Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesthetic indications | Primary or revision breast augmentation with or without mastopexy. |
| |
| Medical indications | Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast augmentation surgery | Procedure | The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and rate of implant rupture | 10 years | |
| Frequency and rate of capsular contracture Baker III-IV | 10 years |
| 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:
|
Not provided
Inclusion Criteria:
Inclusion criteria are:
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:
Genetic female.
Patients from centers participating to the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GCA Clinical affairs department | Contact | +33 783326098 | luna10PMCF@gcaesthetics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Guillaume Lasserre | Recruiting | Villefranche-sur-SaƓne | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Breast reconstruction surgery | Procedure | The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications. |
|
|
| 10 years |
| Patient satisfaction | This will be determined using a questionnaire assessing the qualify of life. | 10 years |
| DScultp Clinic | Recruiting | Barcelona | Spain |
|