Safety Features

OUR TECHNOLOGIES

An unparalleled safety record
<1% device related complications vs market +10%
RFID enablement | Human factors (Ergonomy) | Minimally invasive | Regen and advanced biomaterials
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RFID ENABLEMENT

Qid®: empowering women through knowledge

This next generation safety technology allows healthcare providers to use an external, hand-held reader to identify details about Motiva® after surgery, significantly improving the traceability of the implants.

The product‘s authenticity can also be confirmed with the use of this device. The electronic serial number and related information about implants are kept safe through a battery-free and passive device.

SmoothSilk Ergonomix2®

SmoothSilk Ergonomix2 is a uniform surface developed through 3D inverted imprinting, a manufacturing process that reduces foreign materials in the shell; it minimizes additional steps and greater manipulation.

Research consistently shows that SmoothSilk Ergonomix2® favors a low degree of inflammation and fibrotic response among the surfaces studied across live models, and samples from human recipients.1

For up-to-date Post Market Surveillance data, look here.

TRUEMONOBLOC®

TrueMonobloc® technology favours insertion through smaller incisions due to its shell-gel interaction and improved mechanical properties.2,3

BLUSEAL®

For over four decades, technological advancements have led to a significant improvement in the reduction of silicone diffusion through the shell.


The BluSeal® safety barrier layer is one-of-a-kind; it consists of a lightly tinted blue-barrier layer made with biocompatible dyes, which allows for pre-surgical visual inspection of the shell integrity.

References

1 Doloff JC, Veiseh O, de Mezerville R, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nature Biomedical Engineering. 2021. doi:10.1038/s41551-021-00739-4

2 Zeplin PH. Narbensparende Brustvergrößerung: Erfahrungen mit über 500 Implantaten. Handchirurgie · Mikrochirurgie · Plastische Chirurgie. 2021;53(02):144-148. doi:10.1055/a-1307-3917

3 Lam MC, Vorhold J, Pech T, Wefers N, Kalff JC, Walgenbach KJ. Einfluss der Brustdimension bei der einzeitigen Augmentationsmastopexie auf die Implantatauswahl – Erfahrungen aus 103 konsekutiven Brustaugmentationen mit nanotexturierten Silikonimplantaten. Handchirurgie · Mikrochirurgie · Plastische Chirurgie. 2021;53(02):130-143. doi:10.1055/a-1348-1481

* The Mia® procedure encompasses the introduction of the channel dissector, creation and confirmation of the pocket and implant deployment

Reporting Hotline
Careers

ABOUT

PETER

CALDINI

President

PETER

CALDINI

President

Peter Caldini joined the Company as the President in August 2024.  Prior to joining in August, Peter worked as a consultant with the Company’s leadership team to identify efficiencies and cost savings. Before that, Peter was the Chief Executive Officer at Acreage Holdings, Inc., a publicly traded company, from December 2020 to June 2023. Prior to that, he was the Chief Executive Officer and a director at Bespoke Capital Acquisition Corp., a special purpose acquisition corporation, from June 2019 until December 2020. Prior to that, he held positions of increasing responsibility at Pfizer, Inc., including Regional President North America for Pfizer Consumer Healthcare from 2017 to 2019; Regional President EMEA of Pfizer Consumer Healthcare from 2016 to 2017, and leader of the Northern European cluster from 2015 to 2016. From 2009 to 2014, Peter held roles of increasing responsibility at Bayer Consumer Healthcare, including leading the Global Nutritionals Strategic Business Unit and running a sub-region of emerging markets in EMEA. And from 2002 to 2009, he held roles of increasing responsibility at Wyeth Consumer Healthcare in the US and Internationally. Peter received a Masters of International Economics and Management from Bocconi University in Milan, Italy, an MBA from Northeastern University and a BA, Political Science from Boston University.

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ABOUT

ROSS

MANSBACH
General Counsel & Chief Compliance Officer

ROSS

MANSBACH
General Counsel & Chief Compliance Officer

Ross Mansbach joined the company in August 2022 as the General Counsel and Chief Compliance Officer. He was previously at Avanos Medical, Inc., a publicly traded medical device company, where he held positions including Senior Vice President, Interim General Counsel and Corporate Secretary and Vice President, Deputy General Counsel and Corporate Secretary, between November 2014 and March 2022. Prior to that, Mr Mansbach held positions of increasing responsibility in the Legal Department at Kimberly-Clark Corporation for more than ten years. Earlier in his career, Mr Mansbach was a partner at the law firm of Powell Goldstein Frazer & Murphy, now known as Bryan Cave. He was also a judicial clerk for a United States District Court judge for the Northern District of Illinois. Mr Mansbach received his BA from Yale College and his JD from The University of Chicago.

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ABOUT

JEFF

EHRHARDT

SVP & General Manager – North America

JEFF

EHRHARDT

SVP & General Manager – North America

Mr. Ehrhardt joined the Establishment Labs leadership team in April of 2024 after a distinguished career in Plastic Surgery and Dermatology in the U.S. market.  He was most recently VP and General Manager of the U.S. Plastic Surgery and Regenerative Medicine business unit for Allergan Aesthetics, an Abbvie company.  In his 26 plus years at Allergan he held various senior leadership roles such as VP U.S. Commercial Operations, VP of Sales Plastic Surgery & Regenerative Medicine and VP of Sales and Marketing, U.S. Dermatology.  Notably, he was head of Dermatology Sales for the launch of Botox Cosmetic, acquisition and merger of Lifecell into the U.S. Plastic Surgery organization, acquisition and launch of Aczone®, an acne product, and the launch of the Inspira® line of breast implants.   In his role at Establishment Labs, he will be responsible for the commercialization of the Motiva® Femtech line of breast aesthetics devices in both the U.S. and Canada.   He holds undergraduate degrees in Finance and Marketing from the University of Cincinnati and an M.B.A. from Xavier University.

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ABOUT

PAUL

RODIO

Chief Operating Officer

PAUL

RODIO

Chief Operating Officer

Paul is a seasoned Operations Executive with over 30 years of global experience across supply chain, manufacturing and operations within Med Device, Consumer Packaged Goods and Industrial industries.

Paul joined Establishment Labs on 1 December 2022 from Cardinal Health, where he led the Medical Segment’s Global supply chain planning, procurement, deployment, service and repair, medical device reprocessing operations and key account CPFR as Senior Vice President Global Planning and Operations. Prior to that, he was Vice President Supply Chain, Contract Manufacturing for Medtronic and Covidien. Earlier in his career, he held positions of increasing responsibility at Newell Rubbermaid, Evenflo, Arthur Anderson LLP and Swagelok.

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ABOUT

ROSALYN

COLE D’INCELLI

SVP, Global Clinical, Medical & US Regulatory Affairs

ROSALYN

COLE D’INCELLI

SVP, Global Clinical, Medical & US Regulatory Affairs

Rosalyn d’Incelli has been a part of Establishment Labs® since May of 2020 as the company’s Head of Clinical and Medical Affairs, bringing to the company over 20 years of medical device experience. In this role, she drives global clinical and medical strategy and execution and leads US Regulatory Affairs. Prior to joining us, she was with Sientra Inc., for 11 years as the Vice President of Clinical and Medical Affairs. She was responsible for US PMA approval, Medical Education, PR, Publications and the company’s scientific content. She represented the company with FDA, media and medical education events and congresses. Preceding Sientra, Ms d’Incelli held similar roles with PMA approvals at Mentor/Johnson & Johnson and Inamed (now Allergan/AbbVie). She holds a BA in communication/market research from the University of California, Santa Barbara, and is board-certified in SoCRA and RAP.
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ABOUT

SALVADOR

DADA

Head of Special Projects

SALVADOR

DADA

Head of Special Projects

Mr Dada was one of the founding members of the company back in 2004. Salvador initially led the implementation of Establishment Labs® operations in Costa Rica and the successful certification of the Motiva Implants® product family by the European Union and other high-vigilance countries.

In February 2016, he was appointed as our Chief Operating Officer where he led the expansion of the operations to Brazil, Belgium and, in recent years, to several other European countries where direct commercial operations were launched. Due to health issues, he resigned from his position as COO and now serves as Head of Special Projects. Mr Dada served in various engineering roles at Allergan Medical from 2007 to 2009 and in a variety of production and manufacturing roles at Establishment Biotech, S.A. from 2004 to 2006.

He has an undergraduate and licentiate degree in Industrial Engineering from the University of Costa Rica.

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ROBERTO

DE MEZERVILLE

Chief Technology Officer

ROBERTO

DE MEZERVILLE

Chief Technology Officer

Since 2009, Roberto has risen through several positions in our company, in the areas of quality management, research, regulatory and clinical affairs, and has been our CTO heading Research, Development and Innovation since January 2018.

