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

Catalog Number PROMESHUNK

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

Patient Problems Hematoma (1884); Scarring (2061); Seroma (2069); Not Applicable (3189)

Event Date 09/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Adverse events will be submitted via mw# 2210968-2020-08748, mw# 2210968-2020-08749.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: aesthetic surgery journal 2018, vol 38(6) 635¿643; doi: 10.1093/asj/sjx175; published online: october 14, 2017.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 (prolene suture, ethilon suture, prolene 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?.

Event Description

It was reported in a journal article with title: the suprapubic dermoadipose flap for aesthetic reshaping of the postpregnancy abdomen.This study reports preliminary experiences with a simple, although overlooked, surgical resource designed to prevent late postoperative contour deformities in slim women undergoing abdominoplasties and presenting severe recti abdominis diastasis associated with midline subcutaneous fat atrophy.Between january 2005 and january 2015, twenty-two female patients (ages ranged from 19 to 36 years; mean, 27 years) undergoing abdominoplasty with the suprapubic flap were included in the study.Rectus sheaths were reinforced by vertical plication from the xiphoid process to the pubis with inverted 2-0 polypropylene mattress sutures (prolene, ethicon, somerville, nj).In selected multiparous patients with wide diastasis recti and musculoaponeurotic laxity, an additional abdominal wall reinforcement was indicated by using an onlay polypropylene mesh (prolene, ethicon).Afterwards, the umbilicus was fixed to the fascia with inverted monofilament nylon 4/0 knotted stitches (ethilon, ethicon).The suprapubic flap was then sutured back to the recti abdominis muscle fascia, covering the lower plication area and occupying the infraumbilical area, which requires tissue filling.After the placement of drains, the abdominal incision was closed in three layers with 3/0, 4/0, and 5/0 monofilament nylon sutures (ethilon).Complications included hematoma (n=1) which required a return to the operating room for evacuation; seroma (n=1) which required evacuation; skin slough (n=1) and hypertrophic scarring (n=3).The case of minimal skin slough healed after conservative treatment with wound dressings.Cases of hypertrophic scarring at the medial area was resolved with serial injections of triamcinolone with a 2-week injection interval.In conclusion, the suprapubic dermoadipose flap is an effective option to prevent the midline depression that would otherwise remain on the hypogastric region of post-pregnant slim women with midline fat tissue atrophy.

• 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183; km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10798196
• MDR Text Key: 217358458
• Report Number: 2210968-2020-08750
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• 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