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

Device Problem Migration (4003)

Patient Problem Erosion (1750)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: am j obstet gynecol 2008;199:688.E1-688.E5; doi: 10.1016/j.Ajog.2008.07.029.(b)(4).

Event Description

It was reported in a journal article title : risk factors for mesh/suture erosion following sacral colpopexy the purpose of this prospective planned analysis was to identify demographic and surgical parameters associated with foreign body complications of abdominal sacral colpopexy (asc): specifically, mesh and suture erosion.Three hundred twenty two female patients with stress-continence stage ii to iv pelvic organ prolapse who underwent sacral colpopexy (concomitant burch colposuspension [n=157] and no burch colposuspension [165]).Graft material was sutured to both the anterior and posterior vaginal walls and then anchored to the anterior longitudinal ligament of the sacrum in such a way as to avoid tension on the anterior portion of the graft.Most of the asc were done using woven polyester (mersilene [42%]) and polypropylene (prolene or gynemesh [48%]).Sutures such as prolene and ethibond were used.Within the 2 years of surgery, there were 20 patients who developed mesh erosion.Three of the erosions involved suture only, while 17 had exposed mesh.Two of 3 patients with suture erosions healed after simple removal of suture.The third patient probably had suture erosion, but healing after suture removal has not been confirmed.Of the remaining 17, 13 patients underwent at least 1 surgery for mesh removal (n=2 resolved; n=6 persistent erosion; n=5 lost to follow-up) and 4 were managed without surgery (n=3 no resolution; n=1 lost to follow-up).Of these 20 cases of mesh erosion, 8 utilized prolene or gynemesh graft, 2 used prolene vaginal sutures, 1 used ethibond vaginal sutures, and 7 used ethibond sacral sutures.The statistically significant associations of expanded polytrafluroethylene (eptfe) mesh, concomitant hysterectomy, and smoking were strong ones, with ors ranging from 4-5, and the authors feel confident in these associations; but, as with all retrospective associations, this does not prove causation.Expanded ptfe mesh should not be used for sacral colpopexy.Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.

• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7753270
• MDR Text Key: 116122244
• Report Number: 2210968-2018-74927
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• 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: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention