Supris® Sling System

Warnings and Precautions

Indications

Supris 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 sterile packaging has been compromised 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 of the device is not compromised in any way. A device which has been damaged or on which repairs have been attempted should not be implanted.
  • Do not use Supris in patients with a urinary or vaginal infection.
  • Do not use Supris in patients who are on anticoagulation therapy.
  • The risks and benefits of using Supris 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 Supris.
  • The procedure to insert the device requires a good knowledge of local anatomy and the correct use of the Introducers in order to avoid damage to adjacent anatomical structures.
  • Good surgical practice must be complied with during Supris 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 Supris.
  • Take care to avoid vessel perforation. Observe patient for any signs of retropubic or periurethral bleeding.
  • Take care to avoid perforation of the urethra or the bladder.
  • Cystoscopy should 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 Supris 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.
  • 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.

Adverse Reactions

No undesirable effects that could be directly attributed to the polypropylene fibers have been reported in the literature. As with all foreign bodies, the Supris sling is likely to trigger 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
  • Infection
  • Bladder, bowel, urethra, vessel and nerve perforation

Patients should be monitored regularly after the device has been implanted. Coloplast is not aware of any literature reporting undesirable effects directly attributed to materials used in the Introducers.

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.