We are excited to inform you that our Mo7va Flora® SmoothSilk® Tissue Expander has
obtained 510(k) clearance from the United States Food and Drug Administration
(FDA).
This achievement marks a historic milestone for Establishment Labs by achieving, for the first time, approval
from the FDA for our implantable technology, a process that has involved high-quality studies
subjected to rigorous scrutiny.
The Mo7va Flora® SmoothSilk® Tissue Expander incorporates several patented innovations, including:
SmoothSilk® surface technology, which has been shown to produce less inflammation and skin response
foreign body compared to other implants. In addition, Flora includes a port with technology
RFID without magnets, labeled “MR Condi7onal” by the FDA. Unique in the market, which avoids
interference during magnetic resonance imaging (MRI) and may improve the accuracy of treatment of
oncological radiotherapy.
Now, this expander is available to all women in the United States, revolutionizing e
innovating the standard in breast reconstruction. Strengthening our position as leaders in the
mind of women and the health industry.
We deeply appreciate your collaboration and support on this exciting journey. Thank you for being a
integral part of this achievement!
For more details on this milestone, we invite you to consult the press release via the
following link:
Read the press release
If you have questions or comments, do not hesitate to write to us.
