OptomeshTM
Monofilament non-absorbable surgical meshes are recommented for procedures of soft tissue defects reconstructions
1. Description of the product:
Non-absorbable surgical mesh knitted of transparent, monofilament polypropylene yarn with high degree of tolerance by human organism.
The meshes are available in two variants:
- MACROPORE – mesh with macroporous structure (pore size above 3,3mm2),
- THINLIGHT – universal mesh with standard pore size.
The product list after point 6.
OptomeshTM surgical meshes do not contain any allogenic or animal derivative substances.
The product is characterised by:
- mechanical endurance ensuring mesh-to-fascia anastomosis durability,
- good fixing and multidirectional shape memory,
- low surface mass,
- no fraying on edges and endurance to suture plucking when suturing is placed near mesh edge,
- appropriate pore size facilitating piercing with needle,
- high resistance to suture pull-out,
- monofilament structure minimising the risk of bacterial infection.
Intended use:
OptomeshTM surgical meshes arerecommended for reconstruction of soft tissue defects in the following cases:
- abdominal hernia - primary and recurrent,
- large ring post-operative hernia,
- inguinal hernia,
- femoral hernia,
- periumbilical hernia,
- hernia in post-operative scar.
The OptomeshTM MACROPORE variant is recommended for treatment of extensive connective tissue defects (big hernias) whereas the OptomeshTM THINLIGHT variant has a universal scope of application.
2. Sterilisation:
The OPTOMESHTM meshes are sold sterile - sterilised with ethylene oxide (EO) in a validated process in acc. with PN-EN ISO 11135 norm.
According to EN ISO 10993-7, a mean daily EO dosis for a patient should not exceed 0,1 mg/day or 4mg during first 24 hours - the level of EO residues in surgical meshes introduced to the market is much below the abovementioned requirements.
3. Biological parameters:
Sterility of OptomeshTM surgical meshes is confirmed with sterility tests for each production lot released for the market. The sterilisation indicators placed on each package prove the product's undergoing the sterilisation process.
Bacterial endotoxin content in the lot is much below the requirements - the requirement being 20EU/device (in acc. with USP monoghaphy 161).
Endotoxin content is a very important parameter due to the fact that some part of dead bacteria (endotoxins) is pyrogenic. This is the reason why there is a limit on the content of dead bacteria in medical devices.
Microbiological purity determined in acc. with PN-EN ISO 11737-1; accepted limit: max. 100 microorganisms/1g of the device. Before the sterilisation process periodical tests of microbiological purity of random-chosen products are carried out; such procedure guarantees full safety of use of the product.
OptomeshTM surgical meshes fulfill all the requirements specified in PN-EN ISO 10993-1 norm and they also posess a number of documented biological tests.
4. Chemical parameters:
Permanganate oxidability – an important parameter of chemical purity. It shows the level of contamination, mainly organic, but also some non-organic, such as iron salts (II), sulphides or nitrates (III). The level of permanganate oxidability in serial devices is less than 0,08mg O2/g. Reference - clear water is characterised by the oxidability not exceeding 4mg O2/dm3.
UV absorbance at a given wavelength – this parameter proves the lack of, mainly organic, contamination. The maximum absorbance at a given wavelength for serial products does not exceed 0,3. Reference - clear water is characterised by the absorbance between 0,5 ÷ 2.
5. Physical parameters:
Surface mass – depending on the variant between 60 and 85 g/m2 – assures the comfort of use for the patient.
Mesh thickness – depending on the variantod between approx. 0,4mm to approx. 0,8mm – assures high mechanical resistance.
Filament thickness –meshes are manufactured out of polypropylene yarn adequate for obtaining big pore size which, at the same time, assure high resistance to fixing suture pull-out.
6. Packaging:
The OptomeshTM surgical meshes are packed in double medical packages (fulfilling PN-EN ISO 11607 requirements) - paper-foil bar or sleeve, adequate for EO sterilisation. On the outer packaging there is a TAG label (easy to peel-off, self-adhesive, identifying the device). The double package enables introducing the product into the operating field with no damage to its asepsis. Moreover, the transparent package enables having a look into the package and inspecting the implant. A sterile implant packed into double medical package with IFU and additional double TAG label included is placed in a cardboard envelope. Such package ensures safe storage within the guaranteed validity period.