Roberto has led several impactful research projects that have been key to the science-based design of our Femtech technologies, and has authored peer-reviewed publications. From 2006 to 2009, served in various engineering and quality manager positions with Allergan Medical Costa Rica.

He has a bachelor’s degree in Business Administration from Universidad Interamericana de Costa Rica and a bachelor’s degree in Industrial Environmental Health and Safety Engineering from Instituto Tecnológico de Costa Rica.

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RAJ
DENHOY

Chief Financial Officer

RAJ

DENHOY

Chief Financial Officer

Raj has been part of Establishment Labs® since February 2021. Before his current role as Chief Financial Officer, he served as the company’s Head of Strategy and Investor Relations. Raj joined the company from Jefferies Group, LLC where he was a Managing Director and led the US medical device research team for eleven years, including coverage of Establishment Labs®.

He covered the medical device industry as an equity research analyst for over twenty years. Raj has an impressive academic portfolio, including a bachelor’s degree in biology from UC Berkeley, a master’s degree in Physiology from Georgetown University and an MBA from Cornell University.

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ABOUT

IVAN

BILIC

Senior Vice President of Commercial Operations – OUS

IVAN

BILIC

Senior Vice President of Commercial Operations – OUS

Mr. Bilic has been part of Establishment Labs since April 8, 2019, and is dedicated to advancing women’s health through innovative technology. His career highlights include roles as senior commercial director for European distribution markets, vice president for EMEA, and his current position as senior vice president for OUS. Notable accomplishments include restructuring the commercial function and transforming the German market. In his current role, Mr. Bilic strategically leads Establishment Labs’ commercial efforts, overseeing both the channel and direct markets and shaping B2B and B2B2C strategies for market leadership. He represents Establishment Labs in the non-U.S. plastic surgery market and drives innovative marketing approaches globally. Prior to joining Establishment Labs, he held key positions at Polytech and Allergan and holds a Master of Business Administration from Hult International Business School.

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ABOUT

ROBERT

LANGER

PhD

ROBERT

LANGER

PhD

Robert Langer is an Institute Professor at MIT (there are 13 Institute Professors at MIT; an Institute Professor is the highest honour awarded to a faculty member). His h-index of 232 is the highest of any engineer in history. He has over 1,130 issued and pending patents which have been licensed or sublicensed to over 300 companies. He served as Chair of the FDA’s SCIENCE BOARD (highest advisory board) from 1999-2002.  Langer is one of a very few individuals elected to the National Academy of Medicine, the National Academy of Engineering, the National Academy of Sciences and the National Academy of Inventors.  He is one of four living individuals to receive both the US National Medal of Science and the US National Medal of Technology and Innovation.  In 2015, Dr Langer received the Queen Elizabeth Prize for Engineering.  He has also received the Draper Prize (considered the engineering Nobel Prize), Albany Medical Center Prize, Wolf Prize for Chemistry, Millennium Technology Prize, Priestley Medal (highest award of the American Chemical Society),  Gairdner Prize, Kyoto Prize and the Lemelson-MIT Prize, for being “one of history’s most prolific inventors in medicine”. He holds 29 honorary doctorates including honorary degrees from Harvard and Yale.

ABOUT

PROF. MICHAEL

ATLAN

MD & PhD

PROF. MICHAEL

ATLAN

MD & PhD

Prof. Michael Atlan MD, Ph.D. is currently the chief of the Plastic and Reconstructive Surgery Department at TENON Hospital and a Professor at the Sorbonne Médecine Université.

His main interests are aesthetic breast surgery, breast reconstruction with ADM, free flaps for breast reconstruction, and breast cosmetic surgery (anatomic implants, fat grafting). His areas of expertise include breast implant surface, the evaluation of new devices in plastic surgery, and facial aesthetic surgery.

He is one of the founders of the CAMPUS CHAMPS ELYSEES.

ABOUT

ARDESHIR

BAYAT

MD & PhD

ARDESHIR

BAYAT

MD & PhD

Prof. Ardeshir Bayat is Director of the Medical Research Council Wound Healing Unit and professor at the University of Cape Town, Cape Town in South Africa. He is considered an expert in wound healing, cutaneous repair and skin scarring, with internationally recognised expertise in implant surface technology, fibrosis and capsular contracture. He trained as a surgeon-scientist with a PhD in molecular genetics of fibrosis. He has published extensively in peer-reviewed scientific literature (in excess of 500 articles to date). He is regularly an invited speaker at both national and international tissue repair conferences (over 600 conferences to date) and serves on the editorial boards of several journals.

His team have created and patented novel biomimetic surfaces and continue to work on developing models to understand the process of cell surface interaction/capsular fibrosis and its modulation related to implant surfaces. His investigative work has enabled translation of basic science to therapeutic developments of direct relevance to both cosmetic patients and industry.

ABOUT

BRIAN

KINNEY

MD & Eng

BRIAN

KINNEY

MD & Eng

Dr Brian M. Kinney is a Clinical Associate Professor of Plastic Surgery at the University of Southern California in Los Angeles and a reputable board-certified plastic surgeon. Dr Kinney has served as President of the Plastic Surgery Educational Foundation of the US (PSEF), Chair of the Board of Trustees of the American Society of Plastic Surgeons (ASPS), Deputy Secretary General of the International Confederation of Aesthetic, Plastic and Reconstructive Surgeons (IPRAS), Board member of the American Society for Aesthetic Plastic Surgery (ASAPS), part of the International Society of Aesthetic Plastic Surgeons (ISAPS), Co-founder and member of the board of directors of the International Society of Plastic Regenerative Surgery (ISPRES), as well as Chair and Medical Director of Thermi. Dr Kinney has one of the top plastic surgery practices in southern California for over 25 years and is also a staff member of many major hospitals in West Los Angeles, such as St. John’s Hospital and Health Center and Cedars-Sinai Medical Center. Dr Kinney earned his bachelor’s degree (Biomedical/Mechanical Engineering) and master’s degree (Mechanical/Electrical Engineering) after completing the Harvard/MIT Health Sciences and Technology programme. He then attended medical school at Tulane University and trained in general surgery and plastic surgery at UCLA in Los Angeles, CA, USA.

ABOUT

ARIKHA

MOSES

MD & PhD

ARIKHA

MOSES

MD & PhD

Arikha is an experienced medical device executive and entrepreneur, whose companies developed products that have been implanted in millions of patients worldwide. She was the founder and CEO of Galatea Surgical (now owned by Becton Dickinson), guiding the company from inception, through clinical studies and the commercial release of GalaFLEX© for soft tissue reinforcement. She was also the founder and CSO of TyRx (now Medtronic Infection Control), which commercialised antibiotic eluting products for the prevention of infection associated with indwelling devices. Over more than 20 years in the industry, Arikha has cultivated deep expertise in resorbable surgical products and the development of solutions to complications associated with implantable devices. Arikha is currently an investor and board member of several privately held medical companies and non-profit organisations. She has a PhD in Chemistry from Yale and a BA in Chemistry from Brandeis University.

ABOUT

DR MARCOS

SFORZA

MD

DR MARCOS

SFORZA

MD

Prof. Marcos Sforza, MD Marcos Sforza is one of the most renowned lecturers and researchers in the realm of plastic surgery. He is a Senior Professor of Plastic Surgery and regenerative medicine at the SESA University, Brazil, a Professor of Cosmetic Surgery at UNIFESO School of Medicine, responsible for the Elective Internship in Cosmetic Surgery in the UK and a Fellow of the Royal College of Surgeons of England. 

Prof. Sforza is a registered member of the International Society of Aesthetic Plastic Surgery – ISAPS, the Brazilian Society of Plastic Surgery, the American Society of Plastic Surgery and the American Society of Aesthetic Plastic Surgery. He has more than 100 peer-reviewed published papers and lectures all around the world as the world’s leading authority in nanosurfaced silicone breast implants. He is also the Editor in Chief of the Journal of Surgery and the Annal of Plastic and Reconstructive Surgery Journals.

ABOUT

DR ALEXANDRE

MUNHOZ

MD

DR ALEXANDRE

MUNHOZ

MD

Dr Alexandre Mendonça Munhoz, MD, PhD is Assistant Professor of Plastic Surgery, Breast Surgery Division of Plastic Surgery at University of São Paulo School of Medicine in Sao Paolo, Brazil, and a full member of the Brazilian Society of Plastic Surgery (SBCP). He participates as a guest member of the international consultants of Plastic and Reconstructive Surgery and Breast Journal since 2006.

In the period of 2010–2014, Dr Munhoz took over the role of a permanent member of the editorial board of the Annals of Plastic Surgery and the coordination of the National Commission of Breast Reconstruction of the Brazilian Society of Plastic Surgery.

Dr Munhoz currently has 27 scientific awards related to plastic surgery research, 145 published scientific papers, with 124 indexed in PubMed platform, 93 publications as a first author and in the area of aesthetic and reconstructive breast surgery, which resulted in about the 2967 citations with an H-Index of 29.

