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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 preoperative complaints: on (b)(6) 2006: (b)(6) hospital.Dr.(b)(6), md/ dr.(b)(6) , md.History and physical.History of present illness: ¿this is a pleasant 67-year-old male who is status post transverse colon resection for colon polyps in (b)(6) of 2006.He has subsequently developed a bulge along his midline incision.He did have a wound infection postoperatively after his colon surgery.Patient has noticed the bulge growing larger in size.It is nonpainful at this time.¿ physical exam: abdomen: ¿soft, nontender, nondistended.He does have a large incisional hernia at the superior aspect of his midline incision.His abdomen is soft.His midline incision is well healed.He does have a ventral incisional hernia with approximately 4 to 5 cm fascial defect.It is reducible.¿ impression: ventral incisional hernia.Plan: plan is for laparoscopic ventral hernia repair.Patient does have all the necessary preoperative labs, chest x-ray, and ekg.We will make arrangements for laparoscopic repair next week.On (b)(6) 2006: (b)(6) hospital.Dr.(b)(6), md.Indication: ¿the patient presented with a history of colon cancer with a transverse colectomy through a midline incision.He had developed a bulge in the area.On examination he had a reducible ventral incisional hernia.Risks, benefits, and alternatives to laparoscopic ventral hernia repair with mesh were discussed with the patient in detail.He agreed to proceed with the planned operation¿.Implant procedure: laparoscopic ventral hernia repair with a 20 cm x 26-cm polytetrafluoroethylene mesh.[implant: gore® dualmesh® biomaterial, 1dlmc07/04393536, 20cm x 26cm].Implant date: on (b)(6) 2006 (hospitalization on (b)(6) 2006).On (b)(6) 2006: (b)(6) hospital.Dr., md.Operative report.Assistants: (b)(6).Preoperative and postoperative diagnosis: ventral incisional hernia.Anesthesia: general.Estimated blood loss: less than 25 ml.Procedure: ¿the patient was brought to the operating suite and placed in the supine position under general anesthesia.A foley catheter was placed in the bladder.He was then prepped and draped in the usual sterile fashion, including an ioban steri-drape across his abdomen.A veress needle was used to inflate the abdomen under the left costal margin without difficulty and a 5-mm optiview trocar used to enter the abdominal cavity in the left lateral abdomen.The patient had adhesions of omentum to the anterior abdominal wall.We were able to place a 12-mm balloon-tipped trocar and a 5-mm trocar in the left lateral abdomen.Sharp dissection was then used to remove the adhesions from the anterior abdominal wall.These came down nicely, exposing the entire area of defect.There was no evidence of bowel within this hernia.The falciform ligament was divided.The spinal needles were then used to mark the edges of the fascial defect and an intra-abdominal ruler used to measure the defect.This was 16 cm vertically and 9 cm horizontally.Therefore, a 26 cm x 20-cm ptfe mesh was fashioned, placing a 0 gore-tex suture on each of the four sides.The intra-abdominal ruler was removed.Mesh was brought into the 12-mm trocar site and then unrolled.An intra-abdominal grasper was used to measure a 5-cm overlap in all directions for the fascial defect and the gore suture passer used to bring the stitches up to the anterior abdominal wall.Mesh laid nicely covering the defect well.It was then tacked circumferentially using spiral tacks around the edge 1 cm apart.Addition 0 gore-tex transabdominal fixation sutures were placed every 4 to 6 cm circumferentially around the mesh.The mesh had no laxity.It laid nicely.There was no bleeding from tack or suture sites.The 12-mm trocar site closed with a figure-of-eight 0 gore-tex suture using the suture passer.The trocars were removed under direct camera visualization with no evidence of bleeding from trocar sites.Sponge and needle counts were correct.The skin infiltrated with 60 ml of 0.25% marcaine plain at the suture sites.The skin closed with 4-0 monocryl suture.Sterile dressings were applied, including dermabond skin adhesive.The patient was then awakened and taken to the recovery room in stable condition ¿.On (b)(6) 2006: (b)(6) hospital.Implant sticker: ¿gore dualmesh® biomaterial¿.Ref catalogue number: 1dlmc07.Lot batch code: 04393536.W.L.Gore & associates.On (b)(6) 2006: (b)(6) hospital.Drs.(b)(6).Discharge summary.Hospital course: ¿patient is a 67-year-old gentleman who was seen in clinic by dr.(b)(6) on (b)(6) 2006.Patient presented with an incisional hernia status post transverse colon resection for colon polyp in (b)(6) of 2006.Patient was taken to the operating room on (b)(6) 2006 for the above procedure.The patient did well intraoperatively as well as postoperatively.Patient had no complications.Patient did have pain control issues, and on (b)(6) 2006 patient was tolerating a regular diet his pain was controlled with p.O.Pain medications (ibuprofen and vicodin), and the patient's vital signs were stable.Thus, patient was stable for discharge.¿ diagnosis: ventral hernia.Follow up in 2-3 weeks.Relevant medical information: on (b)(6) 2015: (b)(6) hospital in (b)(6).Dr.