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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Pneumonia (2011); Seroma (2069); Urinary Retention (2119); Hernia (2240); Thrombosis/Thrombus (4440); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Additional information was requested and the following was obtained: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify. Anything you need to know about this is documented in the manuscript. I do not think it had anything to do with the products. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Anything you need to know about this is documented in the manuscript. I do not think it had anything to do with the products. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Not provided. Patient demographics? as a federal facility i cannot provide any patient protected information (demographics). (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. Events related to 3-0 vicryl suture captured via 2210968-2021-03501. Events related to 0-pds suture captured via 2210968-2021-03503. Citation: https://doi. Org/10. 1016/j. Jss. 2019. 03. 046.

Event Description

Title: open, laparoscopic, and robotic inguinal hernia repair: outcomes and predictors of complications this restrospective study aimed to compare outcomes of inguinal hernia repair as performed by an expert in each approach. A total of 1299 inguinal hernia repairs performed at the (b)(6) health care system between 2005 and 2017 was undertaken. Three surgeons performed the operations, each an expert in one approach, and there was no crossover in techniques. A total of 1100 ohrs, 128 lhrs, and 71 rhrs were performed. Patient demographics were similar among groups except for age that was higher in the ohr cohort. Univariable analysis was undertaken to determine associations between techniques and outcomes (ohr versus lhr; ohr versus rhr; lhr versus rhr. Setting complications as a dependent variable, multivariable analyses were undertaken to determine an association with complications as well as independent predictors of complications. During ohr, once the ilioinguinal nerve is identified, it is divided and ligated at themost proximal end with 3-0 vicryl (ethicon). Indirect hernias undergo isolation of the sac and the hernia sac is opened and ligated or reduced if a sliding component is suspected. The floor is imbricated with 0-vicryl (ethicon) if there is a protruding direct component. The floor is then repaired with a 6. 0x3. 0 inch polypropylene mesh (ethicon inc, somerville, nj) that is cut in a cone configuration to accommodate the size of the inguinal floor by creating tails around the cord structures. This is secured inferiorly to the shelving edge of the inguinal ligament with 0- pds (ethicon) in a running fashion and superiorly to the conjoint tendon with interrupted 0-ethibond sutures (ethicon). Reported complications included recurrence (n
=
19),post-op pain beyond 3 months/ inguinodynia (n
=
16), inguinal pain (n
=
9), urinary retention (n
=
20), ileus (n
=
8), ischemic orchitis (n
=
3), hematoma/seroma (n
=
29), fever (n
=
8), acute kidney injury (n
=
8), delirium (n
=
8), bowel perforation (n
=
2), aspiration pneumonia (n
=
2) and deep vein thrombosis (n
=
2). The average follow-up was 5. 2 ¿ 3. 4 y. Average follow-up was longer in the ohr than in the lhr(5. 6 3. 6 y versus 3. 9 1. 8 y; p < 0. 001). It was also longer than that in the rhr (5. 6 3. 6 y versus 2. 4 0. 8 y; p < 0. 001). In the present report, recurrence was associated with a higher rate in the rhr versus ohr (5. 6% versus 1. 7%; p < 0. 02), but not in the lhr versus ohr (3. 9% versus 1. 9%; p
=
0. 09). Inguinodynia was more likely to occur in both the lhr and rhr compared with the ohr (9. 4% and 14. 1 versus 1. 5%; both p's < 0. 001). Urinary retention was also more common in the lhr and rhr than in the ohr (5. 5% and 5. 6% versus 1. 8%, both p's < 0. 05) as was the rate of overall complications (34. 4% and 38. 0% versus 11. 2%, both p's < 0. 001). In conclusion, outcomes in the ohr cohort were, in general, superior compared with both the lhr and rhr. However, this study is not to show that one approach should be performed over another, these strategies should be viewed as complementary. The best approach to an inguinal hernia repair rests on the specific expertise of the surgeon.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11687486
• MDR Text Key: 262219974
• Report Number: 2210968-2021-03502
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/19/2021
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2021
• 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
• Removal/Correction Number: N/A