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Motiva implants under the microscope: 2400 women tracked for safety

NCT ID NCT06938399

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study follows 2400 women who receive Motiva breast implants for cosmetic breast augmentation or revision. Researchers will monitor for signs of connective tissue disease, cancer, reproductive issues, and local complications over time. The goal is to confirm the implants' safety and patient satisfaction in real-world use.

What this could mean

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

Active substance
Motiva SmoothSilk silicone gel-filled breast implants
What this could lead to
If successful, this study will confirm the long-term safety and performance of Motiva breast implants for cosmetic and revision procedures.
What could go wrong
This is an observational post-approval study, not a controlled trial. Results may show rare complications or no clear benefit over other implants.

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 2,400 people

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

Started

May 2025

Expected to finish

Jul 2037

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

22 years and older

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 Motiva Implants®: * Female * Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation * Patient has adequate tissue available to cover implant(s) * Willingness to follow all study requirements * Signs an Informed Consent * Agrees to have device returned to the Sponsor, if explanted * Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised Inclusion Criteria Control group: * Is 22 years of age or older * Female * Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift) * Signs an Informed Consent * Willingness to follow all study requirements Exclusion Criteria Motiva Implants®: * Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 * Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing) * Has an active infection anywhere in their body * 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 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 Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) Exclusion Criteria Control group: * Has a history of silicone implants (anywhere in the body) * Plans to undergo silicone breast implant surgery during the course of the study * Has an active infection anywhere in their body * Has a history of cancer (except skin cancer) * 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

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Conditions

The condition(s) this trial relates to.

breast implant illness

As listed by the trial registrant

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

Breast implant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    33 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AESTHETX Center

    RECRUITING

    Camp Pendleton, California, 95008, United States

  • Advanced Plastic Surgery, LLC

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Aesthetic Center for Plastic Surgery

    RECRUITING

    Houston, Texas, 77024, United States

  • Alicia Billington Plastic Surgery LLC

    RECRUITING

    St. Petersburg, Florida, 33712, United States

  • Align Surgical Associates Inc

    RECRUITING

    San Francisco, California, 94115, United States

    Contact Email: •••••@•••••

  • Austin Plastic Surgeon

    RECRUITING

    Austin, Texas, 78758, United States

  • Belcara Health

    RECRUITING

    Baltimore, Maryland, 21209, United States

  • CaloAesthetics® Plastic Surgery Center

    RECRUITING

    Louisville, Kentucky, 40222, United States

    Contact Email: •••••@•••••

  • Capizzi, MD Cosmetic Surgery & Med Spa

    RECRUITING

    Charlotte, North Carolina, 28203, United States

    Contact Email: •••••@•••••

  • Careaga Plastic Surgery

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • Caroline A. Glicksman MD

    RECRUITING

    Sea Girt, New Jersey, 08750, United States

  • Center for Plastic Surgery

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • Dallas Day Surgery of Texas North

    RECRUITING

    Dallas, Texas, 75231, United States

  • Delaware Valley Plastic Surgery

    RECRUITING

    Cherry Hill, New Jersey, 08003, United States

  • HKB Cosmetic Surgery

    RECRUITING

    Charlotte, North Carolina, 28078, United States

  • Iteld Plastic Surgery

    RECRUITING

    Chicago, Illinois, 60642, United States

    Contact Email: •••••@•••••

  • J. Gerald Minniti, M.D., F.A.C.S.

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Jones Plastic Surgery

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Kristy Hamilton MD, FACS

    RECRUITING

    Houston, Texas, 77027, United States

    Contact Email: •••••@•••••

  • Landis Platic Surgery

    RECRUITING

    Tulsa, Oklahoma, 74114, United States

  • Los Gatos Plastic Surgery

    RECRUITING

    Los Gatos, California, 95032, United States

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

    RECRUITING

    Hauppauge, New York, 11788, United States

  • Neinstein Plastic Surgery

    RECRUITING

    New York, New York, 10019, United States

  • North Texas Plastic Surgery

    RECRUITING

    Southlake, Texas, 76092, United States

  • Parkcrest Plastic Surgery

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Renee Burke Plastic Surgery, Aesthetics, & Med Spa

    RECRUITING

    South Barrington, Illinois, 60010, United States

  • Restora Austin Plastic Surgery Center

    RECRUITING

    Austin, Texas, 78705, United States

  • Schwartz Aesthetic Institute

    RECRUITING

    Westlake Village, California, 91361, United States

  • Southwest Plastic Surgery

    RECRUITING

    El Paso, Texas, 79936, United States

  • The Center for Cosmetic Surgery

    RECRUITING

    Denver, Colorado, 80401, United States

  • The Plastics Clinic & SPA

    RECRUITING

    South Jordan, Utah, 84095, United States

  • The Practice Healthcare

    RECRUITING

    Beverly Hills, California, 90210, United States

  • The Wall Center for Plastic Surgery

    RECRUITING

    Shreveport, Louisiana, 71105, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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