[87371843]
A case was received from the fda (report number: mw5070605). It reported the following: surgery to include seri mesh scaffold (allergan manufactured) since now they have sold to sofregen medical, since initial install on (b)(6) 2015-leading to infection which has resulted in multiple surgeries to remove, efforts to correct damaging effects from the medical device and long term antibiotics. On (b)(6) 2017, the reporter was called and a message was left requesting additional information. On (b)(6) 2017, the reporter called and stated she had thick case file regarding the issues she has experienced. She is willing to share the information with sofregen and will email the information she is willing to share. On (b)(6) 2017 she shared the following information. Procedure date: (b)(6) 2015: operations performed: abdominal wall reinforcement with 10 x 15 cm biological mesh, bilateral implantable doppler placement, and multilevel intercostal nerve blockade with 20 mg of liposomal bupivacaine of chest and abdomen for postoperative analgesia. The findings from these procedures as they pertain to seri are as follows: attention was then turned to closing the abdomen. The abdominal fascia was closed in a layered fashion using a ethibond suture. One piece of 10 x25 cm biological mesh was then overlaid over the fascial repair and inset using 0 ethibond sutures. The patient was then flexed in a beach-chair position. The superior abdominal flap was then tailor tacked to the lower abdominal flap and the umbilicus was inset through a separate chevron incision using 4-6 monocryl and 5-0 prolene sutures. The umbilicus was pink and viable at the completion of the inset. The abdomen was then closed in a layered fashion using #2 quill pdo sutures to close the scarpa fascia, followed by 3-0 pds v-loc sutures in the subticular plane. Two 19-french round drains were placed in the abdomen through separate stab incisions and anchored to the skin using 2-0 prolene sutures. On (b)(6) 2015, the patient had additional procedures performed due to complications of the abdomen with an indolent infection attributed to a spitting suture of the transverse lower abdominal incision as well as at the umbilicus. The procedures performed included the following that pertained to the seri surgical mesh: procedure-abdominal exploration with incision and drainage and debridement of biologic mesh with complex closure of abdomen. Total measurement 30 cm x20 cm. The following are notes from the procedure that pertain to seri. Procedure in detail-attention was then taken to the lower abdominal infection. The tegaderm and gauze were removed. There was some purulent infection identified from the umbilicus as well as from the transverse abdominal incision approximately 1 cm in diameter in both sites. These areas were marked with indelible marker. The area was re-prepped again using betadine. The area was excised full thickness, both the umbilicus and transverse abdominal incision. Upon opening the incision there was purulent damage from the wound which was then cultured and sent off the field. It was identified that the wound infection tracking more laterally, so the remaining mid lower abdominal incision was then opened and the healing tissue as was excised full thickness as well as the skin and subcutaneous tissue down to the abdominal wall fascia. The seri scaffold biologic mesh was identified not incorporated in the underlying abdominal fascia and was sharply debrided. There was gross inflammatory tissue an infection identified in the lower abdomen. The area was copiously irrigated and washed with betadine solution as well as normal saline. The sinus track was then identified to track to the umbilicus which was then further exposed with excising more of the inflammatory infected tissue and debriding more of the biologic seri scaffold mesh. A total of approximately 12 x12 cm of the scaffold mesh was then debrided from the abdomen laterally and superiorly. The majority of the mesh had been incorporated with healing granulation tissue and unable to be debrided. After copious irrigation and washing out, a 19-french round drain was then placed through separate stab incisions on the left side from the area of fat harvest and anchored to the skin using 4-0 nylon as well as 2-0 prolene and set to a close suction drain. The abdominal incision was then closed in a layered fashion, first the scarp fascia using 2-0 vicryl suture, followed by 3-0 vicryl suture through the deep dermal closure, followed by 4-0 nylon in a running continuous fashion over the transverse incision. The lower abdomen had been widely undermined in order for debridement of all the infected mesh as well as incision and drainage of the entire infection, totaling 30 x 30 cm2. A small vertical incision adjacent to the umbilicus was also closed in layered fashion using 2-0 and 3-0 vicryl suture followed by interrupted 4-0 nylon. The area was then covered with steri-strips and a sterile dressing. The patient will be treated with antibiotics continuous for one more week and will follow up in the office in three days to ensure appropriate healing. On (b)(6) 2016, eight weeks following this procedure, the patient then presented with similar chronic nonhealing inflamed areas of her lower abdominal incision and umbilicus again. The procedure notes are as follows: the patient was taken to the operating room and laid supine on the operating room table. All noninvasive hemodynamic monitoring devices were placed as well as bilateral sequential compression devices. Atraumatic endotracheal intubation was performed. The patient was then prepped and draped in a sterile fashion. The lower transverse incision as well as the umbilicus that had small areas that looked likes sterile purulence and exudate as well as chronic inflammatory tissue were then excised full thickness through the skin and subcutaneous tissue. The abdominal flap was then undermined over the umbilicus and approximately 3 cm superior to that area and extensively over the lateral abdominal wall over to the oblique in order to have wide undermining and exposure of any of the biologic seri scaffold mesh. The area of the lower abdomen had a sinus track that was able to be followed with a debakey forceps tracking up to and through towards the umbilical would. Cultures were then taken. This gross inflammatory fragile tissue was identified throughout the entirety of the left hemi abdomen and inferior towards the groin. About a 2 mm thick inflammatory rind was sharply debrided, exposing a completely unincorporated area of seri scaffold mesh. Photographs were taken. The seri scaffold mesh was then sharply debrided with facelift scissors. All bleeding points were controlled with bovie electrocautery. The entirety of the ethibond suture as well as the seri scaffold mesh for abdominal reinforcement was then excised bilaterally. Of note, there was chronic inflammatory rind with areas of nonadherence and non-incorporation with sterile exudate identified throughout the abdomen. The area was then grossly irrigated with antibiotic solution. All bleeding points were controlled with bovie electrocautery. The umbilicus, which had been freed from the abdominal flap, was the inset in layered fashion using 3-0 vicryl suture followed by 4-0 prolene. A small vertical incision was then made at the 6 o'clock position for nontension-free closure. The superior abdominal flap was then tailor tacked to the lower abdominal flap and closed in layered fashion over a 19-french round drain which was exited through a stab incision through the transverse scar in the right lower quadrant. Scarpa fascia was then reapproximated using 2-0 vicryl suture, followed by closure with 4-0 prolene. The umbilicus was pink and viable at the completion of inset. Steri-strips were placed over all incision. The drain was anchored to the skin using 20 prolene suture. The patient was extubated in the operating room and transferred to recovery in stable condition. I was present the entirety of the operation. There were no complication encountered. On (b)(6) 2016, the following operations were performed: abdominal wall reconstruction with bulge repair with 21 x15 inch phasix mesh, abdominal exploration with debridement of skin, subcutaneous tissue, muscle, and fascia, 30 square cm of biologic series scaffold mesh. Thoraco abdominal block for postoperative analgesia with liposomal bupivacaine, and excision of 2. 3 cm benign-appearing skin lesion of the left forearm. The following note was included as the reason for the surgery: reason for medical necessity-this is a (b)(6) old female who had undergone an immediate reconstruction following a bilateral mastectomy with deep inferior epigastric artery perforator flap, the patient had seri scaffold mesh placed for abdominal wall reinforcement and had complications of that placement over the course of the last year with to return to the operating room for debridement of the infected seri scaffold mesh, most recently in (b)(6) 2016 for attempt at full operative debridement. The patient postoperatively developed a lower abdominal bulge from weakening of the lower abdominal wall. After excision of the infected seri scaffold mesh with small new appearing red lesions in the inferior portion of the incision with the potential for informed consent for the operation, with included all risks and benefits of procedure, including but not limited to pain, infection, hematoma, seroma, chronic abdominal weakness, recurrent bulge of the abdomen, transient or permanent parasthesias and numbness of the abdomen or groin, wound complications including dehiscence and scarring, unappealing cosmetic result of the abdomen. After the patient gave verbal written consent we proceeded to operating room in standard fashion. The procedure notes included the following information: the patient was taken to the operating room, laid supine on the operating room table. All noninvasive hemodynamic monitoring devices were placed as well as bilateral sequential compression devices. Preoperative antibiotics were given and atraumatic endotracheal intubation was performed. The patient was then prepped and draped in a sterile fashion from the xiphoid to below the pubis as well as the left forearm for the excision fo the 2. 