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(b)(4).It should be noted that the gore® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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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It was reported to gore that the patient underwent laparoscopic ventral hiatal hernia repair on (b)(6) 2010, (b)(6) 2017, and (b)(6) 2017, whereby gore® dualmesh® plus biomaterial and gore® bio-a® tissue reinforcement were implanted.The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby one of the gore devices were explanted.It was reported the patient alleges the following injuries: removal of gore mesh due to dense erosion and infection, gore mesh was stained throughout due to erosion, foul smell from the infected gore mesh, large portion of the stomach eroded to the gore mesh, gastrectomy due to mesh erosion, portion of gore mesh appeared dark and discolored, dense adhesions noted along the undersurface of the liver, primary repair of recurrent hiatal hernia defect.Additional event specific information was not provided.
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® bio-a® tissue reinforcement 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® bio-a® tissue reinforcementinstructions 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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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: ¿ (b)(6) 2008: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: pregnancy at term, previous cesarean section, desire for repeat cesarean section and for permanent sterilization.Postoperative diagnosis: pregnancy at term, previous cesarean section, desire for repeat cesarean section and for permanent sterilization.Procedure: repeat low transverse cesarean section and a bilateral tubal ligation.¿ (b)(6) 2010: (b)(6) medical center.(b)(6), md.History and physical.Presents for evaluation of some abdominal pain.States that it has been there since september.It is localized to the mid epigastric region.Often feels quite full and bloated.Has had a couple of episodes of nausea and vomiting with this.Occasionally have diarrhea, but that has not been a huge complaint.Admits to smoking a pack every three days for the past 15 years.Exam: abdomen is soft, somewhat tender in the right upper and mid epigastric region; she does have a small umbilical hernia which is nontender.Impression/plan: discussed that the sludge itself is certainly not a reason to proceed with cholecystectomy, but we will send her for a hida scan to see what her ejection fraction is.Should this come back completely negative then i would recommend that we do an upper endoscopy.I explained that some of her symptoms certainly sound like gastritis and that she may find her symptoms improve with some weight loss and decreasing her stress.¿ (b)(6) 2010: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen.Indication: hemangioma.Findings: the entire stomach is herniated into the chest and rotated 180 degrees on a transverse axis.This represents volvulus, but without obstruction.A 9 x 9 x 16-mm umbilical hernia contains only mesenteric fat when supine.Impression: tiny focus of focal fatty infiltration in anterior left liver.Liver is otherwise normal, including in area of recent ultrasound concern.Non-obstructed volvulus of stomach, which is herniated entirely into the chest.Very small fat-containing umbilical hernia.Lipomatous infiltration of the ileocecal valve.No other significant soft tissue abnormalities.Lower lumbar spondylosis, with moderate l4-5 spinal stenosis.¿ (b)(6) 2010: (b)(6) medical center.(b)(6), md.Operative report.Procedure: egd with biopsy.Indications: gastroesophageal reflux disease and epigastric pain.Medications: demerol 25 mg iv; versed 7.5 mg iv.Topical: lidocaine 4% solution.Description of procedure: ¿after the risks benefits and alternatives of the procedure were thoroughly explained, informed consent was obtained.The pentax eg-2990k endoscope was introduced through the mouth and advanced to the pylorus.The instrument was slowly with drawn as the mucosa was fully examined.The patient was monitored throughout for iv conscious sedation to include o2 saturation, blood pressure monitor and cardiac monitor.All of which remained normal during the procedure.A hiatal hernia was found paraesophageal hernia large inflammation was found in the gastroesophageal junction.Multiple biopsies were obtained and sent to pathology.The gastroesophageal junction was 39 cm from central incisors.Retroflexed views revealed a large hiatal hernia.The scope then completely withdrawn from the patient and the procedure terminated.¿ complications: none.Impression: a hiatal hernia was found.Inflammation was found in the gastroesophageal junction.Recommendations: await biopsy results; prilosec; anti-reflux regimen.¿ (b)(6)2010: (b)(6) medical center.