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Added medical record information.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2010: at (b)(6) hospitals.(b)(6), md.History and physical.Presents as a living unrelated donor to her friend.Surgical history: laparoscopic exploration for endometriosis in 2006 and 2009, dilation and curettage x2.Social history: denies any active alcohol, tobacco or drug abuse.Exam: abdomen: soft, non-tender, without any masses, hernias or tenderness noted.Impression/plan: living unrelated donor, friend to friend.Medically cleared.On (b)(6) 2010: at (b)(6) hospitals.(b)(6), md.Operative report.Preoperative diagnosis: living renal donor.Postoperative diagnosis: living renal donor.Procedure: hand-assisted laparoscopic donor nephrectomy of the left kidney.Findings: single renal artery vein and ureter.Disposition: to recovery room in stable condition.On (b)(6) 2010: at (b)(6) hospitals.(b)(6), md.Discharge summary.Patient was admitted as a kidney donor and underwent a hand-assisted, laparoscopic donor nephrectomy of the left kidney on (b)(6) 2010 performed by dr.(b)(6).No complications.Patient discharged home in stable condition.Discharged on percocet as needed for pain.Instructed not to lift anything heavier than a gallon of milk.Follow up with dr.(b)(6) on (b)(6) 2010 in transplant office.On (b)(6) 2010: at (b)(6) health.[signature illegible].History and physical.[handwritten].Procedure: incisional hernia repair.Indication/symptoms: status post lap donor nephrectomy (b)(6) 2010, presents with incisional hernia at gel port site.After he was lifting some heavy [illegible] when she noticed hernia occurrence [illegible] weeks ago.History of drug abuse in the past.Exam: abdomen: soft tender, reducible incisional hernia at gel port site.Plan: admit for incisional hernia for repair; complications/risks discussed.On (b)(6) 2010: at (b)(6) hospitals.Pre-procedure assessment.Weight (b)(6) lbs.On (b)(6) 2010: at (b)(6) hospital.[signature illegible].Anesthesia record.Asa 2.On (b)(6) 2010: at (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Procedure: [incisional hernia repair].Indications for procedure: the patient is a pleasant (b)(6) year-old female who in (b)(6) of 2010 underwent a laparoscopic assisted donor nephrectomy and subsequently developed an incisional hernia which was symptomatic, and it was felt, the patient would benefit from an operation to repair that.Operative details: ¿the patient was brought to the operating room, identified as (b)(6), medical record number (b)(6), placed on the operating room table in supine position.The patient had general anesthesia induced.The patient was prepped and draped in a sterile fashion, and local anesthesia was used to anesthetize small midline incision surrounding the ventral hernia.Careful dissection was carried out to enter the abdominal cavity and dissect the hernia.The hernia was approximately 4 to 5 cm in length, and the fascia was dissected with case.There were minimal adhesions.Following the dissection, the fascia was then closed primarily with 2 running 0 loop pds sutures.Following this, the patient¿s skin was closed with a running 4-0 monocryl suture.The patient tolerated the procedure well and was transferred to pacu extubated in stable condition.¿ on (b)(6) 2010: at (b)(6) hospitals.[signature illegible].Discharge instructions.[handwritten].Activity: lifting: <20 lbs x 4 weeks.Prescription for percocet and tylenol #3 given due to patient¿s drug history.Follow up appointment in 2 weeks.On (b)(6) 2010: at (b)(6) hospital.(b)(6), md.History and physical.Presented with an incisional hernia which was repaired via open incision on (b)(6) 2010.It should be noted that at the time of her initial hernia operating that she states that she was lifting some heavy buckets when she first noticed the hernia.Most recently, has been having pain since operation which has gotten worse over the past week with associated nausea but no emesis.She does state that she had a normal bowel movement earlier today.Appetite has been poor, and energy level has also continued to worsen as well.Pain is of a crampy sensation, notes there appears to be more swelling that she has seen, which she attributes to recurrence of her hernia.Exam: abdomen: tense secondary to her pain, but when she is able to relax, there is subtle upper midline