Warnings and Precautions
The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The product is contraindicated for the following patients:
- Pregnancy or desire for future pregnancy
- Potential for further growth (e.g. adolescents)
- Urinary tract infection and/or infection in operative field
- Taking anti-coagulant therapy
- Sensitivity/allergy to polypropylene
- Abnormal urethra (e.g. fistula, diverticulum)
- Intra-operative urethral injury
- Connective tissue disorder
- Prior damage to target tissue that could compromise healing
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 have been 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.
- Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise a product characteristic which in turn creates an additional risk of physical harm to or infection of the patient.
- 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 in which repairs have been attempted should not be implanted.
- 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 Altis.
- 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 followed while using the Altis Single Incision Sling System.
- 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 Altis, and through a separate vaginal incision if possible.
- 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 bladder. (Cystocopy may be performed to confirm bladder and urethral integrity.)
- Avoid placing excessive tension on the sling implant during placement.
- Do not let the Altis sling come into contact with sharp objects which could cause damage to the device (i.e., staples, clips, or clamping on the sling).
- The patient should be informed that any future pregnancy may negate the benefits of this surgical procedure and the patient may become incontinent again.
- Standard post-operative protocols should be followed.
- Patients should be advised to avoid physical strain, sexual intercourse and heavy lifting for six weeks after surgery, but can resume other normal activities after two weeks or at the surgeon’s discretion.
- 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 post-operative management of contaminated or infected wounds.
- If infection occurs, partial or full sling removal or revision may be necessary, per physician discretion.
- If the product is removed, it should be handled and discarded as biologically hazardous.
Potential adverse reactions are those associated with surgery using implantable mesh materials. As with all foreign bodies, the Altis sling is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. There is also the risk of complete failure of the procedure resulting in incontinence and continued mild to moderate incontinence due to incomplete support or overactive bladder.
Known risks of incontinence surgical procedures with synthetic slings include the following:
- Sling migration
- Transient or permanent urinary retention/obstruction
- Urethral obstruction
- Voiding dysfunction
- Nerve injury
- Vascular injury
- Bladder, Bowel, Urethra, Vessel and/or 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.