Product list:
| product code | size (mm) | type | unit package | shipping unit |
| MA-271-OPMT-001 | 50 x 60 | T | 1 pc | 10 pcs |
| MA-271-OPMM- 001 | 50 x 60 | M | 1 pc | 10 pcs |
| MA-271-OPMT-002 | 50 x 100 | T | 1 pc | 10 pcs |
| MA-271-OPMM-002 | 50 x 100 | M | 1 pc | 10 pcs |
| MA-271-OPMT-003 | 60 x 110 | T | 1 pc | 10 pcs |
| MA-271-OPMM-003 | 60 x 110 | M | 1 pc | 10 pcs |
| MA-271-OPMT-004 | 65 x 125 | T | 1 pc | 10 pcs |
| MA-271-OPMM-004 | 65 x 125 | M | 1 pc | 10 pcs |
| MA-271-OPMT-005 | 80 x 80 | T | 1 pc | 10 pcs |
| MA-271-OPMM-005 | 80 x 80 | M | 1 pc | 10 pcs |
| MA-271-OPMT-006 | 80 x 130 | T | 1 pc | 10 pcs |
| MA-271-OPMM-006 | 80 x 130 | M | 1 pc | 10 pcs |
| MA-271-OPMT-007 | 100 x 160 | T | 1 pc | 10 pcs |
| MA-271-OPMM-007 | 100 x 160 | M | 1 pc | 10 pcs |
| MA-271-OPMT-008 | 125 x 200 | T | 1 pc | 10 pcs |
| MA-271-OPMM-008 | 125 x 200 | M | 1 pc | 10 pcs |
| MA-271-OPMT-009 | 125 x 250 | T | 1 pc | 10 pcs |
| MA-271-OPMM-009 | 125 x 250 | M | 1 pc | 10 pcs |
| MA-271-OPMT-010 | 150 x 150 | T | 1 pc | 10 pcs |
| MA-271-OPMM-010 | 150 x 150 | M | 1 pc | 10 pcs |
| MA-271-OPMT-011 | 150 x 200 | T | 1 pc | 10 pcs |
| MA-271-OPMM-011 | 150 x 200 | M | 1 pc | 10 pcs |
| MA-271-OPMT-012 | 200 x 250 | T | 1 pc | 10 pcs |
| MA-271-OPMM-012 | 200 x 250 | M | 1 pc | 10 pcs |
| MA-271-OPMT-013 | 200 x 300 | T | 1 pc | 10 pcs |
| MA-271-OPMM-013 | 200 x 300 | M | 1 pc | 10 pcs |
| MA-271-OPMT-014 | 220 x 350 | T | 1 pc | 10 pcs |
| MA-271-OPMM-014 | 220 x 350 | M | 1 pc | 10 pcs |
| MA-271-OPMT-015 | 260 x 360 | T | 1 pc | 10 pcs |
| MA-271-OPMM-015 | 260 x 360 | M | 1 pc | 10 pcs |
| MA-271-OPMT-016 | 300 x 300 | T | 1 pc | 10 pcs |
| MA-271-OPMM-016 | 300 x 300 | M | 1 pc | 10 pcs |
| MA-271-OPMT-017 | 60 x 140 | TLI | 1 pc | 10 pcs |
| MA-271-OPMT-018 | 60 x 140 | TLIK | 1 pc | 10 pcs |
| MA-271-OPMT-019 | 45 x 100 | TLI | 1 pc | 10 pcs |
| MA-271-OPMT-020 | 45 x 100 | TLIK | 1 pc | 10 pcs |
T – ThinLight type
M –Macropore type
LI – for Lichtenstein technique in men (with a hole for spermatic cord)
LIK – for Lichtenstein technique in women
| Name | Size | Type |
|---|---|---|
| Product photos: OptomeshTM | 12.43 MB |
| Name | Rozmiar | Type |
|---|---|---|
| Product photos: OptomeshTM | 12.43 MB |