MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH; MESH, SURGICAL, POLYMERIC

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

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Hernia (2240)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 cite: https://doi.Org/10.1016/j.Jviscsurg.2021.02.011.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 (proceed mesh, physiomesh, prolene mesh) 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? event associated with the prolene polypropylene mesh device reported via mw # 2210968-2022-00436.Event associated with the physiomesh device reported via mw # 2210968-2022-00437.

Event Description

It was reported in a journal article with title: comparative study of biological versus synthetic prostheses in the treatment of ventral hernias classified as grade ii/iii by the ventral hernia working group.The objective of this study was to compare the postoperative results after implantation of a biological versus synthetic prosthesis during ventral hernia repair inpatients at risk of septic complication (vhwg grade ii and iii).This is a retrospective, monocentric, comparative cohort study, based on the type of prosthesis implanted (biological or synthetic) during ventral hernia repair at the two digestive surgery departments of the university hospital of (b)(6) between january 1, 2010 and december 31,2017.119 patients met the inclusion criteria were analysed.For these patients, 59 patients received a biological prosthesis (pbio group) and 60 patients received a synthetic prosthesis (psyn group).Patients who were treated with a biological prosthesis (pbio group) or synthetic (psyn group) were compared.Synthetic prosthesis were used in this study (prolene (ethicon), physiomesh (ethicon) and proceed (ethicon).Reported complications included hematoma (n=4), seroma (n=4), evisceration (n=2), surgical site infection (n=4), superficial infection (n=1), deep abscess(n=3), surgical re-intervention (n=3), removal of prosthesis (n=1), clavien dindo 1-2 (n=11), clavien dindo 3-4(n=4), recurrent ventral hernia (n=17).In conclusion in this retrospective study, the use of a bioprosthesis for repair of vhwg ii/iii ventral hernias was associated with a higher rate of both ssi and hernia recurrence at a cost 13 times greater than the use of a synthetic prosthesis.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/15/2022.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 inc., 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.The following information was requested, but unavailable: 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 (proceed mesh, physiomesh, prolene mesh) 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?.

• Brand Name: PROCEED MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13262535
• MDR Text Key: 288888998
• Report Number: 2210968-2022-00436
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention