Indications

The SmartXide Touch Laser (MonaLisa Touch Therapy) is indicated by Health Canada specifically to treat the symptoms of Genitourinary Syndrome of Menopause.

Contraindications

Therapy using the SmartXide Touch laser is contraindicated for those patients who:

• Have vaginal, cervical, or other lesions in the treatment area that have not been evaluated and diagnosed
• Have active vaginal or vulvar infection i.e., (herpes, candida, STDs)
• Pregnant or within 3 months postpartum
• Have vaginal prolapse beyond hymen
• Have history of radiation to vaginal/ colo-rectal tissue
• Have history of reconstructive pelvic surgery with “mesh kits”
• Have a history of impaired wound healing
• Have a history of keloid formation
• Known anticoagulation treatment or thromboembolic condition

NOTE: A qualified practitioner is solely responsible for evaluating each subject’s suitability to undergo laser treatment and for informing those being treated about any risks involved with the treatment, pre-and postoperative care, and any other relevant information.

Warnings and Cautions

WARNING: The SmartXide Touch Laser can cause eye injury. Never use this device without protective eyewear.

CAUTION: Use of controls, adjustments, or performance of procedures other than those specified herein may result in hazardous radiation exposure. To avoid these hazards, the precautions described in the Operator’s Manual must be observed when installing, operating, moving or servicing the system.

CAUTION: Since the Probe, Vaginal Ring, and Handpiece may become contaminated with blood, fluids or human tissue, they must be cleaned and disinfected /sterilized after every treatment.

CAUTION: Laser plume or smoke produced by the laser beam may contain live tissue. Use of a smoke evacuator is advised if plume is present.

CAUTION: Exceeding the Smart Stack recommended maximum setting increases the risk of collateral thermal injury and increases wound healing time.

Side Effects

Possible side effects may include: Spotting,  mild vaginal bleeding, pink or brown vaginal discharge, mild to profuse watery vaginal discharge, redness, swelling, inflammation, tenderness, itching, irritation, burning upon urination, pinpoint bleeding  and discomfort.