Better Health for All

Establishment Labs focuses on breast aesthetics and reconstruction, aiming to improve women's health and wellness.

Their Motiva implants have a 3-year Kaplan-Meier risk of capsular contracture at 0.5% and implant rupture at 0.6% for primary augmentation, with any reoperation at 6.1% and any complication at 8.4% in the US IDE Study. The FDA approved Motiva implants for primary and revision breast augmentation on September 26, 2024. The company's manufacturing facilities are compliant with ISO13485:2016 and FDA 21 CFR 820. The company aims to democratize access to breast reconstruction, working to link surgeons with African women after breast cancer. They distributed 20,000 Dignity Kits into refugee camps and rural areas in 2022. The company instills a patient-centric risk and benefit framework, and publishes an annual Post-Market Surveillance Report. They have over 200 patent applications in 25 separate patent families and over 50 scientific studies. In 2023, they provided 192 medical education programs and over 11,000 hours of training. The company launched a global campaign, Pink Motiva®, in 2020 to raise awareness for early breast cancer detection, and donated 90 mammograms in 2023. They implemented a global Policy on the Protection of Personal Information and comply with GDPR and LGPD. During COVID-19, they implemented new plans and protocols to protect employees and donated 4,000 reusable face shields to healthcare providers in Costa Rica. In 2020, they coordinated online sessions on breast cancer topics with over 80 participants.

Fair Money & Economic Opportunity

The company, Establishment Labs Holdings Inc.

, is a medical technology company focused on breast aesthetics and reconstruction. The provided articles discuss product warranty programs for breast implants and a grant program for healthcare professionals. There is no evidence in the articles to suggest that the company engages in activities related to lending, insuring, moving, or storing money, which are the core activities assessed under the 'Fair Money & Economic Opportunity' value. As no specific, concrete data points for any of the financial services-related KPIs are provided, all KPIs are omitted.

Honest & Fair Business

Establishment Labs has a formal whistleblower policy, adopted in December 2016 and revised in April 2021.

This policy includes anonymous reporting channels via a multilingual Global Ethics Line operated by independent third-party Navex Global, and explicitly prohibits retaliation against those making good faith reports. The policy details investigation procedures, roles of the Audit Committee and CFO, and steps to protect whistleblowers. The company also has a Global Anti-Corruption Compliance Policy, dated January 2021, which prohibits bribery, mandates due diligence on third-party intermediaries, and requires annual compliance certification and training for relevant personnel. The policy outlines monitoring, auditing, and reporting procedures, including a dedicated ethics hotline with country-specific numbers. In 2020, 5 out of 7 directors were independent as defined by NASDAQ guidelines. The company holds several quality management system certifications, including ISO 13485:2016 and MDSAP. However, a short report in October 2022 alleged conflicts of interest in key safety studies and discrepancies in patient testimonials, leading to an investigation by Block & Leviton LLP for potential securities law violations. Furthermore, company-collected data is reported in SEC filings, and external committees (France's CNEDiMTS in January 2022 and South Australia's Policy Advisory Committee in 2019) have pointed out shortcomings in the data.

No War, No Weapons

The company's core business is medical technology, and there is no evidence of involvement in arms, defense contracts, dual-use technology, or sales to embargoed regimes.

Similarly, there is no evidence of lobbying related to arms control, AI military safeguards, or surveillance activities. The company has no defense assets to divest, nor does it invest in peace technology. Establishment Labs has a supply chain policy, effective January 2, 2023, that prohibits procurement from conflict-affected areas, indicating zero procurement from such regions. This policy also prohibits support for illegal security forces, bribery, and fraudulent mineral origin claims, aligning with humanitarian procurement standards. The policy references the Universal Declaration of Human Rights, indicating support for UN Guiding Principles in principle, but implementation details are not provided. The policy includes a risk assessment module and regular due diligence for business partners, with annual reviews of the policy itself, but specific outcomes of war-risk audits or results of annual conflict partner reviews are not published. The policy references the Kimberly Process Certification Scheme for mineral sourcing but does not specify the percentage of the supply chain certified conflict-free. The policy prohibits support for illegal security forces, but does not explicitly codify bans on specific weapon categories or verify zero exposure to controversial weapons.

Planet-Friendly Business

The provided articles offer limited quantitative data regarding Establishment Labs' environmental performance. While the company's headquarters and manufacturing facilities in Costa Rica were recertified as carbon neutral according to the Costa Rican national program,

this information does not provide specific details on total emissions, renewable energy percentage, water usage, waste diversion rates, or the quality and coverage of carbon offsets used. No specific data is available for science-based targets, green building certifications, lifecycle impact analyses, or any other quantitative environmental metrics outlined in the rubric. The articles primarily focus on regulatory approvals, facility openings, and general sustainability reviews without disclosing the specific performance data required for scoring.

Respect for Cultures & Communities

No relevant data was found in the provided articles to assess ESTA.US against the 'Respect for Cultures & Communities' value.

All articles were placeholders and contained no specific information regarding the company's operations, community engagement, cultural impact, or related metrics.

Safe & Smart Tech

The company's privacy policies, last revised in January 2024 and March 2014, indicate compliance with GDPR, FDA regulations for investigational medical devices, and Directive 95/46/EC.

Users are afforded standard controls over their data, including the ability to withdraw consent, opt-out of marketing, and access or modify their data, as well as request data removal. Data retention practices are based on specific purposes and legal requirements. The company also mentions the use of cookies for authentication and security. However, specific details regarding the comprehensiveness of data access and deletion capabilities, encryption methods, or detailed data minimization practices are not provided.

Zero Waste & Sustainable Products

In 2023, the company achieved an 80% waste recovered rate year-to-date, exceeding its 70% goal.

It has implemented numerous waste reduction initiatives, including reducing the number of pages, colors, and paper weight in Instructions for Use by over 30%, transitioning to LED lighting, adopting alternative energy sources, and establishing recycling stations with employee training. The company also converted expired units into samples, achieving over $100,000 in savings, which reflects circular design considerations in some product lines. Products like Motiva Implants have consistently reported superior safety outcomes with less than 1% device-related complications leading to reoperation, and a rupture rate lower than 0.1%, indicating good durability. The company conducts annual external audits to assess legal compliance related to health, safety, and environment. In 2023, six external audits concluded without any warnings or significant regulatory deficiencies, and there were no waste disposal violations in the past three years. Material efficiency has shown improvement, with energy intensity decreasing from 0.0728 gigajoules/unit in 2017 to 0.0225 gigajoules/unit in 2022. The company has a company-wide waste recovered goal of 70% for 2023. Suppliers are required to comply with all environmental laws and treaties related to waste disposal and hazardous material handling.