Hernia Meshes

Optomesh® - features

Optomesh®

  1. General description of the product.
  2. Intended use
  3. Technical parameters
  4. Expiry date
  5. Storage and transport conditions
  6. Sterility status
  7. Use status
  8. Packaging


 

  1. General description of the product.

Optomesh®  is a non-resorbable surgical knitted of high quality monofilament polypropylene yarn. The device is characterised by high mechanical durability. The mesh can be easily placed in  patient’s body and it has low surface mass. The appropriate weave ensures no shredding and fraying  of the edges and it has high endurance to suture tearing. The structure of large pores allows for proper overgrowth of the scar tissue without the effect of ‘bridging’, which is complete tissue overgrowth. Owing to those features the implant does not lose its elasticity even after some time since the operation which enhances comfort of patient’s life. Meshes are characterised by high mechanical properties both in the longitudinal and lateral directions, so they can be safely used for different kinds of hernia.

The implant has atraumatic edges due to the use of thin yarn and special weave which results in no shredding or crumbling while cutting. All the implants may be adjusted during operation and there is no need for the use of special tools.

Safety and effectiveness of Optomesh® is confirmed. The research was conducted in compliance with the PN-EN ISO 10993 norm in terms of: cytotoxicity, irritation and sensitisation, genotoxicity and sub-chronic and general toxicity, as well as the local post-implantation effect.

Optomesh®  device meets the biological safety requirements.

Optomesh®  implants are available in the wide size range, and the mesh size accuracy is provided by the special cutting machine ‘Cutter’.

The mesh does not contain substances which, while being used separately, can be treated as curative product, as well as the blood-related products and it is lacking the animal tissue.

Optomesh®  is a device which is not obtained from tissues and products of human origin.

There are two Optomesh® types available on the market: ThinLight and MacroPore

Optomesh®  MacroPore is recommended for treatment of large tissue depletion, while Optomesh®  ThinLight is universal. The reconstruction nature and medical standards while selecting the proper mesh is left to decide for a surgeon.

Optomesh®  surgical meshes are made of 100% polypropylene.

ThinLight

MacroPore


Class IIB

ThinLight

MacroPore


60-85 g/m2


60-85 g/m2

 

  1. Intended use

Optomesh®  surgical meshes are recommended for reconstruction procedures in order to supplement/reinforce soft tissue defects. They are intended for primary and recurrent hernias, post-operational hernias, inguinal, umbilical, linea alba hernias and the ones with big hernia ring.

 

  1. Technical parameters
No. Parameter Unit Requirements
1. Weight g/m2 60÷85
2. Mesh thickness mm

0,75±0,03 (MP)

0,47±0,03 (TL)

3. Thread thickness mm 0,16
4. Porosity %

63 (MP)

65 (TL)

 

Sizes [mm]
45×100 100×100 64×140
50×60 100×160 200×250
50×100 125×200 200×300
60×110 125×250 220×350
65×125 150×150 206×360
80×80 150xx200 300×300
80×130 200×200

 

  1. Expiry date

Expiry date- 5 years since the production date

 

  1. Storage and transport conditions

Optomesh®  surgical meshes should be stored and transported in conditions which prevent them from sun exposition, mechanical damage, soaking or biological contamination. Storage temperature  is between 15-35̊ C degree and humidity level within 25-65%.

 

  1. Sterility status

Optomesh®  meshes are sterile devices- they were sterilised in the process of ethylene oxide (EO) sterilisation. Meshes cannot be re-sterilised.

 

  1. Use status

Optomesh®  meshes are single-use products.

 

  1. Packaging

Packaging unit (carton envelope) contains one device item which is being packed in double bag (paper-foil) with the tag. The instruction of use is enclosed as well.

Contact

TZMO SA
ul. Żółkiewskiego 20/26
87-100 Toruń
POLAND
Tel. +48 56 6123395

© Copyright 2013-2019 Tricomed.