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Long-term follow-up of Motiva silicone breast implants

Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures

Not applicable Interventional Motiva USA LLC · NCT06938399

This project sees if Motiva silicone breast implants are safe and work well over up to 10 years for adult women having primary or revision breast augmentation.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2400 (estimated)
Ages22 Years and up
SexFemale
SponsorMotiva USA LLC Industry-sponsored
Drugs / interventionsradiation
Locations29 sites (Beverly Hills, California and 28 other locations)
Trial IDNCT06938399 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, multicenter post-market follow-up that collects baseline, operative, and annual postoperative data through years 1–10. Participants receiving Motiva silicone gel implants are tracked for safety and device performance, with imaging (CT, ultrasound, or MRI) used when medically advised and explanted devices returned to the sponsor. A control cohort of adult women undergoing other aesthetic surgeries is enrolled for comparison of outcomes. Data will be used to characterize real-world device performance outside of premarket clinical trials.

Who should consider this trial

Good fit: Adult women (22 years and older for implant recipients) seeking primary or revision breast augmentation with adequate tissue coverage who are willing to follow study procedures and provide informed consent are ideal candidates, with a separate control group of adult women undergoing elective aesthetic surgery.

Not a fit: People under 22, those with pre-malignant breast disease or other exclusionary medical conditions, men, or anyone unwilling to comply with follow-up or imaging requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could provide clearer long-term safety and complication data to help patients and surgeons make better-informed implant choices.

How similar studies have performed: Other post-market registries and long-term follow-ups of silicone breast implants have provided useful safety information, but implant-specific long-term data vary and Motiva-specific published outcomes are more limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Beverly Hills, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast ImplantBreast ImplantsBreast SurgeryBreast AugmentationBreast RevisionSilicone Implants
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.