Press Releases & News

Update to Our Valued Surgeons

April 17, 2019

Dear Valued Plastic Surgeons:

In keeping with our open communication standard, I want to take this opportunity to communicate directly with you in light of some misleading information being circulated. As you may already know, an opinion piece on Establishment Labs was recently posted and reused by competitors, and is riddled with false information, misleading statements and baseless allegations.

The post was based on the opinion of the author, not facts or truths, who is a financial investor that has no authority on the scientific community, nor the medical device and aesthetic industries. Moreover, the author’s firm has made a bet against Establishment Labs stock (sold our stock short) prior to the publishing of this post. This bet will only yield the firm gains if our stock price declines. We find the timing of such false information, misleading statements and baseless allegations to be peculiar and not coincidental given their bet against the company. Furthermore, while propagating such false and misleading statements against Establishment Labs, the firm has taken an investment position in a competing breast implant company stock, a fact not disclosed in the post.

I want to reiterate to you that Motiva Implants® are designed to improve safety and aesthetic outcomes in breast surgery by incorporating the latest advancements in material science and surface technology. We believe that our science foundation is solid based on relevant studies by the Langer Lab at MIT, Manchester Institute of Biotechnology, Rush University Medical Center, Medical University of Innsbruck, Macquarie University and the Center for Biofilm Engineering, among others. Additionally, based on numerous, peer-reviewed publications, we are confident in the data that show low rates of complication and reoperation associated with Motiva® silicone breast implants.*

We are gratified that in response to the post we have heard from surgeons who have used our Motiva Implants® and have shared their positive experiences and expressed their support for us.  We are also gratified to know that independent, reputable and well-respected financial institutions have expressed similarly positive views on this matter.

At Establishment Labs, our commitment is unwavering in our pursuit to transform this industry by focusing on women’s health and by bringing safe solutions based on science and user-centric design. We are guided by our principles of collaboration with scientists and plastic surgeons, integrity, transparency and respect for patients. Moreover, as a publicly traded company on the NASDAQ Stock Market, we abide by all applicable rules and regulations and our financial reporting standards are robust and in line with generally accepted accounting standards.

Thank you for your steadfast commitment and trust in Establishment Labs. We recently held our year-end earnings call where we reported over 76% revenue growth year over year and our IDE study-defined enrollment targets for the aesthetic cohorts of our FDA clinical trial for Motiva Implants®, which include primary augmentation and revision, have been reached. Our accomplishments this year are a testament to the incredible partnerships we have with each of you.

If you have any questions at all, please do not hesitate to reach out to your Motiva® representative.

 

Sincerely,

Chacon-Quiros Signature

Juan José Chacón-Quirós

CEO & Founder

 

About Establishment Labs

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently sold in over 70 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System, MotivaImagine® Centers and other products and services. Please visit the website for additional information: www.establishmentlabs.com.

 

*Bibliography

Atlan M, Nuti G, Wang H, Decker S, Perry T. Breast implant surface texture impacts host tissue response. Journal of the Mechanical Behavior of Biomedical Materials. Dec 2018; 88:377-385. doi: 10.1016/j.jmbbm.2018.08.035      

Barr S, Hill EW & Bayat A. Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness. Journal of the Mechanical Behavior of Biomedical Materials. 2017 Nov;75:75-81; doi: 10.1016/j.jmbbm.2017.06.030

Barr S, Hill EW, Bayat A. Novel Proteomic Assay of Breast Implants Reveals Proteins with Significant Binding Differences: Implications for Surface Coating and Biocompatibility. Aesthet Surg J. August 2018; 38(9):962–969. doi: 10.1093/asj/sjy018

Cappellano, G, Ploner C, Lobenwein S, Sopper S, Hoertnagl P, Mayerl C, et al. Immunophenotypic characterization of human T cells after in vitro exposure to different silicone breast implant surfaces. PLoS ONE 2018;13(2):e0192108. doi: 10.1371/journal.pone.0192108

Chacón M, Chacón M & Fassero J. Six-Year Prospective Outcomes of Primary Breast Augmentation with Nano-Surface Implants. Aesthet Surg J. 2018; doi: 10.1093/asj/sjy196      

Gunnarson JL, Thomsen JB. Prepectoral Hammock and Direct-to-implant Breast Reconstruction in 10 Minutes: A Focus on Technique. Plast Reconstr Surg Glob Open 2018;6:e1931; doi: 10.1097/GOX.0000000000001931      

Huemer GM, Wenny R, Aitzetmüller MM, Duscher D. Motiva Ergonomix Round SilkSurface Silicone Breast Implants: Outcome Analysis of 100 Primary Breast Augmentations over 3 Years and Technical Considerations. Plast Reconstr Surg. 2018; 141(6):831e-842e. doi: 10.1097/PRS.0000000000004367.

James G, Boegli L, Hancock J et al. Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials. Aesth Plast Surg. 2019 Apr; 43:490–497. doi: 10.1007/s00266-018-1234-7      

Jewell ML, Bengtson BP, Smither K, Nuti G, Perry T. Physical Properties of Silicone Gel Breast Implants. Aesthet Surg J. 2019;39(3):264-275. doi: 10.1093/asj/sjy103

Jones P, Mempin M, Hu H, et al. The functional influence of breast implant outer shell morphology on bacterial attachment and growth. Plast Reconstr Surg. 2018;142(4):837-849. DOI: 10.1097/PRS.0000000000004801

Munhoz AM, Santanelli di Pompeo F, De Mezerville R. Nanotechnology, nanosurfaces and silicone gel breast implants : current aspects. Case reports in plastic surgery and hand surgery. 2017; 4(1):99-113. doi: 10.1080/23320885.2017.1407658

Sforza M, Hammond DC, Botti G et al. Expert Consensus on the Use of a New Bioengineered, Cell-Friendly, Smooth Surface Breast Implant. Aesth Surg. J May 2019 https://doi.org/10.1093/asj/sjz054.      

Sforza M, Spear S, Hammond D. The 21st Century Silicone Breast Implant. J Surg Open Access 2016;2(4). doi: 10.16966/2470-0991.e107

Sforza M, Zaccheddu R, Alleruzzo A et al. Preliminary 3-year evaluation of experience with SilkSurface and VelvetSurface Motiva silicone breast implants: a single-center experience with 5813 consecutive breast augmentation cases. Aesthet Surg J. 2018; 38(Suppl 2):S62-S73. doi: 10.1093/asj/sjx150

Sim HB. Revisiting Prepectoral Breast Augmentation: Indications and Refinements, Aesthet Surg J. sjy294, https://doi.org/10.1093/asj/sjy294