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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Date 01/01/2020
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. (b)(4). Device not returned. 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: oper orthop traumatol 2021 · 33:318¿330: https://doi. Org/10. 1007/s00064-021-00721-y.
 
Event Description
It was reported in a journal article with title: hiatal reduction with the 'puborectalis sling': a multicenter randomized controlled trial. This study aims to report medium- term results of a multicenter randomized controlled trial investigating this procedure (prolapse repair). A total of 192 women undergoing prolapse repair at the discretion of the surgeon with a pre-operative hiatal area on valsalva of
=
30cm2, were recruited to a prospective multicenter rct which compared pop surgery alone or pop surgery with pr sling. Mean age at operation was 58 (27-83). Mean body mass index was 29 (15-48). 94 (47%) had a previous hysterectomy, 58 (29%) a previous incontinence or prolapse procedure. Primary outcome was prolapse recurrence on popq and ultrasound at 2 years. The pr sling was inserted after completion of prolapse repair, via bilateral groin and perianal incisions of 2 cm in length. A tunnel was created digitally below the anococcygeal raphe, connecting the two perianal incisions. A 3cm x 25 cm strip of polypropylene mesh (johnson & johnson/ethicon, somerville nj), was passed through this tunnel with the help of an angled clamp. A curved stamey needle (90 degree curvature) was inserted through the obturator foramen to exit in the ipsilateral perianal incision, allowing retrieval of the mesh sling. Needle insertion was performed under digital guidance (vaginal and rectal). The mesh was secured to the periosteum of the inferior pubic rami using absorbable sutures. 192 patients were evaluated at least once post-operatively, with 181 having 4d translabial ultrasound. At 1. 9 (range, 0. 1-6. 7) years, there was an average reduction of 9 cm2 (range 32. 6 to -13. 8) cm2 reduction in hiatal area from a mean pre-operative hiatal area of 42. 1 (30 ¿ 68. 1) cm2. Reported complications included n
=
1 compartment syndrome of the thigh, n
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1 rectal perforation requiring prs removal, n
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1 chronic pain, n
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32 symptoms of prolapse, n
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8 symptoms of incontinence, n
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35 obstructed defecation, n
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34 bladder descent, n
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21 rectal descent, n
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56 vaginal lump or bulge, n
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150 clinical prolapse recurrence, n
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38 recurrence beyond hymen and n
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84 sonographic prolapse recurrence. In conclusion, while there were no significant differences for satisfaction, symptoms of prolapse and popq findings at an average follow-up of 1. 9 years, we found a lower rate of anal incontinence in women after prs. Bladder and rectal descent on imaging as well as prolapse on ultrasound was reduced, the latter highly significantly. Reduction of hiatal area on valsalva was much more pronounced after prs, confirming published observational data.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13125303
MDR Text Key288372659
Report Number2210968-2021-13091
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/31/2021 Patient Sequence Number: 1
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