Long-term follow-up of Motiva silicone breast implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Practice Healthcare
  Beverly Hills, California, United States Recruiting
• J. Gerald Minniti, M.D., F.A.C.S.
  Beverly Hills, California, United States Recruiting
• AESTHETX Center
  Camp Pendleton, California, United States Recruiting
• Los Gatos Plastic Surgery
  Los Gatos, California, United States Recruiting
• Align Surgical Associates Inc
  San Francisco, California, United States Recruiting
• Schwartz Aesthetic Institute
  Westlake Village, California, United States Recruiting

Study contacts

• Study coordinator: Motiva USA LLC
• Email: CIP-001005+enrollment@establishmentlabs.com
• Phone: +506 86263002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.