Trivent Legal | Medical Summaries | Medical Chronologies



XXXX – Hernia Mesh Case Review

Case Report

|Parameter |Findings |PDF Ref |

|Date of implant |04/14/YYYY |51-52 |

|Reason for mesh implant |Large incisional hernia with obstructive symptoms |51-52 |

| |Questionable cyst | |

|Procedure (s) Performed |Repair of incisional hernia with a Kugel patch, removal of cyst of the |51-52 |

| |cul-de-sac. | |

|Implant Details |Product Name: Bard® Composix® Kugel® Hernia Patch |53 |

| | | |

| |Manufacturer Name: Bard | |

| | | |

| |Lot number: 43HND457 | |

| | | |

| |Reference number: 0010208 (Illegible) | |

| | | |

| |Snapshot of the Product Label: | |

| | | |

|Complications Post Implant |Time period: 04/23/YYYY-08/25/YYYY |500, 501, 496, 817, 7, 5, |

| | |34 |

| |Nausea and constipation which are probably related to her narcotic pain | |

| |medication | |

| |Pain at incision site | |

| |Diarrhea – Incision is healing well | |

| |Occasional soreness at the incision site | |

| |07/19/YYYY: Status post fall – Approximately three weeks ago was on a treadmill, | |

| |and all of a sudden, one of her little children turned it on high speed and she | |

| |feel off of it. Since then, she has been falling pain in the left side of the | |

| |abdomen | |

| |CT- scan does show may be a little separation of the mesh from the abdominal | |

| |-wall on the left side. This is the area where she has almost point tenderness | |

| |and a knot feeling | |

| |Questionable stitch irritation with painful tenderness over area exploration. | |

| |History: On exploration it was noted an area of induration, underneath which | |

| |there was plastic wire of the Kugel patch ring which had protruded through and | |

| |was causing the irritation. There was no recurrent hernia noted. (Indirect | |

| |evidence from clinical history of the revision surgery) | |

|Date of Revision |08/25/YYYY: Underwent removal of portion of fiber from Cagul (Must be Kugel) mesh|34-36 |

| |from left abdominal wall for postoperative incisional hernia and possible stitch | |

| |irritation, point tender area in the lateral abdomen on the left side with | |

| |history of previous Kugel patch repair of huge abdominal wall hernia under | |

| |general anesthesia. | |

|Operative Findings |A transverse incision was made, deepened down to the area. When the fascia was |34-35, 516 |

| |incised, I saw a wire protruding through it. This was pulled up as far back as I | |

| |possibly could, and then cut off. At this stage I did not feel any more residual | |

| |wire. The area was injected with 1 mL of Kenalog and closed with interrupted | |

| |suture of 0 Vicryl. Subcutaneous closure was done with 3-0 Vicryl. | |

| | | |

| |Surgical Pathology Report (08/26/YYYY Reported date): Foreign body, clinically | |

| |mesh material (Gross only): Gross description: A cylindrical shaped transparent | |

| |firm piece of material 3 cm in length about 0.1 cm in diameter. No tissue is | |

| |received. | |

|Complications Post Revision |Time Period: 09/02/YYYY-05/10/YYYY |946, 832-835, 669, 668, |

| | |190, 282 |

| |09/02/YYYY: In-Office Wire Excision: A nylon wire of the mesh had broken and was | |

| |sticking out into the subcutaneous tissue. This was excised with a local | |

| |injection of Kenalog. She is doing extremely well. She has had no further pain | |

| |*Reviewer's comment: Interim medical records during 09/02/YYYY-04/18/YYYY are | |

| |thoroughly reviewed and noted no significant events related to hernia mesh case | |

| |review. | |

| |04/18/YYYY: Chronic abdominal pain | |

| |04/19/YYYY: CT of abdomen and pelvis for chronic abdominal pain – Impression: | |

| |Ventral midline abdominal wall hernia repair with mesh. The appearance of the | |

| |mesh is relatively stable from the YYYY study. There is a 2 cm diastasis of the | |

| |rectus musculature below the mesh at the midline lower anterior abdominal wall; | |

| |however, there is no significant herniation through this diastasis. This portion | |

| |of the anatomy was not imaged on the YYYY CT scan. Evidence for recurrence of | |

| |hernia elsewhere not appreciated. No acute inflammatory process in the abdomen or| |

| |pelvis. Unclassified soft tissue-like oblong-shaped structure is present along | |

| |the medical aspect of the cecum adjacent or abutting the cecal wall in the | |

| |pericolonic fat. Measurements are 2.2 x 1.8 cm. This is identified on the YYYY | |

| |abdominal CT and has not changed in its size. It is not causing any bowel | |

| |obstruction and it is without surrounding inflammation. The patient does indicate| |

| |prior colon surgery in YYYY and does not list appendectomy in the history either.| |

| |Therefore it is unclear if this could represent post-surgical scarring and | |

| |remains unchanged since YYYY. The etiology still remains uncertain. | |

| |05/02/YYYY: Was moving stuff around in her attic about three weeks ago and | |

| |developed severe pain. The pain has been lessening, but it is still present – She| |

| |does have a recurrent hernia in the suprapubic area. It is a fairly small defect.| |

| | | |

| |Kugel mesh for hernia with broken ring | |

|Date of Revision along with Additional |06/04/YYYY: Exploratory laparotomy with extensive lysis of adhesions and removal |1-3 |

|Implant Surgery using Parietex ProGrip |of mesh and repair of recurrent incisional hernia with component via the mild | |

|mesh |fascial flap technique for recurrent incisional hernia under general endotracheal| |

| |anesthesia | |

|Operative Findings |Cautery was used to dissect down towards the mesh. Mesh was encountered. |1-3 |

| |Interiorly there was a recurrent, and so the hernia sac was entered sharply | |

| |between hemostats. There were some adhesions there but were fairly thin and they | |

| |were taken down sharply. Mesh could be cut down the midline taking down the | |

| |adhesions underneath before cutting it obviously. Once this was done on the right| |

| |side, it was noted that there were some dense small bowel adhesions to the mesh, | |

| |and it was a very arduous lysis of adhesions, but was carefully done. The small | |

| |bowel was inspected afterwards. There were no enterotomies made the mesh was | |

| |removed in its entirety with cautery. Same thing on the left side although | |

| |thankfully the adhesions were not as dense on the left side. The mesh was removed| |

| |as well. | |

| | | |

| |The two pieces of 15 x 20 Parietex ProGrip mesh were then placed to fully | |

| |reinforce the anterior abdominal wall covering the defect laterally. Especially | |

| |it was secured to the fascia with a running zero Prolene suture circumferentially| |

| |as well as down the midline. Everything was hemostatic. Two drains were placed | |

| |over the mesh and exited out laterally. Excess skin was excised, and then the | |

| |midline was re-approximated subcutaneously with a 2-0 Vicryl | |

|Additional Implant Mesh Details |Product Name: Parietex Progrip |272 |

| | | |

| |Manufacturer Name: Covidien | |

| | | |

| |Lot number: XXX | |

| | | |

| |Reference number: XXX | |

| | | |

| |Snapshot of the Product Label: | |

| | | |

|Complications Post Revision with |Time Period: 06/14/YYYY-08/02/YYYY |667, 666, 665, 782 |

|Additional Implant Surgery | | |

| |Still hurts a fair amount | |

| |No evidence of any recurrent hernia | |

| |She is still hurting but much, much less. Incision looks good. She has a good | |

| |repair – Patient reassured | |

| |09/15/YYYY: Patient related the onset musculoskeletal pain at the time of her | |

| |last hernia repair surgery in YYYY. She says she did not have pain prior to that.| |

| |That was an extensive surgery directed at trying to correct week abdominal tissue| |

| |and she has had to wear an abdominal band ever since to try to keep her abdominal| |

| |contents internal without pushing through the abdominal wall. She says her | |

| |surgeon tells her that there is not much more that can be done. Her initial | |

| |abdominal surgery was for diverticulosis in YYYY and she had her first tourney | |

| |repair in YYYY. The pain began in YYYY after the last surgery. She is on a statin| |

| |drug but she was on a statin drug for years prior to the surgery and never had | |

| |problems with it. Assessment: Chronic pain syndrome | |

| | | |

| |*Reviewer's comment: Interim medical records during 08/02/YYYY-11/21/YYYY are | |

| |thoroughly reviewed and noted to no significant events related to hernia mesh | |

| |case review. | |

|Condition of the Patient Per Last |02/23/YYYY: Presents for pelvic examination. Review of system was significant for|864-869 |

|Available Record |pelvic pain in genitourinary systems – Active problems lists includes chronic | |

| |pain syndrome and she is on pain medications. | |

Patient History

Past Medical History: History of abdominal tenderness left lower quadrant, basal cell cancer, dorsalgia, Hernia, candidiasis, tinea corporis, Lyme’s disease, urinary tract infection, vaginal candidiasis, and vaginitis due to candida albicans. Acute: History of Acute suppurative otitis media, acute upper respiratory infection, acute upper respiratory infection, acute upper respiratory infection and chest pain

Past Surgical History: None

Family History: History of Essential hypertension and hypertension

Social History: Denied: History of alcohol use and exercising regularly, marital history: Currently married, never smoker

Allergies: No known drug allergies.

Detailed Chronology

|DATE |PROVIDER |OCCURRENCE/TREATMENT |PDF REF |

|08/08/YYYY-10/12/YYYY |Hospital/ Provider |Emergency Records for Abdominal Pain And Subsequent Diagnostic Procedures: |733-738 |

| | | | |

| | |08/08/YYYY: ER Visit: Patient presented to ER with complaints of abdominal pain – | |

| | |X-ray for abdominal pain and rectal pain –diagnosed with no acute process – CT of | |

| | |abdomen and pelvis revealed no acute process and small amount of free intraperitoneal | |

| | |fluid within the cul-de-sac. Otherwise, unremarkable CT examination of the pelvis. | |

| | |Assessment: acute exacerbation of abdominal pain. Diverticulosis. Elevated blood | |

| | |sugar. History of hyperthyroidism and microscopic hematuria. Plan: Followup with | |

| | |consultants in Gastroenterology. | |

| | | | |

| | |10/12/YYYY: Diagnostic Studies: Clinical data: Lower abdominal pain and cramping – | |

| | |Underwent CT of abdomen – unremarkable CT examination of the abdomen. CT of pelvis – | |

| | |Mild sigmoid diverticulosis without evidence of diverticulitis and finding suggestive | |

| | |of uterine fibroids. Small left ovarian cyst. | |

|05/13/YYYY-06/26/YYYY |Hospital/ Provider |Multiple Office Visits/Emergency Records/Diagnostic Procedures for Abdominal Pain: |752-754, 739-751, 755, 763, |

| | | |756-762 |

| | |05/13/YYYY: X-Ray report for lower abdominal pain and low back pain –Impression: No | |

| | |acute conventional radiographic abnormalities of the chest or abdomen. CT of abdomen | |

| | |and pelvis – Impression: Small developing diverticular abscess of the mid sigmoid | |

| | |colon. | |

| | | | |

| | |05/14/YYYY-05/20/YYYY: Patient presented to ER with complaints of abdominal pain, | |

| | |which began 10’O clock this morning. It came on fairly suddenly. It has been located | |

| | |along the left lower quadrant and now is radiating to the right lower quadrant and she| |

| | |states that some of it is periumbilical in nature. The pain is sharp severe enough | |

| | |that it has made the patient nauseous and similar gagging and vomiting. She believes | |

| | |that her episode of abdominal pain has been triggering by eating a large tossed salad | |

| | |as well as some peaches. Her husband at the same thing and was not having similar | |

| | |symptoms – Assessment: Acute diverticulitis – X-Ray for diverticular abscess – | |

| | |Impression: Bibasilar subsegmental atelectasis, new to the prior study. Incidental | |

| | |note is made of a calcified lymph node, left hilar region, representing previous | |

| | |granulomatous disease. Otherwise stable chest radiograph – Medical decision making: | |

| | |Complex. This patient presents with abdominal pain with leukocytosis and a left shift | |

| | |in the face of a known history of diverticulitis. Discharged on 05/20/YYYY – at that | |

| | |time intravenous antibiotics were converted to per oral antibiotics as she was able to| |

| | |tolerate a clear liquid diet. As she had resolution of her pain and interval | |

| | |improvement in her acute diverticular flare, she was felt to be a candidate for | |

| | |discharge home on hospital day #7 with a course of per oral antibiotics and interval | |

| | |follow-up in the Southern Surgical group office in one week. She will use Darvocet | |

| | |N-100 on as needed basis for pain. | |

| | | | |

| | |06/18/YYYY: X-Ray report for diverticulitis – Impression: Previous granulomatous | |

| | |disease. No acute process. | |

|06/20/YYYY-06/26/YYYY |Hospital/ Provider |Pelvic & Abdominal Surgery Prior to Hernia Mesh Implantation: |756-762 |

| | | | |

| | |Operative Note (06/20/YYYY): | |

| | |Pre and post operative diagnosis: Sigmoid diverticulitis. | |

| | |Procedure performed: Underwent low anterior resection with mobilization of splenic | |

| | |flexure and primary colonic reanastomosis with coloproctostomy | |

| | |Specimen: Surgical pathology report – Descending colon, Diagnosed with Sigmoid colon, | |

| | |partial excision: Diverticulosis and acute and chronic diverticulitis with abscess | |

| | |Procedure Details: After achievement of a satisfactory level of general endotracheal | |

| | |anesthesia, the abdomen was prepped and draped in a sterile manner. A vertical midline| |

| | |incision was extended from approximately 10 cm above to 10 cm below the umbilicus. | |

| | |This was extended through the soft tissue through the rectus fascia and into the | |

| | |peritoneum taking care to avoid injury to adjacent bowel structures. A 4-quadrant | |

| | |exploration was performed, which yielded a grossly unremarkable liver, gallbladder, | |

| | |stomach, and spleen. The small bowel was run from the ligament of Treitz to the | |

| | |ileocecal junction. The appendix was unremarkable as was the cecum, transverse colon, | |

| | |and descending colon to the level of the sigmoid colon where changes consistent with | |

| | |advanced sigmoid diverticulitis were noted. The sigmoid colon and descending colon | |

| | |were mobilized medially, dividing the peritoneal reflection. The splenic flexure was | |

| | |divided allowing mobilization of the transverse colon. The proximal descending colon | |

| | |was divided using a CIA stapling device, and then the left colonic mesentery was | |

| | |divided between clamps, suture ligating vascular pedicles as they identified, allowing| |

| | |mobilization of the descending colon to the level of the peritoneal reflection of the | |

| | |pelvis. The colon was mobilized, and the proximal rectum was divided using a TA 60 | |

| | |stapling device. The descending colon was passed from the table as a specimen. | |

| | |Hemostasis was achieved using electrocautery. The peritoneal cavity was irrigated with| |

| | |antibiotic saline. Then an end-to-end anastomosis was performed using an EEA 29-mm | |

| | |stapling device. Two intact doughnuts were noted. The colon was tacked to the left | |

| | |pericolic gutter using a series of interrupted silk sutures, closing the mesenteric | |

| | |detect. The peritoneum was then irrigated with antibiotic-containing saline solution, | |

| | |which was aspirated, and with the appreciation of good hemostasis, the fascial layer | |

| | |was re-approximated using a double-stranded #1 PDS suture in a running manner. The | |

| | |skin wound was Irrigated with antibiotic saline and closed using staples. A sterile | |

| | |dressing was applied. The patient tolerated the procedure without complication or | |

| | |difficulty. She was extubated in the operating room and transported to the post | |

| | |anesthesia care unit in hemodynamically stable condition. All sponge, instrument, and | |

| | |needle counts were correct at the conclusion of the procedure. | |

| | | | |

| | |Hospital Course: Postoperative recovery proceed in an unremarkable manner. As bowel | |

| | |function returned, she was able to tolerate PO intake. Discharged on 06/26/YYYY – She | |

| | |followed a restrictive activity schedule and was felt to be a candidate for discharge | |

| | |home in good condition on postoperative day #6. She was using Mepergan. Fortis on as | |

| | |needed basis for pain, tolerating regular diet and following restrictive activity | |

| | |schedule – Follow-up in the Southern Surgical Group office in 1 week. | |

| | | | |

| | |*Reviewer's comment: Interim medical records during 06/26/YYYY-04/12/YYYY are not | |

| | |available for review to know the health condition of the patient. | |

|04/12/YYYY |Hospital/ Provider |Correspondence to Dr. XXXX Regarding Repair of Hernia with Kugel Patch: |6 |

| | | | |

| | |Patient apparently had colon resection in Lexington a couple of years ago. She | |

| | |recently was seen by Dr. XXXX because of vaginal bleeding. At that time. Dr. XXXX | |

| | |noted that she had a rather large incisional hernia. Patient has been having some | |

