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New breast implants under study: are they safer?

NCT ID NCT03579901

Disease control Sponsor: Motiva USA LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the safety and effectiveness of Motiva silicone gel-filled breast implants in 800 women having breast augmentation, reconstruction, or revision surgery. Researchers will track complications like rupture and capsular contracture, and measure patient satisfaction. The goal is to see if these implants are a reliable option for breast surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Motiva silicone gel-filled breast implants
What this could lead to
If successful, this could confirm that Motiva implants are a safe and effective option for breast augmentation or reconstruction.
What could go wrong
This is an observational device study, not a randomized trial. Complications like capsular contracture, rupture, or infection are possible, and long-term safety data are still being collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast implants

Contacts and locations

Locations

  • Body by Z

    Providence, Rhode Island, 02903, United States

  • CaloAesthetics® Plastic Surgery Center

    Louisville, Kentucky, 40222, United States

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • Emory University Hospital

    Atlanta, Georgia, 30308, United States

  • Fifth Avenue Millennium Aesthetic Surgery, PLLC

    New York, New York, 10128, United States

  • Gerald Minitti, MD, FACS

    Beverly Hills, California, 90212, United States

  • Glicksman Plastic Surgery

    Sea Girt, New Jersey, 08750, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery

    Hauppauge, New York, 11788, United States

  • Maxwell Aesthetics, PLLC

    Nashville, Tennessee, 37212, United States

  • May Center for Mount Sinai Doctors

    New York, New York, 10029, United States

  • Meridian Plastic Surgery Center

    Indianapolis, Indiana, 46290, United States

  • Movassaghi Plastic Surgery & Ziba Medical Spa

    Eugene, Oregon, 97401, United States

  • NYU Plastic Surgery Associates

    New York, New York, 10017, United States

  • Northwestern Plastic Surgery

    Chicago, Illinois, 60611, United States

  • Northwestern Specialists in Plastic Surgery, S.C.

    Chicago, Illinois, 60611, United States

  • Parkcrest Plastic Surgery

    St Louis, Missouri, 63141, United States

  • Partners in Plastic Surgery of West Michigan

    Grand Rapids, Michigan, 49546, United States

  • PeaceHealth Plastic Surgery

    Vancouver, Washington, 98664, United States

  • Plastische Chirurgie im Medienhafen

    Düsseldorf, 40221, Germany

  • Portland Plastic Surgery

    Portland, Oregon, 97209, United States

  • Steven Teitelbaum, MD, FACS

    Santa Monica, California, 90404, United States

  • Strock Plastic Surgery

    Fort Worth, Texas, 76104, United States

  • The Center for Cosmetic Surgery

    Golden, Colorado, 80401, United States

  • The Wall Center for Plastic Surgery

    Shreveport, Louisiana, 71105, United States

  • Victoriakliniken

    Stockholm, 13336, Sweden

  • Westlake Cosmetic Surgery Center

    Westlake Village, California, 91361, United States

  • William P. Adams Plastic Surgery

    University Park, Texas, 75205, United States

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