FDA Approval Process Begins for Motiva Breast Implants

It has been a big couple of weeks for Establishment Labs, manufacturer of Motiva implants, with the news that their headquarters in Costa Rica has been awarded Leadership for Energy and Environmental Design (LEED) Gold Certification coming hot on the heels of the announcement that they have begun the process of gaining FDA approval by submitting an Investigational Device Exemption (IDE) filing to the U.S. Food and Drug Administration (FDA) for its Motiva Implants®, the lead product in its portfolio of innovative aesthetic technologies.  Upon acceptance, the IDE would enable the Company to initiate a clinical study in the U.S. to assess the safety profile and patient satisfaction of Motiva Implants.

The submission of the IDE filing also comes after the company received the Medical Device Single Audit Program (MDSAP) regulatory certification of its two manufacturing sites in Costa Rica which are now in compliance with five regulatory bodies including the United States Food and Drug Administration (FDA).

Juan José Chacón-Quirós, CEO and founder of Establishment Labs noted that “Establishment Labs is the first company in the aesthetics industry to obtain the MDSAP certification, which is a testament to the regulatory strength of our Quality Management System (QMS) in both manufacturing facilities in Costa Rica.  Now FDA compliant, these facilities will supply Motiva Implants® for our clinical trial programs in the United States and support our global expansion efforts.”

“This is a very significant milestone for Establishment Labs and patient safety, and hopefully the start of many technologies that we can bring to market in the United States,” said Mr. Chacón-Quirós when asked about the IDE filing.  “Motiva Implants are already sold in over 60 countries worldwide and have been implanted more than 300,000 times over the past seven years. We are confident that a clinical study in the United States will confirm the safety profile we are seeing in all of our markets.”

The IDE submission for this Motiva Implants study proposes a single arm, multi-center study investigating female patients receiving primary breast augmentation, primary breast reconstruction, or revision surgery. Upon acceptance of the IDE, Dr. Caroline Glicksman, a board-certified plastic surgeon in the U.S., has agreed to lead the study as the principal investigator. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA.

“This is a big day for technological improvement in our industry,” said Roberto de Mezerville, VP of Research, Development & Innovation of Establishment Labs. “The science and technology behind Motiva Implants was developed with enhanced patient safety as a priority, and we look forward to demonstrating that a commitment to innovation in this industry can lead to safer and better patient outcomes in both the aesthetics and reconstruction fields.”

In-line with Establishment Labs' ethos of being at the forefront of technology in order to drive safety, is their focus on preserving the environment by utilising innovative ideas and technologies.  This focus has lead to it receiving U.S. Green Building Council’s (USGBC) Leadership for Energy and Environmental Design (LEED) Gold Certification on its new headquarters in Costa Rica.

“This distinction is a great honor for our company and partners worldwide, built on the legacy of Costa Rica as an advocate for the preservation of natural resources," said Mr. Chacón Quirós. “As part of our strategy to bring Motiva Implants® to the U.S. market, we believe patients and doctors alike will appreciate our unique industry goal to meet the highest standards in the world for environmental and medical device regulatory compliance.”

LEED certification, established by U.S. Green Building Council and verified by the Green Building Certification Institute, is the worldwide preeminent program for the design, construction and operation of high performance green buildings. The Manuel E. Chacon B. Center for Advanced Silicone Technologies was unveiled on December 15, 2016 and serves as the headquarters for Establishment Labs. The facility includes state-of-the-art manufacturing facilities, innovation labs and corporate offices. The facility is located in the Coyol Free Zone in Costa Rica, one of the largest and most modern high-tech business parks in Central America, hosting medical device companies including Abbott, Medtronic, Philips, Smith & Nephew and Cooper Vision, among others.

“LEED certification is another significant milestone in establishing operations that meet the highest standards for state-of-the-art, efficient, and sustainable infrastructure,” said Salvador Dada, Chief Operating Officer.  “As a global medical technology company, making a positive impact on humanity with our environmental initiatives is at the core of our company values.  We are pleased with this important validation as we pursue opportunities to adopt green solutions and strive to manufacture the highest quality aesthetic products for patients.”

The project used advanced energy modeling during the design. Some of the highlights of this LEED-Gold Certified facility include:

Energy Efficiency

• Ice Bank system for cooling the controlled air in the clean room and support areas instead of traditional energy-powered chillers.
• Energy micro-grid comprised of solar panels and energy-storage batteries that generates up to 80% of the total energy consumption of the building, including manufacturing areas, allowing for efficiently more air exchanges in the clean rooms for less particulates in the production areas.
• The Chilled-Beams system for soft cooling administrative areas -instead of traditional air conditioning systems- reduce at least 30% of energy consumption and eliminate the use of refrigerants.
• Efficient lighting, movement sensors and Energy-Star appliances and equipment in all administrative areas to reduce 50% of energy consumption compared to traditional designs.

Environment

• Oil-less air compressors for cleaner air throughout the facility.
• Rain-water recovery systems for the irrigation systems and toilets.
• Water efficient systems for administrative areas to reduce 49% of water consumption in comparison with traditional designs.
• Non-volatile organic compound (VOC) paints, coatings, adhesives and other external materials that reduce CO2 emissions and heat.
• Local materials used for energy saving during the construction process.
• 57% of construction waste materials were recycled instead of sending to landfill areas.
• Native plantings in the landscaped areas reduce fertilisation and water usage.
• Preferred parking for low emitting (hybrid) and fuel efficient vehicles and carpooling.

It is this forward-thinking leadership that has lead Motiva implants to be one of the leading breast implant brands worldwide with complication rates of both rupture and capsular contracture grades III and IV each less than 1% after 6 years and no cases of late onset seroma or double encapsulation.  We look forward to bringing you more news on the FDA approval process and other achievements in the future.