| | |pain. She had X-rays today to rule out obstruction and the X-rays really do not show | |

| | |any sign of obstruction except that she does have a lot of fecal material in the | |

| | |colon. Patient is otherwise in good health except for hypertension. She is on several | |

| | |medications including Norvasc, Fosamax, Estrogen, Synthroid and Pravachol. | |

| | | | |

| | |On examination, patient has a long midline incision. Her entire lower abdominal | |

| | |incision below the umbilicus has a rather huge incisional hernia with loops of bowel | |

| | |in it She has multiple defects in the incision. Her abdomen is otherwise very soft. | |

| | |The loops of bowel can be easily reduced back in the abdomen. The rest of the exam is | |

| | |unremarkable. | |

| | | | |

| | |I (XXXX, M.D., FACS) certainly recommend that she undergo repair of this hernia with | |

| | |Kugel patch. I have discussed this with her. The surgery will be done at her earliest | |

| | |convenience. | |

|04/12/YYYY |Hospital/ Provider |Office Visit for Incisional Hernia: |501 |

| | | | |

| | |Patient scheduled repair of incisional hernia with Kugel patch at BMC 04/14/YYYY. | |

| | | | |

| | |Preoperative orders: Bowel prep excluding antibiotics. | |

|04/14/YYYY |Hospital/ Provider |Operative Report for Large Incisional Hernia: |51-52, 53, 103 |

| | | | |

| | |Preanesthesia Evaluation: | |

| | |Height: 5’1” | |

| | |Weight: 140 lbs | |

| | |BMI: 26.4 (Calculated) | |

| | | | |

| | |Pre/Post-Operative Diagnosis: | |

| | |Large incisional hernia with obstructive symptoms | |

| | |Questionable cyst | |

| | | | |

| | |Procedure: | |

| | |Repair of large incisional hernia with a Kugel patch | |

| | |Removal of cyst of the cul-de-sac | |

| | | | |

| | |Anesthesia: General | |

| | | | |

| | |Operative Findings: Showed patient had a huge incisional defect below the umbilicus up| |

| | |to the symphysis pubic. In the upper incision also there were multiple smaller | |

| | |defects. The omentum was adherent anteriorly. In the pelvis, both the ovaries appeared| |

| | |normal. The uterus was slightly enlarged with some fibroids. There were loculated | |

| | |fluids in the cul-de-sac with one small retention cyst. Otherwise, no other | |

| | |abnormality was noted in the adnexa. | |

| | | | |

| | |Description of Procedure: Under general anesthesia and the patient on the operating | |

| | |table in the supine position after a Foley catheter was inserted, the abdomen was | |

| | |prepped and draped in the usual manner. Initially, incision was made from umbilicus to| |

| | |the symphysis pubis, excised at the old scar. This was deepened over the hernia sac. | |

| | |The sac was opened. A huge defect was noted extending from the umbilicus to the | |

| | |symphysis pubis. The omentum, which was adherent underneath, was freed. Then I felt | |

| | |the upper abdominal incision, which also had multiple defects. At this stage, the | |

| | |incision was extended all the way to the upper end of the old incision, excising the | |

| | |scar. The fascia above the umbilicus was not opened: however, I could see the defect | |

| | |from underneath from the peritoneal site. At this stage, after doing adequate lysis of| |

| | |the adhesions, the pelvis was examined. There were a loculated fluid in the pelvis, | |

| | |probably from previous surgery. This was evacuated. | |

| | | | |

| | |A small cyst was seen in the cul-de-sac, which was removed. No adnexal problems were | |

| | |noted, except there was some fibroid of the uterus. At this stage, I went ahead and | |

| | |selected a large oval Kugel patch, which was placed in the abdominal cavity in front | |

| | |of the omentum, behind the abdominal wall. The Kugel patch was sutured at 4 comers | |

| | |initially with #1 Prolene, suturing the ring of the Kugel patch to the abdominal wall.| |

| | |Additional sutures were placed in between to the ring of the patch and abdominal wall.| |

| | | | |

| | | | |

| | |After this, Ethicon stapler device was used, which was used to staple the anterior | |

| | |Prolene mesh to the abdominal wall so that there will be no herniation of bowel in | |

| | |between the sutures. After this was accomplished, I was able to close some of the | |

| | |loose hernia sac to exclude the Kugel patch from the subcutaneous tissue. This was | |

| | |done using #1 Vicryl after the subcutaneous closure done with 3-0 Vicryl, suture | |

| | |closure done with skin staples. A dressing applied. The patient tolerated the | |

| | |procedure well. Sent to the Recovery Room in satisfactory condition. | |

| | | | |

| | |*Related records: Product label for Kugel Hernia Patch (XXXX Health Baptist - | |

| | |Plaintiff Produced - 04557 - 00006) | |

|04/14/YYYY |Hospital/ Provider |Hospitalization Related Records for Repair of large incisional hernia with a Kugel |102-103, 56, 104, 16-112 |

| | |patch: | |

| | | | |

| | |Anesthetic records, labs, post anesthesia evaluation, plan of care | |

| | | | |

| | |*Reviewer's comment: The above cited records are flow sheets; hence they are combined.| |

|04/15/YYYY |Hospital/ Provider |Surgical Pathology Report: |101 |

| | | | |

| | |Specimen: | |

| | |Cul-de-sac cyst | |

| | |Fascia | |

| | | | |

| | |Clinical data: Incisional hernia | |

| | | | |

| | |Diagnosis: | |

| | |Cul-de-sac cyst, excision: Benign cyst | |

| | |Fascia, excision: Dense fibro connective tissue compatible with fascia. | |

|04/19/YYYY |Hospital/ Provider |Discharge Summary: |54 |

| | | | |

| | |Discharge Diagnosis: Large incisional hernia | |

| | | | |

| | |Operation Performed: Repair with Kugel patch. Excision of a cyst of the cul-de-sac. | |

| | | | |

| | |History of Present Illness: This patient previously had a sigmoid colectomy. She now | |

| | |has developed a rather large incisional hernia between the umbilicus to the symphysis | |

| | |pubis with a loop of bowel in it She has been having some partial obstructive | |

| | |symptoms. She was seen by Dr. XXXX A. XXXX for some uterine bleeding. She was on | |

| | |estrogen. The vaginal ultrasound suggested some cyst in the pelvic area and where in | |

| | |the area of ovary or the cul-de-sac was not clear. Examination revealed that she had a| |

| | |rather huge incisional hernia above the symphysis pubis below the umbilicus. | |

| | | | |

| | |Course in Hospital: The patient was advised repair of this hernia. The patient was | |

| | |brought to the Operating Room as a morning admission on April 14, YYYY, and had repair| |

| | |of the large incisional hernia with a Kugel patch. She had a small cyst in the | |

| | |cul-de-sac, which was removed; however, the ovaries appeared normal. Her postoperative| |

| | |course was uncomplicated except for some mild ileus. Her wound healed primarily. She | |

| | |was started on a diet, which she tolerated well. At this stage, she was discharged | |

| | |with instructions in wound care, diet, and activity. She was advised to return to my | |

| | |office for a follow-up visit in about 1 week. | |

| | | | |

| | |Comment: I wish to thank Dr. XXXX Ditzler for allowing me to see this patient. | |

|04/21/YYYY |Hospital/ Provider |Telephone Conversation Nausea and Constipation: |501 |

| | | | |

| | |Patient called complaining of nausea and constipation. | |

| | | | |

| | |Action Plan: Phenergan 25 mg postoperatively every 6 hours as needed for nausea and to| |

| | |use suppository for constipation. | |

|04/23/YYYY |Hospital/ Provider |Post-Operative Visit Status post Kugel Mesh Implantation: |500 |

| | | | |

| | |Patient postop repair of a rather large incisional hernia. She is doing quite well | |

| | |except for some nausea and constipation. Both of these are probably related to her | |

| | |narcotic pain medication. All staples are removed. Steri-strips are applied. She was | |

| | |given a prescription for Bextra 20 mg once daily for pain control in place of the | |

| | |narcotics. Return to see me in 2 weeks for follow-up. | |

|04/26/YYYY |Hospital/ Provider |Telephone Conversation Regarding Pain At Incision Site: |501 |

| | | | |

| | |Patient called complaining with pain at incision site. | |

| | | | |

| | |Action Plan: Vicodin #30 every 6 hours as needed. | |

|04/27/YYYY |Hospital/ Provider |Post-Operative Visit Status post Kugel Mesh Implantation for Diarrhea: |499 |

| | | | |

| | |Patient complains of diarrhea. She has been taking quite a bit of Vicodin. Her | |

