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Motiva Implants® Post-Approval Study

Motiva USA LLC · NCT06938399

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
2400
US sites recruiting
33
Study start
May 1, 2025
Record last updated
July 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.

Being studied: Silicone gel-filled breast implants - Motiva Implants®; Aesthetic Surgery

Conditions: Breast Implant

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • The Practice Healthcare

    Beverly Hills, CA 90210

    Site contact: Holly Contreras · hollyc@thepracticehealthcare.com

  • J. Gerald Minniti, M.D., F.A.C.S.

    Beverly Hills, CA 90212

    Site contact: Samantha Miles · 310-275-004 · samantha@drminniti.com

  • AESTHETX Center

    Camp Pendleton, CA 95008

    Site contact: Kamakshi Zeidler, MD, FACS · 408-559-7177 · drz@aesthetx.com

  • Los Gatos Plastic Surgery

    Los Gatos, CA 95032

    Site contact: Emily McMaster · 408-559-7177 · emily@sviaplasticsurgery.com

  • Align Surgical Associates Inc

    San Francisco, CA 94115

    Site contact: Thomas Satterwhite, MD · Office@AlignSurgical.com

  • Schwartz Aesthetic Institute

    Westlake Village, CA 91361

    Site contact: Stephanie Cohen, RN · 805-706-0742 · rn@drschwartz.com

  • The Center for Cosmetic Surgery

    Denver, CO 80401

    Site contact: Jen Atkinson · 303-907-0077 · leads@denverccs.com

  • Advanced Plastic Surgery, LLC

    Washington D.C., DC 20037

    Site contact: Troy Pittman, MD, FACS · 202-915-2362 · drpittman@spmeddc.com

  • Careaga Plastic Surgery

    Coral Gables, FL 33134

    Site contact: Barbara Garcia · 305-960-7511 · bgarcia@absolutemedicalcenter.com

  • Alicia Billington Plastic Surgery LLC

    St. Petersburg, FL 33712

    Site contact: Alicia Billington MD · 727 341 0337 · Alicia@billingtonmd.com

  • Iteld Plastic Surgery

    Chicago, IL 60642

    Site contact: Lawrence Iteld MD · 312-757-4505 · Info@driteld.com

  • Renee Burke Plastic Surgery, Aesthetics, & Med Spa

    South Barrington, IL 60010

    Site contact: Luiza Ramanoska · 847-382-4400 · luiza@reneeburkemd.com

  • CaloAesthetics® Plastic Surgery Center

    Louisville, KY 40222

    Site contact: Michael Bradley Calobrace, MD, FACS · 502-814-3016 · SurgeryCoordinators@calobrace.com

  • The Wall Center for Plastic Surgery

    Shreveport, LA 71105

    Site contact: Terry Brantley · 318-795-0801 · info@wallcenter.com

  • Belcara Health

    Baltimore, MD 21209

    Site contact: Sarah McMillan, MD · (410) 296-0414 · drmcmillan@belcarahealth.com

  • Center for Plastic Surgery

    Chevy Chase, MD 20815

    Site contact: Diana Altman, RN · 301-888-7264 · Diana@cpsdocs.com

  • Parkcrest Plastic Surgery

    St Louis, MO 63141

    Site contact: Patricia McGuire, MD, FACS · 314-569-0130 · jodig@parkcrestplasticsurgery.com

  • Delaware Valley Plastic Surgery

    Cherry Hill, NJ 08003

    Site contact: Evan Sorokin, MD · 856-797-0202 · esorokin@delawarevalleyplasticsurgery.com

  • Caroline A. Glicksman MD

    Sea Girt, NJ 08750

    Site contact: Caroline Glicksman, MD, FACS · drglicksman.office@gmail.com

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

    Hauppauge, NY 11788

    Site contact: Kimberly Wagner · 631-689-1100 · kwagner@epsteinplasticsurgery.com

  • Neinstein Plastic Surgery

    New York, NY 10019

    Site contact: Anne Steve, MD · 212-249-0949 · mimi@neinsteinplasticsurgery.com

  • HKB Cosmetic Surgery

    Charlotte, NC 28078

    Site contact: Devin B. White · 704-659-9000 · devin@hkbsurgery.com

  • Capizzi, MD Cosmetic Surgery & Med Spa

    Charlotte, NC 28203

    Site contact: Peter Capizzi, MD, FACS · 704-655-8988 · patientcare@capizzimd.com

  • Jones Plastic Surgery

    Oklahoma City, OK 73120

    Site contact: Lori Podany, RN · (405) 848-3459 · nurse@drjustinjones.com

  • Landis Platic Surgery

    Tulsa, OK 74114

    Site contact: Dana Mulvey · dana@landisplasticsurgery.com

  • Restora Austin Plastic Surgery Center

    Austin, TX 78705

    Site contact: Ashley Gordon, MD, FACS · 512-371-8817 · ashleygordonmd@gmail.com

  • Austin Plastic Surgeon

    Austin, TX 78758

    Site contact: Johnny Franco, MD · 512-334-9917 · Jchervanik@morebeautifulyou.com

  • Dallas Day Surgery of Texas North

    Dallas, TX 75231

    Site contact: Barbie Reed, RN · barbie.reed@dpsi.org

  • Southwest Plastic Surgery

    El Paso, TX 79936

    Site contact: Marcela Aguilar · 915-590-7900 · marcy@swplasticsurgery.com

  • Aesthetic Center for Plastic Surgery

    Houston, TX 77024

    Site contact: Kirk Zihlman Clinical Research Director · 832-647-3417 · kzihlman@kalonaesthetics.com

  • Kristy Hamilton MD, FACS

    Houston, TX 77027

    Site contact: Liliana Hernandez · 713-770-6257 · info@drkristyhamilton.com

  • North Texas Plastic Surgery

    Southlake, TX 76092

    Site contact: Sandy Roos, MD · 817-587-0884 · sandy@northtexasps.com

  • The Plastics Clinic & SPA

    South Jordan, UT 84095

    Site contact: KinCaid Fajardo · 801-839-5557 · kincaid@theplasticsclinic.com

Study contacts (from the official record)

  • Motiva USA LLC · +506 86263002 · CIP-001005+enrollment@establishmentlabs.com
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Motiva Implants® Post-Approval Study (NCT06938399) | Bored Studies