In 2013, he became Head of the Breast Reconstruction Department of the Cancer Institute of São Paulo (ICESP). In 2015, Dr Munhoz took over the Department of Plastic Surgery of the Moriah Hospital. In 2016, he was elected by American Society of Plastic Surgery (ASPS) as Associated Editor of Plastic and Reconstructive Surgery Global Open Journal. In 2022, Dr Munhoz became an international member of the American Society of Plastic Surgery (ASPS) and a full member of International Society of Aesthetic Plastic Surgery (ISAPS).

ABOUT

DR DENNIS

HAMMOND

MD

DR DENNIS

HAMMOND

MD

Dr Dennis Hammond, a board-certified plastic surgeon by the American Board of Plastic Surgery, is one of the world’s most recognised and respected authorities in breast aesthetic and reconstructive surgery. He is a member of and has served on numerous committees for the American Society of Plastic Surgeons (ASPS) as well as for the American Society for Aesthetic Plastic Surgery (ASAPS), and is a member of the prestigious American Association of Plastic Surgeons.

Dr Hammond has co-edited one of the most influential textbooks in plastic surgery along with his friend and colleague Dr Scott Spear from Georgetown University in Washington DC. He has authored many scientific papers, and serves as a reviewer for scientific articles for Aesthetic Plastic Surgery, Plastic and Reconstructive Surgery and the Journal of Aesthetic Surgery.

Dr Hammond wrote the “Atlas of Aesthetic Breast Surgery”, first published in 2009, a book which became a gold standard on how to perform new and innovative techniques for surgically and artistically augmenting, reshaping, lifting and reducing the breast.

ABOUT

DR NIAMH

CORDUFF

MD

DR NIAMH

CORDUFF

MD

Dr Niamh Corduff qualified from Charing Cross Medical School, the University of London, in 1984 and subsequently did her basic surgical training in the UK before emigrating to Australia in 1988. Dr Corduff completed her specialist plastic surgical training in Melbourne, Australia, and in 1993, became a Fellow of the Royal Australasian College of Surgeons. With more than 2 decades of experience, this Australian surgeon is a member and former president of the Australasian Society for Aesthetic Plastic Surgery and an honorary member of the Australian Society of Plastic Surgeons. Dr Corduff developed a special interest in breast surgery and since 2000 her surgical practice was focused solely on aesthetic and reconstructive breast surgery. She has published and lectured on aesthetic breast surgery both locally and internationally.

ABOUT

DR FEDERICO

MAYO

MD

DR FEDERICO

MAYO

MD

Born in Spain in 1967, Dr Mayo holds a degree in medicine and surgery from Universidad Complutense de Madrid, a doctorate in research skills from Universidad Complutense de Madrid and a medical specialty in plastic aesthetic and reconstructive surgery since 2001, recognised by the UK. He is a member of the General Medical Council, validated in Switzerland and has professional experience in Zurich and currently in Madrid. 

He is the author of chapters in specialty books, and his works have been published in renowned journals, such as Aesthetic Plastic Surgery and Plastic and Reconstructive Surgery. Dr Mayo is an active member of the scientific society, including the Sociedad Española de Cirugía Estética y Plástica, the Asociación Española De Cirugía Estética, the International Society of Aesthetic Plastic Surgery and the American Society of Plastic Surgery. He is a reviewer for the Aesthetic Plastic Surgery Journal and has patented ideas applicable in breast implant manufacturing. He has completed over 12,000 surgical interventions as primary surgeon and has implanted over 10,000 breast implants in more than 20 countries around the world as part of conferences, Masterclasses and other scientific events.

ABOUT

JEFFREY
BETTINGER
Global Head of People

Jeffrey Bettinger joined Establishment Labs® in November 2021 from Nu Skin, a global leader in beauty and wellness, where he served as the Chief People and Places Officer. In addition, he held a variety of executive and senior leadership roles in medical devices, financial services, pharmaceuticals, and engineering.

Some of his past employers are USAA, Petco, State Farm, Fluor, and Walmart. He has had the honor of receiving regional and national recognition for leadership development and culture transformation. Moreover, he has been published on a variety of human capital topics. Mr. Bettinger has an extensive academic background, starting with a bachelor’s degree in communication, a master’s degree in Organizational Communication and Educational Administration from Idaho State University, and a Master’s in Business Administration from Liberty University.

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