De klinische gegevens in de studie zijn gebaseerd op een gemiddelde follow-up van 17 jaar van de patiënt. Dit is ongekend in de borstimplantaat sector en bevestigt het ongeëvenaarde veiligheidsrecord van GC Aesthetics, gebouwd op 40 jaar innovatie en samenwerking met chirurgen over de hele wereld.

DUBLIN–(BUSINESS WIRE)– GC Aesthetics, Ltd. (GCA), een beursgenoteerd medisch technologiebedrijf dat esthetische en reconstructieve oplossingen biedt voor de wereldwijde gezondheidszorgmarkten, heeft de resultaten aangekondigd van een onafhankelijk klinisch onderzoek dat de toonaangevende veiligheid en patiënttevredenheid heeft gedocumenteerd resultaten voor de borstimplantaten van GCA, gebaseerd op een gemiddelde follow-up van 17 jaar van de patiënt.

De veiligheid van borstimplantaten is een belangrijke zakelijke drijfveer en bedrijfsfocus voor GC Aesthetics, vooral op de lange termijn. Korte termijn-gegevens of beperkte gegevens kunnen misleidende informatie opleveren voor chirurgen en patiënten, aangezien de feitelijke complicaties kunnen worden onderschat of voortijdig kunnen worden beoordeeld op kortere termijnen.

Third-Party Clinical Study Documents Industry-Leading Long-Term Safety Record and Patient Satisfaction for GC Aesthetics Breast Implants

The clinical data in the study is based upon an average of 17 years of patient follow-up. This is unprecedented in the breast implant industry and confirms GC Aesthetics’ unparalleled safety record, built upon its 40-years of innovation and collaboration with surgeons worldwide.

DUBLIN–(BUSINESS WIRE)– GC Aesthetics, Ltd. (GCA), a privately held medical technology company providing aesthetic and reconstructive solutions for global healthcare markets, has announced the results of an independent clinical study that documented industry-leading safety and patient satisfaction results for GCA’s breast implants, based upon an average of 17 years of patient follow-up.

Breast implant safety is a key business driver and corporate focus for GC Aesthetics, especially over the long-term. Short-term, or limited, data can provide misleading information to surgeons and patients, since actual complication rates can be underestimated or prematurely judged over shorter terms.

GCA already had a very positive and compelling 10-year clinical study, published in 2018, involving over 500 women who received its implants (Duteille et al. 2018). The new study was lead by Prof van der Lei in The Netherlands (Kooiman et al. 2021). It analysed the very long-term patient satisfaction and exceptionally low revision rate for GCA round micro-textured breast implants. It also reported no ALCL (Anaplastic Large Cell Lymphoma) cases from GCA implants.

In breast augmentation surgery with implants, it has been seen that the cumulative risk of complications, such as capsular contracture, increases over time. Having significant long-term clinical data regarding the safety of GCA’s breast implants adds important information to the scientific literature, and it also provides powerful evidence of the long-term safety of GC Aesthetics’ breast implants.

“The proven and long-standing safety record of GCA’s products has enabled us to build market-leading positions in key markets around the world, and to earn the confidence of surgeons and patients across the globe. Results like this have allowed GCA to ensure that our products are safe and highly effective in achieving the needs of the industry” said Carlos Reis Pinto, CEO of GC Aesthetics. “This clinical study by Prof. Dr. Berend van der Lei, provides evidence of what we have professed for years: long-term data matters, and great long-term results for patients matters even more. Most breast implants in the market are not backed by this kind of data.”

The new clinical study results are once again demonstrating what makes GC Aesthetics an industry leader, as the company continues to expand its market reach and its innovative product portfolio, for both aesthetic and reconstruction breast surgeries. Its products are backed by decades of research, addressing key market needs. GCA has aggressive growth planned for 2022, fueled by its innovative product launches, and its further expansion in key markets, capitalizing on its success in 2021.

About GC Aesthetics

GC Aesthetics is a long-established global medical technology company that develops, manufactures in-house, and markets a comprehensive range of proprietary aesthetic and reconstructive products.

Throughout its 40 years of operation, GCA has been dedicated to advancing the science of medical aesthetics. GCA is proud to have sold more than 3 million implants across 70 countries, with its products supported by long-term 10-year clinical data that clearly demonstrates the compelling safety and clinical effectiveness of its products.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220201005810/en/

Contacts

Fara Macias – CMO

+353 (0)1 293 3836