Contraindications - Bard Ajust Helical Gebrauchsanweisung

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CAUTiOn
Federal (USA) law restricts this device to sale by or on the order of a physician. This product is intended for use only by
physicians trained in the surgical procedures and techniques required for the treatment of female stress urinary incontinence
and the implantation of nonabsorbable meshes. The physician is advised to consult the medical literature regarding
techniques, complications, and hazards associated with the intended procedures.
DEViCE DEsCRiPTiOn
The A H Adjustable Single-Incision Sling System is a minimally invasive suburethral sling intended for the
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treatment of female stress urinary incontinence. The system consists of an adjustable polypropylene mesh sling with
permanent, self-fixating, polypropylene anchors, introducers and a flexible stylet for advancing the sling lock after adjustment.
The device is terminally sterilized by ethylene oxide. Refer to Figure 1 below for a detailed depiction of the A
System components.
COnTEnTs
inDiCATiOns FOR UsE
The A H
Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting
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from urethral hypermobility and/or intrinsic sphincter deficiency.

COnTRAinDiCATiOns

The A H Sling System is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary
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tract infection, anticoagulant therapy, and/or infection in the operative field.
WARnings
The implant procedure and the instrumentation associated with the surgical placement of the A
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carry an inherent risk of infection and bleeding, as do similar urological procedures. The use of surgical staples, clips,
screws, or other non-suture attachment mechanisms not supplied with the A
implant.
• After use, the product and its packaging should be treated as a potential biohazard. Handle and dispose of in accordance
with accepted medical practice and applicable local, state, and federal laws and regulations.
PRECAUTiOns
The usual precautions associated with urological procedures should be followed:
• An experienced and trained physician must determine – based on a thorough preoperative assessment – whether the
patient and the underlying condition is suitable for the implant procedure. Additional consideration should be given to use
of the implant in patients with a compromised immune system, any condition that would compromise healing, or any
patient with a history of prior abdominal or pelvic surgeries. Consideration should also be given to the ability of the patient
to tolerate the surgical procedure.
• Accepted surgical practice and precautions must be followed for the management of contaminated or infected wound
sites, when the A
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• Postoperative bleeding may occur in some patients and must be controlled prior to patient release.
• The implant procedure requires diligent attention to anatomical structures and diligent care to avoid injury of large
vessels, nerves, bladder, bowel, urethra and any viscera during introducer passage.
• Anatomical distortion can result from pelvic organ prolapse. If the patient requires cystocele repair, it should be
performed prior to the implantation of the suburethral sling.
• Proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the
urethra.
The A H
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Sling System. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity
and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury,
illness or death of the patient.
ADJUSTABLE SINGLE-INCISION SLING
Instructions For Use
Figure 1: Detailed Depiction of the A
H Sling System is used.
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Sling System is intended as a single-use device. Do not resterilize any portion of the A
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Sling System components
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For patient's left side
For patient's right side
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