GC Aesthetics launches ‘world’s first’ MDR-approved breast implant

GC Aesthetics (GCA), a leading designer, manufacturer, and distributor of breast implants and medical devices for the global aesthetics industry, has announced a micro-textured anatomical breast implant LUNA XT. The company says it is the first breast implant in the world approved under the new European Medical Device Regulation (MDR).

Under the new MDR rules, medical standards are updated rigorously to improve product safety ensuring greater openness, traceability and clinical safety evidence. GC Aesthetics says it takes pride in being the ‘first breast implant manufacturer’ globally to introduce a new product under the newly approved MDR rules in their commitment to women’s healthcare and safety.

Breast augmentation continues to be the most common surgical procedure for women globally according to GCA, with over 31,000 procedures in 2022 and in the past decade, there have been frequent calls for tighter licensing regulations for medical devices and implants in the EU says the company.The new Luna XT Anatomical Breast Implant provides support for women undergoing immediate and delayed breast reconstruction surgery. Its microtextured surface, cohesive silicone gel and high-performance shell are a state-of-the-art option for women ho wish to undergo breast procedures claims GCA.

“Being the first to launch the first MDR-approved breast implant in the market is a testimonial of GC Aesthetics' commitment to women's healthcare and safety. MDR rules have been designed to improve product safety ensuring greater openness, traceability, and clinical safety evidence. Having the first breast implant manufacturing system in the world certified under the new MDR rules demonstrates that our company continues to pursue excellence and customer satisfaction,” said Carlos Reis Pinto, CEO at GC Aesthetics.

Fara Naomi Macías, CMO of GCA, said: “It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women. We are committed to deliver safe options that establish a newer, higher, and more beneficial standard of care for women who seek to recover their breast and nipple shape, look, and feel.”