| | |incision is healing well. I asked her to take some Metamucil for bulking of the | |

| | |stools. She was advised to stop taking Vicodin and maybe take Advil and Darvocet which| |

| | |she has at home. Return to see me at her scheduled appointment on the 7th. | |

|05/07/YYYY |Hospital/ Provider |Post-Operative Recheck Visit Status post Kugel Mesh Implant: |497 |

| | | | |

| | |Patient s postop incisional hernia repair. She is doing quite well Wounds are healing | |

| | |nicely. She is now getting back to normal slowly. She is eating regular diet and | |

| | |having normal bowel activity. Incision has healed nicely without infection. Patient is| |

| | |basically reassured and advised to see me in 4 weeks for follow-up | |

|06/04/YYYY |Hospital/ Provider |Post-Operative Recheck Visit Status post Kugel Mesh Implant: |496 |

| | | | |

| | |Patient is postoperative incisional hernia repair. She is doing quite well. She has | |

| | |occasional soreness in the incision and lateral to it, otherwise no problems. | |

| | | | |

| | |Examination: | |

| | |She has no sign of any recurrent hernias, seromas etc | |

| | | | |

| | |Assessment/Plan: | |

| | |She is discharged. Instructions of activity were given. Return on as needed basis now.| |

|07/19/YYYY |Hospital/ Provider |Office Visit Status Post Fall From Treadmill: |817 |

| | | | |

| | |Patient approximately three weeks ago was on a treadmill, and all of a sudden, one of | |

| | |her little children turned it on high speed and she feel off of it. Since then, she | |

| | |has been falling pain in the left side of the abdomen. | |

| | | | |

| | |Examination: I feel a little knotty feeling in left side of the abdomen where the mesh| |

| | |had been sutured to the abdominal wall. | |

| | | | |

| | |Assessment/Plan: There is no true hernia. I am giving her a prescription for Bextra 20| |

| | |mg twice a day for seven days. I will go ahead and get a CT scan of her abdomen. We | |

| | |will see her again after that. | |

|07/19/YYYY |Hospital/ Provider |CT of Abdomen and Pelvis: |511-512 |

| | | | |

| | |Reason for Exam: Recurrent incisional hernia | |

| | | | |

| | |Findings: The lung bases are clear. The upper abdominal structures are unremarkable | |

| | |including liver, spleen, kidneys, | |

| | |adrenals, pancreas and retroperitoneum. The aorta is normal in caliber. The | |

| | |gallbladder and biliary tree are normal. There are scattered surgical clips around the| |

| | |abdomen. There is no obvious inflammatory lesion or mass. | |

| | | | |

| | |At about the level of the umbilicus, on both right and left sides, there is some | |

| | |nonspecific soft tissue thickening in the subcutaneous fat which seems to abut the | |

| | |abdominal wall but these do not appear to represent herniated loops of bowel. In fact,| |

| | |I see no obvious abdominal wall defect at these levels or elsewhere. | |

| | | | |

| | |Scans in the pelvis reveal no additional active findings such as mass or fluid | |

| | |collection. There are probably some uterine fibroids present. These were reported on a| |

| | |prior scan but I do not have those images available. There is no obvious inflammatory | |

| | |lesion or evidence of diverticulitis. | |

| | | | |

| | |Impression: | |

| | |No definite active or acute findings of the abdomen or pelvis. | |

| | |See comments regarding some tissue thickening in the subcutaneous fat at about the | |

| | |level of umbilicus. However, this does not appear to represent herniated loops of | |

| | |bowel and there are no obvious abdominal wall defects or areas of herniation. | |

|08/10/YYYY |Hospital/ Provider |Office Visit for Review of CT Scan: |7 |

| | | | |

| | |Patient comes back. Her CT- scan does show may be a little separation of the mesh from| |

| | |the abdominal -wall on the left side. This is the area where she has almost point | |

| | |tenderness and a knot feeling. | |

| | | | |

| | |Assessment/Plan: I think that this area definitely needs to be explored and see what | |

| | |we can do to fix it back again. I explained this to her. The patient agreed to the | |

| | |surgery, which will be scheduled. | |

|08/25/YYYY |Hospital/ Provider |History And Physical Examination for Painful Area Left Lateral Abdominal Wall: |5 |

| | | | |

| | |Patient complaints of painful area left lateral abdominal wall following a fall. | |

| | |Patient had repair of a large abdominal wall hernia with mesh fell few weeks ago. | |

| | | | |

| | |Physical Examination: | |

| | |Abdomen: Pain tender area left lateral abdominal wall with induration. No recurrent | |

| | |abdominal wall hernia. | |

| | | | |

| | |Diagnosis: Questionable stitch irritation with painful tender area | |

| | | | |

| | |Plan: Exploration. | |

|08/25/YYYY |Hospital/ Provider |Operative Report for Removal Of Kugel Mesh Fiber from Left Abdominal Wall: |34-36 |

| | | | |

| | |Preoperative Diagnosis: Point tender area in the lateral abdomen on the left side. | |

| | |Previous Kugel patch repair of huge abdominal wall hernia. | |

| | | | |

| | |Procedure performed: Removal of portion of fiber from Cagul (Must be Kugel) mesh from | |

| | |left abdominal wall. | |

| | | | |

| | |Anesthesia: General. | |

| | | | |

| | |History: This patient had a huge hernia repaired with Kugel patch in April. She | |

| | |apparently fell off her treadmill and felt some pain the abdomen. She has been having | |

| | |constant pain in the lateral left side of the abdomen in a point tender area. I did a | |

| | |CT scan on her which showed no recurrent hernias. But because of her point tenderness | |

| | |in the area and some induration and suggestion of possible stitch irritation, I | |

| | |thought it would need to be explored. On exploration I found an area of induration, | |

| | |underneath which there was a plastic wire of the Kugel patch ring which had protruded | |

| | |through and was causing the irritation. There was no recurrent hernia noted. | |

| | | | |

| | |Description of Procedure: Under general anesthesia with the patient on the operating | |

| | |table in the supine position, at the point of palpable tender indurated area, 0.5% | |

| | |Naropin was injected locally. A transverse incision was made, deepened down to the | |

| | |area. When the fascia was incised, I saw a wire protruding through it. This was pulled| |

| | |up as far back as I possibly could, and then cut off. At this stage I did not feel any| |

| | |more residual wire. The area was injected with 1 mL of Kenalog and closed with | |

| | |interrupted suture of 0 Vicryl. Subcutaneous closure was done with 3-0 Vicryl. | |

| | |Subcuticular closure was done 4-0 Monocryl. Dressing was applied. The patient was sent| |

| | |to the Recovery Room in satisfactory condition. | |

|08/25/YYYY |Hospital/ Provider |Hospitalization Records Related to Hernia Repair: |17-34, 8, 11-14, 16, 36-47 |

| | | | |

| | |Pre-operative assessment, orders, operative report progress notes, Anesthesia Record, | |

| | |nursing notes, post anesthesia care record, surgical documentation | |

| | | | |

| | |*Reviewer's comment: The above cited records have been combined. | |

|08/25/YYYY |Hospital/ Provider |Discharge Instructions: |25 |

| | | | |

| | |Patient may shower after 48 hours, shampoo-spongebath now. | |

| | |Keep the dressing dry and intact for 48 hours. Remove the dressing after 48 hours, | |

| | |then may shower. | |

| | | | |

| | |Medication: | |

| | |Lortab 5 mg tab, take two tabs every four-six hours as needed for pain relief. | |

| | | | |

| | |Appointment: Thursday September 2nd, YYYY @ 9.15 am | |

| | | | |

| | |No heavy lifting or staining until instruction given by your doctor. Consult your | |

| | |doctor for problems, questions or concerns. | |

|08/26/YYYY |Hospital/ Provider |Surgical Pathology Report: |516 |

| | | | |

| | |Specimen (Source): Piece of mesh from abdomen | |

| | | | |

| | |Clinical data: Ventral hernia possible stitch irritation. | |

| | | | |

| | |Diagnosis: Foreign body, clinically mesh material (Gross only) | |

| | | | |

| | |Gross description: A cylindrical shaped transparent firm piece of material 3 cm in | |

| | |length about 0.1 cm in diameter. No tissue is received. | |

|09/02/YYYY |Hospital/ Provider |Postoperative Recheck Visit Status Post Revision Surgery: |815 |

| | | | |

| | |Patient comes in for follow-up. A nylon wire of the mesh had broken and was sticking | |

| | |out into the subcutaneous tissue. This was excised with a local injection of Kenalog. | |

