The breast implants have received approval based on findings from the Motiva IDE study. Credit: kpakook / Shutterstock.

Establishment Labs has announced the receipt of the US Food and Drug Administration (FDA) approval for its Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants.

This approval enables the use of the implants in primary and revision breast augmentation.

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The Motiva implants feature the patented SmoothSilk surface, which is designed to enhance biocompatibility and promote low inflammation.

The Ergonomix device is claimed to be the first breast implant that incorporates ergonomic science, allowing it to mimic natural breast tissue’s movement and feel.

Establishment Labs’ Motiva SmoothSilk Ergonomix implants are designed to adapt to the body’s position, maintaining a natural teardrop shape when standing and a round shape when lying down.

The Round implants are tailored to provide increased fullness and softness in the upper breast while retaining a consistent form.

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Establishment Labs founder and CEO Juan José Chacón-Quirós said: “Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals.

“We have never wavered in our commitment to women’s health and our entire organization is ready to bring this passion and technology to the US.”

The approval is supported by the results from the Motiva US investigational device exemption (IDE) study, which included 32 centres in the US and three in Western Europe.

This study reported high patient compliance and low risk rates for complications such as capsular contracture, rupture, breast pain, and infection at the three-year follow-up.

The Motiva devices became commercially available in 2010 and nearly four million of them have since been delivered to reconstructive and plastic surgeons in more than 85 countries.

In October 2023, Establishment Labs obtained approval from the FDA for tissue expander for breast reconstruction surgery.