Brava breast reconstruction study stopped taking new patients

What do you mean the FDA "irrationally" closed the study to new patients?  Do you mean as part of the approved investigation plan submitted to the FDA, the total number of patients allowed for that stage of the study was reached and the enrollment stopped while the data was analysed and submitted for review?  Or was there such big problems with complications that the FDA stopped the study to avoid putting additional study subjects at risk?

If it is the first scenario, then additional test subjects will be enrolled as the study goes on to its next stage or the device will be approved and openly marketed.  If the second scenario is the case, the device will never be legally available for use.

In any case, you can not get the device.  Your surgeon may be willing to try and get the device for use outside the study, but I doubt he will find it easy to obtain one.

And no, there is no such thing as compassionate use of the device for you.  The IDE regulations have no provision for such use and you don't qualify for an "emergency" use  (basically defined as a last ditch effort to save a patient's life although it has been stretched by the Agency to include saving the function of an organ. It has never included anything cosmetic, which as much as we may yell and scream, is what breast reconsruction is).  In any case, such a use would still need to be submitted to the FDA and approved by the Agency.

macb,

Sorry to hear about your frustrating situation.  To finally find a method that would work for you and then hit this brick wall!  Ugh!  In many ways it seems uneccesary to do the study as there is a lot of supporting evidence through the study Brava did, but I guess in the long run it's a good idea to have an independent study done.  Hopefully, will open the way for many more women to do this option! 

Looks like you should be able to get this from Brava for simple augmentation and then your MD can decide to use it as an off label indication.

 Here is a statement by Dr. Khouri about the recent situation:

"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."

Roger Khouri, MD

from fatgraftpatients.com (discussion section)

Hope this helps!
Wishing you all the best!

Fair enough. However, if someone is interested in this procedure, how do you find out what the current status is of the FDA review process?

Does anyone know the status of having the Brava approved for reconstruction so insurance will cover the cost?