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

A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.

The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction, Revision Breast Reconstruction; Breast Augmentation; Breast Reconstruction; Breast Revision-Augmentation; Breast Reconstruction With Silicone Implants; Breast Augmentation and Breast Reconstruction
• Intervention / Treatment: Procedure: Breast augmentation surgery; Procedure: Breast reconstruction surgery

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: GCA Clinical affairs department; Phone Number: +33 783326098; Email: luna10PMCF@gcaesthetics.com

Study Locations

• France
  • Villefranche-sur-Saône, France
    • Recruiting
    • Dr Guillaume Lasserre
    • Contact: Dr Guillaume Lasserre; Email: dr.lasserre.guillaume@orange.fr
    • Principal Investigator: Guillaume Lasserre
• Spain
  • Barcelona, Spain
    • Recruiting
    • DScultp Clinic
    • Contact: Dr David Sanz; Email: administracion@plasticabarcelona.com
    • Principal Investigator: David Sanz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients from centers participating to the study.

Description

Inclusion Criteria:

• The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.

Inclusion criteria are:

1. Genetic female subjects aged between 18 and 65 years old.
2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:

i. Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs (synthetic or natural).

ii. Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.

Exclusion criteria are:

1. Subjects with a BMI >35.
2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
3. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.
4. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
5. Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.
6. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
7. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.
8. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
9. Subjects with a known history of compromised wound healing.
10. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
11. Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants.
12. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aesthetic indications; Primary or revision breast augmentation with or without mastopexy.	Procedure: Breast augmentation surgery; The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.; Other Names: Cosmetic breast implant surgery; Aesthetic breast implant surgery
Medical indications; Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy.	Procedure: Breast reconstruction surgery; The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.; Other Names: Immediate breast reconstruction; Delayed breast reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency and rate of implant rupture	10 years
Frequency and rate of capsular contracture Baker III-IV	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of the secondary surgical procedures required for correction of complications		10 years
Rate and frequency of local complications	These complications may be related to the device itself or to the surgical procedure: Capsular contracture of Baker Grade I-II; Haematoma; Rupture; Seroma; Severe and continuing pain; Post-operative infection; Explantation as a result of infection; Implant displacement/extrusion; Implant misplacement/malrotation; Wrinkling/folds; Breast Implant Associate Anaplastic Large Cell Lymphoma; BII/Asia; Delayed or abnormal wound healing occurring within the first 3 months of surgery; Any other complications considered by the Investigator to be related to the device or surgical procedure	10 years
Patient satisfaction	This will be determined using a questionnaire assessing the qualify of life.	10 years

Collaborators and Investigators

• Sponsor: GCA (Eurosilicone)

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Luna XT; Anatomical breast implant; Mammary implant
• Other Study ID Numbers: CLA-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No