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NCT06938399NARecruitingAccepts Healthy Volunteers

Motiva Implants® Post-Approval Study

Motiva USA LLC

Start Date

5/1/2025

Completion Date

7/31/2037

Summary

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.

Detailed Description

Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.

Eligibility Criteria

Age Range: 22 years to No maximum

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

Interventions

DEVICE

Silicone gel-filled breast implants - Motiva Implants®

OTHER

Aesthetic Surgery

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Breast Implant

Locations

The Practice Healthcare

Beverly Hills, California 90210

United States

J. Gerald Minniti, M.D., F.A.C.S.

Beverly Hills, California 90212

United States

AESTHETX Center

Camp Pendleton, California 95008

United States

Los Gatos Plastic Surgery

Los Gatos, California 95032

United States

Align Surgical Associates Inc

San Francisco, California 94115

United States

Schwartz Aesthetic Institute

Westlake Village, California 91361

United States

The Center for Cosmetic Surgery

Denver, Colorado 80401

United States

Advanced Plastic Surgery, LLC

Washington D.C., District of Columbia 20037

United States

Careaga Plastic Surgery

Coral Gables, Florida 33134

United States

Alicia Billington Plastic Surgery LLC

St. Petersburg, Florida 33712

United States

Iteld Plastic Surgery

Chicago, Illinois 60642

United States

Renee Burke Plastic Surgery, Aesthetics, & Med Spa

South Barrington, Illinois 60010

United States

CaloAesthetics® Plastic Surgery Center

Louisville, Kentucky 40222

United States

The Wall Center for Plastic Surgery

Shreveport, Louisiana 71105

United States

Belcara Health

Baltimore, Maryland 21209

United States

Center for Plastic Surgery

Chevy Chase, Maryland 20815

United States

Parkcrest Plastic Surgery

St Louis, Missouri 63141

United States

Delaware Valley Plastic Surgery

Cherry Hill, New Jersey 08003

United States

Caroline A. Glicksman MD

Sea Girt, New Jersey 08750

United States

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

Hauppauge, New York 11788

United States

Neinstein Plastic Surgery

New York, New York 10019

United States

HKB Cosmetic Surgery

Charlotte, North Carolina 28078

United States

Capizzi, MD Cosmetic Surgery & Med Spa

Charlotte, North Carolina 28203

United States

Jones Plastic Surgery

Oklahoma City, Oklahoma 73120

United States

Landis Platic Surgery

Tulsa, Oklahoma 74114

United States

Restora Austin Plastic Surgery Center

Austin, Texas 78705

United States

Austin Plastic Surgeon

Austin, Texas 78758

United States

Dallas Day Surgery of Texas North

Dallas, Texas 75231

United States

Southwest Plastic Surgery

El Paso, Texas 79936

United States

Aesthetic Center for Plastic Surgery

Houston, Texas 77024

United States

Kristy Hamilton MD, FACS

Houston, Texas 77027

United States

North Texas Plastic Surgery

Southlake, Texas 76092

United States

The Plastics Clinic & SPA

South Jordan, Utah 84095

United States