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 Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

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.Attempts are being made to obtain the following information.If further details are received at the 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 product 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 product involved? citation: hernia.2015; 19: 141¿146.Doi: 10.1007/s10029-013-1143-2.(b)(4).

Event Description

It was reported via journal article "title: comparison between the short-term results of onlay and sublay mesh placement in the management of uncomplicated para-umbilical hernia: a prospective randomized study" authors: s.S.Bessa, a.M.El-gendi, a.-h.A.Ghazal, t.A.Al-fayoumi citation: hernia.2015; 19: 141¿146.Doi: 10.1007/s10029-013-1143-2.The aim of this study was to compare between the short-term results of onlay and sublay mesh placement in the prosthetic repair of uncomplicated para-umbilical hernia (puh).A total of 80 patients with a defect size ranging from 4 to 10 cm were prospectively randomized to either the onlay group (40 patients; 6 male and 34 female patients; age range: 26 to 57 years old; bmi: 25 to 37) or the sublay group (40 patients; 5 male and 35 female patients; age range: 24 to 59 years old; bmi: 25 to 36).The operative time, postoperative complications, and short term recurrence were reported.In the sublay group, the retromuscular space was developed to allow the insertion of a 15 ×15 cm monofilament prolene polypropylene mesh (ethicon) in all patients as follows.The peritoneal cavity was then closed by suturing the peritoneum-posterior rectus sheath layer of both sides.Third, peripheral fixation of the mesh was performed as follows.A prolene 0 suture (ethicon) was placed through the infolded edge of the mesh.In the onlay group, the margins of the defect were identified and secondary defects were searched for carefully and connected with the main defect.Next, the defect was vertically closed by simple interrupted non-absorbable prolene 1-0 sutures (ethicon).Next, skin and subcutaneous flaps were elevated to fit a 15 × 15 cm monofilament prolene polypropylene mesh (ethicon).The mesh was fixed to the abdominal wall muscles as an onlay patch using interrupted non-absorbable prolene 2-0 sutures (ethicon).In the sublay group, reported complication included superficial wound infection (n-1) which required antibiotics guided by culture and sensitivity studies and recurrence of hernia (n-2).In the onlay group, reported complication included seroma (n-2) which required re-insertion of the catheter tube drain under local anesthesia for an extra week and recurrence of hernia (n-2).The main findings of the present study suggest that both mesh positions were associated with comparable complication and recurrence rates and that both techniques may be applied effectively in the management of uncomplicated puh.Both the sublay and onlay mesh placement techniques are safe, efficient, and are associated with comparable complication and recurrence rates.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7927482
• MDR Text Key: 122457635
• Report Number: 2210968-2018-76223
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• 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: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention