A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast augmentation surgery, Breast reconstruction surgery.
- Who it may be relevant to
- Registry conditions: Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Frequency and rate of implant rupture [Time frame: 10 years]
- Frequency and rate of capsular contracture Baker III-IV [Time frame: 10 years]
Secondary outcome measures (3)
- Rate of the secondary surgical procedures required for correction of complications [Time frame: 10 years]
- Rate and frequency of local complications [Time frame: 10 years]
- Patient satisfaction [Time frame: 10 years]
Eligibility criteria
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:
- Genetic female subjects aged between 18 and 65 years old.
- 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:
- Subjects with a BMI >35.
- 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.
- 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.
- 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.
- 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.
- Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
- 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.
- Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
- Subjects with a known history of compromised wound healing.
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants.
- Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Dr Guillaume Lasserre — Villefranche-sur-Saône
Spain · 1 center
- DScultp Clinic — Barcelona
Identifiers
NCT: NCT07679594 · CLA-0007