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 Problem Necrosis (1971)

Event Date 08/31/2017

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 regarding the additional events.  citation: journal of plastic surgery and hand surgery, 52:3, 172-177 doi: 10.1080/2000656x.2017.1372292.  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 the ethicon products (ultrapro hernia system and ultrapro hernia plug) 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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events related to (b)(6)-year-old male patient with prolene suture reported via mw # 2210968-2021-03708.Adverse events related to (b)(6)-year-old male patient with proceed mesh reported via mw # 2210968-2021-03709.Adverse events related to (b)(6)-year-old male patient with prolene mesh reported via mw # 2210968-2021-03710.Adverse events related to (b)(6)-year-old female patient with prolene suture reported via mw # 2210968-2021-03711.Adverse events related to (b)(6)-year-old female patient with proceed mesh reported via mw # 2210968-2021-03712.Adverse events related to (b)(6)-year-old female patient with prolene mesh reported via mw # 2210968-2021-03713.Adverse events related to all other patients in study with prolene suture reported via mw # 2210968-2021-03714.Adverse events related to all other patients in study with proceed mesh reported via mw # 2210968-2021-03715.Adverse events related to all other patients in study with prolene mesh reported via mw # this report.

Event Description

It was reported in a journal article with title: diaphragm reconstruction combined with thoraco-abdominal wall reconstruction after tumor resection.This retrospective study aims to describe the approach for repairing thoraco-abdominal wall defects combined with diaphragm defects.Between 1997 and 2015, 21 patients (male and female; age: 23¿81 years; mean age: 58.9 years) underwent diaphragm resection and reconstruction, in combination with thoraco-abdominal wall reconstruction, in the department of plastic surgery at helsinki university hospital in helsinki, finland.Chest wall and/or abdominal wall stabilization and large diaphragm defects were reconstructed with prolene mesh (ethicon), proceed surgical mesh (ethicon), if the diaphragm defect was <3¿4 cm, the diaphragm was pulled directly and sutured to the mesh on thoraco-abdominal wall.The diaphragm was pulled to its original position and sutured directly (n=15) or reconstructed with mesh (n=6).Chest wall or abdominal wall reconstructions were performed with mesh (n=14), while chest wall defects with large soft tissue defects were reconstructed with a mesh and a free flap (n=3), mesh and a pedicled flap (n=3), and smm and a pedicled flap (n=1).During the procedures, when a defect is located in the thoraco-abdominal region, it is important to consider maintaining a diaphragmatic dome to create a functional diaphragm.If the diaphragm resection was more than 3¿4 cm, mesh was required for reconstruction because the diaphragm cannot be pulled to its original position with too much tension.An artificial mesh was inserted in the area of the diaphragmatic defect and sutured with 0 or 1/0 polypropylene (ethicon) and/or polyester sutures, with a sufficient margin.If the chest wall defect was large and stabilization was needed, mesh reconstruction was used.For chest wall defects located on the sternal area and larger than 10_10 cm, smm was required for chest wall stabilization: methyl methacrylate cement was placed between two layers of polypropylene mesh (ethicon).Chest wall reconstruction began with the suturing of a mesh from cranially.For the diaphragm reconstruction, the diaphragm (or diaphragm with mesh) was pulled distally and radially/laterally to its original position and sutured to the thoraco-abdominal wall reconstruction mesh.Then, the abdominal part of the defect is reconstructed by suturing the mesh into the muscular layers of the abdominal wall, and soft tissue coverage was achieved with direct closure or flap reconstruction.According to the size of the defect, location and reconstructive options, either latissimus dorsi pedicled flaps or tensor fascia lata free flaps were selected.Reported complications included: one year and 5-year survival rates were 85.7 (n=?) and 65.9% (n=?), respectively , overall recurrence-free rates were 80.4 (n=?)and 60.8% (n=?), respectively.(patient no 1) a case of a (b)(6) year old male had sepsis, venous thrombosis flap partial necrosis and underwent revision with vein graft, skin graft.Venous thrombosis was corrected with re-anastomosis.(patient no 15) a case of a (b)(6) year old female had flap partial necrosis and underwent revision with simple suture.It was concluded, diaphragm reconstruction has low morbidity and mortality.These reconstructions involved adequate stability and water-tight and air-tight closure of the chest wall cavity.There were no cases of paradoxical movement of the chest or hernias.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 06/11/2021.Additional information was requested and the following was obtained: 1.Were the cases discussed in this article previously reported to ethicon? no 2.Does the surgeon believe that the ethicon products (prolene suture, prolene mesh, proceed mesh) involved caused and/or contributed to the postoperative complications described in the article? no 3.Does the surgeon believe there was any deficiency with the ethicon product (prolene suture, prolene mesh, proceed mesh) used in this procedure? no 4.What is the specific/underlying cause of deaths in patients mentioned in the study where the one year and 5-year survival rates were 85.7% and 65.9%, respectively? primary disease and/or others 5.Were these death events attributed to the ethicon products (prolene suture, prolene mesh, proceed mesh) used in the procedures? no this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint # (b)(4).Date sent to the fda: 06/11/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11718619
• MDR Text Key: 250796975
• Report Number: 2210968-2021-03716
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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: 05/13/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR