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Motiva Implants® Post-Approval Study for Breast Augmentation

This study is looking at the long-term safety of Motiva Implants®, a type of silicone gel-filled breast implant. Researchers want to see if people who receive these implants develop connective tissue disease (CTD) symptoms over 10 years, compared to people who have other aesthetic surgeries. You may be able to join if you are a woman aged 22 or older, seeking either a first-time breast augmentation or a revision (replacement) of existing breast implants, and have enough tissue to cover the implants. The study aims to enroll 2400 participants. The current recruitment status is unclear.

Study design
This is a prospective, non-randomized study involving 2400 participants across multiple centers.
What's involved
You would have data collected at baseline (before surgery), during surgery, and then annually for 10 years after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years after their surgery to monitor for connective tissue disease symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06938399

Motiva Implants® Post-Approval Study

Recruiting
NAAges 22+InterventionalTreatment
Motiva USA LLC
~2,400 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Silicone gel-filled breast implants - Motiva Implants®Aesthetic Surgery

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants
Measured over 10 Years

Conditions

Breast Implant

Explore related trials

Augmentation MammoplastyBreast Lesion

Where it's being run

33 sites across 15 states
Texas7
California6
Florida2
Illinois2
Maryland2
New Jersey2
New York2
North Carolina2

Who to contact

Motiva USA LLC
[email protected]
+506 86263002
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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)
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

What this trial measures

  • Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants10 Years

    Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey