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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abscess (1690); Hematoma (1884); Seroma (2069); Abnormal Vaginal Discharge (2123); Hernia (2240); 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. No specific patient information regarding events has been provided. Attempts are being made to obtain the following information. 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? if yes, provide details of event and specific product code. Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions. Are the product code and lot numbers available for ethicon devices used? citation: dis colon rectum. 2017; 60: 178 186. Doi: 10. 1097/dcr. 0000000000000710. [(b)(4) - fu 2017. Pdf].
 
Event Description
It was reported in journal article: ¿title: risk factors for recurrence after laparoscopic ventral rectopexy¿ authors: cherylin w. P. Fu, m. B. B. S, m. Med, f. R. C. S. Ed; andrew r. L. Stevenson, m. B. B. S, f. R. A. C. S citation: dis colon rectum. 2017; 60: 178 186. Doi: 10. 1097/dcr. 0000000000000710. The objectives of this retrospective cohort study aimed to evaluate factors contributing to recurrence after laparoscopic ventral rectopexy (lvr). A total of 231 patients underwent lvr and were included in the study. All of the procedures were performed by or under the direct supervision of a single surgeon experienced in the lvr technique. The procedure was fully laparoscopic, and either a synthetic mesh or a biologic graft was used. The method of fixation of the graft to the sacral promontory used was pds sutures in 41 patients and the type of mesh used were prolene and ultrapro synthetic mesh in 32 patients. It was also noted that modifications to the technique evolved throughout the study period. Reported complications included pelvic abscess which required laparoscopic wash-out, rectovaginal seroma/hematoma, vaginal discharge, wound hernia, wound infection, and recurrent prolapse which required redo lvr, sutured transanal mucosectomy and plication, sacral nerve modulation, ligation of hemorrhoids, stoma, and prosthetic sphincter augmentation. It was reported that the authors identified certain technical aspects of lvr that can contribute to failure and recurrent prolapse: inadequate apposition of the mesh/graft to the lateral and anterior surfaces of the rectum, especially at the midrectum, resulting in inadequate rectal suspension and recurrent internal prolapse or rectoanal intussusception, slippage of mesh attachment from the sacral promontory, which may be attributed to excessive tension on the mesh or poor anchoring technique to the sacral promontory, and the distal part of the mesh/graft being too narrow, resulting in inadequate support of the lateral aspects of the rectum and pelvic floor. It was concluded that recurrent prolapse after lvr is multifactorial and risk factors are both clinical and technical. The use of biologic grafts was associated with lower recurrence as compared with synthetic mesh.
 
Manufacturer Narrative
(b)(4). Additional information was requested and the following was obtained: none of the recurrences were related to ethicon products.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7396586
MDR Text Key104403353
Report Number2210968-2018-71879
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1
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