| | |She is doing extremely well. She has had no further pain. | |

| | | | |

| | |Examination: The incision has healed nicely. She certainly has no recurrent hernias. | |

| | | | |

| | |Assessment/Plan: I basically reassured her and discharged her. | |

| | | | |

| | |*Reviewer's comment: Interim medical records during 09/02/YYYY-04/30/YYYY are not | |

| | |available for review to know the health condition of the patient. | |

|04/30/YYYY-07/25/YYYY |Hospital/ Provider |Multiple Office Visits for Hyperlipidemia and Osteoporosis: |949-950 |

| | | | |

| | |@04/30/YYYY: Weight: Decreased by 21 lbs. | |

| | |Height: 5’½” | |

| | |Weight: 139 | |

| | |BMI: 26.7 (Calculated) | |

| | |Patient presents for hyperlipidemia, osteoporosis ______ | |

| | | | |

| | |@07/25/YYYY: | |

| | |Height: 5’½” | |

| | |Weight: 139 | |

| | |BMI: 26.7 (Calculated) | |

| | | | |

| | | | |

| | |(The handwritten notes are illegible; hence included as snapshot) | |

| | | | |

| | |*Reviewer's comment: The records are reviewed to record only precise significant | |

| | |details. | |

|08/03/YYYY |Hospital/ Provider |Office Visit for Hypothyroidism, Hyperlipidemia and Osteoporosis: |947 |

| | | | |

| | |Patient presents for annual exam for hypothyroidism, hyperlipidemia and osteoporosis. | |

| | | | |

| | |Height: 5 | |

| | |Weight: 138 | |

| | |BMI: 26.9 (Calculated) | |

| | | | |

| | |*Reviewer's comment: The records are reviewed to record only precise significant | |

| | |details. | |

|01/29/YYYY-08/24/YYYY |Hospital/ Provider |Multiple Office Visits for Hypothyroidism, Hyperlipidemia, Essential Hypertension, |571-579, 945 |

| | |Upper Respiratory Infection, Insomnia: | |

| | | | |

| | |01/29/YYYY: BMI: 26.7 (BMI calculated with weight as 143 lbs and height 5 feet and | |

| | |1.38 inches) – Patient having some hemorrhoids and some stress. Patient is here for | |

| | |follow up of chronic medical conditions. Please refer to past medical history for | |

| | |detailed active medical conditions addressed today – diagnosed with hyperlipidemia, | |

| | |hypothyroidism, essential hypertension, sinusitis, osteopenia, hemorrhoids – | |

| | |prescribed with Proctozone-HC Rectal cream, urinary tract infection (UTI) Cipro 500 | |

| | |mg. | |

| | | | |

| | |07/05/YYYY: BMI: 26.5 (BMI calculated with weight as 142 lbs and height 5 feet and | |

| | |1.38 inches) – Patient presents with complaints of cold symptoms. Having hoarseness | |

| | |and chills – Diagnosed with acute upper respiratory infection. X-ray of chest shows no| |

| | |infiltrate but what looks like an old granuloma in the left hilar area. | |

| | | | |

| | |07/27/YYYY: BMI: 26.3 (BMI calculated with weight as 141 lbs and height 5 feet and | |

| | |1.38 inches) – Patient complaints of joint pain and also continues to have a barky | |

| | |nonproductive cough – Diagnosed with acute upper respiratory infection and | |

| | |fibromyalgia. Prescribed antibiotics and recommended for lab studies. | |

| | | | |

| | |08/01/YYYY: BMI: 26.3 (BMI calculated with weight as 141 lbs and height 5 feet and | |

| | |1.38 inches) – She could not tolerate the Cymbalta. She is having more RLS symptoms | |

| | |than anything else now. She would like to try something for that. She is still | |

| | |coughing but feels like the Symbicort has helped. Will also try some Requip for RLS. | |

| | | | |

| | |08/24/YYYY: BMI: 26.9 (BMI calculated with weight as 141 lbs and height 5 feet and ¾ | |

| | |inches) – Patient presents for annual exam with hyperlipidemia, hypothyroidism, | |

| | |hypertension and osteoporosis | |

| | | | |

| | |*Reviewer's comment: The records are reviewed to record only precise significant | |

| | |details. | |

|04/30/YYYY |Hospital/ Provider |Office Visit for Burning in Pelvic Area: (Illegible notes) |946 |

| | | | |

| | |Patient presents for pain of burning in pelvic area. Also complains of frequency, | |

| | |burning. | |

| | | | |

| | |Physical examination: | |

| | |Pelvis: With No Lesions (WNL) | |

| | | | |

| | |Assessment: Atrophic vaginitis. | |

| | | | |

| | |Plan: Nitrofurantoin 100 mg, Mycolog II cream and Premarin vaginal cream. | |

|03/11/XXXX |Hospital/ Provider |Procedure Report for Colonoscopy with Biopsy: |585 |

| | | | |

| | |Procedure Performed: Colonoscopy with biopsy. | |

| | | | |

| | |Indication: History of polyps and diarrhea. | |

|03/11/XXXX |Hospital/ Provider |Surgical Pathology Report: |663 |

| | | | |

| | |Specimen: | |

| | |Descending poly x 1 | |

| | |Ascending polyp x 1 | |

| | | | |

| | |Clinical information: Polyps | |

| | | | |

| | |Diagnostic opinion: | |

| | |Colon (descending ), biopsy: Adenomatous polyp, tubular type | |

| | |Colon (ascending), biopsy: Adenomatous polyp, tubular type. | |

|01/31/XXXX-10/20/XXXX |Hospital/ Provider |Multiple Office Visits for Hypothyroidism, Hyperlipidemia, Essential hypertension, |580-582, 569-570, 688, |

| | |Osteopenia, Insomnia, upper respiratory infection: |557-568, 944 |

| | | | |

| | |01/31/XXXX: BMI: 26.9 (BMI calculated with weight as 144 lbs and height 5 feet and | |

| | |1.38 inches). | |

| | | | |

| | |02/14/XXXX: BMI: 27.4 (BMI calculated with weight as 147 lbs and height 5 feet and | |

| | |1.38 inches) – Patient complaints of cold symptoms. The patient presents with | |

| | |complaints of moderate right ear pain, described as sharp and tender, radiating to the| |

| | |right cheek, right face, right jaw and right neck, starting about 5 days ago. On a | |

| | |scale of 1 to 10, the patient rates the pain as 8. She is currently experiencing ear | |

| | |pain. She states the symptoms are worsening. The patient confirms having swollen lymph| |

| | |nodes – Diagnosed with acute suppurative Otitis media. | |

| | | | |

| | |02/17/XXXX: BMI: 27.4 (BMI calculated with weight as 147 lbs and height 5 feet and | |

| | |1.38 inches) – Patient was found to have diverticular disease. At some point in YYYY, | |

| | |she developed a postoperative hernia in YYYY, requiring surgery as well. She at times | |

| | |has pain in the left lower quadrant for which she takes Metamucil and or a laxative. | |

| | |She also has more frequent episodes of diarrhea since her surgery. She has had no | |

| | |gross blood in the stool. Her appetites is good and she has not lost weight. She in | |

| | |fact voices no other current GI complaints – diagnosed with diarrhea planned for | |

| | |Colonoscopy with biopsy. | |

| | | | |

| | |04/01/XXXX: BMI details not available – Patient complaints of ear fullness. Presents | |

| | |with stitch removal and discuss Dexa meds. The patient is currently asymptomatic. No | |

| | |associated symptoms are reported. Current treatment includes levothyroxine. By report,| |

| | |there is good compliance with treatment, good tolerance of treatment and good symptom | |

| | |control. The patient is being seen for a routine clinic follow-up of osteoporosis. | |

| | |Onset was 8 year(s) ago. She describes this as severe and worsening. Current treatment| |

| | |includes bisphosphonates. By report, there is good tolerance of treatment and poor | |

| | |symptom control. Past evaluation has included dual energy x-ray absorptiometry scan. | |

| | |Also presents with complaints of gradual onset of mild left ear fullness, described as| |

| | |pressure. The patient denies having earache, nasal symptoms and facial pain – | |

| | |diagnosed with acute suppurative otitis media, osteopenia and hypothyroidism. | |

| | | | |

| | |07/01/XXXX: BMI: 26.7 (BMI calculated with weight as 143 lbs and height 5 feet and | |

| | |1.38 inches) – Patient complaints of Tick bite on the neck, hard and swollen. Found | |

| | |the tick on Wednesday. Painful joints on Thursday upon waking up. Hypothyroidism | |

| | |(LFP): The patient is being seen for an initial evaluation of hypothyroidism. The | |

| | |patient is currently asymptomatic. No associated symptoms are reported. Hyperlipidemia| |

| | |(LFP): The patient is being seen for a routine office follow-up of hyperlipidemia. The| |

| | |patient states she has been stable with her hyperlipidemia control since the last | |

| | |visit. Associated Symptoms: No associated symptoms are reported. Medications: The | |

| | |patient is adherent with her medication regimen. She denies medication side effects. | |

| | |Hypertension (LFP): The patient is being seen for a routine follow-up of essential | |

| | |hypertension. The patient states she has been stable with her Hypertension control | |

| | |since the last visit. Associated Symptoms: She denies recent or current chest pain, | |

| | |shortness of breath, headache or other cardiovascular symptoms. The patient is | |

| | |adherent with her medication regimen She denies medication side effects Checks Blood | |

| | |Pressure Sporadically – Essential hypertension, hyperlipidemia and hypothyroidism. | |

| | | | |

| | |08/03/XXXX: Patient presents with annual exam for hyperlipidemia, hypothyroidism and | |

| | |hypertension. | |

| | | | |

| | |09/21/XXXX: BMI: 26.5 (BMI calculated with weight as 142 lbs and height 5 feet and | |

| | |1.38 inches) – Patient complaints of cold symptoms. She presents with complaints of | |

| | |cold symptoms. The patient confirms having post nasal drainage, scratchy throat and | |

| | |plugged ear(s). The patient denies having fever – diagnosed with acute upper | |

| | |respiratory infection. | |

| | | | |

| | |10/20/XXXX: BMI: 27.1 (BMI calculated with weight as 145 lbs and height 5 feet and | |

| | |1.38 inches) – Patient complaints of edema – diagnosed with acute respiratory | |

| | |infection and chest pain. | |

| | | | |

| | |*Reviewer's comment: The records are reviewed to record only precise significant | |

| | |details. | |

|04/18/YYYY |Hospital/ Provider |Office Visit for Abdominal Pain: |832-835 |

| | | | |

| | |Patient complaints of abdominal pain. Patient is being seen for a routine office | |

| | |follow-up of and not resolving abdominal pain. Moderate diarrhea and symptoms improved| |

| | |by antidiarrheal. She states the symptoms are unchanged. | |

| | | | |

| | |Review Of System: Musculoskeletal: Myalgias and left mid back pain. | |

| | | | |

| | |Physical Exam: Abdomen: The abdomen was tender in the left upper quadrant and in the | |

| | |left lower quadrant. | |

| | | | |

| | |Assessment: Abdomen tenderness direct left lower quadrant and mid back pain | |

| | | | |

| | |Discussion: Regarding back pain/left paraspinal muscle spasm – states she has med for | |

| | |this at home which works (Ultram). Regarding what is becoming chronic abdominal pain –| |

| | |she is concerned that the “mesh” placed by Dr. XXXX is causing a problem – described a| |

| | |persistent abdominal pulling and internal irritation; will scan and refer to Dr. XXXX.| |

|04/19/YYYY |Hospital/ Provider |CT of Abdomen and Pelvis: |691-692 |

| | | | |

| | |Clinical Data: Left lower quadrant pain, prior history of abdominal mesh for hernia | |

| | |repair in YYYY | |

| | | | |

| | |Impression: | |

| | |Ventral midline abdominal wall hernia repair with mesh. The appearance of the mesh is | |

| | |relatively stable from the YYYY study. There is a 2 cm diastasis of the rectus | |

| | |musculature below the mesh at the midline lower anterior abdominal wall; however, | |

| | |there is no significant herniation through this diastasis. This portion of the anatomy| |

| | |was not imaged on the YYYY CT scan. Evidence for recurrence of hernia elsewhere not | |

| | |appreciated. | |

| | |No acute inflammatory process in the abdomen or pelvis. Unclassified soft tissue-like | |

| | |oblong-shaped structure is present along the medical aspect of the cecum adjacent or | |

| | |abutting the cecal wall in the pericolonic fat. Measurements are 2.2 x 1.8 cm. This is| |

| | |identified on the YYYY abdominal CT and has not changed in its size. It is not causing| |

| | |any bowel obstruction and it is without surrounding inflammation. The patient does | |

| | |indicate prior colon surgery in YYYY and does not list appendectomy in the history | |

| | |either. Therefore it is unclear if this could represent post-surgical scarring and | |

| | |remains unchanged since YYYY. The etiology still remains uncertain. | |

|05/02/YYYY |Hospital/ Provider |Office Visit For Severe Abdominal Pain Status Post Moving Objects: |669 |

| | | | |

| | |She is an old patient of Dr. XXXX, She had a colectomy in YYYY and in YYYY, and Dr. | |

| | |XXXX put a Kugel patch in that was fairly large, although he did not mention the size.| |

| | | | |

| | |*Reviewer's comment: The size of the Kugel mesh according to the product label is | |

| | |noted to be 17.8 cm x 22.9 cm. | |

| | | | |

| | | | |

| | |Shortly thereafter, the ring broke and she had severe pain, and part of the ring was | |

| | |taken out. She was moving stuff around in her attic about three weeks ago and | |

| | |developed severe pain. The pain has been lessening, but it is still present. | |

| | | | |

| | |On exam, her abdomen is a little protuberant; It is nontender except with deep | |

| | |palpation. She does have a recurrent hernia in the suprapubic area; It is a fairly | |

| | |small defect. Right now, since she is doing better, we are not going to rush into | |

| | |doing anything further, I am going to see her in six weeks and see how she is doing. | |

| | | | |

| | |We may have to consider removing the mesh versus just a small patch within there. I do| |

| | |not think she would be a candidate for a laparoscopic repair. | |

|05/10/YYYY |Hospital/ Provider |Office Visit for CT Review And Surgery Scheduling: |668 |

| | | | |

| | |Patient returns. CT scan just showed recurrence/diastasis of her hernia in the lower | |

| | |abdomen. No inflammatory changes. She is having severe pain, She cannot stand it | |

| | |anymore. I told her that we ought to probably go in and remove the mesh. The Kugel | |

| | |mesh when the ring breaks has been known to cause pain. This would not be seen on CT | |

| | |scan. | |

| | | | |

| | |Since we will be left with a large defect, to close it we are going to do component | |

| | |separation. She understands she will lose her umbilicus. She understands there is a | |

| | |potential for wound complications, and she also understands that this may not fix her | |

| | |abdominal pain but I think it will. She understands she will be in the hospital for | |

| | |some time. She has no other questions; We are going to get her scheduled at her | |

| | |earliest convenience. | |

|06/04/YYYY |Hospital/ Provider |Pre-operative Visit for Broken Mesh/Preanesthesia Evaluation: |190, 282 |

| | | | |

| | |Patient complaints of abdominal pain. She presents with Kugel mesh for hernia with | |

| | |broken ring. | |

| | | | |

| | |Height: 5 feet 1 inch | |

| | |Weight: 140 | |

| | |BMI: 26.4 (Calculated) | |

| | | | |

| | |Diagnosis: Abdominal pain, broken mesh and recurrent hernia | |

| | | | |

| | |Plan: Removal and component separation repair. | |

|06/04/YYYY |Hospital/ Provider |Operative Report for Removal of Mesh and Repair of Recurrent Incisional Hernia with |1-3, 272 |

| | |Component Separation via the Mild Fascial Flap Technique: | |

| | | | |

| | |Pre/Post-Operative Diagnosis: Recurrent incisional hernia | |

| | | | |

| | |Procedure: Exploratory laparotomy with extensive lysis of adhesions and removal of | |

| | |mesh and repair of recurrent incisional hernia with component separation via the mild | |

| | |fascial flap technique. | |

| | | | |

| | |Anesthesia: General Endotracheal | |

| | | | |

| | |Indications: Patient has had a couple of laparotomies in the past. She has had a large| |

| | |Kugel mesh placement for repair of incisional hernia. She has developed pain in the | |

| | |right lower quadrant with a recurrence. She presents today for repair and mesh | |

| | |removal. | |

| | | | |

| | |Operative Findings: She had a lot of dense adhesions of the mesh. The ring of the | |

| | |Kugel patch had been broken. This was known because the ring portion of the broken | |

| | |ring had been previously removed. Her recurrence was inferiorly. | |

| | | | |

| | |Description of Procedure: The patient was taken from the holding area and brought to | |

| | |the Operating Room where anesthesia successfully induced general endotracheal | |