(b)(6), md.History and physical.Evaluation and treatment of hiatal hernia.Has been having increasing and somewhat debilitating chest pain and mid epigastric symptoms over the past several months.Notes while she does have some acid reflux type heartburn being placed on acid suppression medication has not taken care of the predominant discomfort symptoms however.Describes the ongoing problems as being severe bloating and fullness in the upper abdomen and chest.After eating a regular meal she at times has difficulty taking a deep inspiration.As part of her evaluation radiologic evidence was found of a large hiatal type hernia.On egd however she has a significant i believe paraesophageal hernia which is largely contributing to her symptoms.Did as well have evidence of mild reflux esophagitis also.Continues on acid reflux, proton pump inhibitor medication and wishes to move forward with her hernia repair and nissen fundoplication.Smokes approximately one pack of cigarettes every three days and has for some 15 years.Exam: abdomen is soft, nondistended with normoactive bowel sounds.I don¿t appreciate any abdominal masses or peritoneal findings.She may have a small umbilical hernia.Impression: large hiatal hernia likely paraesophageal with some gastroesophageal reflux symptoms.Plan: i¿ve discussed my recommendation of nissen fundoplication with hernia repair.We talked about using mesh placement depending on the size of her diaphragmatic hernia along with the risks and benefits to include but not limited to bleeding, infection, recurrence as well as anesthetic risk.Wishes to proceed.Implant procedure #1: laparoscopic hiatal hernia repair with mesh and nissen fundoplication.Implant: gore® dualmesh® plus biomaterial [1dlmcp02/06816090, 8 x 12] implant date #1: (b)(6) 2010 (hospitalization (b)(6) 2010).¿ (b)(6) 2010: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: large hiatal hernia and gastroesophageal reflux disease.Postoperative diagnosis: large hiatal hernia and gastroesophageal reflux disease.Assistant: culbertson.Anesthesia: dr.Harrison ¿ general endotracheal.Ebl: less than 5 cc.Crystalloids were used intraoperatively.Goretex dual plus mesh was used for the repair.Foley catheter was placed intraoperatively as well.There were no complications.Description: ¿anna brace presents with a large diaphragmatic defect with one-third to one-half for her stomach in the thorax intermittently.She as well has gastroesophageal reflux disease.The patient was taken to the operating room after informed consent and placed in the supine position at which time general endotracheal anesthesia was induced without difficulty.She was placed in the low lithotomy position at this point.A foley catheter had been placed earlier.Her abdomen was prepped and draped in a sterile fashion.The proposed trocar sites were anesthetized with 0.5% marcaine injection.Using veress needle infraumbilical technique an appropriate pneumoperitoneum was established.Four additional 5 mm trocars ports were placed under direct visualization ¿ two in the midepigastric area and two each in the subcostal margin areas.A liver retractor device was used to hold the liver cephalad exposing the large diaphragmatic defect.Next, using grasper devices and the harmonic scalpel the stomach was reduced from the thorax.This was done by dividing extensive fibrous adhesions.Once the stomach was completely reduced the bougie dilator was placed within the lumen of the esophagus to identify the esophageal location precisely.A posterior window was created at the base of the esophagus and a penrose drain was placed around the esophagus base at this point for retraction.The diaphragmatic crura muscles were identified and cleared of looser tissue for the closure.The diaphragmatic repair was carried out by using horizontal mattress sutures with 0 ethibond suture and goretex dual plus mesh pledgets thereby reapproximating the crura muscles in the midline.A 5-8 bougie dilator was in the esophageal lumen to judge the appropriate closure of the repair.Next, with the bougie dilator partially withdrawn the fundus of the stomach was passed posterior to the esophagus after the short gastric vessels were taken down using the harmonic scalpel.A shoestring technique was used to ensure that there was no twisting of the fundus.The fundoplication was then completed with the bougie dilator once again advanced into the esophagus.The fundoplication was created with multiple interrupted 0 ethibond sutures incorporating slips of esophagus within the each of the sutures.Next, the bougie dilator was withdrawn and the fundoplication was noted to be floppy in nature without any axial torsion or kinking.The fundoplication was then as well sutured to the crura repair circumferentially to avoid reherniation.Hemostasis was confirmed.There was no evidence of gross visible injury of the stomach or the esophagus as the area of dissection was carefully irrigated and suctioned.Next, the penrose drain was removed from within the abdomen.The instrumentation at this point was then removed.The skin edges were then coapted with surgical skin staples and sterile dressings were placed over each wound site as well.The patient tolerated the procedure without event.The sponge, instrument, needle count were found to be correct and there were no complications.She was taken to the recovery room extubated in stable condition.