Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants. This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant. The two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter. The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications

NCT Number	NCT06013514
Lead Sponsor	GCA (Eurosilicone)
Conditions	Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction After Mastectomy, Breast Reconstruction Surgery, Breast Implants
Enrollment	60 participants
Start Date	2024-06-01
Primary Completion	2038-09 (estimated)
Study Completion	2038-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-29