| Manual
1. DESCRIPTIONDynaMesh-IPST is a mesh implant for reinforcement of connective tissue structures with a central penetration point for intestinal parts. DynaMesh-IPST does not have any pharmacological effect of its own and is non-toxic. DynaMesh-IPST is knitted using non-absorbable, biostable PVDF and polypropylene monofilament fibre.
2. FIELDS OF APPLICATIONDynaMesh-IPST is used for the prophylaxis and therapy of hernias and fascial defects in the abdominal wall after formation of an artificial anus (anus praeter, stoma) to reinforce connective tissue structures and prevent intestinal prolapse. It is used both in laparoscopy and in open surgery.
Common applications follow the intraperitoneal onlay mesh technique since the mesh is composed of different materials, which allows intraperitoneal application. Different surface structures (parietal side = polypropylene, visceral side = polyvinylidene fluoride) ensure ideal integration into the abdominal wall and reduced adhesion between the intestine and the mesh. Therefore, it is absolutely vital that the surfaces are aligned properly. The central penetration point is provided with a funnel that should be directed toward the abdominal cavity. This ensures integration of the stoma loop in the funnel without increasing the risk of penetration. Furthermore, this position effectively prevents intestinal prolapse. The diameter of the surgical mesh’s flue must account for the size of the loop stoma. While a tight fit is desirable to avoid a prolapsing of the stoma, a diameter that is too small may lead to an excessive constriction of the intestine. An optimal application of the mesh is guaranteed when a visible widening of the flue is observed when guiding the loop stoma through it. The parietal side is marked with filament ends for clear identification and accordingly must be directed toward the abdominal wall in order to induce the desired in-growth. The filament ends point upward so that elasticity can be oriented in a cranio-caudal direction.
DynaMesh-IPST can be cut to size outside the operating field using sharp scissors or a scalpel. However, it is strongly recommended that the original size be used to ensure wide overlapping of the penetration point of the stoma loop through the abdominal wall by at least 5cm.
Fixation
For fixation of the mesh, non-absorbent suture should be used. If fixation only involves the suture, a spacing of 1-2cm must be maintained between the individual sutures, and at least 1cm of mesh border should be added. Alternatively, a continuous suture technique can be used. The size of the suture depends on the surgeon’s preference and the type of reconstruction but should not be less than the filament/suture size of 2-0.
Alternatively, clips, staplers, or clamps can be used. However, care must be taken to ensure that fixation is performed not only in the peritoneum but also in the fascias or muscular structures. Experience has shown that spiral clips are most suitable for this.
3. CONTRAINDICATIONS
All the typical contraindications for use as a tissue support implant also apply to the use of DynaMesh-IPST.
These include the following:
- On account of an increased risk of infection, the mesh should not be used if the abdominal cavity has previously been contaminated with faeces.
- The mesh is not suitable for use as a plug.
Care must be exercised in case of growing paediatric patients, manifest infections, and pregnancies. DynaMesh-IPST cannot be used on patients with an established allergy to polypropylene or PVDF (very rare).
4. WARNINGS
The user must be familiar with the hernioplasty techniques applied before using DynaMesh-IPST.
Misaligning the implant may lead to substantial adhesion to the intestine, infectious complications, or even fistulation. Moreover, the mesh may fail to grow into the abdominal wall. If DynaMesh-IPST is used in a contaminated wound, i.e. not in the abdominal cavity with all-round contact with the peritoneum, there is a possibility of subsequent infection, which may necessitate the removal of the material. Prior to implantation, strict care must be taken to ensure sterile handling. The product must be applied in aseptic rooms.
Damaged implants must not be used; in particular, contact with sharp objects must be avoided.
DynaMesh-IPST must not be implanted if,
- the minimum shelf life has been exceeded, or
- the packaging is damaged or
- there is any doubt about its intactness.
The implant is packed in sterile double packaging. The inner packaging should only be opened prior to actual use of the mesh. It is recommended that the mesh be handled only with sterile, unpowdered gloves and clean instruments.
Meshes in general are associated with the following complications: seromas, haematomas, relapses, infections, visceral adhesions, mesh migration with fistulation. The surgeon is responsible for any complications which are due to an incorrect indication, an inadequate operating technique, or failure to maintain aseptic conditions. In all cases, it is recommended that the intervention be accompanied by appropriate follow-up.
5. SIDE EFFECTS
The literature does not provide any reference to undesirable side effects caused by the polypropylene or PVDF used. As with all foreign bodies, DynaMesh-IPST can have a detrimental effect on pre-existing infections and lead to temporary local irritation. Procedures involving intraperitoneal implantation include the general risk that points of adhesion will develop between the implant and the intestines. This applies, in particular, if the patient has undergone adhesiolysis prior to the implantation or if the peritoneum has been damaged in some other way.
6. STERILITY
The product is sterilized with ethylene oxide.
DynaMesh-IPST must not be re-sterilized!
The product must not be used if the packaging is damaged or already open! Any products which have been opened but not used must be discarded!
7. STORAGE CONDITIONS
Recommended storage conditions:
- 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 after the expiry date!
| Latest News Searching for distribution partners in the following regions:
Eastern Europe
Asia
Australia
Africa |