The Brava AFT System is a medical device that is used as an adjunct in autologous fat grafting to the breast and is intended to be used under the supervision of a doctor. In the U.S., the Brava AFT System is currently available for investigational use only. The Brava AFT System is CE marked and has received approval for sale by regulatory authorities in Europe, Canada, Taiwan, Australia, Singapore and Argentina.

Autologous fat transfer for breast reconstruction and augmentation is a medical procedure now available to women. It involves the harvesting, minimal manipulation and re-injecting of an individual's own fat tissue to reconstruct or augment the breast. The procedure is usually outpatient and minimally invasive. The Brava AFT System is indicated for daily use to expand the breast before and after autologous fat grafting. The device is worn a few weeks before and after the medical procedure. It is worn pre-procedure to prepare the graft site to expand the tissue planes and perfuse the area. It is worn after the procedure to splint the grafted tissue and protect it from inadvertent contact.

Contraindications:

The Brava AFT System should not be used by:

• Women with a history of silicone allergies
• Women with untreated breast cancer
• Smokers
• Women that are pregnant and breast feeding

Adverse Reactions to the Brava AFT System:

• Bruising
• Skin Irritation
• Itching
• Excessive Sweating
• Blistering
• Temporary Increase in the sensitivity of Nipples
• Hyperpigmentation
• Costochondritis
• Painful Rib swelling
• Lactation

Please consult your physician for information the fat transfer procedure or Brava at 305-856-4242 for additional information.