Breast ImplantsNCT03579901
Study of the Safety and Effectiveness of Motiva Implants®
A study testing Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants in people with Breast Implants, run by Motiva USA LLC at 29 sites in 3 countries.
Trial summary
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implants
- What is being tested?
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 6 Apr 2018to 28 Feb 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Genetic female.
- Patient is seeking one of the following procedures:
- Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction
- Patient has adequate tissue available to cover implant(s).
- Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
- Agrees to have device returned to Establishment Labs if explanted.
- Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.
Who cannot join
- Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
- Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
- Has an abscess or infection.
- 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.
Show all 14Show fewer
- Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others.
- Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
- 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 anaplastic large cell lymphoma (ALCL).
- Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States27 sites
Emory University Hospital
Atlanta, Georgia, 30308
Gerald Minitti, MD, FACS
Beverly Hills, California, 90212
Northwestern Plastic Surgery
Chicago, Illinois, 60611
Northwestern Specialists in Plastic Surgery, S.C.
Chicago, Illinois, 60611
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, Oregon, 97401
Strock Plastic Surgery
Fort Worth, Texas, 76104
The Center for Cosmetic Surgery
Golden, Colorado, 80401
Partners in Plastic Surgery of West Michigan
Grand Rapids, Michigan, 49546
Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery
Hauppauge, New York, 11788
Houston Methodist
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Meridian Plastic Surgery Center
Indianapolis, Indiana, 46290
CaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, 40222
Maxwell Aesthetics, PLLC
Nashville, Tennessee, 37212
NYU Plastic Surgery Associates
New York, New York, 10017
May Center for Mount Sinai Doctors
New York, New York, 10029
Fifth Avenue Millennium Aesthetic Surgery, PLLC
New York, New York, 10128
Portland Plastic Surgery
Portland, Oregon, 97209
Body by Z
Providence, Rhode Island, 02903
Steven Teitelbaum, MD, FACS
Santa Monica, California, 90404
Glicksman Plastic Surgery
Sea Girt, New Jersey, 08750
The Wall Center for Plastic Surgery
Shreveport, Louisiana, 71105
Parkcrest Plastic Surgery
St Louis, Missouri, 63141
William P. Adams Plastic Surgery
University Park, Texas, 75205
PeaceHealth Plastic Surgery
Vancouver, Washington, 98664
Westlake Cosmetic Surgery Center
Westlake Village, California, 91361
About this study
Official title: Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
Read the detailed description
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
- Conditions
- Breast Implants
- Being tested
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Keywords
- Breast Implants, Breast Surgery, Breast Augmentation, Breast Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsDevice
Breast augmentation
| Study group | Role | What they receive |
|---|---|---|
| Primary Breast Augmentation | Other | Subjects age 22 and over, indicated to increase breast size Receives: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants |
| Primary Breast Reconstruction | Other | Subjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly. Receives: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants |
| Revision Augmentation | Other | Revision surgery to correct or improve the results of a previous breast augmentation Receives: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants |
| Revision Reconstruction | Other | Revision surgery to correct or improve the results of a previous breast reconstruction. Receives: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
Measured: 10 Years
Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.
Measured: 10 Years
Secondary outcomes (9)
Kaplan-Meier analysis of all complications, including reoperation and explantation
Measured: 10 Years
Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture
Measured: 10 Years
Kaplan-Meier analysis of rupture.
Measured: 10 Years
Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms
Measured: 10 Years
Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)
Measured: 10 Years
Patient Satisfaction with Breast (BREAST-Q™) Questionnaire
Measured: 10 Years
Physician Satisfaction (5-point Likert scale)
Measured: 10 Years
Validated Quality of Life questionnaires
Measured: 10 Years
Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start6 Apr 2018
- Primary completion30 Aug 2032 (estimated)
- Study completion28 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Multicenter Single arm
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motiva USA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579901
- Sponsor's protocol ID
- CLIN-17-008
- Status last verified
- Nov 2025
- First submitted
- 12 Apr 2018
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
- ClinicalTrials.gov ID
- NCT03579901
- Acronym / sponsor ID
- CLIN-17-008
- Conditions
- Breast Implants
- Keywords
- Breast Implants, Breast Surgery, Breast Augmentation, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Motiva USA LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 30 Aug 2032 (estimated)
- Study completion
- 28 Feb 2033 (estimated)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
Detailed description
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multicenter Single arm
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Augmentation | Other | Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsSubjects age 22 and over, indicated to increase breast size |
| Primary Breast Reconstruction | Other | Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsSubjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly. |
| Revision Augmentation | Other | Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsRevision surgery to correct or improve the results of a previous breast augmentation |
| Revision Reconstruction | Other | Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsRevision surgery to correct or improve the results of a previous breast reconstruction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Genetic female.
- Patient is seeking one of the following procedures:
- Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction
- Patient has adequate tissue available to cover implant(s).
- Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
Key exclusion criteria (14 listed)
- Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
- Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
- Has an abscess or infection.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone gel-filled breast implants - Motiva Implants® Investigational breast implantsBreast augmentation | Device | Primary Breast Augmentation, Primary Breast Reconstruction, Revision Augmentation, Revision Reconstruction |
Primary outcome
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
Time frame: 10 Years
Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.
Time frame: 10 Years
9 secondary outcomes
Kaplan-Meier analysis of all complications, including reoperation and explantation
Time frame: 10 Years
Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture
Time frame: 10 Years
Kaplan-Meier analysis of rupture.
Time frame: 10 Years
Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms
Time frame: 10 Years
Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)
Time frame: 10 Years
Patient Satisfaction with Breast (BREAST-Q™) Questionnaire
Time frame: 10 Years
Physician Satisfaction (5-point Likert scale)
Time frame: 10 Years
Validated Quality of Life questionnaires
Time frame: 10 Years
Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants in people with Breast Implants, run by Motiva USA LLC at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event. (time frame: 10 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.