Study of the Safety and Effectiveness of Motiva Implants®

Running, not enrolling · Not applicable

Conditions studied: Breast Implants

In brief

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Key facts

Study ID

NCT03579901

Run by

Motiva USA LLC

People needed

800

Starts

2018-04-06

Expected to finish

2033-02-28

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Gerald Minitti, MD, FACS — Beverly Hills, California, United States
• Steven Teitelbaum, MD, FACS — Santa Monica, California, United States
• Westlake Cosmetic Surgery Center — Westlake Village, California, United States
• The Center for Cosmetic Surgery — Golden, Colorado, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Plastic Surgery — Chicago, Illinois, United States
• Northwestern Specialists in Plastic Surgery, S.C. — Chicago, Illinois, United States
• Meridian Plastic Surgery Center — Indianapolis, Indiana, United States
• CaloAesthetics® Plastic Surgery Center — Louisville, Kentucky, United States
• The Wall Center for Plastic Surgery — Shreveport, Louisiana, United States
• Partners in Plastic Surgery of West Michigan — Grand Rapids, Michigan, United States
• Parkcrest Plastic Surgery — St Louis, Missouri, United States
• Glicksman Plastic Surgery — Sea Girt, New Jersey, United States
• Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery — Hauppauge, New York, United States
• NYU Plastic Surgery Associates — New York, New York, United States
• May Center for Mount Sinai Doctors — New York, New York, United States
• Fifth Avenue Millennium Aesthetic Surgery, PLLC — New York, New York, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• Movassaghi Plastic Surgery & Ziba Medical Spa — Eugene, Oregon, United States
• Portland Plastic Surgery — Portland, Oregon, United States
• Body by Z — Providence, Rhode Island, United States
• Maxwell Aesthetics, PLLC — Nashville, Tennessee, United States
• Strock Plastic Surgery — Fort Worth, Texas, United States
• Houston Methodist — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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