Establishment Labs Celebrates 10 Years of Motiva Safety Data - Seite 2

Data Details
The results presented are post-market surveillance data reported from patients and/or physicians to the Company’s Quality Management System complaint database.² From October 2010 to September 2020, approximately 1,288,000 Motiva breast implants have been implanted worldwide with fewer than 400 device-related clinical events reported, including capsular contracture and implant rupture. This represents an event rate of approximately 0.03%.

Since 2010, approximately 145,000 women have registered their implants in the MotivaImagine App, a practice that denotes an additional degree of patient awareness of product warranty in case of an adverse event. Through September 2020, 216 registered patients (0.15%) reported a device-related complication that resulted in reoperation.

Since September 2015, approximately 12,500 women have purchased an extended warranty, which provides financial assistance where surgical intervention is required to address complications such as capsular contracture or rupture. Through September 2020, only 90 of these patients (0.73%) required coverage for a reoperation.

Eight peer reviewed publications with Evidence Levels 3 and 4, spanning well-designed case-control or cohort studies, and well-designed controlled trials without randomization, have been published in the major plastic surgery journals about Motiva Implants. These studies have reported device-related complications of between 0% and 1.3%, with patient follow-up ranging from six months to six years.

Symposium Details
Today’s symposium will commence at 2:00 pm Eastern time. To register, please go to
https://establishmentlabs.zoom.us/webinar/register/WN_82jqSm6jSseoYfrV .... After the conclusion of the program, there will be a separate question and answer session for investors and analysts.  A recording of this event will be archived on the company’s website.

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 commercially available in more than 80 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 and other products and services. Please visit our website for additional information at www.establishmentlabs.com.