¿ ¿ (b)(6) 2010: (b)(6) medical center.Implant record.Device description: mesh dual 8 x 12.Item #: 1dlmcp02.Body site: abdomen.Expiration: 05/01/2012.Lot #: 06816090.Manufacturer: w.L.Gore & associates.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp02/ 06816090) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2010: (b)(6) medical center.(b)(6), md.Discharge summary.Admission diagnosis: large hiatal hernia and gastroesophageal reflux disease.Postoperative course was typical.By second postoperative day she was tolerating a pureed diet, self ambulating, and had reasonable pain control.Wounds were clean, dry and intact without evidence of infection, and her abdomen was otherwise soft with normoactive bowel sounds.Was given wound care instructions and would continue with a pureed diet over the next 4 weeks along with restricted light activity.¿ (b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: abdominal pain.Findings: small to moderate sized hiatal hernia.Status post repair gastric volvulus.Impression: hiatal hernia.Postoperative changes.Otherwise normal ct abdomen and pelvis.¿ (b)(6) 2011: (b)(6) medical center.(b)(6), md.History and physical.Ongoing abdominal pain episodes.She describes severe bloating in the midabdomen but without any particular temporal to food or activity.She¿s tried antigas and antacid medications and feels as though these may have helped a little but she continues with symptoms.Also has had vomiting and regurgitation episodes.Feels a sense of dysphagia particularly with solid foods.Smokes up to a pack every other day.Exam: abdomen is soft, nontender, nondistended with normoactive bowel sounds.I don¿t appreciate any abdominal masses or peritoneal findings.Impression: episodic mid upper abdominal pain of unclear origin.Also some dysphagic and nausea, vomiting type symptoms associated with the above as well.Plan: i¿ve discussed my recommendations of upper endoscopy along with the associated risks and benefits.¿ (b)(6) 2011: (b)(6)medical center.(b)(6), md.Operative report.Procedure: egd with biopsy.Indications: gastroesophageal reflux disease.Medications: demerol 25 mg iv; versed 7 mg iv.Topical lidocaine 4% solution.Description of procedure: ¿after the risks benefits and alternatives of the procedure were thoroughly explained, informed consent was obtained.The pentax eg-2990k endoscope was introduced through the mouth and advanced to the second portion of the duodenum.The instrument was slowly with drawn as the mucosa was fully examined.The patient was monitored throughout for iv conscious sedation to include o2 saturation, blood pressure monitor and cardiac monitor.All of which remained normal during the procedure.Multiple erosions were found in the gastroesophageal junction.Multiple erosions were found a hiatal hernia was found multiple erosions were found in the gastroesophageal junction.Multiple biopsies were obtained and sent to pathology.A hiatal hernia was found.The gastroesophageal junction was 37 cm from central incisors.Retroflexed views revealed hiatal hernia.The scope was then completely withdrawn from the patient and the procedure terminated.¿ complications: none.Impression: multiple erosions were found in the gastroesophageal junction.A recurrent hiatal hernia was found.Slipped nissen.Recommendations: continue acid suppression.Anti-reflux regimen.Follow up in office to discuss results.¿ (b)(6) 2011: (b)(6)medical center.(b)(6), md.History and physical.Returned to office following recent upper endoscopy.Over the past several months has been having worse midepigastric abdominal bloating and pain along with significant regurgitation episodes.At times states she¿ll actually vomit up food shortly after ingestion.Has had some dysphagia symptoms as well.Is status post nissen fundoplication nearly 2 years ago and has had an excellent result up until the past few months when her symptoms recurred.As part of her evaluation she had undergone upper endoscopy which revealed what is thought to be a recurrent hernia along with partially slipped and/or relaxed nissen fundoplication.Her gastroesophageal junction grossly had ulcerations and on biopsy at this level obvious inflammatory changes consistent with above.I had a long discussion with the patient regarding an attempt to abate her symptoms with increasing proton pump inhibitor therapy as well as further lifestyle and dietary changes.The patient notes she is on proton pump medication twice daily and antacids frequently for breakthrough symptoms.We also discussed revision/redo laparoscopic nissen fundoplication.The patient understood our discussion and wishes to proceed with surgery.History of thyroid disease, severe gastroesophageal reflux disease and a large hiatal hernia.Surgical history of cesarean sections x 2, tubal ligation and hiatal herniorrhaphy with laparoscopic nissen fundoplication nearly 2 years ago.Smokes up to a pack of cigarettes every other day and denies drug or alcohol abuse.Exam: abdomen is soft, nontender, nondistended with normoactive bowel sounds.Impression: past history of laparoscopic nissen fundoplication with evidence of slipped versus relaxed nissen fundoplication and recurrent hiatal hernia.Symptomatic gastroesophageal reflux disease.Plan: i had a long detailed conversation with the patient regarding medical versus revision versus redo nissen fundoplication.She wishes to move forward with surgery.