MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Hematoma (1884); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(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.Citation: the american journal of surgery 190 (2005) 61¿64 / doi:10.1016/j.Amjsurg.2004.09.021.(b)(4).

Event Description

It was reported via journal article: "title : umbilical hernia repair with the prolene hernia system".Author: cafer polat, m.D.*, adem dervisoglu, m.D., gokhan senyurek, m.D., mehmet bilgin, m.D., kenan erzurumlu, m.D., kayhan ozkan, m.D.Citation: the american journal of surgery 190 (2005) 61¿64 / doi:10.1016/j.Amjsurg.2004.09.021.The purpose of this prospective study was to assess, in comparison with currently available techniques, the effectiveness of the prolene hernia system (phs) in repairing umbilical hernias.Between jan 2000 and oct 2003, a total of 50 patients underwent elective repair of umbilical hernia.The patients were divided into three groups: phs [n=17 (n=4 male, n=13 female, mean age 49 ± 12 years (28-70))], mayo repair [n=18 (n=4 male, n=14 female, mean age 49.7 ± 14 years (27-82))] and onlay repair with mesh [n=15 (n=5 male, n=10 female, mean age 53.7 ± 11 years (33-72))].In patients under phs group, the peritoneum was separated from the posterior aponeurosis of the rectus abdominis muscle to create enough space within the preperitoneal area for underlay patch of the phs.The underlay patch of the phs was placed in the preperitoneal space without suture.The edge of the aponeurosis was closed with interrupted sutures, leaving a hole at the umbilical ring where the connector was passed through.Onlay patch was fixed to the anterior rectus sheath with polypropylene suture prolene 2/0.Umbilicus was sutured to the connector with an absorbable material.In onlay repair with mesh group, the defect of peritoneum was closed with a 3/0 polyglactin suture (vicryl); then a polypropylene (prolene) mesh in suitable dimension was placed tension-free with interrupted 2/0 polypropylene suture (prolene) on the anterior rectus sheath.In phs group, postoperative complications included postoperative pain mcgill pain score scale (pss) on first day [n=1.9 ± 0.7 (2-6)], second day [n=1.0 ± 0.5 (0-2)], seventh day (n=0.6 ± 0.2) and visual analogue pain scale (vas) on first day [n=24.7 ± 10.9 (10-45)], second day [n=12.6 ± 6.8 (5-30)], seventh day [n=2.3 ± 3.5 (0-10)] which were treated with analgesics; seroma (n=1); wound infection (n=1).In onlay repair with mesh group, postoperative complications included postoperative pain mcgill pain score scale (pss) on first day [n=2.4 ± 0.5 (2-3)], second day [n=1.6 ± 0.5 (1-2)], seventh day (n=0.6 ± 0.3) and visual analogue pain scale (vas) on first day [n=37.3 ± 6.5 (25-51)], second day [n=22.6 ± 6.7 (10-305], seventh day [n=11.7 ± 7 (0-25)] which were treated with analgesics; hematoma (n=2); wound infection (n=1).In conclusion, the outcomes of the phs for umbilical hernia repairs appear to be better for selected patients than the other techniques in terms of minimal postoperative pain and less requirement of analgesics.It also offers an advantage of combination of 3 techniques, such as stoppa¿plug¿onlay mesh repair, against recurrence.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8426414
• MDR Text Key: 139041910
• Report Number: 2210968-2019-79525
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2019
• 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: 02/22/2019
• 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