Study of the Safety and Effectiveness of Motiva Implants®
1 other identifier
interventional
800
3 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2018
CompletedFirst Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2033
November 12, 2025
November 1, 2025
14.4 years
April 12, 2018
November 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Kaplan-Meier analysis of all complications, including reoperation and explantation
10 Years
Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture
10 Years
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
- +4 more secondary outcomes
Study Arms (4)
Primary Breast Augmentation
OTHERSubjects age 22 and over, indicated to increase breast size
Primary Breast Reconstruction
OTHERSubjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly.
Revision Augmentation
OTHERRevision surgery to correct or improve the results of a previous breast augmentation
Revision Reconstruction
OTHERRevision surgery to correct or improve the results of a previous breast reconstruction.
Interventions
Breast augmentation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Motiva USA LLClead
Study Sites (29)
Gerald Minitti, MD, FACS
Beverly Hills, California, 90212, United States
Steven Teitelbaum, MD, FACS
Santa Monica, California, 90404, United States
Westlake Cosmetic Surgery Center
Westlake Village, California, 91361, United States
The Center for Cosmetic Surgery
Golden, Colorado, 80401, United States
Emory University Hospital
Atlanta, Georgia, 30308, United States
Northwestern Plastic Surgery
Chicago, Illinois, 60611, United States
Northwestern Specialists in Plastic Surgery, S.C.
Chicago, Illinois, 60611, United States
Meridian Plastic Surgery Center
Indianapolis, Indiana, 46290, United States
CaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, 40222, United States
The Wall Center for Plastic Surgery
Shreveport, Louisiana, 71105, United States
Partners in Plastic Surgery of West Michigan
Grand Rapids, Michigan, 49546, United States
Parkcrest Plastic Surgery
St Louis, Missouri, 63141, United States
Glicksman Plastic Surgery
Sea Girt, New Jersey, 08750, United States
Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery
Hauppauge, New York, 11788, United States
NYU Plastic Surgery Associates
New York, New York, 10017, United States
May Center for Mount Sinai Doctors
New York, New York, 10029, United States
Fifth Avenue Millennium Aesthetic Surgery, PLLC
New York, New York, 10128, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, Oregon, 97401, United States
Portland Plastic Surgery
Portland, Oregon, 97209, United States
Body by Z
Providence, Rhode Island, 02903, United States
Maxwell Aesthetics, PLLC
Nashville, Tennessee, 37212, United States
Strock Plastic Surgery
Fort Worth, Texas, 76104, United States
Houston Methodist
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
William P. Adams Plastic Surgery
University Park, Texas, 75205, United States
PeaceHealth Plastic Surgery
Vancouver, Washington, 98664, United States
Plastische Chirurgie im Medienhafen
Düsseldorf, 40221, Germany
Victoriakliniken
Stockholm, 13336, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
July 9, 2018
Study Start
April 6, 2018
Primary Completion (Estimated)
August 30, 2032
Study Completion (Estimated)
February 28, 2033
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share