3 cm lesion. The lower transverse abdominal incision was then injected with 1% lidocaine with epinephrine. Using a 15 blade skin knife, the lower abdominal transverse scar was excised through skin and subcutaneous tissue down to the underlying fascia. The umbilicus was then also dissected free from the superior abdominal wall with a 15 bade skin knife as well as the inferior vertical portion of the skin, through the full thickness skin to subcutaneous tissue. The lower transverse abdominal flap was then elevated off the scarred abdominal wall fascia. Upon entering the abdomen, the chronic inflammatory/purulent type material was identified. Similar to the previous operations from the unincorportated seri scaffold mesh. Photographs were taken of the inflammatory tissue/exudate. The pocket was then explored excising using bovie cautery and a 4/6 cm piece of unincorporated seri scaffold mesh was identified and excised, as well as had to be debrided from the surrounding rind of scar inflammatory tissue and partial infection which was then muscle and fascia with skin and subcutaneous tissue all debrided a total of 50 square cm down to the pubic tubercle. The remaining superior portion of the abdomen where the prior seri scaffold mesh was debrided did not have any sign of residual mesh features and the area of bulge was primarily inferior to the umbilicus from ais to sis from area from the prior seri scaffold debridement and anterior rectus sheath debridement. A transverse abdominal plane block was then performed deep to the inferior oblique muscle and superficial to the transverse abdominus bilaterally completing the peripheral block for postoperative analgesia, blocking nerve roots form tb-l1 bilaterally. A phasix mesh was then brought into the field, washed with triple antibiotic solution consisting of 50,000 units of bacitracin, 80 mg of gentimicin and 1 gram ancef. The mesh was then fashioned to the xiphoid subcostal margin bilaterally and to the asis inferiorly and down to the public tubercle which was fashioned and placed on tension with 0 pds suture and was inset with 0 pds v-loc circumferentially. A small slip was then cut through the center portion for transposition for the umbilicus. The superior abdominal flap was then transposed over the lower abdominal flap and scarpa's was then closed using 0 v-loc suture, followed by 3-o pds v-loc and then umbilicus which was pink and viable at inset was then completed in layered fashion using 3-0 monocry suture, followed by a 5-0 prolene. Two 19-french round drains were placed in the abdomen through separate stab incisions of the skin using 2-0 prolene suure. The abdominal flap was pink and viable with bleeding from the dermal edges prior to completion of closure attention was then taken to the left forearm. The 2. 3 cm lesion was then ellipsed out with 15 blade skin knife. Bovie cautery was used for prospective hemostasis and the tissue was then advanced and closed in layered fashion using 3-0 monocry suture, followed by 5-0 prolene and steri-strips. Dermabound was placed over the abdominal surgical incisions. An abdominal binder was placed. The patient was extubated in the operating room and transferred to recovery in stable condition. There were no complications during the operation. I was present for the entirety and patient was then transferred to the pacu. On (b)(6) 2017, the patient underwent a laparoscopic incisional hernia repair with mesh. The following information is from the surgical notes. The narrative of operation included: (b)(6) female has a history of breast cancer and is status post reconstruction with a deep flap. She had mesh implantation at that time that became infected and she underwent multiple abdominal wall debridements. She now presents with a large incisional hernia in her lower abdomen. All the risks and benefits of surgery were discussed with patient. The risks included but were not limited to bleeding, infection, nerve injury, bowel injury, bladder injury, vascular injury, recurrence of hernia, dvt, pulmonary embolism, myocardial infarction, respiratory failure, stroke and death. The risk of mesh implantation was also discussed with the patient including mesh infection, erosion of mesh into bowel or bladder and chronic pain from mesh. The patient fully understood and consented. After proper consent was fully understood and signed by the patient he was bought into the operating room and placed in the supine position with the arm tucked to the side. All the pressure points padded appropriately. Sequential compression devices were placed on the bilateral lower extremities. Prophylactic antibiotics were given by the anesthesiologist. A timeout was performed by the attending surgeon and the entire or staff. General anesthesia and intubation was initiated by the anesthesiologist. A foley catheter was placed under sterile conditions. The abdomen was then prepped an draped in the typical surgical sterile fashion. A veress needle was introduced in left upper quadrant of the abdomen. Pneumoperitoneus was initiated to 15 mmhg of co2. A 5 mm first access port was introduced in the let upper quadrant of the abdomen. The abdomen was explored. There are no signs of any injury upon entry of the veress needle or the first access port. Another 5 mm port was placed in the right upper quadrant under direct visualization. Two more 5 mm ports were placed in the left and right lateral abdomen. There was a large fascial defect in the lower abdomen below the umbilicus. The peritoneum was incised above the umbilicus and a preperitoneal dissection was performed all the way down to the public symphysis. The dissection was continued laterally on both sides. There was significant splaying of the rectus muscle and absence of most of the rectus abdominus muscle. There were healthy oblique muscles laterally. The falciform ligament was also taken down to allow proper placement of mesh with adequate overlap. A 25 cm x20 cm ventralight st mesh was then opened and 2-0 prolene sutures are placed in the 4 corners of mesh. A 12 mm port was then placed in through a vertical infraumbilical incision. Mesh was placed intra-abdominally. A carter thompson suture passer was used to grasp the prolene sutures and the root brought trans-facially to secure the mesh to the anterior abdominal wall. The sutures were grasped through the healthy oblique muscles laterally, through healthy rectus abdominus muscle superiorly and through the suprapubic foraminal ligament inferiorly. A protek was then used to secure the mesh to the pubic symphysis and the cooper's ligament bilaterally. A sorbafix absorbable tack was then used to circumferentially tack the mesh to the fascia. A more trans-facial sutures are placed in between the prior placed trans-fascial sutures using the carter thompson and a 2-o prolene. The peritoneum was then brought over the mesh to cover the entire mesh and secured with a sorbafix absorbable tacker. The 12 mm port site fascia was closed with figure-of-eight 2-0 vicryl. All of the ports removed and the pneumoperitoneus was evacuated. All the ports site skin was closed with interrupted 4-0 monocryl in a subcuticular fashion. Dermabond was used for dressing and all the port sites. The abdominal binder was placed. All the ensuing counts, needle counts, and sponge counts were correct by the or staff. Patient awoke from anesthesia without, conditions, was expected, and brought to recovery are breathing spontaneously. Thank you very much for allowing me to participate in the care of the patient. On (b)(6) 2017, the patient went in for another procedure due to infected abdominal wall mesh with abscess. The following procedures were performed: incicison and drainage of abdominal wall, abdominal wall debridement of about 600 cm, removal of infected mesh and the subcutaneous tissue. Per the surgical findings: infected mesh with abscess cavity. The narrative of the operation included the following: (b)(6)female that has a history of a diep flap for breast reconstruction and has a sirius mesh implantation. She has complication from the mesh that later had to be removed and another partially absorbable mesh was placed. She subsequently underwent a laparoscopic ventral hernia repair to reinforce the abdominal wall. Yesterday she presented to the office with an abscess in the left lower quadrant of the abdomen. The abscess was drained in the office but there was extensive necrosis of the surrounding tissue then would require debridement, so she is scheduled for debridement today in the operating room under anesthesia. All the risks and benefits of surgery were discussed with the patient. The risks including, but not limited to, bleeding, infection, recurrent hernia, persistent infection, dvt, pulmonary embolism, paresthesias, myocardial infarction, respiratory failure, stroke and death. The patient fully understood and consented. After proper consent was fully understood and signed by patient, she was brought to operating placed in supine position on the operating table. All the pressure points padded appropriately. Sequential compression devices were placed on bilateral lower extremities. Prophylactic antibiotics are given by the anesthesiologist. He timeout was performed by the attending surgeon entire or staff. General anesthesia and lma placement was initiated with anesthesiologist. The abdomen was prepped and draped with fletadine in the typical surgical sterile fasion. A horizontal lower midline incision was made through the prior pfannenstiel incision. The abscess cavity was entered and cultures were taken. The cavity of the abscess was excised using sharp dissection. There was exposed mesh that was above the muscle and was infected. Debridement of the mesh along with abdominal wall circumferentially at be performed for about 30 cm wide and 20 cm in a vertical dimension, incorporating about 600 cm of sharp debridement of the abdominal wall and removal of the infected mesh. The area was then pulse lavaged with bacitracin irrigation. The wound was packed with saline soaked gauze and a sterile dressing was applied. All this with counts, needle counts, and sponge counts were correct the or staff. The patient awoke from anesthesia without complications and was brought to recovery area breathing spontaneously. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5