---
schema_version: "secwatch.filing_event.v1"
accession: "0001688757-24-000084"
form_type: "8-K"
ticker: "ESTA"
cik: "0001688757"
company_name: "ESTABLISHMENT LABS HOLDINGS INC."
filed_at: "2024-09-26T23:59:59+00:00"
generated_at: "2026-05-31T01:35:45.092214+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA approves Motiva SmoothSilk implants for breast augmentation; first new PMA since 2013

## Summary
- FDA approval for Motiva SmoothSilk Ergonomix and Round implants in primary and revision breast augmentation.
- Three-year clinical trial data: capsular contracture 0.5%, rupture 0.6%, infection 0.9% in primary augmentation cohort.
- First new breast implant PMA approved by FDA since 2013; nearly 4 million Motiva devices already delivered in 85+ countries.
- CEO Juan José Chacón-Quirós calls approval transformative for U.S. breast aesthetics, citing differentiated technology.
- Study conducted at 32 U.S. and 3 European centers; patient compliance at 92.4% at 3-year endpoint.

## SEC filing metadata
- accession: 0001688757-24-000084
- form_type: 8-K
- ticker: ESTA
- cik: 0001688757
- company_name: ESTABLISHMENT LABS HOLDINGS INC.
- filed_at: 2024-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1688757/000168875724000084/0001688757-24-000084-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1688757/000168875724000084/esta-20240926.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001688757-24-000084
- JSON: https://secwatch.observer/filing/0001688757-24-000084.json
- Plain text: https://secwatch.observer/filing/0001688757-24-000084.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.