I am part of the IRB trial for BRAVA use for breast augmentation and reconstruction using fat graft and transfer.
I received a letter recently stating BRAVA was “told effective immediately no new patients can be enrolled in this clinical study. Patients who have already begun the BRAVA use can continue in the study per the informed consent and clinical protocol.” They expect it will be 1-3 months before patient enrollement in to the study may resume.
I didn’t like hearing this news. Tissue expansion and stretch is important to be able to transfer fat to the breast. Without it, fat transfer to the breast may not be as successful.
I spoke with someone at BRAVA. The traditional BRAVA domes (to use with the sportbox only to give nonsurgical breast enlargement) are still for sale. What is not being sold right now is the pre surgery tubing and pump kit, which includes a hand held pump to help stretch the skin. The details as to why the FDA has put them on a hold are murky. The study has been ongoing for a while, with over 600 patients and very few complications.
Odd to see this restriction on BRAVA, as our society (the ASPS) just released a guideline statement on fat transfer and graft for breast cancer reconstruction in which they allow fat transfer as a reconstructive option- it gives aesthetic improvement, possible relief of pain syndrome, and has low complication and risk.
Hopefully this blip in waiting for BRAVA will be short.