FDA Approves Additional U.S. Sizes for Motiva Breast Implants

Establishment Labs Holdings Inc. announced that the U.S. Food and Drug Administration has approved an expanded range of Motiva breast implants for use in the United States.

Yahoo News reported that the approval covers additional sizes of Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomix breast implants. TradingView also reported that Establishment Labs received FDA approval for additional sizes of Motiva implants.

FDA approval expands Motiva range

According to Yahoo News, Establishment Labs announced FDA approval for an expanded U.S. range of its Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomix breast implants.

The announcement concerns additional implant sizes for use in the United States. The supplied reports do not identify the individual sizes included in the expanded range.

TradingView’s report similarly described the FDA action as approval for additional sizes of Motiva implants.

Company and product context

Yahoo News described Establishment Labs as a global medical technology company dedicated to women’s health and wellness, principally in breast aesthetics and reconstruction.

The products named in the company announcement are Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomix breast implants. The reported FDA approval applies to an expanded range of those products in the United States.

The supplied evidence does not provide further details on the approved sizes, product specifications, clinical information, labeling, or availability.

Reported FDA action

Yahoo News published the company announcement on October 05, 2026. TradingView also carried a report on October 05, 2026, stating that Establishment Labs received FDA approval for additional sizes of Motiva implants.

For medical-device sales professionals following breast aesthetics and reconstruction, the reported event is an FDA approval affecting the U.S. Motiva implant range. The available reports identify the products and the expanded range, while leaving the individual approved sizes unspecified.