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Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopic ventral hernia of epigastric.Laparoscopic ventral hernia of suprapubic.[unable to read due to poor copy quality].Implant: gore® dualmesh® biomaterial [1dlmc07,(b)(4)] [1dlmc04,(b)(4)].Implant date: (b)(6) 2000 (hospitalization [ni]).On (b)(6) 2000: (b)(6) hospitals and clinics.(b)(6).Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia x2.Anesthesia: general.Preoperative medications: cefotan 1 gram iv.Indications for procedure: the patient has had a previous midline incision for a left hemicolectomy.She presents to the office at this time with about a 4-5 cm defect in the epigastric area.No other defects were noted on exam.She ss brought to the operating room at this time for laparoscopic ventral herniorrhaphy.Description of procedure: after consent was obtained, the patient was brought to the operating room where her abdomen was prepped and draped in a sterile manner.A veress needle was placed in the right upper quadrant and the abdominal cavity was insufflated with carbon dioxide.The veress needle was removed and a 5 mm trocar was inserted through the same site.The abdominal cavity was inspected.There appeared to be no gross abnormality except for the anterior abdominal wall.In the epigastric area, this showed about a 4-5 cm defect with omentum adhesed up into this.There was a second smaller hernia at the umbilicus, fairly close to the first hernia.There was a third and separate hernia that was suprapubic and could not be appreciated on preoperative exam.This measured about 4 cm long x 2 cm wide.The adhesions were taken down out of the epigastric hernia.In looking at the anterior abdominal wall and then epigastric area, it was noted between the umbilicus and the epigastric hernia, the fascia was quite attenuated and would probably herniate in the near future.Therefore, the total defect measured 19 cm long x 5 mm wide.A piece of mesh measuring 11 cm x 25 cm was then cut to length.This was a gore-tex dual mesh.Stay sutures were placed on all four corners and this was introduced in the abdominal cavity.Using separate stab incisions at the four corners, the stays were pulled up, making sure that the mesh portion of the graft was towards the abdominal wall.Using a 5-mm tacking gun, we then tacked the mesh circumferentially to the abdominal wall.Using separate stab incisions circumferentially, the graft was then further secured using interrupted 0 prolene.The defect down below measured out to be about 6 cm in diameter at its greatest point and therefore, a 12-cm diameter piece of mesh was cut to length.Again 4 stay sutures were placed and the graft was introduced in the abdominal cavity.The 4 stay sutures were brought out the 4 corners and secured.Again, using a tacking gun, the mesh was then secured circumferentially.This gave a good configuration of both grafts.The trocars were then removed under direct vision.The abdominal cavity was desufflated.The skin incisions at the trocar sites were closed with interrupted 4-0 vicryl and the small stab incisions made circumferentially around the hernias were closed with steri-strips.The patient tolerated the procedure well.Sponge and needle counts were reported as correct.Estimated blood loss is less than 20 cc.¿ on (b)(6) 2000: (b)(6) hospital.Implant sticker.Gore-tex dualmesh biomaterial.Item #: 1dlmc07.Lot #: (b)(4).Gore-tex dualmesh biomaterial.Item #: 1dlmc04.Lot #: (b)(4).The records confirm a gore® dualmesh® biomaterial (1dlmc07/(b)(4)) and (1dlmc04/(b)(4)) was implanted during the procedure.Relevant medical information: on (b)(6) 2004: (b)(6) hospital and clinics.(b)(6) md.Operative report.Preoperative diagnosis: pelvic prolapse, uterine prolapse, cystocele, rectocele, history of ventral hernia and desired panniculectomy, elective.Postoperative diagnosis: pelvis prolapse, uterine prolapse, cystocele, rectocele, history of ventral hernia and desired panniculectomy, elective; extensive adhesions secondary to mesh placement for hernia.Exploratory laparotomy, lysis of adhesions, total abdominal hysterectomy, right salpingo-oophorectomy, cystocele repair, hernia repair and panniculectomy per dr.(b)(6) and dr.(b)(6) respectively.Assistant: (b)(6); (b)(6) md.Anesthesia: general with oral endotracheal tube.Complications: none.Estimated blood loss: 300 cc.Fluids: crystalloid.Drains: none.Specimens: uterus, tube and ovary to pathology for evaluation.Findings: patient noted to have uterine prolapse; however, very limited pelvis which made a vaginal approach to hysterectomy nearly impossible.A moderate cystocele was repaired.Once the surgery was completed rectocele was not present and therefore did not need to be fixed.Significant adhesions noted form the mesh to the omentum and bowel anteriorly on entry into the pelvis.History: patient is a (b)(6) year-old female with a history of prolapse and symptoms secondary to this who presented for definitive therapy.Operative procedure: ¿when the procedure was explained and consent obtained patient was taken to the operating room where she was placed under a general anesthetic.She was prepped and draped in the usual sterile fashion.A midline vertical incision was made through previous scar and this was taken down sharply to the fascia.The fascia was nicked in the midline and extended superiorly and inferiorly.Upon entry the mesh was noted and was cut through and then began the extensive lysis of adhesions that was required in order to gain entry into the pelvis.Because of how extensive the adhesions were and because on the right side there was bowel adherent immediately to the mesh, decision made to try to proceed below.A speculum was placed into the vagina but difficult in the patient¿s positioning with her legs not highly elevated in order to have good prolapse of the uterus for removal, and so attention turned to performing an anterior repair.An incision was made in the anterior vaginal mucosa up to approximately 1 cm below the urethral meatus and the opposing and underlying fascial tissue was pushed down towards the midline for reapproximation across the bladder and the bladder neck.The fascia was reapproximated with 2-0 vicryl in an interrupted fashion.Following this the excess vaginal mucosa was removed and then the vaginal mucosa was reapproximated with 2-0 vicryl in interrupted fashion.Once this was completed and there was good hemostasis attention was turned to trying to begin a vaginal hysterectomy.The circumferential cervical area was infiltrated with 1% lidocaine with epinephrine and a circumferential incision was made.Posterior peritoneum was then entered after pushing the vaginal mucosa back and long weighted speculum was placed.Anterior peritoneum was very difficult to be entered and two pedicles were taken with zeppelin clamps, the pedicles being suture with 0 vicryl in the usual fashion and held to be incorporated into the cuff at a later time.At this point not entering the anterior peritoneum the decision was made to try to proceed above.In the interim time dr.