Establishment Labs Holdings, a global medical technology company focused on women’s health and breast aesthetics, has announced that it has submitted its Motiva implants for FDA approval in primary and revision breast reconstruction. 

 

The implants were previously approved for breast augmentation in September 2024.

 

“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” said Jeff Ehrhardt, Senior Vice President and General Manager of North America. 

 

“Breast reconstruction has seen little innovation for more than a decade, despite these patients often needing improved and more advanced technology. This milestone brings us closer to offering the benefits of Motiva to women after mastectomy, providing the same proven technology that has seen rapid adoption in breast augmentation.”

 

The FDA submission is backed by data from the Motiva US IDE Study, conducted at 17 US centers and one Western European center, involving 274 post-mastectomy reconstruction patients—220 primary and 54 revision cases.

 

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation.

 

“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” said Mark Clemens, Professor of Plastic Surgery at MD Anderson Cancer Center. 

 

“While surgical techniques have advanced significantly, innovation in reconstructive devices has been more gradual, making technologies that address real clinical limitations especially important. 

 

"In my experience, the ability to safely image patients with MRI during the expansion process and to improve precision during radiation planning has made MRI-conditional tissue expanders, like Motiva Flora, a valuable addition to reconstructive care. 

 

"The availability of a reconstruction indication for Motiva implants expands our options further, allowing surgeons to thoughtfully incorporate device characteristics such as unique surface design and clinical performance data into individualized reconstructive planning.”