Key Takeaways

  1. The Introduction of Luna XT marks a milestone as the first MDR-approved breast implant, reflecting a shift toward enhanced safety standards in the medical field.
  2. Escalating numbers of breast reconstruction surgeries underscore the demand for MDR-approved products, highlighting the importance of stringent safety standards.
  3. Luna XT is designed to meet diverse patient needs in breast reconstruction surgery.


Breast implant provider GC Aesthetics (GCA) has introduces Luna XT, the first breast implant approved under the new European Medical Device Regulation (MDR). GCA officials say these regulations prioritize product safety, transparency, and clinical evidence, marking a significant shift in medical standards.

Rising Number of Breast Reconstruction Surgeries

The demand for MDR-approved products, devices, and implants is underscored by the escalating numbers of breast reconstruction surgeries. According to the NHS website, the UK witnessed 2,100 breast reconstruction surgeries in 2022, with a further 460 procedures carried out through independent/private clinics. This marks a notable 36% increase since 2017, highlighting the necessity for products adhering to stringent safety standards outlined in the new MDR.

The Luna XT Anatomical Breast Implant is designed to support women undergoing immediate and delayed breast reconstruction surgery. It features a microtextured surface, cohesive silicone gel, and high-performance shell, reflecting advancements in the field. Luna XT is available in different projections, heights, and volumes to meet various patient needs.

First MDR-Certified Breast Implant

Carlos Reis Pinto, CEO at GC Aesthetics, endorsed Luna XT, stating: “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.” 

Fara Naomi Macías, chief marketing officer of GCA, also spoke out about Luna XT: “It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women. We are committed to delivering 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.”