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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 Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Pain (1994); Hernia (2240); Ulcer (2274); Perforation of Esophagus (2399); Insufficient Information (4580)
Event Date 10/19/2021
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). 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: https://doi. Org/10. 1007/s00464-021-08828-w. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (vicryl mesh and prolene polypropylene mesh) 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 involved? patient demographics? event related to vicryl mesh device reported via mw # 2210968-2022-01204.
 
Event Description
It was reported in a journal article with title: impact of surgical repair on type iv paraesophageal hernias (pehs). This study aims to compare surgical outcomes after laparoscopic repair between type iii and iv paraesophageal hernias (pehs). Between january 2006 and january 2020, a total of 103 patients (n
=
70 men; n
=
33 women) who underwent laparoscopic paraesophageal hernia repair (lpehr) at the department of digestive surgery of the nouvel hôpital civil (nhc) in strasbourg, france were included. Mean age was 67. 88 ± 13. 25 years, and mean bmi was 29. 21 ± 5. 84 kg/ m2. The main presenting symptoms were gerd in 50 patients (48. 54%) and pyrosis in 20 patients (19. 42%). Most patients underwent primary repair in an elective setting, i. E. 92 patients (89. 32%) as compared to 11 patients (10. 68%) who had a redo surgery. Gastric volvulus was present in 16 cases (15. 53%). Only six patients (5. 83%) required an emergency surgery. Intraoperative evaluation showed that type iii pehs were the most frequent ones as they were present in 91 patients (88. 35%) vs. 12 patients (11. 65%) in type iv pehs. In type iv pehs, the additional herniated organ was the colon in 11 patients (91. 6%) with the pancreas in 3 patients (25%), and the first portion of the duodenum in one patient only. Nissen fundoplication was the most commonly used surgical technique in 63 patients (61. 17%) followed by toupet fundoplication in 13 patients (12. 62%). An extensive mobilization of the mediastinal esophagus was performed as part of the surgical technique to preclude axial tension. Esophageal lengthening using a collis gastroplasty was performed in 14 patients (13. 59%). Only one patient required a sleeve gastrectomy due to gastric fundus necrosis. Mesh reinforcement was performed in 64 patients (62. 14%), a polyglactin 910 mesh (vicryl; ethicon, somerville, nj, united states) was used in (n
=
56) patients while a polypropylene mesh (prolene®; ethicon inc. Somerville, nj, united states) was used in only (n
=
3) patients. Mean operative time was 147. 43 ± 76. 03 min. Only one patient (0. 97%) required conversion to thoracotomy because of pulmonary vein injury, which occurred during the transmediastinal dissection of a recurrent paraesophageal hernia (peh). Reported complications included n
=
3 clavien dindo i, n
=
4 clavien dindo ii, n
=
1 clavien dindo iiia, n
=
5 clavien dindo iiib, n
=
1 30-day postop readmission, n
=
1 chronic dysphagia, n
=
1 epigastric pain, n
=
16 recurrence and n
=
3 reoperation. In conclusion, patients with type iv pehs appear to be older and frailer. The higher incidence of postoperative complications in patients with type iv pehs should advocate for a precise indication for surgical treatment, which should be performed in centers of expertise.
 
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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 Key13565273
MDR Text Key289317382
Report Number2210968-2022-01205
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
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 02/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2022
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: 02/19/2022 Patient Sequence Number: 1
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