| Manual
1. DESCRIPTIONDynaMesh-SIS is a mesh implant for reinforcing connective-tissue structures and ligaments. DynaMesh-SIS does not have any pharmacological effect of its own and is non-toxic.
DynaMesh-SIS is knitted from non-absorbable, bio-stable polyvinylidene fluoride monofilament fibre. The specially developed knitted structures and the ideal mesh size of DynaMesh-SIS are optimally matched to the fields of application for which it is intended.
2. FIELDS OF APPLICATIONDynaMesh-SIS is used to support and stabilise connective-tissue structures and ligaments. Common applications are suburethral, tension-free slings for treating female stress urinary incontinence resulting from an urethral hypermobility and/or intrinsic sphincter deficiency.
The surgeon selects the method of surgery and position of the sling, both of which will depend on his/her preference, on the one hand, and on the instruments used, on the other. These instruments may be procured separately. Normally, the implant is brought in through a vaginal or a suprapubic access. The resulting sling position is either retrosymphysary, or the sling is passing through the foramen obturatum.
3. CONTRAINDICATIONSDynaMesh-SIS 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
The user must be familiar with the technique involved in implanting a suburethral, tension free sling before using DynaMesh-SIS.
If DynaMesh-SIS is used in a contaminated wound, there is a possibility of subsequent infection, which may necessitate removal of the material.
Insertion of the needle may cause damage to blood vessels, nerves, the bladder or intestine, which will require immediate surgical attention.
Meshes in general may lead to the following complications: seromas, haematomas, infections, fistulisation, inflammations or arrosions.
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-SIS 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.
The reusable instruments are to be checked before use to ensure that they are in perfect condition.
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.
Overcorrection of the sling may lead to postoperative problems ranging from disturbed micturition with residual urine to suppression of urine resulting from the tautness of the strip.
The patient’s attention should be drawn to the fact that such physical activities as heavy lifting, jogging, riding or sexual intercourse should not be resumed until the attending physician has been consulted.
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-SIS 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-SIS 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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