The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering,
and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used
with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to
be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™
System is intended for use in the following surgical specialties when the aspiration of soft tissue is
desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological
surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic
IMPORTANT SAFETY INFORMATION
Contraindications to autologous fat transfer include the presence of any disease processes that adversely
affect wound healing, and poor overall health status of the individual.
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient
in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission
of communicable diseases. Do not use the product if sterile packaging is damaged.
This device will not, in and of itself, produce significant weight reduction. This device should be used
with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory
system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect
intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate,
timely replacement is essential for patient safety.
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently
transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means
of formal professional training or sanctioned continuing medical education (including supervised operative
experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure
will vary depending upon patient age, surgical site, and experience of the physician. Results of this
procedure may or may not be permanent. The amount of fat removed should be limited to that necessary
to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume
line can lead to occlusion of the mesh resulting in mesh tear.
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction
of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with
REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response,
allergic reaction, and inflammation.
REVOLVE™ System is available by prescription only.
For more information, please see the
Instructions for Use (IFU) and
User Manual for REVOLVE™ System.
To report an adverse reaction, please call Allergan at 1.800.367.5737.