potential defect that may be the area in question regarding the recurrence of her incisional hernia.No obvious defect or loop of bowel is appreciated.The incision itself is clean and dry without any erythema or drainage.Impression/plan: potential recurrence of incisional hernia.Patient will be admitted for pain control, made nothing my mouth except for medications.Will be obtaining a ct scan of abdomen and pelvis to delineate her anatomy better.Pending this, most likely will require re-exploration and repair of her potential hernia.On (b)(6) 2010: at (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen.Clinical history: clinical question of midline incisional hernia after donor left nephrectomy.Findings: the anterior midline abdominal wall incision is apparent and there are small area of fat centrally within the healing vertical wound.However, it is not clear that there is any definite hernia through the muscular abdominal wall.No abnormal focal fluid collections are found here.The study reveals no other significant changes except for the absence of the left kidney and associated surgical clips.All of the other anatomy from the level of the lower chest to the groins is well demonstrated and normal.Impression: no incisional hernia nor other abdominal wall hernias found.There are no other notable findings beyond evidence of previous left nephrectomy.Implant procedure: incisional hernia repair with goretex dual mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/(b)(4)].Implant date: (b)(6) 2010 (hospitalization (b)(6), 2010).On (b)(6) 2010: at (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis/postoperative diagnosis: [ni, not indicated].Assistant: (b)(6), md.Anesthesia: general with local 1% lidocaine.Indications: the patient is a (b)(6) year-old female with a past medical history of laparoscopic donor nephrectomy in (b)(6) 2010.She presented back to (b)(6) medical center in (b)(6) 2010 with an incisional hernia which was repaired primarily.She continued to have persistent postoperative pain that was significant greatest at the superior portion of her wound for which a cat scan was done on (b)(6) 2010 to evaluate.There was no evidence of any recurrent hernia, however given the patient¿s degree of tenderness which was out of proportion to expected postoperative course.A decision was made to take her to the operating room for an exploration.Operative findings: the patient was brought into the operating room, identified as ¿(b)(6)¿ and placed supine on the operating room table.Anesthesia was induced and the patient was prepped and draped in sterile fashion.An incision was made approximately 3 cm superior and 2 cm inferior to her previous incision and her wound was explored.It was found that one of her loop pds sutures had broken with a small hernia sac identified in the superior portion of her wound.Her wound was completely opened from superior to inferior aspect and good fascia was found.A goretex dual mesh was sutured in to close the defect.This was done utilizing four 2-0 prolene sutures run on either side of the wound form north and south poled and met the middle.This closed the defect without any tension.After which the wound was irrigated.Great care was taken to ensure adequate hemostasis after which the wound was closed with 3-0 vicryl deep sutures interrupted followed by a running 4-0 monocryl suture.Dermabond was used to cover the wound.All counts were correct at the conclusion of the case.The patient tolerated the procedure well, was extubated and transferred to the pacu in stable condition.¿ on (b)(6) 2010: at (b)(6) hospitals.Implant sticker.Gore® dualmesh® plus biomaterial.Ref: catalogue number: 1dlmcp04.Lot batch code: (b)(4).The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/(b)(4)) was implanted during the procedure.Relevant medical information: on (b)(6) 2010: at (b)(6) hospital.