¿ (b)(6) 2011: (b)(6) medical center.[signature illegible].Anesthesia record.Weight 220 lbs.Tobacco x 17 yrs, quit x 1 year.Surgical history of umbilical hernia.Asa: ii.Implant procedure #2: laparoscopic redo and nissen fundoplication and hiatal hernia defect repair with mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp03/06600368, 10x15] implant date #2: (b)(6) 2011 (hospitalization october (b)(6) 2011).¿ (b)(6) 2011: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: recurrent hiatal hernia and refractory gastroesophageal reflux disease, status post nissen surgery.Postoperative diagnosis: recurrent hiatal hernia and refractory gastroesophageal reflux disease, status post nissen surgery with a very large diaphragmatic defect and extensive adhesions.First assistant: diane greenfield.Anesthesia: dr.Pomicter-general endotracheal anesthesia.A 0.5% marcaine for local anesthetic.Estimated blood loss: 150 cc.Fluids crystalloids were given intraoperatively.Foley catheter was placed intraoperatively without event.No complications.Operative procedure: ¿anna brace presents with recurrent reflux symptoms and intermittent chest pain following a nissen fundoplication nearly two years ago.On evaluation she was found to have, once again, a large hiatal defect and relaxed or slipped nissen.After informed consent regarding the risks and benefits, the patient was taken to the operating room and placed in the supine position at which time general endotracheal anesthesia was induced without difficulty.The patient¿s abdomen and chest were then prepped and draped in a sterile fashion after she was placed in low lithotomy positioning and a foley catheter had been placed without event.The proposed trocar sites were anesthetized with 0.5% marcaine injection.Using an open hasson trocar technique infraumbilically, an appropriate pneumoperitoneum was established.Four additional 5 mm trocar ports were placed under indirect visualization in the areas of her previous laparoscopic scars.The left lobe of the liver was retracted cephalad.The patient had extensive scarring in the area of her prior nissen and hiatal repair.The adhesions were taken down with both the harmonic scalpel and electrocautery and endoshears as well as with blunt dissection.Once the fundoplication was removed off of the surface of the liver and the left and right crura muscles, it was evident that her diaphragmatic repair had completely come apart.It appears that the pledgetted reapproximation was intact, however, she had a new crura muscle defect towards the patient right side.Next after several hours of dissecting the nissen off of the esophagus using the bougie dilator as a guide for locating the esophagus, the stomach was once again mobile particularly the fundus.At this point there was no noted injury grossly to the stomach, esophagus, or other organs.The crura defect was too large to repair primarily, so dual gore-tex mesh was used for the repair using a keyhole type pattern.The mesh was sown to the inferior diaphragmatic surface using multiple interrupted ethibond sutures circumferentially.The mesh was then encircled around the esophagus with the bougie dilator within the esophageal lumen for appropriate sizing.Next the fundus of the stomach was passed posterior to the esophagus and the fundoplication was recreated as originally.The gastric fundus was secured to the seromuscular layer of the anterior stomach with multiple interrupted 0 ethibond sutures.Each suture incorporated slips of smooth muscle involving the anterior esophagus to prevent slippage.At this point the bougie dilator was then removed upon completion of the fundoplication.The fundoplication appeared to be floppy in nature without any axial torsion or kinking.The fundoplication was further secured to the crura muscles posteriorly as to prevent reherniation.Hemostasis was confirmed.The area of dissection was copiously irrigated and suctioned at this point.The penrose drain placed previously around the esophagus for retraction was removed.The liver retractor device was removed as well as the other instrumentation.The pneumoperitoneum was allowed to decompress at this point.The sponge, instrument and needle counts were found to be correct.There were no complications.The umbilical fascial defect was reapproximated with 0 vicryl sutures.The skin edges were coaptated with surgical skin clips.The patient tolerated the procedure without event.She was extubated in the operating room and taken to the recovery room in stable condition.¿ ¿ (b)(6) 2011: (b)(6) medical center.Implant record.Implant: mesh dual plus 10 x 15.Manufacturer: gore.Lot #/batch #: 1dlmcp03.Cat #/serial #: (b)(6).Size: 10x15.Site: abdomen.Exp.Date: 01/12.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/ 06600368) was implanted during the procedure.See attachment for h10/11 continuation.
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