Breast Implants
Conditions
Keywords
Breast Implants, Breast Surgery, Breast Augmentation, Breast Reconstruction
Brief summary
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
Detailed description
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
Interventions
DEVICESilicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Sponsors
Motiva USA LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Multicenter Single arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Genetic female. * Patient is seeking one of the following procedures: Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction * Patient has adequate tissue available to cover implant(s). * Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent. * Agrees to have device returned to Establishment Labs if explanted. * Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.
Exclusion criteria
* Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type. * Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing). * Has an abscess or infection. * Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment. * Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications. * Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications. * Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others. * Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited. * Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure. * Has been implanted with any non-FDA approved breast implant. * Has been implanted with any silicone implant other than breast implants. * HIV positive (based on medical history). * Has been diagnosed with anaplastic large cell lymphoma (ALCL). * Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analyze and report the total adverse events rate (any complication) of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event. | 10 Years |
| Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups. | 10 Years |
Secondary
| Measure | Time frame |
|---|---|
| Kaplan-Meier analysis of rupture. | 10 Years |
| Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms | 10 Years |
| Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others) | 10 Years |
| Kaplan-Meier analysis of all complications, including reoperation and explantation | 10 Years |
| Physician Satisfaction (5-point Likert scale) | 10 Years |
| Validated Quality of Life questionnaires | 10 Years |
| Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline | 10 Years |
| Patient Satisfaction with Breast (BREAST-Q™) Questionnaire | 10 Years |
| Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture | 10 Years |
Countries
Germany, Sweden, United States
Outcome results
None listed