| | |anesthesia. Her abdomen was prepped and draped sterilely. Foley catheter was placed | |

| | |sterilely. The entire abdomen was prepped and draped sterilely, and the previous skin | |

| | |incision was used. Cautery was used to dissect down towards the mesh. | |

| | | | |

| | |Mesh was encountered. Interiorly there was a recurrent, and so the hernia sac was | |

| | |entered sharply between hemostats. There were some adhesions there but were fairly | |

| | |thin and they were taken down sharply. Mesh could be cut down the midline taking down | |

| | |the adhesions underneath before cutting it obviously. Once this was done on the right | |

| | |side, it was noted that there were some dense small bowel adhesions to the mesh, and | |

| | |it was a very arduous lysis of adhesions, but was carefully done. The small bowel was | |

| | |inspected afterwards. There were no enterotomies made the mesh was removed in its | |

| | |entirety with cautery. Same thing on the left side although thankfully the adhesions | |

| | |were not as dense on the left side. The mesh was removed as well. | |

| | | | |

| | |The decision was made to do component separation for the repair of the hernia. Flaps | |

| | |were elevated on the anterior fascia going all the way lateral to the obliques on the | |

| | |left and right side, going from the rib cage to the iliac crest. The external oblique | |

| | |fascia was then incised from the rib cage to the iliac crest on both sides. This | |

| | |allowed the myofascial flap on both sides to re-approximate to the midline with zero | |

| | |tension. This was then closed with a number one looped PDS. | |

| | | | |

| | |The two pieces of 15 x 20 Parietex ProGrip mesh were then placed to fully reinforce | |

| | |the anterior abdominal wall covering the defect laterally. Especially it was secured | |

| | |to the fascia with a running zero Prolene suture circumferentially as well as down the| |

| | |midline. Everything was hemostatic. Two drains were placed over the mesh and exited | |

| | |out laterally. Excess skin was excised, and then the midline was re-approximated | |

| | |subcutaneously with a 2-0 Vicryl and the skin was closed with skin clips. Drains were | |

| | |secured with 2-0 silk. The patient tolerated the procedure well. There were no | |

| | |apparent complications. | |

|06/04/YYYY |Hospital/ Provider |Hospitalization Records Related to Hernia Repair: |275-285, 810-814 |

| | | | |

| | |Anesthesia record, pre-anesthesia evaluation, nursing notes, orders | |

|06/05/YYYY |Hospital/ Provider |Progress Notes: |220 |

| | | | |

| | |Patient is very sore. Vital Signs Stable (VSS). Abdomen soft, tender without rebound; | |

| | |JPs serosanguinous. Labs ok. | |

| | | | |

| | |Assessment and plan: Improving | |

| | | | |

| | |Orders: Full liquids, continue IV Patient Controlled Analgesia (PCA). | |

|06/06/YYYY |Hospital/ Provider |Progress Notes: |219 |

| | | | |

| | |Patient feeling better, less nausea, starting to take in per oral. | |

| | | | |

| | |Abdomen soft, incisional tenderness drains serosanguinous. | |

| | | | |

| | |Continue same; wean PCA in morning. | |

|06/07/YYYY |Hospital/ Provider |Progress Notes: |218 |

| | | | |

| | |Pain improving; no bowel movement, no nausea. AF VSS. Abdomen soft, incisional | |

| | |tenderness drains serosanguinous. | |

| | |Post-op day # 3: | |

| | |Advance diet and discharge continuous on PCA. | |

|06/08/YYYY |Hospital/ Provider |Progress Notes: |217 |

| | | | |

| | |Patient feels better, till feels like she needs IV narcotics. AF VSS abdomen soft, | |

| | |incisional tenderness, JP’s serosanguinous. | |

| | | | |

| | |Continues PCA and needs bowel movement. | |

|06/09/YYYY |Hospital/ Provider |Progress Notes: |216 |

| | | | |

| | |Patient still with pain. AF VSS. Abdomen soft, incisional tenderness, incisional looks| |

| | |good, JPs minimal. Wean off IV narcotics questionable home morning. | |

|06/10/YYYY |Hospital/ Provider |Discharge Instructions: |193-201 |

| | | | |

| | |Patient discharged home. Diet: Regular. Activity: As tolerated. Call for questions or | |

| | |concerns. Call if drains come out. Preventing surgical site, infection fall prevention| |

| | |__________ call to make follow-up appointment. General discharge instruction sheet. | |

| | | | |

| | |*Reviewer's comment: The detailed discharge summary is not available for review; | |

| | |therefore, we have elaborated the individual progress notes in its entirety. | |

|06/14/YYYY |Hospital/ Provider |Postoperative Recheck Status Post Hernia Mesh Removal Surgery: |667 |

| | | | |

| | |Patient is doing well. She is moving around a little bit better. She still hurts a | |

| | |fair amount. Drains are minimal, so they were discontinued. Her incision looks good. I| |

| | |removed all the staples and applied Steri-Strips; She is going to continue wearing an | |

| | |abdominal binder and continuing to slowly increase activity to more walking and slowly| |

| | |wean herself off the pain medicine. I am going to see her back in three weeks. | |

|07/05/YYYY |Hospital/ Provider |Postoperative Recheck Status Post Hernia Mesh Removal Surgery: |666 |

| | | | |

| | |Patient returns. She is doing better. She is still hurting, Bowels are working. Her | |

| | |incisions look good. No evidence of any recurrent hernia. I basically reassured her. | |

| | |We are going to give her some Percocet for pain, and I am going to see her in four | |

| | |weeks. | |

|08/02/YYYY |Hospital/ Provider |Postoperative Recheck Status Post Hernia Mesh Removal Surgery: |665 |

| | | | |

| | |Patient returns. She is doing good. She is still hurting but much, much less. Incision| |

| | |looks good. She has a good repair. I reassured her. I am going to see her in four | |

| | |weeks to ensure continued healing. | |

|01/30/YYYY-11/05/YYYY |Hospital/ Provider |Multiple Office Visit for Dysuria, Vaginitis, Abdominal pain, Insomnia, Joint Pain: |544-556, 935 |

| | | | |

| | |01/30/YYYY: BMI: 25.8 (BMI calculated with weight as 141 lbs and height 5 feet and 2 | |

| | |inches) – Patient complaints of dysuria. She presents with complains of gradual onset | |

| | |episodes of moderate dysuria. Episodes started about 5 days ago. The patient having | |

| | |internal burning, urgency and frequency – diagnosed with essential hypertension, | |

| | |hyperlipidemia, hypothyroidism and urinary tract infection. | |

| | | | |

| | |03/19/YYYY: BMI: 25.8 (BMI calculated with weight as 141 lbs and height 5 feet and 2 | |

| | |inches) – Patient complaints of dysuria. Really her chief concern is for some redness | |

| | |he said around the vulva and upper thighs. Her gynecologist recently called in some | |

| | |Flagyl. Gave her no relief – diagnosed with candida albicans vaginitis. | |

| | | | |

| | |08/06/YYYY: BMI: 25.62 – Patient complaints of knee pain. Followup for medication | |

| | |refill a fasting labs – diagnosed with diffuse joint pains, essential hypertension, | |

| | |hyperlipidemia, hypothyroidism, insomnia and restless legs syndrome. | |

| | | | |

| | |09/28/YYYY: BMI: 25.83 – Patient complaints of cold symptoms – Diagnosed with acute | |

| | |upper respiratory infection. | |

| | | | |

| | |11/05/YYYY: Patient presents for yearly exam, pap and complained of bleeding in | |

| | |vaginal area. | |

|01/22/YYYY-11/21/YYYY |Hospital/ Provider |Multiple Office Visits for Hyperlipidemia, Hypothyroidism, Essential hypertension, |537-543, 882-885 |

| | |Insomnia, UTI: | |

| | | | |

| | |01/22/YYYY: BMI: 26.32 (BMI calculated with weight as 143 lbs and height 5 feet and 2 | |

| | |inches) – History Reviewed. Diagnosed with hyperlipidemia, hypothyroidism, restless | |

| | |syndrome, essential hypertension and insomnia. | |

| | | | |

| | |08/30/YYYY: BMI: 27.03 (BMI calculated with weight as 145 lbs and height 5 feet and | |

| | |1.5 inches) – History Reviewed. Diagnosed with hyperlipidemia, hypothyroidism, and | |

| | |pain in joint, essential hypertension. | |

| | | | |

| | |11/21/YYYY: BMI: 27.21 (BMI calculated with weight as 146 lbs and height 5 feet and | |

