Safety

The Cellfina® System is CE Mark-certified for long-term reduction of cellulite, up to three years, by precise release of targeted structural tissue (fibrous septae). The Cellfina® System is FDA-cleared for long-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to three years of observation. Safety and effectiveness in other anatomical areas have not been established. The most common side effects reported were soreness, tenderness, and bruising. The Cellfina® System is only available through a licensed physician. For full product and safety information, refer to the Instructions for Use.

Contraindications

The Cellfina® System should not be used on patients who have (or who are):

 

  • Coagulant disorders
  • Diabetic
  • Excessive obesity
  • Had recent surgery (6 weeks)
  • On anticoagulant medications
  • Phlebitis and vasculitis
  • Pregnant
  • Skin infections/ open lesions
  • Uncontrolled hypertension
  • Tumors
  • Vascular fragility
  • Varicose veins (in the area of treatment)

Potential Side Effects

 

Potential adverse events are those typically associated with anesthesia infiltration, liposuction, subsurface tissue cutting, and other methods of body sculpting including:

 

  • Abscess
  • Anetoderma
  • Anxiety (nervousness, apprehension)
  • Blanching (generalized whiteness)
  • Blurred or double vision
  • Bleeding
  • Dizziness, drowsiness, confusion
  • Ecchymosis/bruising
  • Fluid accumulation (swelling, edema)
  • Fluid extravasation
  • Hematoma
  • Hemosiderosis
  • Hyperpigmentation
  • Hypopigmentation
  • Induration, fibrosis
  • Infection
  • Inflammation / generalized redness
  • Nausea/vomiting
  • Numbness, tingling, or sensitivity change
  • Petechiae or purpura (vacuum acquisition marks)
  • Red Spots (from needle punctures)
  • Redness, erythema, or rash
  • Scarring or keloid formation
  • Sensations of heat or cold
  • Seroma
  • Skin necrosis
  • Skin surface convexity, depression or other irregularity
  • Soreness or discomfort - pain
  • Tinnitus
  • Toxic, allergic, or other reaction from the injected anesthetic