(b)(6), md.Discharge summary.Admit date: (b)(6) 2010.Diagnosis: incisional hernia, status post primary repair.Procedure: incisional hernia repair with mesh.Past medical history of laparoscopic nephrectomy of her left kidney on (b)(6) 2010.Presented afterwards to (b)(6) on (b)(6) 2010 with an incisional hernia which was repaired with an open incision with primary repair.Now presented to the hospital with pain since the operation which has worsened over the past week with associated nausea, but no vomiting.Was having normal bowel movements.Her appetite was been poor.The pain is described as crampy in nature.History of nonepileptic seizures and iv drug abuse.Ct on (b)(6) 2010 read as no incisional hernia, no other abdominal wall hernias were found.Patient however, still having pain with dilaudid and decided to take the patient to the operating room.On (b)(6) 2010 patient was taken to the operating room and had incisional hernia repair with mesh.Tolerated procedure well and continued on iv dilaudid postoperatively.Stated on oral percocet postoperative day #2 and was given iv dilaudid only for breakthrough pain.Patient was discharged on (b)(6) 2010 and was given percocet 1 to 2 tablets every 4 to 6 hours, tylenol 3, 1 to 2 tabs every 4 to 6 hours for pain as needed and told to continue home medications.Patient was told to follow up with dr.(b)(6) in office and to call to make an appointment.On (b)(6) 2010: at (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen/pelvis.Clinical history: history of recent hernia repair.Findings: enteric system.Diverticulosis of the sigmoid colon is present without findings of acute diverticulitis.Anterior abdominal wall mesh is present extending from just below the level of the xiphoid process to inferior to the umbilicus.The central portion of the mesh is flattened adjacent to the peritoneal surface with the right and left lateral margins of the mesh folded anteriorly (resulting in a ¿u¿ shaped folded appearance).There is inflammation of the subcutaneous deep soft tissues anterior to the surgical site/mesh and the central anterior margins of the rectus abdominus muscle.The inflammation extends in the superior/inferior dimension 8.3 cm, 2.6 cm in anterior/posterior dimensions and 1.5 cm in transverse dimensions.There are no drainable fluid collections present, however the lack of iv contrast material does not allow for the evaluation for small abscess pockets.There is mild inflammatory stranding of the anterior peritoneal surface along the posterior mesh margin.Recurrent hernia is not evident.Impression: since the previous ct evaluation a hernia mesh has been placed along the anterior peritoneal surface.There is inflammation within the peritoneum just deep to the mesh as well as within the anterior trauma wall.The subcutaneous and deep soft tissue anterior bowel wall inflammation extends in rectus abodminis muscle to the skin surface and is most pronounced at the level of the umbilicus.No drainable fluid collections present.There is none within the soft tissues to definitively indicate the presence of infection.Differential possibilities include cellulitis, granulation tissue reaction to the mesh material, normal postoperative change or infection.Recurrent hernia is not demonstrated.Bilateral small ovarian follicles.Physiologic amount of fluid in the cul-de-sac.Patient status post left nephrectomy.On (b)(6) 2010: at (b)(6) hospital.(b)(6).Discharge summary.Admit date: (b)(6) 2010.Diagnosis: abdominal pain.History: presents with abdominal pain.Prior abdominal problems: revision of incisional hernia with mesh on (b)(6) 10 at (b)(6) by dr.(b)(6).The risk factor is negative.Patient saw dr.(b)(6) today who said mass was scar tissue.Patient presenting to the emergency room because she wants a different evaluation.Social history: smokes.25 packs per day.Exam: abdomen: soft midline incisional hernia clear/dry/intact; +5 cm soft tissue mass at base of incision with no surrounding erythema.Nonreducible.Notes: patient with persistent postsurgical pain.Seen by surgeon today and told was scar tissue.Lab work normal.Afebrile.Ct shows no evidence of bowel obstruction or fluid collection.Patient states she will follow up with dr.(b)(6) tomorrow.Impression/plan: abdominal pain.Discharge home.Follow up with (b)(6) within 1-2 days.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Discharge summary.Admit date: (b)(6) 2011.Discharge diagnosis: intractable abdominal pain.Discharge meds: percocet, ultram, cipro.History: patient donated a left kidney in (b)(6) 2010 through an anterior abdominal midline incision.She developed an incisional hernia which was repaired without mesh in (b)(6) 2010 at (b)(6) hospital.She then developed recurrent incisional hernia which was repaired with gore-tex dual mesh at (b)(6) hospital in (b)(6) 2010.Since that surgery the patient had fairly persistent nausea and increasing incisional pain.For the week prior to this admission, she had frequent vomiting and retching.She states she has lost 20 lbs since (b)(6) 2010.She denied fever and chills and had no drainage from the incision.She had no melena, rectal bleeding and no hematemesis.Hospital course: underwent endoscopy on (b)(6) 2011, which showed no abnormalities.