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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (ug/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (ug/cm3)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: at (b)(6) 2005: (b)(6) hospital (b)(6).(b)(6) m.D.¿mrs.(b)(6) (b)(6)-year-old female, who underwent an excision of an ovarian cyst in the past through a midline incision.The patient developed a hernia, thereafter, and the hernia has progressively increased in size.A laparoscopic repair was felt to be indicated.The risks and benefits were discussed in detail with the patient and she desired to proceed.¿ implant procedure: attempt at laparoscopic repair of ventral hernia with conversion to open repair of ventral hernia with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp08/03561525, 26cm x 34cm x 1mm thick, oval] implant date: (b)(6) 2005 [hospitalization (b)(6) 2005] at (b)(6) 2005: (b)(6) hospital (b)(6).(b)(6) m.D.Operative report.Resident surgeon: (b)(6) md.Preoperative and postoperative diagnoses: ventral incisional hernia.Anesthesia: general.Estimated blood loss: 200 cc.Complications: none.At (b)(6) 2005: wound classification: [not provided].Procedure: ¿after appropriate informed consent was obtained, the patient was taken to the operating room and placed in the supine position on the operating table.After adequate general anesthesia had been induced, the patient's abdomen was prepped and draped in sterile fashion.Ioban dressing was placed on the abdomen.In the left upper quadrant, using a veress needle technique, the abdomen was insufflated and access was gained to the peritoneal cavity using a 10 mm trocar.The laparoscopic camera was then introduced in the left lateral abdominal wall.One more 5 mm port was placed in left mid-abdomen in the left lower quadrant, and also a 10 mm port was placed on the right side.This was to allow for the use of a 10 mm camera throughout the procedure.The adhesions were lysed with only a small amount of difficulty and the patient was found to have a very large ventral hernia, which extended from well above her umbilicus, to well below her umbilicus down toward her pubic bone.The hernia measured out so as to require a 26 x 34 piece of mesh, which was positioned over the anterior abdominal wall and cut to an appropriate size.Stay sutures of 0 ethibond were placed at 12:00, 3:00, 6:00 and 9:00 position and the mesh was introduced in the abdomen.Because of limitations of space and difficulty with technically applying even the spiral tacks to the edges of the mesh, once the mesh had been initially put in place, the patient required an open incision.The midline was opened in a vertical fashion and the hernia sac was entered.The edges of the fascia had already been dissected out, circumferentially, but a space was created in between the fascia and the subcutaneous tissues for passage of the transfixing sutures for subfascial placement of the mesh.The same piece of mesh which had been already placed in the abdomen, was freed from the initial attachments, which had placed laparoscopically, and the mesh was sewn circumferentially with multiple interrupted stitches of 0 nylon.Once the mesh had been sutured into place and care had been taken to exclude all the visceral contents, the subcu (subcutaneous) was irrigated out thoroughly.The midline was closed in multiple layers, beginning initially with the hernia sac, which was closed with a running 3-0 vicryl stitch.The deep dermis was then closed with a running 3-0 vicryl stitch and the skin was closed with staples.All port sites were closed with staples as well, and, although it was not mentioned previously, before closure of the abdomen all 10 mm port sites were closed from internally with a single stitch of 0 nylon.A clean dressing was then applied and then the patient was awakened from anesthesia and transported to the recovery room in stable condition, having tolerated the procedure very well.¿ at (b)(6) 2005: (b)(6) hospital (b)(6).Implant record: device description: ¿mesh dual plus 26cm x 34cm.¿ item number: id442376.Catalog number: 1dlmcp08.Lot #: 03561525.Manufacturer: w.L.Gore & associates inc wl gore.Implanted 1.0.Body site: abd (abdomen).¿ no pathology specimen was sent.Explant preoperative complaints: at (b)(6) 2008: (b)(6) hospital (b)(6).(b)(6) m.D.History of present illness: ¿ms.(b)(6) has a complicated surgical history for which she had initially a ventral hernia repair, which resulted in actually an infected seroma and infected mesh.According to the yes outside hospital, it was noted to be (b)(6).The patient had an episode of bowel obstruction, which required actual revision of her hernia and lysis of adhesions; however, the patient comes with again persistent fluid collections on top of her previous mesh and recurrence or actually development of another hernia caudally to the mesh she had.Risks, benefits, and potential complications were explained to the patient and an informed consent was obtained.¿ explant procedure: exploratory laparotomy and lysis of adhesions, ventral hernia repair, excision and removal and culture of an infected mesh.[implant: bard (b)(6)] explant date: (b)(6) 2008 [hospitalization (b)(6) 2008] at (b)(6) 2008: (b)(6) hospital (b)(6).(b)(6) m.D.(b)(6) resident m.D.Operative report.Anesthesia: general.Preoperative and postoperative diagnoses: recurrent ventral hernia and infected mesh.Complications: none.At (b)(6) 2008: wound classification: not provided.Procedure: ¿the patient was brought to the operating room and was placed in the supine position.After induction of anesthesia, the patient was prepped and draped in the usual sterile fashion.We started with a midline incision, which was carried carefully using both of electrocautery and sharp dissection until the fascia was identified.The patient tissue planes were actually completely distorted due to the multiple surgeries she had before and also due to the infectious process she had.Extensive time was taken to carefully enter the abdomen until that was achieved.No bowel injury was noted; however, the patient had a big 10 x 10 cm hernia sac with a bowel in the sac, however, no evidence of strangulation at all.Careful separation of the bowel from the sac and the sac was then amputated and resected and sent for the path.We then turned our attention to the previous mesh placed and careful dissection was also carried to completely remove the mesh and a piece of that mesh was sent for cultures and sensitivities.After that, we started identifying as much as possible of the healthy fascial edges, so we can actually do a repair.Once that was achieved, we proceeded with copious irrigation of the abdomen with several liters of warm saline with bacitracin.To be noted that there was no frank pus that was noted, however, due to the fact of the possibility of presence of infection and the copious irrigation was done and the cultures were sent from the mesh, we proceeded with repair with a (b)(6) mesh and that was tacked into the fascia using interrupted 0-prolenes.Once the defect was closed, we used 0-vicryl to close the superficial fascial layer and approximated together.Then, we used #3-0 vicryl for the subq tissue and then we applied the wound vac on top of the wound.The procedure was over without any complications and the patient was transferred in a stable condition to the pacu.¿ at (b)(6) 2008: (b)(6) hospital (b)(6).Implant record: (b)(6).Pathology report for the specimens removed during the (b)(6) 2008 procedure was 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 with wholes 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 with wholes 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.".
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