Warnings and Precautions
Aris is an implantable, sub-urethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Warnings and Precautions
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.
- Do not use product that has damaged or opened packaging, as sterility may be compromised.
- This device is sold sterile for single use only, and should never be resterilized. In the event the product becomes contaminated prior to use, the device should be returned to Coloplast for replacement.
- Each device should be carefully examined prior to surgery and continuously monitored throughout the surgical procedure to ensure the structural integrity and sterility of the device has not been compromised in any way. A device which has been damaged or on which repairs have been attempted should not be implanted.
- Do not use Aris in patients with a urinary or vaginal infection.
- Do not use Aris in patients who are on anticoagulation therapy.
- The risks and benefits of using Aris in patients with compromised immune systems or any other conditions that affect healing should be carefully considered.
- This product should only be used by surgeons who are qualified to perform this type of surgery and who are familiar with the use of non-absorbable mesh and the specific insertion technique for Aris.
- The procedure to insert the device requires a good knowledge of local anatomy and the correct use of the Introducer Needles in order to avoid damage to adjacent anatomical structures.
- Good surgical practice must be complied with during Aris insertion.
- Special care should be taken in cases of bladder prolapse because of anatomical deformation. If the patient requires a cystocele repair, it should be completed prior to using Aris.
- Take care to avoid vessel perforation. Observe patient for any signs or retropubic or periurethral bleeding.
- Take care to avoid perforation of the urethra or the bladder.
- Cystoscopy can be performed to confirm bladder integrity or to recognize bladder perforation.
- Check that the sling has been positioned tension free under the mid-urethra.
- Do not let the Aris sling come into contact with sharp objects which could cause damage to the device (i.e., staples, clips or clamps).
- The patient should be informed that any future pregnancy will negate the benefits of this surgical procedure and the patient is likely to become incontinent again.
- Standard post-operative protocols should be followed.
- Patients should be advised to avoid physical strain, sexual intercourse and heavy lifting for one month, but can resume other normal activities after two weeks.
- Patients should be instructed to see their surgeon immediately to report any onset of bleeding, pain dysuria or sign of infection that occurs at any time.
- Proper surgical practice should be followed for management of contaminated or infected wounds.
- If infection occurs, a portion or the entire mesh may have to be removed or revised.
- If the product is removed, it should be handled and discarded as biologically hazardous.
No undesirable effects that could be directly attributed to the polypropylene fibers have been reported in the literature. As with all foreign bodies, the Aris sling is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, and inflammation or fistula formation. The following complications are known to occur with synthetic slings:
- Vaginal Erosion
- Urethral Erosion
- Bladder, Bowel, Urethra, Vessel and Nerve perforation
Patients should be monitored regularly after the device has been implanted. No undesirable effects directly attributed to materials used in the Introducer Needles have been reported in the literature.
Known risks of incontinence surgical procedures include the following: extrusion, erosion, infection, sling migration, pain, transient or permanent retention, and complete failure of the procedure resulting in incontinence and continued mild to moderate incontinence due to incomplete support or overactive bladder.