Talk to Me AFT Dr's What Going on with Brava and Fat Grafting? Where Do You Stand. Are You Pausing?
Doctor Answers (2)
BRAVA on pause
I am of the strong opinion that BRAVA for breast reconstruction is not for every situation not every patient. In the right patient, it is a wonderful option with excellent, healthy fat after grafting. Unfortunately the FDA has essentially placed a hold on any further enrollment in the IRB so at this time I am only treating patients already enrolled in the IRB.
Brava Bra & AFT: With Innovation Comes Controversy
Having followed the Brava Bra develoopment for some time, there is no question that this is an important innovation in Plastic Surgery. I have participated in the IRB and delivered outstanding results with the device. I believe that AFT to the breast should be done with Brava as part of an IRB. This is the most ethical and safest way to move this innovation forward. Unfortunately the FDA has stopped the IRB in their infinite wisdom. This decision was probably some what capricious. It will be difficult for the average doctor outside some of the thought leaders in the field to continue to offer this procedure. The medico-legal risk will be too high. If patients want to do something, a grass roots appeal to the FDA in favor of Brava with AFT would be helpful. There is no question that cosmetic and difficult reconstructive breast surgery patients have been helped by this innovation. Thank you for your question. Alll the best.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.
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