| Manual
DynaMesh-PP
Mesh implant (standard) for hernia surgery, made of PP monofilament
Mesh implant (light) for hernia surgery, made of PP monofilament
1. DESCRIPTIONDynaMesh-PP is a mesh implant for reinforcing connective-tissue structures. DynaMesh-PP does not have any pharmacological effect of its own and is non-toxic.
DynaMesh-PP is knitted from non-absorbable, bio-stable polypropylene monofilament fibre. The specially developed knitted structure and the ideal mesh size of DynaMesh-PP are optimally matched to the dynamometry of the abdominal wall.
DynaMesh-PP is available in 4 different sizes (6 cm x 11 cm, 10 cm x 15 cm, 15 cm x 15 cm, 30 cm x 30 cm) and in two weights:
Standard weight (PP01) with approx. 65 g/mē
Light weight (PP02) with approx. 38 g/mē
2. FIELDS OF APPLICATIONDynaMesh-PP is used to support tissue and stabilise fascial structures of the abdominal wall.
Common applications are repairing inguinal hernias and incisional hernias in all conventional methods of surgery such as the Lichtenstein technique or TIPP, as well as the laparoscopic techniques of transabdominal preperitoneal hernioplasty (TAPP) and total extraperitoneal hernioplasty (TEP).
DynaMesh-PP is selected from the range of products according to the size of the defect and can be cut accordingly 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
For fixation at least 1 cm of mesh border should be grasped; a spacing of 1 2 cm should be maintained between the individual sutures. The weight of such a material should depend on the surgeonīs preference and method of reconstruction.
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-PP. They include the following:
- On account of an increased risk of infection, the mesh should not be used if preceded by enterotomy.
- The mesh must always be separated from the abdominal cavity by the peritoneum.
- The mesh is not suitable for use as a plug.
Care must be exercised in the case of growing paediatric patients, patients with manifested infections, and pregnancies.
4. WARNINGS
The user must be familiar with the hernioplasty technique used before using DynaMesh-PP.
If DynaMesh-PP 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-PP 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, infections and visceral adhesions.
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 be accompanied by appropriate follow-up.
5. SIDE-EFFECTS
There are no references in the literature to any undesirable side-effects caused by the polypropylene used. As with all foreign bodies, DynaMesh-PP can have a detrimental effect on a pre-existing infection and lead to temporary local irritation. There is a possibility of adhesions occurring if the implant has direct contact with the intestine.
6. STERILITY
The product is sterilised with ethylene oxide.
DynaMesh-PP 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
- Protect against ultraviolet light
- Only store in the original packaging
- Do not use if the expiry date has elapsed!
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