Manual

1. DESCRIPTION

DynaMesh-PR2 and -PR4 is a mesh implant for reinforcing connective-tissue structures.

DynaMesh-PR2 and -PR4 does not have any pharmacological effect of its own and is non-toxic.

DynaMesh-PR2 and -PR4 is knitted from non-absorbable, bio-stable polyvinylidene fluoride monofilament fibre.

The specially developed knitted structures and the ideal mesh size of DynaMesh-PR2 and -PR4 are optimally matched to the fields of application for which it is intended.

2. FIELDS OF APPLICATION

DynaMesh-PR2 and -PR4 is used to support and stabilise fascial structures and connective tissue.

Common applications featuring all conventional methods of surgery are repairing inguinal hernias and incisional hernias as well repair procedures involving descensus and prolapse surgery.

DynaMesh-PR2 and -PR4 is selected from the range of products according to the nature and size of the defect and can be cut as required by the defect in question outside the operating field.

The mesh has to be sized in such a way that it overlaps the defect by approx. 5 cm on all sides.

The mesh can be cut to size with sharp scissors or a scalpel according to the particular requirements.

Fixation
In the case of application requiring a fixation procedure, at least 1 cm of mesh border should be grasped, and a space of 1-2 cm should be maintained between the individual sutures. Alternatively, clips, staplers or clamps can be used. Clamp size and spacing should be selected by the surgeon on the basis of previous experience.

3. CONTRAINDICATIONS

All the usual contraindications for use as a tissue support implant also apply to the use of DynaMesh-PR2 and -PR4. They include the following:

• On account of an increased risk of infection, the mesh should not be used if preceded by enterotomy.
• The mesh is not suitable for use as a plug.

DynaMesh-PR2 and -PR4 should not be used where infection is present or in the case of current or intended pregnancy or patients with potential for future growth.

4. WARNINGS

DynaMesh-PR2 and -PR4 is intended for single use only. Re-use can lead to functional, immunological, toxicological or hygienic impairments.
The user must be familiar with the mesh technique used before using DynaMesh-PR2 and -PR4.

If DynaMesh-PR2 and -PR4 is used in a contaminated wound, there is a possibility of subsequent infection, which may necessitate removal of the material.

Up to implantation strict care must be taken to ensure sterile handling. Application may only take place in aseptic rooms.

Damaged implants must not be used; in particular, contact with sharp objects must be avoided.

DynaMesh-PR2 and -PR4 must not be implanted if

• the minimum shelf life has being exceeded or
• the packaging is damaged or
• there is any doubt about its integrity.

The implant is packed in sterile double-packaging.

The inner packaging should not be opened until the mesh is about to be used.

It is recommended that the mesh only be handled with sterile, unpowdered gloves and clean instruments.

Meshes in general may lead to the following complications: seromas, haematomas, recurrences and infections.

The surgeon is responsible for any complications which may be due to an incorrect indication, an inadequate operating technique or an error in maintaining aseptic conditions.

In all cases it is recommended that the intervention is accompanied by appropriate follow-up.

5. SIDE-EFFECTS

There are no references in the literature to any undesirable side-effects caused by the polyvinylidene fluoride used.

As with all foreign bodies, DynaMesh-PR2 and -PR4 can have a detrimental effect on a pre-existing infection and lead to temporary local irritation.

6. STERILITY

The product is sterilised with ethylene oxide. DynaMesh-PR2 and -PR4 must not be re-sterilised!

The product must not be used if the packaging is damaged or already opened!

Any products which have been opened but not used must be discarded!

7. STORAGE CONDITIONS

The recommended storage conditions are as follows:

• Store in a dry place at room temperature
• Protect against moisture and direct heat
• Only store in the original packaging
• Do not use if the expiry date has elapsed!

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