MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT; MESH, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.  the single complaint was reported with multiple events.There are no additional details regarding the additional events.  citation: journal of laparoendoscopic & advanced surgical techniques (2020); doi: 10.1089/lap.2020.0878.  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 the ethicon products involved 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 involved? patient demographics? adverse events associated with the proceed mesh device reported via mw # 2210968-2021-06193.Adverse events associated with the prolene blue suture reported via mw # 2210968-2021-06195.Adverse events associated with the ethilon black suture reported via mw # 2210968-2021-06196.Adverse events associated with the ethilon black suture for the specified male patient reported via mw # 2210968-2021-06197.Adverse events associated with the prolene blue suture for the specified male patient reported via mw # 2210968-2021-06198.Adverse events associated with the physiomesh device for the specified male patient reported via mw # 2210968-2021-06199.Adverse events associated with the proceed mesh device for the specified male patient reported via mw # 2210968-2021-06200.

Event Description

It was reported in a journal article with title: quality of life using the carolinas comfort scale for laparoscopic incisional hernia repair: a 12-year experience in a retrospective observational study.The primary aim of this prospectively collected date of a retrospective observational study was to assess the impact of lihr on patient satisfaction and the impact on qol.Secondary aims included describing the standardized technique used throughout a 12-year experience of a single surgeon at a large district general hospital, the intraoperative details and other postoperative surgical outcomes such as los in hospital, complications, and functional recovery, including return to work and normal daily activities.Between 2007 to 2019, a total of 97 patients (34 male and 63 female; median age = 57 years; bmi = 32 kg/m2) who underwent a primary or repeated elective laparoscopic incisional hernia repair (lihr) were included in the study.Surgery was performed by using a composite mesh [proceed (ethicon), physiomesh (ethicon), or competitor].The mesh is sized adequately and 2-0 polypropylene sutures [2-0 prolene (ethicon)] are placed at each of the poles (fig.3).The edges of the hernial defect are approximated using transfascial 1 nylon extracorporeal sutures [ethilon (ethicon)], which are introduced through stab incisions using an endoscopic suturing device.These are passed 1 cm from the hernial defect edge and at 2¿2.5 cm intervals (fig.4).This does not apply to hernia repairs related to pfannenstiel incisions, where the defect closure is not feasible.The 2-0 polypropylene sutures on the mesh are transfascially fixed to the abdominal wall with the use of the endoscopic suturing device.The median follow-up period for patients was 42 months, ranging from 2 to 140 months.Reported complications included a male patient (n=1) had small bowel obstruction which required a laparotomy during which the mesh was removed.He was discharged from hospital 12 days after the initial operation; iatrogenic bowel injuries (n=2) which occur intraoperatively, one was repaired primarily and one required bowel resection with a primary anastomosis; recurrence of incisional hernia (n=1); wound infection (n=1); seroma (n=9) requiring radiological drainage in 2 patients while 7 patients were managed conservatively; hematoma (n=3) requiring a laparoscopic washout in 1 patient while 2 were managed conservatively; pain after surgery (n=6) where 2 patients reattended the hospital with severe acute pain but recovered subsequently, while 4 developed chronic pain; a total ccs scores between 11 and 60 indicating moderate discomfort (n=12); a total ccs score higher than 90 indicating debilitating discomfort (n=1); poor patient satisfaction (n=1); very poor patient satisfaction (n=3).In conclusion, the technique for lihr displayed in this study is safe and effective.There was an acceptable rate of complications, with a low recurrence rate.Patients were highly satisfied and had a good qol after the procedure.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 08/09/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products involved 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 involved? patient demographics? email received from author: we have not discussed these cases previously with ethicon.The primary surgeon does not feel that specifically using ethicon products led to any of the complications encountered, nor is this implied in the study.Similarly, the surgeon does not believe there is a defect with the ethicon products used, and this is not implied in the study either.The patient demographics are included in the study.For further details of demographics specifically in relation to the ethicon products used, this would need to formally be requested through the east kent hospitals university nhs foundation trust¿s research & innovation department to ensure ethical compliance with regards to sharing any further data.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12147938
• MDR Text Key: 262671060
• Report Number: 2210968-2021-06194
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention