Does Anyone Know Why AFT with Brava Has Lost Its FDA Approval?
Doctor Answers 1
The FDA has not recalled the Brava device
The FDA has not recalled the Brava device. The FDA has asked Brava to stop enrollment into Clinical Protocol 2004-03, the current IRB study, until they can review the protocol that is in place. This is a safety study that has been going on for a number of years with several hundred patients enrolled and no significant complications.
There have not been any new complications or reports of any problem to prompt this FDA position.
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.
However, to our surprise, and for reasons that we were unable to understand and that made no sense to us and to many experts, the FDA suddenly decided that when used in preparation for fat grafting, that very same Brava device should now be classified in the same category as life sustaining implantable heart and brain devices.
When placed into this high-risk category of devices, Brava needs an Investigational Device Exemption (IDE) filed and approved before starting a clinical study (or resuming the current one with possible modifications).
BRAVA filed an application for an Investigational Device Exemption (IDE) at the end of March and the FDA should answer within 30 days of this filing.
It is important to note that the FDA controls the sale of medical devices. The FDA does not regulate the practice of medicine. Medical societies regulate the practice of medicine.
Physicians often use in their practice devices for indications other than the ones specifically approved by the FDA. This is called off label use. (For example, Botox was FDA approved for the treatment of muscle spasm but it was used off label for many years for the treatment of wrinkles until the FDA finally approved that new application.)
This off label use and the practice of Medicine is regulated by medical societies. 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. The Society has organized many courses where Dr. Khouri is invited to teach it and promote it as a major advance in the care of our patients.
Dr. Khouri and a few other surgeons across the world have used the very same Brava device that was approved for sale by the FDA as an off label indication to prepare the breast for fat grafting. Initially, before we really knew the full benefits and the potential risks, all patients were enrolled in a clinical study approved by an Institutional Review Board (IRB), an independent ethics committee that reviews any research work involving human subjects and gives its stamp of approval.
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.
Brava was asked by the FDA to stop the current IRB study until they can review the study’s protocol. Therefore, last week, Brava issued a letter to the 150+ plastic surgeons enrolled in the study, requesting that they temporarily suspend enrollment.
Plastic surgeons like Dr. Khouri who after years of using Brava on hundreds of patients are convinced of its safety and efficacy have decided to continue offering it to their patients as an off label use. They consider fat grafting after Brava preparation is no longer experimental and therefore now offer it as part of their regular practice. No need for the IRB anymore.
Since their patients can no longer get the Brava devices from the company as patients in the IRB study, they now have to obtain the devices as women seeking simple non-surgical augmentation. Their plastic surgeon will then elect to treat them with or without the Brava device.
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