Breast Augmentation, Breast Augmentation and Breast Reconstruction, Breast Reconstruction, Breast Reconstruction, Revision Breast Reconstruction, Breast Reconstruction With Silicone Implants, Breast Revision-Augmentation
Conditions
Keywords
Luna XT, Anatomical breast implant, Mammary implant
Brief summary
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
PROCEDUREBreast augmentation surgery
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
PROCEDUREBreast reconstruction surgery
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Sponsors
GCA (Eurosilicone)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and rate of implant rupture | 10 years |
| Frequency and rate of capsular contracture Baker III-IV | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of the secondary surgical procedures required for correction of complications | 10 years | — |
| Rate and frequency of local complications | 10 years | 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 * Breast Implant Ilness (BII)/ Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (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 |
| Patient satisfaction | 10 years | This will be determined using a questionnaire assessing the qualify of life. |
Countries
France, Spain
Contacts
CONTACTGCA Clinical affairs department
Outcome results
None listed