---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-047762"
form_type: "8-K"
ticker: "ESTA"
cik: "0001688757"
company_name: "ESTABLISHMENT LABS HOLDINGS INC."
filed_at: "2023-04-20T23:59:59+00:00"
generated_at: "2026-06-16T22:35:49.649558+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Establishment Labs reports 3-year Motiva IDE study data; capsular contracture rate 0.5%

## Summary
- 3-year follow-up on 451 primary augmentation patients; compliance 92.4%.
- Kaplan-Meier risk rates: capsular contracture 0.5%, rupture 0.6%, breast pain 0.7%, infection 0.9%.
- Any reoperation 6.1%, any complication 8.4% at 3 years.
- Data submitted to FDA as part of final PMA module; device not yet approved in US.
- Results consistent from year 2 to year 3 with no increase in capsular contracture or rupture.

## SEC filing metadata
- accession: 0001104659-23-047762
- form_type: 8-K
- ticker: ESTA
- cik: 0001688757
- company_name: ESTABLISHMENT LABS HOLDINGS INC.
- filed_at: 2023-04-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/0001104659-23-047762-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/tm2313294d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-047762
- JSON: https://secwatch.observer/filing/0001104659-23-047762.json
- Plain text: https://secwatch.observer/filing/0001104659-23-047762.txt

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