| | |1.5 inches) – Complaints of breast and pelvic – diagnosed with history of hernia | |

| | |repair, encounter for routine gynecological examination and screening for colon | |

| | |cancer. | |

|02/20/YYYY-11/17/YYYY |Hospital/ Provider |Multiple Office Visits Essential Hypertension, Hypothyroidism, Hyperlipidemia, Basal |529-532, 533-536, 775-788 |

| | |Cell Cancer and Chronic Pain: | |

| | | | |

| | |02/20/YYYY: BMI: 27.36 (BMI calculated with weight as 146 lbs and height 5 feet and | |

| | |1.25 inches) – History Reviewed – Diagnosed with essential hypertension, | |

| | |hyperlipidemia, hypothyroidism, restless legs syndrome, insomnia, osteoarthritis, | |

| | |myalgia and myositis. | |

| | | | |

| | |09/10/YYYY: BMI: 26.61 (BMI calculated with weight as 142 lbs and height 5 feet and | |

| | |1.25 inches) – History Reviewed - Diagnosed with essential hypertension, | |

| | |hyperlipidemia, hypothyroidism and pain, eye left | |

| | | | |

| | | | |

| | |11/17/YYYY: BMI: 24 (BMI calculated with weight as 146 lbs and height 5 feet and 5 | |

| | |inches) – Routine follow-up of diffuse musculoskeletal pain – chronic pain syndrome, | |

| | |hand joint pain, osteoarthritis and fibromyalgia. | |

|09/15/YYYY |Hospital/ Provider |Office Visit for Evaluation of Polyarthralgias and Polymyalgias: | |

| | | | |

| | |Patient referred for evaluation of polyarthralgias and polymyalgia in association with| |

| | |a moderate elevation in ANA of 1:640, mixed homogeneous and speckled pattern. Patient | |

| | |related the onset musculoskeletal pain at the time of her last hernia repair surgery | |

| | |in YYYY. She says she did not have pain prior to that. That was an extensive surgery | |

| | |directed at trying to correct week abdominal tissue and she has had to wear an | |

| | |abdominal band ever since to try to keep her abdominal contents internal without | |

| | |pushing through the abdominal wall. She says her surgeon tells her that there is not | |

| | |much more that can be done. Her initial abdominal surgery was for diverticulosis in | |

| | |YYYY and she had her first tourney repair in YYYY. The pain began in YYYY after the | |

| | |last surgery. She is on a statin drug but she was on a statin drug for years prior to | |

| | |the surgery and never had problems with it. She says Dr. XXXX the statin for a month | |

| | |seen that were contributing to her pain and there was no change in her overall pain | |

| | |presentation. She has good days and bad days and has good and bad times throughout the| |

| | |day. She does admit to having pain pretty much every day of the week throughout most | |

| | |of the day. This is been now for 2 years if not longer. She wonders about the | |

| | |diagnosis of fibromyalgia. | |

| | | | |

| | |Assessment: | |

| | |Polyarthralgias, | |

| | |polymyalgia and | |

| | |Chronic pain syndrome | |

| | |Hand joint pain. | |

| | | | |

| | |Discussion/Summary: | |

| | |Polyarthralgias and polymyalgias of uncertain etiology-differential diagnostics | |

| | |possibilities for this includes diffuse osteoarthritis, fibromyalgia, less likely an | |

| | |ANA associated illness given the absence of other stigmata of those diseases. I am | |

| | |going to finish the workup for autoimmunity and also get some more specifying imaging | |

| | |studies. I have asked her to continue with her current pain regimen that Dr. XXXX has | |

| | |started and I will see her back in a few weeks. | |

| | | | |

| | |Elevated ANA of uncertain clinical Significance-I agree with Dr. XXXX's concerns but | |

| | |do not see strong evidence for an ANA associated process at this time. All subtype | |

| | |antibody analysis has been negative. I am not sure what the skin lesions are that she | |

| | |is experiencing Dr. XXXX is working those up. | |

| | | | |

| | |Osteoarthritis-there is evidence for osteoarthritis of the left hand, the second DIP | |

| | |and the fourth DIP joint. The cystic lesion on the extensor surface of the fourth DIP | |

| | |is a cyst from a Heberden's node. | |

| | | | |

| | |I want to thank Dr. XXXX and Dr. XXXX for allowing me to participate in the care of | |

| | |their patients. | |

|02/02/YYYY-10/26/YYYY |Hospital/ Provider |Multiple Office Visits for Chronic Pain Syndrome, Essential Hypertension, |772-774, 522-528, 764-770, |

| | |Hyperlipidemia, Hypothyroidism, Upper Respiratory Infection: |518-521 |

| | | | |

| | |02/02/YYYY: BMI: 27.3 (BMI calculated with weight as 144 lbs and height 5 feet and 1 | |

| | |inches) – Patient presents for routine follow-up for diffuse osteoarthritis a well as | |

| | |fibromyalgia-on meloxicam mg daily in combination with when necessary tramadol. Since | |

| | |her last visit to me she states that she could not tolerate Gabapentin. Made her dizzy| |

| | |and feel like she was going to come out of her skin. She had a similar reaction to | |

| | |Lyrica when she was tried on that time ago. She has tolerated the Meloxicam and is | |

| | |willing to go up on the dose. She also has been taking tramadol a whole tablet at a | |

| | |time as opposed to half a tablet when she takes it and found that to be helpful – | |

| | |diagnosed with osteoarthritis. | |

| | | | |

| | |02/13/YYYY: BMI: 27.02 (BMI calculated with weight as 146 lbs) – Complaints of | |

| | |dysuria. Associated symptoms include frequency and vaginal itching. | |

| | | | |

| | |05/21/YYYY: BMI: 27.21 (BMI calculated with weight as 144 lbs) – Patient complaints of| |

| | |cold symptoms. Associated symptoms include sore throat, hoarseness, productive cough, | |

| | |facial pressure, facial pain, headache and ear pain, but no fever – acute upper | |

| | |respiratory infection. | |

| | | | |

| | |07/09/YYYY: BMI: 26.85 (BMI calculated with weight as 142 lbs and height 5 feet and 1 | |

| | |inches) – Routine follow-up for osteoarthritis of the hands as well as fibromyalgia-on| |

| | |Mobic some 0.5 mg daily in combination with Tramadol 25-50 mg when necessary severe | |

| | |pain – diagnosed with hand joint pain, fibromyalgia and knee pain, bilateral. | |

| | | | |

| | |09/16/YYYY: BMI: 27.02 (BMI calculated with weight as 143 lbs and height 5 feet and 1 | |

| | |inches) – History Reviewed – Diagnosed with fibromyalgia, hypothyroidism, | |

| | |hyperlipidemia, restless legs syndrome. | |

| | | | |

| | |10/26/YYYY: BMI: 27.1 (BMI calculated with weight as 143 lbs and height 5 feet and 1 | |

| | |inches) – Patient presents for diffuse musculoskeletal pain secondary to | |

| | |osteoarthritis and fibromyalgia – on Mobic 7.5 mg daily in combination with Tramadol | |

| | |50 mg 1 or 2 daily as necessary – Diagnosed with fibromyalgia and osteoarthritis. | |

|02/23/YYYY |Hospital/ Provider |Office Visit for Breast and Pelvic: |864-869 |

| | | | |

| | |Patient complaints of breast and pelvic. Also complains of dysuria and | |

| | |perirectal/vulvar itching. No significant discharge. No bleeding has treated with | |

| | |Nystatin without relief. | |

| | | | |

| | |Assessment: | |

| | |Encounter for routine gynecological examination | |

| | |Dysuria | |

| | |Vulvar itching. | |

| | |Plan: Abnormal urinalysis, hematuria – urine culture. | |

| | |Acute vaginitis, encounter for screening mammogram for breast cancer | |

| | |Rash – start Clobetasol Propionate. | |

|00/00/0000 |Hospital/ Provider |Follow-up Visit Status Post Hernia Mesh Revision Surgery: |664 |

| | | | |

| | |Patient still having some pain, but usually when not wearing binder. Abdomen soft, | |

| | |minimal tenderness, no hernia | |

| | | | |

| | |Continue abdominal binder as needed. | |

| | | | |

| | |Follow-up in 2 months. Hopefully will become free with o binder. | |

| | | | |

| | |*Reviewer’s comment: | |

| | |The above office visit is undated; hence placed at the end of the chronology as per | |

| | |the sequencing order. | |

| | |Further medical records pertaining to the hernia mesh case review are not available | |

| | |for review. | |

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