The company is seeking approval in primary and revision breast reconstruction, aiming to expand its indication following a multicenter IDE study in post-mastectomy patients.
Establishment Labs Holdings Inc announced that it has submitted Motiva implants for approval in primary and revision breast reconstruction to the US Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on Sept 27, 2024.
“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” says Jeff Ehrhardt, senior vice president and Establishment Labs’ general manager of North America, in a release. “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 Motiva US IDE study was conducted at 17 centers in the US and one center in Western Europe and included 274 post-mastectomy reconstruction patients, including 220 primary and 54 revision patients. Motiva SmoothSilk Round and Ergonomix implants feature the patented SmoothSilk surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation.
The Motiva SmoothSilk Ergonomix device is designed to adapt, react, feel, and move like natural breast tissue. Their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva SmoothSilk Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position. Since approval for breast augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.
“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” says Mark Clemens, MD, MBA, FACS, and professor of plastic surgery at The University of Texas MD Anderson Cancer Center, in a release. “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.”
The Motiva Flora tissue expander was cleared for use in the United States in 2023 and is in use at over 200 cancer centers for breast reconstruction following breast cancer. Flora has an integrated port using radio-frequency technology that is MRI conditional.
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