(b)(6) had come into the case and had taken down adhesions from the bowel to the mesh and stayed in order to assist because of great difficulty.The patient had an extremely deep pelvis and due to body habitus as well as adhesive disease the hysterectomy became a very complicated procedure.A balfour retractor was placed, but even despite this a significant amount of retraction was needed just to access the pelvic area and to begin removal of the uterus, tube and ovary.Long kocher clamps were placed in the cornual areas and zeppelin clamp was used to take the infundibulopelvic ligament on the right side in an area above the ureter.This area was doubly ligated with 0 vicryl sutures and then cut.The round ligaments were taken on either side and in a descending fashion the parametrial tissue was clamped with zeppelins and sutured with 0 vicryl, and as we got lower on the uterus the bladder flap was then taken down with the use of metzenbaum and pickups and with the use of a pusher at the base of the cervix.The specimen was removed with the use of scissors and the cuff was then closed with 0 vicryl sutures in a figure-of-eight fashion.When the uterine specimen had been removed from the abdomen and the bleeding had been quiet in terms of the pedicles from above, the attention turned to below where the vaginal cuff was closed in its entirety with the use of 0 vicryl sutures in an interrupted fashion and incorporation of the uterosacral ligaments into the cuff for suspension.When all that was completed and appeared to be dry and a foley catheter had been placed and the uterine appeared blue because indigo carmine had been placed into the iv, then attention was turned to evaluation of rectocele repair.However, at this point, after the cystocele and hysterectomy had been performed, there did not appear to be a significant rectocele and therefore decision made not to proceed accordingly.A vaginal pack was then placed with premarin cream and at this point dr.(b)(6) and then dr.(b)(6) completed the case.The patient was taken to recovery in stable condition following all her surgery.¿ explant procedure: recurrent lower abdominal incisional hernia.Removal of residual fascial graft material; primary closure of recurrent incisional hernia.Explant date: (b)(6) 2004 (hospitalization [ni]).On (b)(6) 2004: (b)(6) hospitals and clinics.(b)(6) md.Operative report.Preoperative diagnosis: recurrent lower abdominal incisional hernia.Postoperative diagnosis: operative findings: the patient had a number of adhesions to the gore-tex graft used for her previous incisional hernia.The bowel was able to taken off this without enterotomy or other complicating event.The graft material was loose, especially in the lower left portion of the graft.This was removed in its entirety.There were some densely adherent residual patch material present in the upper right portion of the incision.Which was left in place.The anterior rectus sheath was able to brought together primarily with minimal tension using a primary closure.The use of graft material given the patient's hysterectomy was felt contraindicated.Description of procedure: ¿after the induction of satisfactory general endotracheal anesthesia, with the patient in the supine stirrup position, dr.(b)(6) proceeded with hysterectomy using a vaginal/abdominal approach.There were fairly moderate adhesions which dr.(b)(6) took down.Additional adhesions were taken down as the uterus and right ovary and tube were clear.Following hysterectomy by dr.(b)(6), additional adhesions were taken down as the fascial edges were cleared circumferentially.Residual patch graft material was removed notably in the left lower quadrant where there was recurrent herniation.The anterior rectus sheath was clear on both sides.It was then reapproximated with running #1 looped maxon starting from each end.The subcutaneous fat was irrigated with antibody solution.The skin incision was closed with staples.Dr.(b)(6) then proceeded with abdominoplasty.¿ relevant medical information: on (b)(6) 2005: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Primary repair of recurrent incisional hernia.Operative findings: the patient had recurrent herniation at the lower portion of her prior incision just above at pubic ramus.This was able to be re-approximated with minimal tension.Procedure: ¿after the induction of satisfactory general endotracheal anesthesia, the patient's abdomen was prepped and draped in the usual fashion.A longitudinal incision was made just above the pubic symphysis and carried into the subcutaneous fat directly down onto the hernia sac.This was opened and contents were reduced.The hernia was cleared through the fascial level.The hernia sac was then excised and discarded.The fascial edges were cleared on all sides.They were then reapproximated primarily with interrupted sutures of 0 ethibond placed in far-near-near-far fashion.Following the fascial reconstruction, the subcutaneous tissues were reapproximated with interrupted 3-0 vicryl stick ties.The skin incision was closed with 4-0 vicryl placed in a subcuticular fashion followed by steri-stripping.The patient tolerated the procedure without complicating event.¿ it should be noted that the gore® dualmesh® 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.".
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® 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® 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 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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