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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT MESH, SURGICAL

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ETHICON INC. MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT MESH, SURGICAL Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Not Applicable (3189)
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. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. Does the surgeon believe that 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 used in this procedure? citation: int urogynecol j. 2013; 24: 731 733. Doi: 10. 1007/s00192-012-2016-4 please see referenced article attached. (b)(4).

 
Event Description

It was reported in a journal article title: robotic-assisted laparoscopic. Sacrocolpopexy for stage iii pelvic organ prolapse. Abdominal sacrocolpopexy is the gold standard treatment for pelvic organ prolapse and can be performed laparoscopically. Robotic assistance allows optimal dissection and placement of the prosthesis. The authors presented a video of the technique along with the results on 90 patients (age range: 33 to 80 years old; bmi: 18. 5 32) with stage ii prolapse and were included in the study. During the surgical procedure, the authors performed a posterior dissection down to the level of the muscles and an anterior dissection down to the trigone. The meshes are made of mersuture polyester mesh (ethicon) and tailored by the surgeon. The authors made the choice of a mersuture mesh because it has been widely validated in sacrocolpopexy through laparotomy and because they noticed in the experience with classic laparoscopy that it was very well tolerated with rare inflammatory reaction and scarce periprosthetic fibrosis. Reported complications included vaginal posterior wound leading to recurrent subsequent exposure and finally withdrawal of the posterior mesh (n-1), bladder effraction (n-1), posterior vaginal effraction (n-1), and posterior prosthesis exposure (n-1). With the technique as described, the authors were able to perform a complete treatment for severe prolapse by a minimally invasive approach with a low rate of recurrence at this point. There is no specific complication when much care is taken of the abdominal wall. The procedure is notably facilitated by the use of the robot and the comfort of the surgeon is remarkably improved.

 
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Brand NameMERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL
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 Key7835993
MDR Text Key118883565
Report Number2210968-2018-75557
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 08/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2018 Patient Sequence Number: 1
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