Bard Ajust Helical Gebrauchsanweisung Seite 3

• Patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of such
implant procedure and incontinence may recur. The patient is advised to consult with the physicians in case of a
planned pregnancy.
• The safety and effectiveness of the A
treatment of stress urinary incontinence in males or children under the age of 18.
• Cystoscopy should be considered at the physician's discretion.
• Check the integrity of the packaging before use. Do not use the implant or introducers if the packaging is opened or
damaged.
• As for any implantable material, it is recommended to first open the package at the time of implantation.
Upon opening the A
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field. The tray should not be inverted to remove components.
• Post operatively the patient should be advised to refrain from heavy lifting, exercise (e.g. cycling, jogging) and/or
intercourse until the physician determines it is suitable for the patient to return to normal activities.
ADVERsE EVEnTs
Complications associated with the proper implantation of the A
• Postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant
procedure.
• Urinary retention, bladder outlet obstruction and other voiding dysfunctions. These conditions may be associated with
over correction/typically too much tension placed on the implant.
• Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, vagina, rectum or any viscera, which may
occur during the implantation procedure.
• Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence,
inflammation and/or infection.
• Extrusion through vaginal epithelium or erosion into surrounding viscera or adjacent organs.
• Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure
resulting in recurrence of incontinence.
iMPlAnT PROCEDURE
The A H
Sling System may be implanted using local, regional, or general anesthesia.
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Operative Preparation:
1. Position the patient in a dorsal lithotomy position with hips in flexion at approximately 90 degrees and the buttocks even
with the edge of the table. Standard operative preparation of the surgical site should be completed. Insert a Foley catheter
and drain the bladder until empty.
2. Identify the mid-urethra by first locating the external urethral meatus and then the bladder neck by identifying Foley
catheter balloon.
3. Inject solution (e.g., 1% lidocaine with epinephrine) at the midline between the vaginal wall and urethra, hydrodissecting
and creating an urethro-vaginal space. Additional hydrodissection can be performed by injecting solution laterally towards
the cephalad aspect of the ischiopubic ramus in order to better identify the lateral sulci.
4. Place Allis clamps at the level of the mid-urethra on the anterior vaginal wall.
5. Make a small (approximately 1.5 cm) incision in the anterior vaginal wall beginning approximately 1 cm under the urethral
meatus. The depth of the incision should extend into the vaginal muscularis. Gently free the urethra from the anterior
vaginal wall. Using scissors (e.g., Metzenbaum scissors), dissect laterally in a 45 degree angle until the tip of the
scissors makes contact with the medial-cephalad aspect of the ischiopubic ramus (approximately 1-2 cm). This
procedure is repeated on the contralateral side.
A implant Placement Using helical introducers
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Operative Guidelines:
The A H
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intended for placing the fixed anchor into the patient's right side obturator muscle/membrane complex.
• Prior to insertion, ensure that the sling implant is extended in line with the introducer handle. This will aid in visualization of
the blue midline indicator during insertion of the anchors (Figure 2).
Figure 2: Correct orientation of sling implant relative to introducer prior to insertion
nOTE: Prior to introducer insertion, read the placement guidelines below
• When the anchors are properly deployed in the correct anatomical location, they provide secure fixation in the
surrounding tissue.
• If an anchor is positioned incorrectly (e.g., if the midline indicator is greater than 1 cm away from the urethra), apply
gentle traction to "test" securement. If the anchor can be loosened or removed with reasonable force and with minimal
tissue disruption, reload the anchor in the introducer and repeat the insertion. If substantial resistance is encountered,
it is recommended to section the sling laterally to preserve the surrounding tissue integrity. After sectioning, another
sling procedure may be performed.
H
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H
Sling System tray, the components should be carefully transferred into the sterile
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Sling System is packaged with the fixed anchor of the sling implant preloaded in the introducer
Sling System implant procedure has not been established for the
H Sling System may include, but are not limited to:
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