Safety Information

The Ulthera® System is intended for lifting and sculpting of skin by way of the deposition of micr-focused ultrasound energy at depths between 1.5mm and 4.5mm beneath the skin resulting in stimulation of new collagen and elastin as part of the healing process. Also intended for the treatment of Auxillary Hyperhidrosis by targeting the depth at which sweat glands reside. Coagulation takes place in tissue located at the dermal hypo dermal interface using a surface contact applicator.³

The Ulthera System, in conjunction with the Ulthera DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to ensure proper coupling of the transducer to the skin and confirm appropriate depth of treatment such as to avoid bone. Consult with a practitioner to discuss if Ultherapy is right for you.

Reference 3. Ulthera Public ARTG Summary ARTG ID 225194

Contraindications

The Ulthera® System is contraindicated for use in patients with open wounds or lesions in the treatment area, severe or cystic acne in the treatment area, and active implants (e.g., pacemakers or defibrillators) in the treatment area.²

Reference 2: Instructions for Use

Precautions

During the treatment, ultrasound energy will be delivered using the Ulthera® System. Depending on where you are treated, the procedure can last anywhere from 30 minutes to 2 hours. Some patients see an immediate result, but you should expect to see results appear over 2-3 months or even up to 6 months post-treatment.

 

  • The Ulthera System has not been evaluated for use over various materials. Therefore, treatment is not recommended directly over those areas with mechanical implants, dermal fillers, or breast implants. Treatment energy is not recommended for use directly on an existing keloid. The Ulthera System has not been evaluated for use in patients on an anticoagulant treatment plan.
  • It is recommended that the following areas be avoided during treatment: thyroid gland, thyroid cartilage, and trachea; major vessels; breast tissue or breast implants.²
  • The Ulthera System has not been evaluated for use in the following patient populations:
    • Pregnant or breast feeding women
    • Children
    • Those with the following disease states
      • A hemorrhagic disorder or hemostatic dysfunction
      • An active systemic or local skin disease that may alter wound healing
      • Herpes Simplex
      • Autoimmune Disease
      • Diabetes
      • Epilepsy
      • Bell’s Palsy

Reference 2: Instructions for Use

Potential Side Effects4

Side effects reported in the clinical evaluation of the Ulthera System for the brow, submental (under the chin) area and neck treatment(s) were mild and transient in nature. These were limited to:

  • Erythema (redness): The treated area may exhibit erythema immediately following treatment. This typically resolves within a few hours of treatment.
  • Edema (swelling): The treated area may exhibit mild edema following treatment. This typically resolves within 3 to 72 hours of treatment.
  • Pain: Momentary discomfort may be experienced during the procedure while energy is being deposited. Post procedure discomfort typically resolves within 2 hours and 2 day. Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.
  • Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within 2 days to 2 weeks of treatment.
  • Nerve Effects
    • Transient local muscle weakness may result after treatment due to inflammation of a motor nerve. This typically resolves in 2 to 6 weeks of treatment.
    • Transient numbness may result after treatment due to inflammation of a sensory nerve. This typically resolves in 2 to 6 weeks of treatment.
    • Transient pain, paresthesia and/or tingling may be experienced. This typically resolves in 2 to 6 weeks of treatment.
    • No permanent injuries to facial nerves have been reported.
  • Scarring: The possibility for scar formation (which may respond to medical care) may exist if incorrect treatment technique is used.

Side effects reported in the clinical evaluation of the Ulthera System for the décolleté treatment were mild and transient in nature. These were limited to:

  • Erythema (redness): The treated area may exhibit erythema immediately following treatment. This typically resolves within a few hours of treatment.
  • Edema (swelling): The treated area may exhibit mild edema following treatment. This typically resolves within 3 to 48 hours of treatment.
  • Pain: Momentary discomfort may be experienced during the procedure while energy is being deposited. Post procedure discomfort typically resolves within 2 hours and 2 day.
  • Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.
  • Raised area of edema: The treated area may exhibit a localized area of linear visible edema following treatment. This typically resolves within 1 day to 3 weeks of treatment.
  • Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within 3 days and 3 weeks of treatment.
  • Transient Sensory Nerve Effects (as a result of inflammation of the nerve):
    • Paresthesia and/or numbness may be experienced and typically resolves within 4 days to 5 weeks of treatment.
    • Tingling may result after treatment and typically resolves within 3 to 5 days of treatment.
    • Itching may result after treatment and typically resolves within 1 to 3 weeks of treatment.
    • No permanent nerve injuries have been reported.
  • Scarring: The possibility for scar formation (which may respond to medical care) may exist if incorrect treatment technique is used.

Reference 4. US IFU

Complaints and Adverse Events

No serious adverse events were observed during the clinical study evaluation of the Ulthera System.

Ulthera follows the TGA (Therapeutic Goods Administration) rules for handling complaints and adverse events. Should an adverse event be suspected or reported, contact Merz Australia or your local Merz representative.

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