Establishment Labs Holdings Inc, a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, announces its latest clinical data demonstrating 10 years of outstanding safety outcomes reported in women who have received the Company’s Motiva silicone breast implants.
During a recent virtual symposium “Motiva: A Decade of Contributions to Women’s Health,” the Company presented 10-year post-market surveillance data demonstrating a device-related complication rate of less than 1% for the key safety endpoints of capsular contracture and implant rupture, with nearly 1.3 million breast implants placed worldwide outside of the United States.
These rates are consistent with data reported in the Company’s patient registry of more than 145,000 patients, as well as studies reported in peer-reviewed publications. There have reportedly been no cases of BIA-ALCL reported with Motiva Implants, according to the company in a news release.
Also during the symposium, plastic surgeons with extensive global experience using the Company’s Motiva Implants discussed their own results.
“In 428 primary and revision breast augmentations over the last six years, the complication rate for my patients receiving Motiva is 0.3%. “Importantly, my patients see more natural results in terms of softness, comfort and ergonomy with their Motiva Ergonomix implants.”
— Dr Giovanni Botti, an independent plastic surgeon and clinical Professor of Plastic Surgery at the University of Padua, and author of the medical text Aesthetic Mammaplasties
“These 10-year findings are another validation of the rigorous science and engineering behind the strong safety profile of our Motiva Implants. The placement of nearly 1.3 million Motiva Implants in over 80 countries, along with positive real-world data sets, implant registries and independent publications, are evidence of the high degree of confidence plastic surgeons and patients have in Motiva.”
— Juan José Chacón-Quirós, Chief Executive Officer of Establishment Labs
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. 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 6 months to 6 years.
[Source(s): Establishment Labs Holdings Inc, GlobeNewswire]
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