Establishment Labs, primarily focused on breast aesthetics and reconstruction, has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for its Motiva Flora SmoothSilk Tissue Expander.

Establishment Labs is a global medical technology company that works to improve the health and wellness of women.

The firm has designed the Motiva Flora tissue expander to enhance the outcomes in breast reconstruction following breast cancer.

The Flora SmoothSilk Tissue Expander is said to have several proprietary innovations, including the company’s patented SmoothSilk surface technology.

Compared to other implant surfaces, SmoothSilk has been demonstrated to cause the least degree of irritation and a foreign body reaction, Establishment Labs claimed.

The device also includes an RFID-enabled, non-magnetic port, designated as MR Conditional by the FDA.

According to the medical technology firm, Flora’s magnet-free nature prevents the interference that magnets might produce during MRI, which could increase the accuracy of radiation oncology treatment.

All other commercially marketed breast tissue expanders are said to have magnets.

Establishment Labs founder and CEO Juan José Chacón-Quirós said: “This is an incredibly important day in the history of Establishment Labs, as the first of our implantable technologies has been approved by the FDA.

“Our SmoothSilk surface will now be available to women in the US, and this technology is transformative for our industry and patient outcomes.

“Tissue expanders have seen little innovation for more than a generation, and, in partnership with breast cancer centres, Establishment Labs is creating a new standard of care in breast reconstruction.”

The device has been available in Europe and other global markets since 2021 and has been assessed in multiple independent scientific publications.

In a blinded head-to-head study, a patient’s breast treated with Flora reported significantly higher aesthetic and comfort scores, along with less breast pain, discomfort, and nipple sensitivity compared to other available tissue expanders on the other breast.

In the first-in-human multi-centre trial of patients undergoing 3-Tesla MRI, Establishment Labs’ device did not affect the image quality of the key part of the breast MRI protocol and there were no MRI-associated complications or damage to the expander port.