Establishment Labs — Motiva® Implants — LATAM Clinical Evidence Supporting FDA PMA Approval (Sept 2024)

Establishment Labs, the maker of Motiva® breast implants, partnered with bioaccess® to build large-scale, multi-year LATAM clinical follow-up data. That evidence base contributed to the clinical dossier supporting Motiva®'s FDA PMA approval on September 27, 2024 — the first new breast-implant PMA since 2013. In December 2025, Establishment Labs also submitted a PMA supplement for a reconstruction indication.

Study facts

• Sponsor / company: Establishment Labs
• Indication / area: Plastic & Reconstructive Surgery
• Country: Costa Rica & Colombia
• Study type: Pivotal Clinical Trial

Key metrics

• Study Duration: Multi-year
• Countries: 2
• Submission: FDA PMA
• PMA Approval: Sep 2024

The challenge

Establishment Labs needed large-scale, multi-year clinical follow-up data across diverse populations to meet stringent FDA PMA requirements and support global regulatory filings for their next-generation breast implant technology.

bioaccess® solution

bioaccess® managed clinical trial sites across Costa Rica and Colombia, overseeing long-term patient follow-up, data collection, and quality assurance aligned with FDA PMA submission standards. Our team ensured consistent data quality across all sites throughout the multi-year study period.

Results

• Multi-year clinical follow-up data collected across LATAM sites
• Data contributed to Motiva®'s global regulatory submissions
• Consistent, high-quality data across all sites and years
• bioaccess® contributed to the clinical evidence base supporting Motiva®'s FDA PMA approval (September 27, 2024) — the first new breast-implant PMA since 2013
• Establishment Labs submitted a PMA supplement for a reconstruction indication in December 2025
• Thousands of patients enrolled and followed per protocol

Frequently asked

What did bioaccess® do for Establishment Labs?

bioaccess® managed clinical trial sites across Costa Rica and Colombia, overseeing long-term patient follow-up, data collection, and quality assurance aligned with FDA PMA submission standards. Our team ensured consistent data quality across all sites throughout the multi-year study period.

Where was the Establishment Labs Pivotal Clinical Trial study run?

The Establishment Labs Pivotal Clinical Trial study was executed in Costa Rica & Colombia by bioaccess® in the plastic & reconstructive surgery area.

What was the outcome of the Establishment Labs study?

Reported outcomes for Establishment Labs's device: Multi-year clinical follow-up data collected across LATAM sites; Data contributed to Motiva®'s global regulatory submissions; Consistent, high-quality data across all sites and years.

Run a similar trial: Clinical trials in Colombia

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