(b)(6) , md.Operative report.Preoperative diagnosis: right inguinal hernia.Postoperative diagnosis: right direct inguinal hernia.Procedure: laparoscopic right inguinal hernia repair with 16 cm x 13 cm polypropylene mesh.Implant: prolene mesh.Anesthesia: general.Estimated blood loss: less than 20 ml.Indications: ¿patient presented with a history of bulge in his right groin.On exam he had a reducible right inguinal hernia.The risks, benefits, and alternatives of laparoscopic repair with mesh were discussed with the patient in detail and he agreed to proceed with planned operation.¿.Procedure: ¿patient brought to the operating suite, placed in supine position under general anesthesia, prepped and draped in the usual sterile fashion.A veress needle was used to insufflate the abdomen under the left costal margin.A 5 mm optiview trocar used to enter the abdominal cavity.The patient had adhesions of a few areas of omentum as well as small intestine to his previously placed midline mesh.These were able to be taken down sharply and were very filmy adhesions.This allowed us to examine the groins.Patient demonstrated a moderate-sized right direct inguinal hernia.A 12 mm trocar was placed in the midline, 5 mm in the right lateral abdomen.The peritoneum above the hernia defect was incised, and the peritoneum brought down from the abdominal wall.We preserved the epigastric and testicular vessels.Vas deferens was identified and preserved.The large wad of pre peritoneal fat within the direct hernia was able to be reduced.This allowed us to then clear a large preperitoneal space, exposing cooper's ligament medially.The peritoneum was brought back nicely, hemostasis was excellent.A 13 x 16 cm polypropylene mesh was then placed into the preperitoneal space.It was secured to cooper's ligament using absorbable tacks, secured to the posterior rectus using absorbable tacks.It covered the area of defect quite well.The peritoneum was then reclosed over the mesh using absorbable tacks, covering it completely.Care was taken not to place any tacks below the iliopubic tract to avoid cutaneous nerve entrapment.The 12 mm trocar site, which had been placed through the patient's previous midline mesh.Was then closed using a figure-of-eight o ethibond suture.All trocars were then removed under direct visualization, no evidence of bleeding from trocar sites.Sponge and needle counts were correct skin infiltrated with 30 ml 0.25% marcaine plain, and skin closed with 4-0 monocryl suture and dermabond on the skin.Patient was awakened, and taken to the recovery room in stable condition.¿ on (b)(6) 2015: (b)(6) hospital in (b)(6).Medical device/tissue graft identification sheet.Prolene mesh.25cm x 15 cm.Lot: jaj646.Product code: pmh.Ethicon, llc.Implant #2 preoperative complaints: on (b)(6) 2018: (b)(6) hospital in (b)(6).Dr.(b)(6), md.Indication: ¿patient presented with a history of previous midline ventral incisional hernia repair.He had developed a small hole through the defect within this mesh resulting in a recurrent small hernia.Risks, benefits, alternatives to laparoscopic repair with mesh were discussed the patient in detail.He agreed to proceed with the planned operation.¿.Implant #2 procedure: laparoscopic ventral incisional hernia repair with 15-cm x 15-cm gore ptfe dualmesh.[implant: gore® dualmesh® biomaterial, 1dlmc04/17877459, 15cm x 19 cm].Implant #2 date: on (b)(6) 2018 (hospitalization (b)(6) 2018).On (b)(6) 2018: (b)(6) hospital in (b)(6).Dr.(b)(6), md.Operative report.Assistant: (b)(6) , cnor.Preoperative and postoperative diagnosis: ventral incisional hernia.Anesthesia: general.Estimated blood loss: less than 30 ml.Procedure: ¿the patient was brought back to the operating suite, placed in supine position under general anesthesia.Foley catheter was placed.He was prepped and draped in the usual sterile fashion.Veress needle was used to insufflate the abdomen under the left costal margin.A 5-mm optiview trocar was used to enter the abdominal cavity.The patient had a few adhesions of omentum to his previous mesh.These were easily swept down as they were quite filmy.This identified the area of small bowel that was herniated into a small defect in the middle of the mesh itself.This was able to be taken down with sharp dissection.No evidence of any injury to the serosa of the bowel throughout the dissection.The defect itself was approximately 3.5 x 4 cm.We used a 15 x 15 cm gore ptfe dual mesh with o gore-tex suture on each of the four sides.It was brought into the abdominal cavity through the defect itself so that area would be covered.An intra-abdominal grasper was used to measure a 5-cm overlap in all directions from the defect and the mesh brought up to the anterior abdominal wall with the four sutures.The mesh was then tacked circumferentially using spiral tacks and covered the defect quite well.Hemostasis was excellent.All trocars were removed under direct visualization.No evidence of bleeding from trocar sites.Sponge and needle counts correct.Skin infiltrated with 30 ml 0.25% marcaine plain.Skin closed with 4-0 monocryl suture and dermabond skin adhesive.Patient was awakened and taken to the recovery room in stable condition.¿.On (b)(6) 2018: (b)(6) hospital in (b)(6).(b)(6), rn.Implant sticker.Implant: ¿1 mesh dual 15x 19¿.Catalog #: 1dlmc04.Serial #: (b)(4).W.L.Gore co.Expiration date: 3/31/2023.Quantity: 1.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® 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 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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