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); Unspecified Infection (1930); Pain (1994); Seroma (2069); Decreased Sensitivity (2683); Peripheral Edema (4578)

Event Date 02/13/2020

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, prolene suture and vicryl suture) involved caused and/or contributed to the early and late post-operative complications (scrotal edema, hematoma, seroma, groin pain, surgical site infection, change/loss of sensation, foreign body feeling) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon product (prolene mesh, prolene suture and vicryl suture) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (scrotal edema, hematoma, seroma, groin pain, surgical site infection, change/loss of sensation, foreign body feeling).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, prolene suture and vicryl suture product codes/lot numbers used in these cases.Citation: p j m h s vol.14, no.2, apr ¿ jun 2020.Events were submitted: 2210968-2021-03062 and 2210968-2021-03063.

Event Description

Title: lichtenstein versus desarda technique for inguinal hernia repair: a randomized clinical trial.This randomized clinical trial aims to compare the results of lichtenstein mesh repair with non mesh desarda¿s technique.From jan.2017 to jun.2018 ,a total of 100 adult male patients aged between 18 to 80 years with uncomplicated inguinal hernias were included in the study.The patients were randomly allocated intraoperatively to undergo one of the two surgical repairs: the classic lichtenstein mesh repair or desarda tissue-based repair.There were 50 patients with mean age of 48.4 years who underwent lichtenstein repair and 50 patients with mean age of 47.2 years who underwent desarda repair.During the procedures, for lichtenstein repair (l group), after dealing with the sac,the posterior wall of inguinal canal was reinforced with prolene mesh (ethicon).The mesh was sutured to the fibro-periosteum of the pubic bone and inguinal ligament with prolene 2/0 (ethicon) continuous sutures.Above, it was sutured to internal oblique with prolene 2/0 interrupted sutures.On the lateral part of mesh, a slit was made in the mesh to accommodate the cord at deep ring.The two limbs of mesh sutured together lateral to deep ring also mesh anchored to the internal oblique here.The cord was places in position.The inguinal canal was closed by suturing the two edges of eoa with prolene 2/0 continuous sutures, leaving adequate space for superficial ring.The superficial fascia closed with vicryl (ethicon) and skin with prolene 2/0.For the desarda repair (d group): after dealing with the sac,incision was made in the upper leaf of eoa, 2 cm from its divided margin, thereby separating 2 cm strip of eoa from the upper leaf, but keeping its continuity at both ends.It was extending from symphysis pubis medially, to about 1 cm lateral to the deep ring laterally.This strip of eoa was pulled down behind the cord and sutured to the inguinal ligament below with prolene 2/0 (ethicon)continuous sutures and to the arch of the muscle above with prolene 2/0 (ethicon) interrupted sutures, thereby reinforcing the posterior wall by natural tissue without tension.The cord was places in position.The lower leaf of eoa was sutured to the new upper leaf of eoa in front of the cord using prolene 2/0 interrupted sutures, leaving adequate space for superficial ring.The superficial fascia closed with vicryl and skin with prolene 2/0.After discharge from hospital patients were seen in surgical outpatient department at day 7 and month 1, 3, 6 and 12 post-operatives.Reported complications included : for lichtenstein repair (l group), early complications (within 30 days): scrotal edema (n=3) resolved in all patients within 30 days, wound hematoma (n=3), wound hematoma needing drainage (n=1) , seroma day 7 (n=3), seroma day 30 (n=1) 1 patient needed aspiration once ,others resolved spontaneously for wound seroma, groin pain (n=3) , surgical site infection (n=2) treated by partial wound opening, irrigation and antibiotics ,and late complications (3-12 months): groin pain (n=1) chronic mild groin pain , change or loss of sensation ( n=8), foreign body feeling (n=6).For the desarda repair (d group),early complications (within 30 days):scrotal edema (n=2) resolved in all patients within 30 days, wound hematoma (n=4), seroma day 7 (n=1) resolved spontaneously, groin pain (n=2), surgical site infection (n=1) treated by partial wound opening, irrigation and antibiotics, and late complications (3-12 months): change or loss of sensation (n=9) , foreign body feeling (n=4).It was concluded, that inguinal hernia can be treated successfully without mesh by desarda repair technique.Its recurrence rates are comparable to standard lichtenstein procedure.It is cost effective (no mesh), patients have less postoperative pain.The other complications are similar or less than lichtenstein repair.However, the basic hindrance in performing desarda technique is intraoperative finding of weak, thin, or splitfibers of external oblique aponeurosis, and here lichtenstein technique has advantage.

• 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: 11624297
• MDR Text Key: 261203218
• Report Number: 2210968-2021-03061
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention