(all info received from Dr. Roger K. Khouri)
The status of the FDA and BRAVA - UPDATED* (as of June 11, 2013)
- The only Brava clinical study approved by the FDA just reached the maximum allowed number of enrollees and closed last week.
- The hope is that there will be another one later this summer, but not sure yet when it will start. This will be a controlled study, which means after a patient is enrolled, she will be randomly assigned to either Brava + Fat Graft or Fat Graft without Brava.
- While we are quite confident that Brava is necessary, many surgeons are still not convinced and are offering fat grafting without Brava. So the only way to prove the benefit of Brava is to have the same surgeon do the procedure with and without Brava and then compare the results. Women enrolled in this study "might" be able to get their Brava device covered by Medicare if they have Medicare as their insurance. Not sure private ensurers will cover the Brava as part of the clinical study. However, once the study is complete and we prove the need for Brava it will be covered by all insurances."
The status of the FDA and BRAVA - UPDATED* (as of May 13, 2013)
"It is important to clarify that 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 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 everybody’s surprise, and for unknown reasons, the FDA suddenly decided that when used in preparation for fat grafting, that very same Brava device should now be classified in the same high risk category as life sustaining implantable heart and brain devices. This certainly made no sense to anybody, but the FDA’s decision cannot be put into question.
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). The FDA had time to review the data and recently concurred that if used as we are now, Brava poses no significant risk. They therefore allowed the IRB study to continue but asked Brava to limit enrollment to only 5 centers and 60 more patients.
The FDA therefore no longer questions the safety of Brava when used in preparation for fat grafting. But they asked Brava to design a study that will prove efficacy. A study that will require a few centers to enroll patients in a randomized study where half would be grafted after Brava expansion and half the patients would be grafted without Brava. This is the only kind of study that will prove to the FDA that Brava truly has a significant beneficial effect.
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. Nonetheless, the FDA is not accepting this data because it is not derived from a prospective randomized study where half the patients of a particular surgeon are randomly assigned to having Brava and half assigned to no Brava.
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.
However, in the near future, a small group of select surgeons will need to enroll patients into a prospective randomized +/- Brava study that will be monitored by the FDA. It is not until the results of this study are out and reviewed by the FDA that Brava will become approved . On a positive note, when that happens, Brava will be reimbursable by Medicare and most insurance companies.
Till then, only a few patients from a few doctors will be able to get Brava from the company as patients in the IRB study. The others will have to obtain the devices as women seeking simple non-surgical augmentation as it is currently approved by the FDA. It is their plastic surgeon’s decision to then have them use Brava as an off label indication.
- 1. There was no recall of Brava by the FDA.
2. FDA has now just reviewed the current study data and determined there was no significant risk.
3. FDA wants to limit the current study to only 5 doctors and 50 more patients… They want this to be over so we can start the next study.
4. In the meantime all other fat graft patients will have to get the regular Brava and then use it as they wish, but Brava is no longer allowed to be involved and to support them.
5. FDA wants to closely monitor a new prospective randomized study of patients who will be assigned on a random basis to have fat grafting with or without Brava and then compare results a few months later to confirm that the ones on Brava did better…
6. It is only after they review such a study that the FDA will approve Brava for fat grafting. Good news is that once they do this, Brava will be covered by Medicare & all insurance companies. There will be no question that Brava is necessary for successful grafting large volumes to the breast.
Roger Khouri, MD"