SAFETY INFORMATION SEE LESS -
REVOLVETM and REVOLVE ENVITM 600 ADVANCED ADIPOSE SYSTEM
CONSUMER INDICATIONS AND IMPORTANT SAFETY INFORMATION
How is REVOLVETM System or REVOLVE ENVITM 600 System used?
The REVOLVETM Advanced Adipose System (REVOLVETM System) and REVOLVE ENVITM 600 Advanced Adipose System (REVOLVE ENVITM 600 System) are used for aspiration, harvesting, filtering, and transferring of fat for aesthetic body shaping. The REVOLVETM System and REVOLVE ENVITM 600 System are intended for use in the following surgeries when drawing fat is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, bone or muscle surgery, gynecological surgery, thoracic surgery, and minimally invasive surgery.
IMPORTANT SAFETY INFORMATION
When should REVOLVETM System or REVOLVE ENVITM 600 System NOT be used?
The device should not be used by your physician if you currently have any disease that adversely affects wound healing, and poor overall health status.
What should I discuss with my doctor before my procedure?
The device will not, in and of itself, produce significant weight reduction. The device should be used by your physician with extreme caution if you have a chronic medical condition such as diabetes, heart, lung, or circulatory system disease, or obesity.
What else should I know?
The device is designed to remove localized deposits of excess fat through a small incision and subsequently transfer the tissue back to you. Use of the device is limited to those physicians who have the appropriate level of medical education and surgical experience in the appropriate surgical procedures. Results of the procedure will vary depending upon your age, surgical site, and experience of your physician. Results of the procedure may or may not be permanent.
What are possible side effects of the procedure?
Some common adverse effects associated with use of the REVOLVETM System or REVOLVE ENVITM 600 System and/or autologous fat transfer procedures are unevenness, over- and/or under-correction, tissue lumps, bleeding, scarring, fat cell death, formation of cysts, chronic immune system response, allergic reaction, infection and inflammation of various levels.
This information is not intended to replace a discussion with your surgeon and does not describe all the potential risks associated with fat transfer procedures. Please consult with your surgeon to determine if the use of REVOLVETM System is right for you.
REVOLVETM System and REVOLVE ENVITM 600 System are for use only by a licensed physician.
For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVETM System available at www.allergan.com/RevolveIFU and Instructions for Use (IFU) for REVOLVE ENVITM 600 System at www.allergan.com/RevolveENVI-IFU or call 1.800.678.1605.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
SAFETY INFORMATION
REVOLVETM and REVOLVE ENVITM 600 ADVANCED ADIPOSE SYSTEM
CONSUMER INDICATIONS AND IMPORTANT SAFETY INFORMATION
How is REVOLVETM System or REVOLVE ENVITM 600 System used?
The REVOLVETM Advanced Adipose System (REVOLVETM System) and REVOLVE ENVITM 600 Advanced Adipose System (REVOLVE ENVITM 600 System) are used for aspiration, harvesting, filtering, and transferring of fat for aesthetic body shaping. The REVOLVETM System and REVOLVE ENVITM 600 System are intended for use in the following surgeries when drawing fat is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, bone or muscle surgery, gynecological surgery, thoracic surgery, and minimally invasive surgery.
IMPORTANT SAFETY INFORMATION
When should REVOLVETM System or REVOLVE ENVITM 600 System NOT be used?
The device should not be used by your physician if you currently have any disease that adversely affects wound healing, and poor overall health status.
What should I discuss with my doctor before my procedure?
The device will not, in and of itself, produce significant weight reduction. The device should be used by your physician with extreme caution if you have a chronic medical condition such as diabetes, heart, lung, or circulatory system disease, or obesity.
What else should I know?
The device is designed to remove localized deposits of excess fat through a small incision and subsequently transfer the tissue back to you. Use of the device is limited to those physicians who have the appropriate level of medical education and surgical experience in the appropriate surgical procedures. Results of the procedure will vary depending upon your age, surgical site, and experience of your physician. Results of the procedure may or may not be permanent.
What are possible side effects of the procedure?
Some common adverse effects associated with use of the REVOLVETM System or REVOLVE ENVITM 600 System and/or autologous fat transfer procedures are unevenness, over- and/or under-correction, tissue lumps, bleeding, scarring, fat cell death, formation of cysts, chronic immune system response, allergic reaction, infection and inflammation of various levels.
This information is not intended to replace a discussion with your surgeon and does not describe all the potential risks associated with fat transfer procedures. Please consult with your surgeon to determine if the use of REVOLVETM System is right for you.
REVOLVETM System and REVOLVE ENVITM 600 System are for use only by a licensed physician.
For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVETM System available at www.allergan.com/RevolveIFU and Instructions for Use (IFU) for REVOLVE ENVITM 600 System at www.allergan.com/RevolveENVI-IFU or call 1.800.678.1605.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
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