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(b)(4).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2008: (b)(6) operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Operation: repair of recurrent incisional hernia with gore-tex dual mesh.Indications and findings: ¿this lady is 5 feet 9 inches tall (b)(6), had undergone repair of a recurrent umbilical hernia with some incarcerated bowel several years ago.She presented to emergency room several weeks ago with pain and a bulge and was found to have another recurrent hernia.Ct scan showed several loops of bowel in the hernia.At operation there was no bowel in the hernia.There was a fairly large hernia sac although the defect was only 4 x 6 cm.Previously placed mesh was adherent to the right side of the fascia but it pulled out of the left side of the fascia.Gore-tex dual mesh was used to repair the defect.An oval shaped piece of mesh was placed subfascially and then a second piece was placed over the fascia.¿ detail: ¿the patient in the supine position, the abdomen was prepped with betadine and draped in a sterile fashion.Previous midline incision scar was excised and the incision was carried superiorly.We dissected down through the subcutaneous tissue which was quite thick and just above the umbilicus came upon the fascia.We dissected this laterally along the left side and identified the hernia sac.The hernia sac was then dissected free from the surrounding subcutaneous tissue.It extended mainly to the left and then superiorly.Once we got the left side freed up we came around the right side and then opened the sac.There was bowel adherent to the peritoneum near the edge of the fascial defect.We elevated this into the wound and excised the adhesions to free up the bowel from the abdominal wall.In one area we did nick the serosa and this was repaired with several sutures of interrupted 3-0 silk.Once this was done the defect was about 4 x 6 cm.We cut an oval shaped piece of dual mesh slightly larger than that and then sutured this to the fascia placing through and through mattress sutures through the fascia and then through the mesh with the smooth side facing internally toward the bowel and then back up through the fascia.These were all placed first and then pulled up and tied down placing this mesh essentially subfascially.We then approximated the proximal and distal ends of the fascia in the midline with interrupted 0 prolene.We then cut another piece of dual mesh and placed it with the smooth side down over top the defect and sutured this to the fascia outside the defect with interrupted sutures of 0 prolene.The wound was then irrigated with antibiotic solution.A jackson-pratt drain was placed through a stab wound to the right side of the incision.The subcutaneous tissue was approximated with 0 vicryl.The skin edges were approximated with staples.Dressing was applied.She tolerated the procedure well and left the operating room in good condition.Sponge and instrument counts were correct.She had some wheezing prior to the procedure and because of her size and history of intermittent asthma we will observe her overnight to make sure she does not have any breathing difficulties.If all is well she may be discharged in the morning.¿ on (b)(6) 2008: (b)(6) specimens.Old scar.Hernia sac.On (b)(6) 2008: (b)(6) implant record.Goretex dualmesh 1mym08.Qty: 1.Manufacturer: l.Orgore.Lot #: 05093538.Catalog #: 1dlmcp03.Qty: 1.Size: 10 cm.Site: abd.Exp date: 04/01/10.Comment: dual mesh plus biomaterial.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/05093538) was implanted during the procedure.[10cm x 15cm x 1mm thick, oval].The records confirm a gore® mycromesh biomaterial (1mym08) was implanted during the procedure.[5cm x 10cm x 1mm thick, keyhole].On (b)(6) 2008: [missing records: a pathology report detailing analysis of the specimens collected during the (b)(6) 2008 procedure was not provided.] on (b)(6) 2008: (b)(6) operative report.Preoperative diagnosis: wound infection with infected seroma and mesh from previous recurrent incisional hernia repair.Postoperative diagnosis: wound infection with infected seroma and mesh from previous recurrent incisional hernia repair.Operation: debridement of wound infection with excision of infected seroma and mesh.Indications and findings: ¿this lady has undergone recurrent incisional hernia repair about 6 weeks ago using gore-tex dualmesh.She had a wound hematoma which was debrided in the office.There did not appear to be any infection at that time.The wound actually healed and she returned to work two weeks ago.She presented to the office yesterday with an obviously infected wound.At operation, she had a large thick-walled seroma/hematoma, which was grossly infected.The mesh was at the base of the seroma.The mesh was removed along with the seroma which was dissected out and removed in its entirety.¿ description: ¿with the patient in the supine position, the abdomen was prepped with betadine and draped in a sterile fashion.An elliptical incision was made around the previous incision to encompass the opening in the center of the wound and this was carried down into subcutaneous tissue.We eventually dissected wide enough so that we were in normal subcutaneous tissue.We dissected down onto the thickened capsule of the seroma which was oval shaped and approximately 10 x 12 x 8 cm.We dissected around this, staying out in the more normal subcutaneous tissue where there was a lot of edema and eventually got down to the level of the fascia.On the left side, we actually got subfascial and removed some of the rectus sheath.We eventually were able to identify some suture material and found the edge of the gore-tex dualmesh.We dissected beneath this and eventually freed up the entire encapsulated infected seroma with the dualmesh.New cultures were obtained and this area was removed in its entirety.The wound was then irrigated using the pulsavac system.It was then irrigated with bacitracin solution.There was a lot of fibrous tissue and perhaps part of the capsule beneath where the mesh had been and i could not definitely identify any hernia defect.I therefore put no other type of mesh or foreign body in the wound.Two jackson-pratt drains were placed through stab wounds on each side of the midline and placed into the depth of the wound.The subcutaneous tissue was closed over the drains with 0 vicryl.The skin edges were loosely approximated with 2-0 nylon, placing acticoat between the sutures.Dressings were applied.She tolerated the procedure well, left the operating room in good condition.Sponge and instrument count were correct.¿ on (b)(6) 2008: (b)(6) pathology report.Accession#: rs08-825la.Tissues: abdomen, nos-abdominal wall abcess [sic] and infected mesh.Clinical diagnosis: wound infection, hematoma.Gross description: submitted in formalin, the specimen consists of a roughly rounded fragment of rubbery yellow to tan-brown tissue measuring 11x9.5x7.8-cm.In greatest dimensions.One portion of this specimen¿s surface is covered by friable greenish-tan material.Sections through the large ovoid structure reveal a central cystic-appearing lesion measuring 6-cm.In diameter.It is mostly filled with semisolid yellow-orange material.Surrounding fatty tissue demonstrates areas of scarring and fat necrosis.Also submitted are two excisions of wrinkled brown-gray skin.These measure 11x2.2x2 and 7x1.2x2-cm.In greater dimensions.On section, each of the skin excisions demonstrates areas of apparent scar formation.A sheet of fabric-like mesh measuring 6.8x4.3 cm.Is attached to the main specimen with blue sutures.Representative sections submitted in two cassettes.Microscopic diagnosis: abdominal wall abscess and infected mesh, resection: a soft tissue abscess is associated with artificial graft material.Sections of skin demonstrate dermal scarring.On (b)(6) 2008: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2008 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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® mycromesh 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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.
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