BRAVA Breast Expansion Device Reclassified by FDA
FDA asks for Investigational Device Exemption for BRAVA Studies
The FDA, in a surprising move, has re-classified the BRAVA breast expansion device into a higher risk category for the ongoing BRAVA clinical trials. We want to assure our patients (those who are currently using the device, have used it in the past, or who contemplate future use) that we are not aware of any evidence of any safety issues regarding the use of the device, and there is no reason to discontinue or postpone its use.
In order to continue the studies with FDA approval, Brava submitted an IDE (Investigational Device Exemption) application to the FDA on March 28, 2013. In the meantime, any studies involving BRAVA have been temporarily curtailed until the FDA approves the exemption (probably 1-3 months).
We have recommended the use of the BRAVA device for several years, but did not enroll patients in the clinical study. We have been impressed with the ability of the device to expand the breast tissue, allowing us to place larger volumes of fat; and studies suggest that the use of the BRAVA device post-surgery enhances graft survival.
Dr. Roger Khouri, Principal Investigator in the study, has discussed this issue at length. He recently announced the following:
“Brava as a stand-alone device to enlarge the breast without surgery has a well established safety record. It has been used by tens-of-thousands of women for over the past 10 years with no significant complications whatsoever…… The American Society of Plastic Surgeons, the most important plastic surgery society condones Brava + Fat grafting. The Society just promoted it with a large teaching course with live surgery out of the Miami Breast Center operating room…… Over the past 8 years several hundred women were enrolled in this IRB study sponsored by Brava. Results show that fat grafting after Brava expansion allows us to successfully graft much more fat and achieve much better augmentation and breast reconstruction results than if Brava was not used. Most importantly, there were essentially no complications. Certainly less than the implant and flap alternatives.”
Should you have any additional concerns, please feel free to contact our office by asking questions on this blog site or one of the following:
For more information on BRAVA, please look at the following links:
BREAST AUGMENTATION WITH BRAVA AND COLEMAN FAT GRAFTING
Patient Testifies how Coleman Fat Grafting Combined with BRAVA changed her life.
DR. SYDNEY COLEMAN OF NEW YORK CITY COMBINES THE BRAVA SYSTEM WITH BREAST LIPOSTRUCTURE