(b)(6) had developed a large olive-sized mass at the inferior end of the incision prior to the admission.This was enlarging while here in the hospital.Taken to the operating room on (b)(6) 2011 where the gore-tex dual mesh was removed as well as several areas of fat necrosis resected and a 3 x 6-inch marlex mesh was placed along with a subcutaneous jackson-pratt drain.Postoperatively tolerating diet well.Ambulating without difficulty and having flatus.Seen in consultation by dr.(b)(6) as well as dr.(b)(6).She was also followed by dr.(b)(6).Disposition: discharge with home care.She will be seen in my office in one week for drain removal.Instructions were given her regarding her activities and care of her wound and she was asked to call if any problems.On (b)(6) 2011: at (b)(6) hospital.(b)(6).Discharge summary.Patient states approximately 5 cm of drainage tube is now outside of site.States decreased drainage in drainage ball, and has increased pain in past 24 hours.Admits to bloody drainage from incision site of drain and increased redness surrounding site, midline sutures appear healthy and closed.Patient states called dr.(b)(6) and told to be seen in office tues.Exam: abdominal: tenderness.Right upper quadrant right lower quadrant.Pain on palpation, minimal erythema surrounding right lower quadrant drainage site.No active drainage, minimal drainage in collection ball, sutures intact, no active bleeding.Midline sutures appear healthy, no dehiscence, no erythema.Impression/plan: drain removal.Abdominal pain.Dispositioned to home.Follow up with william (b)(6) within 1-2 days.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Radiology ¿ x-ray.Clinical history: abdominal pain, vomiting.Impression: nonspecific bowel gas pattern with no evidence of air-filled bowel obstruction.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.History and physical.Complaint of vomiting, diarrhea, abdominal pain.Status post removal of goretex dualmesh and excision areas of fat necrosis, insertion of marlex mesh in incisional hernia site 1 to 2 weeks ago.Has been doing well at home.Seen in emergency room for discomfort at jackson pratt site.No infection seen, but drainage was low, therefore drain removed in emergency room.Normal labs at that time.Called me yesterday complaint of vomiting and diarrhea, with subsequent incisional area pain.No drainage from drain site or incision.No fever or chills.Taking ensure for weight gain.Admitted for dehydration.Procedure history: donor l nephrectomy (b)(6) 2010, incisional hernia repair without mesh (b)(6) 2010, recurrent incisional hernia repair with goretex dualmesh (b)(6) 2010, all at (b)(6).Seen postop by her surgeon several times.Developed abdominal pain and vomiting, sought 2nd opinion from me.Patient refused to return to her original surgeon, and refused 2nd opinion at (b)(6).Ct here revealed unusual shape of the gortex mesh, and on physical exam patient had an enlarging painful mass at bottom edge of midline incision.Underwent removal of the gortex dualmesh and areas of fat necrosis, with insertion of marlex mesh for a wide gap incisional hernia, without complication.Exam: gastrointestinal: soft, non-tender, non-distended.Normal bowel sounds, incision healing well.No signs of infection, no seroma, no recurrence of incisional hernia, no masses.Abdomen: no guarding.No rebound tenderness.No hernia.Impression: gastroenteritis, status post incisional hernia repair.Education and follow up.