Observational Study Evaluating Eurosilicone Luna Silicone Breast Implants in Women Aged 18 to 65 Undergoing Breast Augmentation or Reconstruction

What this Trial Is About

Researchers are observing the outcomes of Eurosilicone Luna breast implants in women aged 18 to 65 undergoing breast augmentation or reconstruction. This study aims to determine the frequency and rate of implant rupture and capsular contracture Baker III-IV over a 10-year period after surgery. It includes women undergoing primary or revision surgeries for cosmetic or medical reasons, including reconstruction after mastectomy, with or without associated therapies. Participants receive breast implant surgeries performed according to the surgeons preference, including choices about incision location and implant placement. The study covers primary or revision breast augmentation with or without mastopexy and breast reconstruction that may be immediate or delayed, with possible chemotherapy or radiotherapy. The implants studied are the Eurosilicone Luna mammary implants. No treatments are assigned by the study, as it is observational. During the 10-year follow-up, participants will have regular assessments to track implant rupture, capsular contracture, local complications, and any secondary surgeries needed. Researchers will also evaluate patient satisfaction. Monitoring includes clinical evaluations and adherence to follow-up appointments as per the study protocol. The total participation duration spans 10 years to observe long-term outcomes and safety.

A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants