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); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 06/13/2018

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, demographics regarding the additional events.Attempts are being made to clarify 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.Does the surgeon believe that ethicon products (prolene mesh and prolene polypropylene suture) involved caused and/or contributed to the post-operative complications (seroma, hematoma, wound infection, varicocele, significant post-op decrease in testicular volume, minimal hydrocele, and varicocele+minimal hydrocele) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon products (prolene mesh and prolene polypropylene suture) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications such as seroma, hematoma, wound infection, varicocele, significant post-op decrease in testicular volume, minimal hydrocele, and varicocele+minimal hydrocele.If yes, were there any medical /surgical treatment performed for post-op complications? please specify.Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.If available, please provide prolene mesh and prolene suture product codes used in these cases.Citation: updates in surgery (2018) 70:513520 https://doi.Org/10.1007/s13304-018-0554-0 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-03047.

Event Description

Title: self-fixing parietex progrip versus the standard sutured prolene mesh in tension-free repair of inguinal hernia: effect on testicular volume and testicular blood flow this retrospective study aims to compare self-fixing lightweight polyester (parietex" progrip") mesh versus the standard heavy weight polypropylene mesh in tension-free lichtenstein inguinal hernia repair as regard to the effect of mesh implantation and perimesh fibrosis on testicular blood flow were included in the study.From january 2015 to april 2016, a total of 80 patients with primary uncomplicated inguinal hernia undergoing lichtenstein tension-free hernioplasty were allocated to use either self-fixing, lightweight polyester (parietex progrip¿) ,group i with 40 patients with mean age range of 2162 years ,or the standard heavyweight polypropylene mesh ,group ii with 40 patients with age range of 2060 , were included in the study.The prolene mesh used in our study is prolene" (ethicon).During the procedures, in group ii, a sheet of polypropylene¿ (pp) mesh cut to shape and placed over the inguinal floor so it overlapped the pubic tubercle by at least 1 cm medially.Fixed with a running polypropylene 2/0 suture to the inguinal ligament and interrupted sutures to the conjoint area.A slit were cut for the spermatic cord and the tails secured back together around the cord with permanent sutures, as described by lichtenstein.Finally, the external oblique aponeurosis and the skin closed.Operation details were gathered immediately after the surgery was completed.Operative time (from skin incision until suturing of the cutis) and mesh fixation time were recorded in minutes.After discharge, the patients were seen at the outpatient clinic by the surgeon with an initial post-operative visit at the 7th post-operative day, then at the 1, 3 and 6 months.Reported complications included : seroma (n=2), hematoma (n=1), wound infection (n=1), there was a significant postoperative decrease in testicular volume (p < 0.001) accompanied by a significant increase in ri as compared to their pre-operative values (p = 0.009) (n=?) , post-operative changes as regard to other doppler findings: varicocele (n=6), minimal hydrocele (n=2), varicocele + minimal hydrocele (n=4).It was concluded, that mesh implantations has an effect on testicular size and blood flow by decreasing the testicular size and increasing the ri.This effect was more obvious in the parietex progrip than with the standard prolene mesh.Although there is an indirect relation between ri and the sperm count, testicular blood flow alone is not enough to judge fertility.

• 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: 11617005
• MDR Text Key: 260677158
• Report Number: 2210968-2021-03048
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1