Recruiting
Not applicable
Motiva Implants® Post-Approval Study
Condition(s) studied
Breast Implant
Investigational drug(s) / intervention(s)
Silicone gel-filled breast implants - Motiva Implants®Aesthetic Surgery
Silicone gel-filled breast implants - Motiva Implants®: Breast Surgery
Aesthetic Surgery: Aesthetic procedure other than breast implant surgery
Study 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.
Eligibility
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
Primary outcome measure(s)
- Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants — 10 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
Trial sites (33)
| Facility | City | Region | Status |
| The Practice Healthcare |
Beverly Hills |
California |
Recruiting |
| J. Gerald Minniti, M.D., F.A.C.S. |
Beverly Hills |
California |
Recruiting |
| AESTHETX Center |
Camp Pendleton |
California |
Recruiting |
| Los Gatos Plastic Surgery |
Los Gatos |
California |
Recruiting |
| Align Surgical Associates Inc |
San Francisco |
California |
Recruiting |
| Schwartz Aesthetic Institute |
Westlake Village |
California |
Recruiting |
| The Center for Cosmetic Surgery |
Denver |
Colorado |
Recruiting |
| Advanced Plastic Surgery, LLC |
Washington D.C. |
District of Columbia |
Recruiting |
| Careaga Plastic Surgery |
Coral Gables |
Florida |
Recruiting |
| Alicia Billington Plastic Surgery LLC |
St. Petersburg |
Florida |
Recruiting |
| Iteld Plastic Surgery |
Chicago |
Illinois |
Recruiting |
| Renee Burke Plastic Surgery, Aesthetics, & Med Spa |
South Barrington |
Illinois |
Recruiting |
| CaloAesthetics® Plastic Surgery Center |
Louisville |
Kentucky |
Recruiting |
| The Wall Center for Plastic Surgery |
Shreveport |
Louisiana |
Recruiting |
| Belcara Health |
Baltimore |
Maryland |
Recruiting |
| Center for Plastic Surgery |
Chevy Chase |
Maryland |
Recruiting |
| Parkcrest Plastic Surgery |
St Louis |
Missouri |
Recruiting |
| Delaware Valley Plastic Surgery |
Cherry Hill |
New Jersey |
Recruiting |
| Caroline A. Glicksman MD |
Sea Girt |
New Jersey |
Recruiting |
| Mark D. Epstein, MD, FACS Center for Aesthetic Surgery |
Hauppauge |
New York |
Recruiting |
| Neinstein Plastic Surgery |
New York |
New York |
Recruiting |
| HKB Cosmetic Surgery |
Charlotte |
North Carolina |
Recruiting |
| Capizzi, MD Cosmetic Surgery & Med Spa |
Charlotte |
North Carolina |
Recruiting |
| Jones Plastic Surgery |
Oklahoma City |
Oklahoma |
Recruiting |
| Landis Platic Surgery |
Tulsa |
Oklahoma |
Recruiting |
| Restora Austin Plastic Surgery Center |
Austin |
Texas |
Recruiting |
| Austin Plastic Surgeon |
Austin |
Texas |
Recruiting |
| Dallas Day Surgery of Texas North |
Dallas |
Texas |
Recruiting |
| Southwest Plastic Surgery |
El Paso |
Texas |
Recruiting |
| Aesthetic Center for Plastic Surgery |
Houston |
Texas |
Recruiting |
| Kristy Hamilton MD, FACS |
Houston |
Texas |
Recruiting |
| North Texas Plastic Surgery |
Southlake |
Texas |
Recruiting |
| The Plastics Clinic & SPA |
South Jordan |
Utah |
Recruiting |
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