Manual

1. DESCRIPTION

DynaMesh-SIS minor is a mesh implant for reinforcing connective tissue structures and ligaments. DynaMesh-SIS minor does not have any pharmacological effect of its own and is non-toxic.
DynaMesh-SIS minor is knitted using non-absorbable, biostable polyvinylidene fluoride monofilament fibre. The three-dimensional tape ends provide an additional means of fixating the implant in its final position. No provision has been made for additional fixation with sutures or other means of fixation such as clips or staplers. The specially developed knitted structure and the optimal mesh size of the DynaMesh-SIS minor are perfectly matched to its field of application.

2. FIELDS OF APPLICATION

DynaMesh-SIS minor serves to support and stabilise connective tissue structures and ligaments. DynaMesh-SIS minor is used as a suburethral, tension-free sling for treating female stress urinary incontinence caused by a urethral hypermobility and/or intrinsic sphincter deficiency.

The choice of the operation technique and the final position of the tape is left to the surgeon’s discretion.
The operation should be carried out under general, local or regional anaesthetic.
After positioning the patient, an urethral catheter is to be inserted and the bladder emptied. The catheter should remain in the bladder during the operation.
DynaMesh-SIS minor can be inserted both in the direction of the retrosymphysary and in the direction of the transobturatoric tape position. The start of the operation is identical for both localisations. A sagittal colpotomy of approx. 1 - 2 cm is performed approx. 1 cm under the urethral meatus and the insertion of the mesh implant is prepared to the right and left of the incision with dissection scissors making a blunt atraumatic dissection in the direction of the perineum.
For the retrosymphyseally aligned strip position, the surgeon aligns the scissors at an angle of 45° to the lower edge of the pubic bone and slightly splays the instrument as it is withdrawn. The DynaMesh-SIS minor is now removed under sterile conditions and placed tension-free in a U-shape under the urethra using forceps. The three-dimensional structure of the ends of the mesh enables corrections to be made.
For the transobturatorically aligned tape position, the scissors are guided almost horizontally by the surgeon in the direction of the lower edge of the pubic branch to the inside of the obturator membrane. A blunt atraumatic dissection will also suffice here. Again, it must be ensured that the mesh implant is removed under sterile conditions and placed carefully with the forceps.
The DynaMesh-SIS minor should always be inserted tension-free, ensuring contact with the urethra is made with care.
After the implant has been positioned, the colpotomy is closed.

3. CONTRAINDICATIONS

DynaMesh-SIS minor should not be used if there are indications of urinary tract infections, or if the patient is currently or intends to become pregnant, on females who are still growing, or on patients undergoing an anticoagulation therapy.

4. WARNINGS

DynaMesh-SIS minor is intended for single use only. Re-use can lead to functional, immunological, toxicological or hygienic impairments.
The user should be familiar with the technique for implanting a suburethral, tension-free sling before using DynaMesh-SIS minor.

If DynaMesh-SIS minor is used in a contaminated wound, a subsequent infection is possible which may necessitate a removal of the material.
When the DynaMesh-SIS minor is being implanted, damage to blood vessels, nerves or the bladder may occur requiring immediate surgical treatment. If an injury to the bladder or urethra is suspected, a urethrocystoscopy must be carried out in all cases.
The following complications may arise with meshes in general: seromas, haematomas, infections, fistula formations, inflammations or arrosions.
The procedure must be carried out under strictly sterile conditions up to implantation. The application must be carried out only in aseptic rooms.
Damaged implants must no longer be used. Contact with sharp objects in particular must be avoided.
DynaMesh-SIS minor must not be implanted if:
• the expiry date has passed
• the packaging has been damaged
• there is reason to suspect that the packaging has been damaged.

The implant is packed in a sterile double packaging. The inner packaging should not be opened until the mesh is about to be used. It is recommended that the mesh be handled only with sterile, unpowdered gloves and clean instruments.
The surgeon is responsible for complications arising from an incorrect indication, an inadequate operating technique or failure to ensure sterile conditions. In all cases it is recommended that the intervention is accompanied by appropriate follow-up.
The patient should be advised that physical activities such as heavy lifting, jogging, riding or sexual intercourse should be resumed only after consultation with the doctor in attendance.

5. SIDE-EFFECTS

There are no indications in the literature that the polyvinylidene fluoride used has adverse side effects. As with all foreign bodies, DynaMesh®-SIS minor may have a negative effect on a pre-existing infection and may lead to temporary local irritations.

6. STERILITY

The product is sterilised with ethylene oxide.
It is not permissible to resterilise DynaMesh-SIS minor.
The product must not be used if the packaging has been damaged or if it has been opened. Opened, unused products must be discarded!

7. STORAGE CONDITIONS

The recommended storage conditions are follows:
• Store in a dry place at room temperature,
• Protect from moisture and the direct effect of heat,
• Store only in the original packaging,
• Do not use after the expiry date.
back