Establishment Labs Holdings Inc., a global medical technology company focused on women's health, has submitted its Motiva® implants to the U.S. Food and Drug Administration (FDA) for approval in primary and revision breast reconstruction. The Motiva implants were previously approved by the FDA for breast augmentation on September 27, 2024. This regulatory submission aims to expand the availability of Motiva implants for women undergoing breast reconstruction after mastectomy, offering advanced technology that has already seen rapid adoption in augmentation procedures. The company’s Motiva Flora® tissue expander, already cleared in the U.S., is in use at over 200 cancer centers and is notable for its MRI-conditional integrated port technology.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Establishment Labs Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251229658937) on December 29, 2025, and is solely responsible for the information contained therein.