac were tagged with allis clamps and the sac was dissected free from the surrounding subcutaneous tissue down to the level of the fascia defect.The sac was then resected.Adhesions into the sac of omentum had to be lysed so that this could be reduced into the peritoneal cavity as well.After excising the sac, it was determined that a gore-tex dual mesh patch would be necessary to repair the defect.A piece measuring approximately 8 x 12 cm was brought onto the field.The edges were trimmed to rounder and then it was sutured in place with horizontal mattress sutures which were placed through to fasten the mesh.It was sutured to the inside of the fascia in this manner.All sutures were placed and tagged with crile clamps and when all sutures were in position the mesh was cinched up to the inside of the abdominal wall and the sutures tied in succession.A secure tension free repair was accomplished this way.The wound was copiously irrigated.Bleeding points were controlled with cautery.With hemostasis adequate a 10 mm hemovac drain was placed and brought out through a separate stab incision lateral and inferior to the wound and sutured to the skin with a 2-0 silk suture.Then some of the tissues in the lower aspect of the wound were brought together to cover over the mesh.The subcutaneous tissue and dermis was (sic)closed with interrupted sutures of 3-0 vicryl and the skin reapproximated with a running suture of 4-0 prolene placed in the subcuticular position.This intermediate closure of this wound which was approximately 10 cm in length was accomplished as described.Steri-strips were placed over the wound.Dry dressings were placed and opsites were placed to cover both the incision and the exit site of the drain.The patient was awakened, the lma was removed.The patient was then transported to recovery in stable condition.¿ (b)(6) 2003: (b)(6) hospital.Implant sticker.Dualmesh corduroy antimicrobial.Item# 1dlmcp05.Lot# 01284551.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp05/ (b)(6)) was implanted during the procedure.Explant preoperative complaints.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Operative report.History: ¿this is a very pleasant 72 year (sic) lady who comes in after multiple abdominal surgeries with a left lower quadrant incarcerated hernia that contains small bowel and some fluid in the abdomen.The risks, benefits, and alternatives to surgery including and not limited to bleeding, infection, recurrence, possibility of need to excise the old mesh.The risks and benefits for a prosthetic mass [sic] versus biologic mesh, postoperative mi, respiratory failure, and even death were (sic) discussed.All of her questions were answered, and informed consent was signed.The patient was then prepped and brought to the operating room for an open recurrent left lower quadrant incisional hernia repair, possible excision of mesh, possible small bowel resection.¿ explant procedure: exploratory laparotomy, lysis of adhesions, excision of an old mesh, ventral hernia repair with a 13 x 13 cm underlay of biological mesh.Explant date: (b)(6) 2014 (hospitalization dates unknown).(b)(6) 2014: (b)(6) medical center.(b)(6), md.Operative report.Assistant #1: (b)(6), do, pgy-3.Pre- and postoperative diagnosis: partial small bowel obstruction with an incarcerated recurrent left lower quadrant incisional hernia.Anesthesia: general.Specimen: old mesh to pathology.Estimated blood loss: 50 ml.Drains: two 10-mm kp drains were placed.Number 1 was in the space above the mesh and below the fascia closure, and #2 was in the subcutaneous dead space.Findings: incarcerated but not strangulated small bowel loops which actually pinked up and were healthy.An old mesh that had torn away superiorly which was excised and passed off the field.The resulting approximately 7 x 7-cm defect was repaired with an underlay of 13 x 13-cm biologic mesh.The patient tolerated the procedure well, was extubated, and transferred to recovery room in satisfactory condition.Description of procedure: ¿the patient was placed supine on the or table.Care was taken to position the patient so as to prevent post procedure complication secondary to positioning.The patient was induced by anesthesia after having received the appropriate preoperative antibiotics, scd stockings, and subcutaneous heparin.The abdomen was then draped and prepped in the normal sterile surgical fashion.Using a 10 blade, an incision was made in the left lower quadrant.Using the patient¿s prior incision as a guide, subcutaneous tissues were dissected and the hernia sac was identified.It was circumferentially cleaned of the subcutaneous tissue and carefully opened.Upon entering the hernia sac, it was noted that there was small bowel stuck to what appeared to be some mesh.That was old from her prior repair.We set up retraction and then proceeded to open this area, and lysis of adhesions due to patient¿s multiple abdominal surgeries then ensued which took approximately 45 minutes to an hour.There was 1 questionable small enterotomy which was made and oversewn with a 3-0 silk in a lembert-type fashion in the bowel, but there were no other injuries as we ran the bowel from the area of obstruction proximally and distally.The small bowel was then reduced and the edges of fascia were identified.We excised part of the hernia sac and passed it off the field as specimen.We then set up and measured the defect, and it measured about 7 x 7 cm in greatest dimension.We therefore took a piece of biologic mesh, cut it to be the appropriate size, to be about 13 x 13 cm, and decided to use this as an underlay.Using #1 ethibond sutures, we laid in u sutures with good bites in the fascia and through the mesh at 3 o¿clock and 9 o¿clock and one at 12 o¿clock.We then very carefully without injuring the bowel put u stitches between 12 o¿clock and 3 o¿clock and 3 o¿clock and 9 o¿clock.These then all tied in place.We then looked at the inferior fascia edges, and there seemed to be bladder adherent to it, so we dissected it down very gently without injuring the bladder.We then identified the fascia inferiorly, and prior to repairing it, decided to test the bladder to make sure there was no evidence of injury during this dissection, we infused about 300 ml of saline with methylene blue in it and inspected the bladder, and there was no injury or extravasation so we put it to drainage.We then laid in again a u stitch of #1 ethibond to hold the mesh as an underlay with good bites in the fascia at around 6 o¿clock.We then did the same thing that we had done before and laid u sutures through the mesh in the abdominal wall with good fascial bites from 9 o¿clock to 6 o¿clock to 3 o¿clock.These were then tied in place and cut.The wound was then copiously irrigated with saline.Hemostasis was meticulously evaluated.We used pressure and cautery and were happy with the hemostasis.Then through a stab wound medially from the right side, we placed a 10-mm jp drain above the mesh but below the fascia repair, and secured it to the skin with a 2-0 silk suture.We then closed the fascia over the biologic mesh with simple interrupted #1 ethibond sutures.We then irrigated the subcutaneous tissues again, inspected for hemostasis and were happy with the hemostasis.We put a 2nd 10-mm flat jp drain, this one coming from the left side and subcutaneously, to drain the areas of dissection that was to prevent seroma formation.We then sutured the drain to the skin again with 2-0 silk suture.Then once i was happy with the hemostasis, we closed the subcutaneous tissues in 2 layers, first of simple interrupted 2-0 vicryl and then simple interrupted 3-0 vicryl to take tension off the skin.The wound was then stapled closed.The jp drains had grenades placed on them, and a sterile surgical dressing of 4 x 4, abd, and tape was placed over the wounds, and the jp drains were labeled and attached to the dressing with safety pins.The patient was then awoken from anesthesia, extubated, transferred to recovery room in satisfactory condition.¿.Pathology for specimens removed during the (b)(6) 2014 procedure was not provided.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus 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.¿ there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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.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).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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