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

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

Patient Problems Abdominal Pain (1685); Sepsis (2067); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.Component code: (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: annals of surgery (2021); doi: 10.1097/sla.0000000000005206.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 (physiomesh and proceed 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? events associated with proceed mesh device reported via mw # 2210968-2021-11559 events associated with physiomesh device reported.

Event Description

It was reported in a journal article with title: reoperation for recurrence is affected by type of mesh in laparoscopic ventral hernia repair: a nationwide cohort study.The purpose of this nationwide cohort study on a prospectively collected data from the (b)(6) ventral hernia database and the (b)(6) national patient register was to investigate the effect of different meshes on the reoperation for recurrence rate during laparoscopic ventral hernia repair.Between january 1, 2007 to april 1, 2020, 2,802 patients with primary hernias and 2,608 patients with incisional hernias, who underwent laparoscopic ventral hernia repair with an intraperitoneally placed mesh, were included in the study.In the primary ventral hernia cohort, surgery was performed using physiomesh¿ in 599 patients (193 female; mean age of 54 (46-64) years), proceed¿ surgical mesh in 133 patients (31 female; mean age of 54 (46-61) years), and competitor devices in the rest of the patients.In the incisional ventral hernia cohort, surgery was performed using physiomesh¿ in 486 patients (268 female; mean age of 60 (49-69) years), proceed¿ surgical mesh in 150 patients (82 female; mean age of 59 (48-67) years), and competitor devices in the rest of the patients.Reported complications include abdominal pain (n=?), deep wound infection (n=?), gastrointestinal disease (n=?), and sepsis (n=?) requiring readmission within 90 days; and hernia recurrence (n=?) requiring reoperations.In conclusion, for laparoscopic repair of primary hernias, proceed¿ surgical mesh and physiomesh¿ had in this study a higher reoperation rate for recurrence than dynamesh®-ipom.For incisional hernia, several meshes had in this study higher rates of reoperation for recurrence compared with the ventralight¿ st mesh, and these meshes were physiomesh¿, ventralex¿ hernia patch, parietex¿ composite (incl.Optimized), and proceed¿ surgical mesh.When it comes to reoperation rates for recurrence, the findings in this study indicate that the type of mesh may correlate with the outcome, and the choice of mesh should depend on the hernia being either a primary or an incisional hernia.Moreover, it could be considered if meshes with higher reoperation rates should be recalled.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12831790
• MDR Text Key: 285753941
• Report Number: 2210968-2021-11560
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K093932
• 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
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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: 10/21/2021
• 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