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Discharge summary.Admit date: (b)(6) 2011.Final diagnosis: gastroenteritis.Anxiety.Depression.Discharge meds: percocet, tramadol.Hospital course: on (b)(6) 2011 underwent removal of several areas of fat necrosis in the incision as well as removal of the gore-tex dual patch and insertion of marlex mesh with a jackson-pratt drain.Progressed well and went home several days later.She was seen in emergency room on (b)(6) 2011 with pain at the drain site.The drain site was free of infection and she had no seroma or leakage from the incision.Had no fever, chills and her cbc was within normal limits.Drain was removed as it was draining minimal serous fluid.She was discharge from the emergency room that day.She was back in the emergency room on (b)(6) 2011 after calling me complaining of diarrhea and vomiting and subsequent incisional pain from the muscular contractions from the vomiting and diarrhea.I asked her to go to the emergency room and she was admitted overnight.Today she is doing well.Has no vomiting or diarrhea.Afebrile.Wbc was 8,300.Today is 6,800.She was seen in consultation by dr.(b)(6) and dr.(b)(6) today.She will continue her klonopin and paxil.(b)(6) was asked to call if she develops a fever, increased abdominal pain, vomiting, drainage from the incision.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Radiology ¿ x-ray abdomen.History: abdominal pain/vomiting/postop hernia repair.Impression: no active disease in the chest.Nonspecific bowel gas pattern.No evidence of obstruction.No significant change from (b)(6) 2011.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen/pelvis.History: bruising and abdominal pain.Recent hernia repair and removal of mesh.Findings: the metallic mesh what was present in the anterior domino [sic] walled the previous study has been removed.No recurrent hernia is evident.Fluid collection measuring 4 cm in transverse 2.2 cm in anterior/posterior dimensions extending for approximately 6.6 cm.This fluid measures 13 hounsfield units and extends from the anterior peritoneal surface to just beneath the anterior abdominal wall at posterior margin of the umbilicus.This most likely represents a seroma.There is no air present within this collection to indicate acute infection.Impression: anterior abdominal wall fluid collection occurring within the region of the recently removed hernia mesh is most compatible with seroma.Although infection cannot be completely excluded with imaging, there is no air present within the collection to indicated infection.No recurrent hernia is evident.No bowel obstruction.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.History and physical.Complaint of abdominal pain, nausea, vomiting for past several days.Has been to er several times postoperatively for same reasons, as well as in office for several postop visits.Complaint of abdominal pain, nausea, vomiting.No fever/chills.No drainage from incision.Having flatus and bowel movements.Review of systems: nausea, vomiting, constipation, abdominal pain.No diarrhea.No hematemesis.No abdominal distention.No abdominal tenderness.No jaundice.No melena.No rectal bleeding.Exam: abdomen: soft non-tender, non-distended, normal bowel sounds.No guarding, no rebound tenderness, no hernia.Impression/plan: postop seroma, a common postop occurrence.No signs of infection, but patient is difficult to evaluate clinically, with this degree of discomfort.Will ask interventional radiology to drain.Postop seroma does not explain the nausea, since bowel has not been involved, or abnormal on cts¿.Gastrointestinal consult.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Procedure report.Interventional radiology ¿ drainage.Indication: anterior abdominal wall fluid collection status post hernia repair.Procedure: the patient was prepped and draped in sterile fashion.Using real time ultrasound guidance, a 5 f yuch catheter was introduced into the fluid collection.An initial 5 ml sample was aspirated and sent for microbiology evaluation.The needle was removed and the catheter was then connected to a syringe and a total of 20 ml of clear, straw-colored fluid was removed and sent for microbiology evaluation.The catheter was then removed and the wound covered with a sterile occlusive dressing.Findings: ultrasound demonstrates a multi-septated, approximately 4 x 2 x 7 cm anterior abdominal fluid collection.Post-aspiration ultrasound demonstrates near complete evacuation of the fluid collection.Impression: successful ultrasound guided anterior abdominal wall fluid collection aspiration.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Discharge summary.Admit date: (b)(6) 2011.Final diagnosis: abdominal pain.Nausea.Seroma at site of incisional hernia repair.History of narcotic addiction and rehabilitation.History of pseudo seizures.Procedure: interventional radiology percutaneous drainage of incisional seroma (b)(6) 2011.Discharge meds: percocet, tramadol.History: admitted through emergency room on (b)(6) 2011 with abdominal pain and nausea.Underwent removal of the gore-tex mesh as it appeared to not be flat, it appeared to be bunched.Surgery was on (b)(6) 2011.At that time an area of fat necrosis was also removed revealing tear, chronic inflammation, fibrosis, fat necrosis, foreign body, giant cell granulomas and inflammatory exudate.Since that time denise has been seen in the office several times and has also been in the emergency room with recurrent incisional pain and nausea.(b)(6) has had numerous cbcs drawn, they have all been within normal limits.On this admission wbc was 9,300 with a normal diff.Repeat cbcs being within normal limits as well as the differentials.On (b)(6) 2011 underwent ultrasound guidance drainage of an incisional seroma, per drainage measuring 4 x 2 x 7 cm, 20 ml of clear straw-colored fluid was removed and sent for culture.Culture shows no growth in two days and no organisms were seen.Remained afebrile throughout this hospitalization as she has been since her surgery of (b)(6) 2011.She is now tolerating her diet.Still complains of incisional pain.Was seen in consultation by dr.(b)(6) as well as dr.(b)(6) and dr.(b)(6).Seen on her last admission at (b)(6) hospital by dr.(b)(6).Stated on klonopin and her paxil continued by dr.(b)(6).Does have an outpatient counselor who she sees as well as support in place for her past narcotic addiction having a sponsor and tells me she keeps in contact with the sponsor frequently.Discharged to be seen in my office in one to two weeks.She has not been wearing an abdominal binder but has promised to wear it now.Was asked to call with any problems or a fever greater than 101 or any vomiting.Follow through with outpatient counseling.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen.History: abdominal hernia mesh removal.Findings: anterior abdominal wall seroma currently measures 4.5 x 3.0 x 1.5 centimeters previously measuring 6.6 x 4.0 x 2.2 cm.A focal spot of air is noted likely at the site of drainage around the local [sic].Impression: decreased size of anterior abdominal wall seroma.On (b)(6) 2011: at (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen/pelvis.History: hernia repair.Incisional pain and bleeding.Findings: again, demonstrated is an anterior abdominal wall fluid collection measuring 7.6cm in superior/inferior, 1.2 cm in anterior/posterior and 2.9 cm in transverse dimensions.The density of this fluid collection ranges between 25 hounsfield units and 34 hounsfield the punctate amount of air present within the collection.Findings are most likely secondary to complex seroma/organizing hematoma.The amount of air present is similar to the previous examination; presumably introduced during the recent aspiration.Infection needs to be excluded clinically.Mild inflammatory stranding about the medial and anterior margins of both rectus abdomen muscles, slight anterior abdominal wall skin thickening and interstitial densities extending from the complex seroma to the anterior skin surface in the periumbilical region.The findings are stable compared to the previous study.Impression: appearance of the complex fluid collection in the anterior abdominal wall is similar to the previous ct study.Presence of air and increased density of this collection suggests this represents either probably complex proteinaceous fluid/seroma and/or organizing hematoma is a punctate area of air within the collection, smaller compared to the previous examination probably related to recent drainage.Persistent inflammatory stranding.Cul-de-sac free fluid is probably physiologic.Gallbladder distention may be secondary to mild gallbladder dysfunction or more likely secondary to a fasting state.Clinical correlation suggested.This represents the 7th abdominal and pelvis ct performed on this patient since (b)(6) 2010.Limiting further abdominal/pelvis ct radiation exposure is highly recommended.Consideration to utilization of ultrasound or mri if necessary to reassess the anterior abdominal wall seroma suggested.On (b)(6) 2011: [facility ni].(b)(6), md.History and physical.Presents with open abdominal wound status post multiple recurrent hernia surgeries following kidney donation (b)(6) 2010 at (b)(6).Hernia repairs occurred (b)(6) 2010, and lastly (b)(6) 2011 dr.(b)(6) where mesh was placed.Seen by dr.(b)(6) on (b)(6) 2011, placed on bactrim twice daily, wound culture obtained.Also, culture in (b)(6) emergency department on (b)(6) 2011.History of asthma.Social history: active smoker.History of 1 pack per day x 16 years.Weight (b)(6) lbs, bmi 20.26.Review of systems: gastrointestinal: abdominal wall open wound with dressing over top.Occasional warm compresses, nausea with intense pain.Exam: abdomen: soft, tenderness is present.Midline abdominal incision open mid incision with purulent yellow drainage.No packing.Generalized tenderness surround open wound, no erythema.Impression/plan: incisional wound infection, likely seroma.Eval regarding second opinion dr.(b)(6) wound management.Decision to eval emergency department for pain management, assess wound ct/us, wound culture, likely admission.On (b)(6) 2011 [assigned]: at (b)(6) health system.(b)(6), md.Operative report.Preoperative diagnosis: infected abdominal mesh.[postoperative diagnosis]: infected abdominal mesh.Procedures performed: bilateral component separation and bilateral muscle flaps of the trunk.Removal of infected mesh in the abdomen.Repair of ventral hernia.Implantation of bioprosthetic mesh approximately 100 sq cm, permacol.Indication for operation: this is a patient of dr.(b)(6), who was transferred from an outside hospital, who has previously donated kidney and developed a ventral hernia.This was subsequently repaired multiple times most recently with a marlex mesh and unfortunately, she presents with an open wound with draining sinus down to the mesh and decision was made to take the patient back to the operating room for removal and explantation of mesh and repair of any antecedent ventral hernia.The patient was consented for implantation of bioprosthetic mesh, which should be more resistant to infection.Operative details: ¿the patient was consented and identified in the holding area where she was subsequently brought back to the operating room.She was given a dose of preoperative antibiotics as well as subcutaneous heparin injection.She was subsequently induced with general endotracheal anesthesia and prepped and draped in usual sterile fashion.We began by completely opening up the midline incision.Specimen was sent for purulent debris that was located in the superficial subcutaneous tissues and fat necrosis as well as some pus and this tracked all the way down to the marlex mesh.After sending up this microbiological specimen, we raised medial and lateral skin flaps bilaterally and exposed the underlying marlex mesh.Prolene sutures were removed and the marlex mesh was removed in its entirety to leave a ventral hernia defect that was approximately 5 cm in the midline.We then identified the anterior rectus sheath and also identified the posterior rectus sheath from this midline incision.An incision was made in the posterior rectus sheath using electrocautery and the posterior rectus sheath bilaterally was sewn together using a running # 1 looped maxon suture.Next, we performed a bilateral component separation by releasing the external oblique off of the rectus fascia.This was done bilaterally.We elevated the external oblique down to the lateral perforators bilaterally.This allowed for greater mobilization and less tension on the repair.Next, 100 square centimeter piece of permacol was implanted behind the rectus muscles and sewn into place relatively snug using # 1 prolene sutures in a u-stitch fashion.Lastly, the anterior rectus sheath was then closed over top again using interrupted #1 prolene in a buried fashion.Two #10 jp drains were placed in the subcutaneous tissues and the skin was reapproximated with 3-0 vicryl deep dermal sutures and a 4-0 biosyn subcuticular suture.The wounds were dressed with bacitracin and gauze.The patient was extubated and taken to recovery in stable condition.¿ on (b)(6) 2011: [facility ni].Implant record.Procedure record.Description: permacol.Model: p151828.Lot #: 09b0508.Size: 18 x 28 cm x 1.Weight (b)(6) lbs.Height 5¿2¿¿.
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus 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.¿ there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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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