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(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved (securestrap, polyproylene suture, pds ii polydioxanone suture, physiomesh, proceed mesh) caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (securestrap, polyproylene suture, pds ii polydioxanone suture, physiomesh, proceed mesh) used in this procedure? the patient demographic info: age, gender, weight, bmi at the time of index procedure citation: surg laparosc endosc percutan tech (2016); 26:476¿483.(b)(4).
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It was reported via journal article: "title: comparison of absorbable versus nonabsorbable tackers in terms of long-term outcomes, chronic pain, and quality of life after laparoscopic incisional hernia repair: a randomized study" author/s: virinder k.Bansal, mbbs, ms, facs,* krishna asuri, ms,*sridhar panaiyadiyan,ms,* subodh kumar,ms,* rajeshwari subramaniam,md,rashmi ramachandran, md,w rajesh sagar, md,z and mahesh c.Misra, ms* citation: surg laparosc endosc percutan tech (2016); 26:476¿483.This randomized study was designed to compare chronic pain, qol, return to activity, patient satisfaction, and cost effectiveness during nonabsorbable or absorbable tacker fixation of mesh for laparoscopic incisional and ventral hernia repair (livhr).This prospective randomized trial was conducted from may 2012 to april 2014 involving 90 patients who underwent laparoscopic incisional hernia repair during the study period.The patients were randomized into 2 groups: in nat group, 45 patients (14 male and 31 female; age range: 26-75 years; bmi: 18.5 to 39.2 kg/m2) underwent mesh fixation with nonabsorbable tackers in a double-crown fashion and also fixation with 4-corner transfascial nonabsorbable sutures polypropylene suture 1-0 (ethicon).In at group, 45 patients (9 male and 36 female; mean age: 27-67 years; bmi: 18.5 to 36.14 kg/m2) underwent mesh fixation with securestrap 5-mm absorbable strap fixation device (ethicon) in a double-crown fashion and fixation with 4-corner absorbable polydiaxanone 1-0 (ethicon) transfascial sutures.Polypropylene-polyglecaprone composite flexible mesh physiomesh (ethicon) was the most commonly used mesh in 51 patients (57.3%).Lightweight polypropylene polydioxanone¿oxidized regenerated cellulose proceed (ethicon) was used in 26 patients, polypropylene with carboxymethylcellulose-sodium hyaluronate coating in 9 patients and polyester-collagen-polyethylene glycol-glycerol were used in 2 patients.Reported complications in the nat group included mild/moderate/severe adhesion (n-?) in which 1 patient had a conversion, serosal injury (n-1) in which an open onlay repair was done, contents were not completely reducible (n-2) in which a small transverse incision was made over the hernial bulge and adhesiolysis done and contents reduced completely and these patients recovered uneventfully, mild pain at the operation site at 3 months postoperatively (po) (n-2), persistent pain at 6 months of follow-up localized to a point in left iliac region (n-1) and a total of 5ml of 0.5% bupivacaine was injected at the site of pain, and the patient had pain relief, subacute intestinal obstruction at 1-month follow-up with abdominal distension, obstipation, vomiting, and air fluids (n-1) which was managed conservatively with nil per oral, nasogastric tube insertion and were recovered uneventfully with no further obstructive features at 6 months follow-up, seroma at 1-week follow-up (n-7), persistent seromas at 1 month follow up (n-3), chronic pain by 3 months follow up (n-2) in which 1 patient required local analgesic infiltration at 6-month follow-up.Reported complications in the at group included mild/moderate/severe adhesion (n-?), contents were not completely reducible (n-2) in which a small transverse incision was made over the hernial bulge and adhesiolysis done and contents reduced completely and these patients recovered uneventfully, mild pain at the operation site (n-1) at 3 months postoperatively (po), suspicious small bowel injury with an impending gangrenous segment of ileum (n-1) which was resected and bowel anastomosis done and the mesh placed during laparoscopic incisional hernia repair was removed and primary repair of the defect done, burst abdomen (n-1) in which the patient underwent split thickness skin graft to cover the skin defect after burst abdomen with no recurrence at 6 months follow up, fever, pain, and induration at the left hypochondrium port site at 2 months follow up (n-1), subcutaneous collection at the port site (n-1) in which an ultrasonography-guided aspiration of 15ml pus was done and subsequently patient made an uneventful recovery, subacute intestinal obstruction at 1-month follow-up with abdominal distension, obstipation, vomiting, and air fluids (n-1) which was managed conservatively with nil per oral, nasogastric tube insertion and were recovered uneventfully with no further obstructive features at 6 months follow-up, seroma at 1-week follow-up (n-5), persistent seromas at 1 month follow up (n-2), chronic pain by 3 months followup (n-1) in which 1 patient required local analgesic infiltration at 6-month follow-up.In conclusion, nat is a cost-effective method of mesh fixation in patients undergoing livhr with comparable early and late postoperative outcomes in terms of pain, quality of life, and patient satisfaction scores.
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(b)(4).Date sent to the fda: 08/30/2019.Corrected information: adverse event or product problem, outcomes attributed to adverse event, type of reportable event¿ it was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.The following additional information was received: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.No cases have been reported to ethicon.Does the surgeon believe that ethicon products involved (securestrap, polyproylene suture, pds ii polydioxanone suture, physiomesh, proceed mesh) caused and/or contributed to the post-operative complications described in the article? the complications reported in this paper are intrinsic to the procedure and not product related.Does the surgeon believe there was any deficiency with the ethicon products (securestrap, polyproylene suture, pds ii polydioxanone suture, physiomesh, proceed mesh) used in this procedure? no.
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