Breast Implants
Conditions
Brief summary
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.
Detailed description
This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.
Interventions
DEVICELight Weight Breast Implants
Light Weight Breast Implants
Sponsors
Bnai Zion Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Genetic women at ages 18 to 65 seeking breast enlargement * Signed informed consent * Agreement to complete all required follow up visits * A medically acceptable candidate * Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)
Exclusion criteria
* Patients with active infection anywhere in their body * Women who are currently pregnant or nursing * Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization * Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases * Patients with a history of psychiatric treatment * Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants) * Expected allergies or extraordinary immune response to implants * Wound healing impairments or heavy burn scars * Existing costal injuries * The Patient Participated in an investigational trial within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No reoperation | during 6 months follow up period |
Secondary
| Measure | Time frame |
|---|---|
| Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed. | 6 month |
Countries
Israel
Outcome results
None listed