Motiva Implants® for Breast Enhancement

Recruiting at 43 trial locations

Overseen By Laura Vindas, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Motiva USA LLC

Must not be taking: Blood thinners

Disqualifiers: Breast disease, Pregnancy, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

800 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the safety and effectiveness of Motiva Implants® in women who want to enhance or rebuild their breasts. The implants are surgically inserted to improve breast appearance. The study will track patient outcomes over a long period. Motiva Implants have demonstrated excellent safety and effectiveness in primary breast augmentation over several years.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that interfere with blood clotting or increase surgical risks.

What safety data exists for Motiva Implants® used in breast enhancement?

Motiva Implants® have been studied for safety, showing some early complications like seroma (fluid buildup) occurring in 5.26% of cases, but no significant difference in overall complications compared to other implants. They are designed to reduce historical issues with breast implants, and studies suggest they have a longer survival rate compared to some other brands. ^{1 2 3 4 5}

How is the Motiva Implants® treatment different from other breast enhancement options?

Motiva Implants® are unique because they use advanced technology to create a smooth, cell-friendly surface that aims to improve both the look and safety of breast implants. This new design is part of the fifth generation of silicone gel-filled implants, which are engineered to optimize aesthetic outcomes and reduce complications compared to older implant types. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Motiva Implants® for breast enhancement?

Research shows that Motiva Implants® are designed to improve both the look and safety of breast enhancements. Studies have reported positive outcomes in terms of aesthetics and safety over several years, indicating their effectiveness in breast augmentation. ^{1 2 3 8 9}

Eligibility Criteria

This trial is for genetic females seeking breast augmentation, reconstruction, or revision surgery. Candidates must have enough tissue to cover the implants and be willing to follow study protocols, including MRI scans if needed. Exclusions include those with certain medical conditions, high surgical risks like obesity or diabetes, previous non-FDA approved implants, or a history of specific breast diseases.

Inclusion Criteria

I am willing to have an MRI if my doctor recommends it.

I am genetically female.

I am considering a breast surgery, either for the first time or as a revision.

Exclusion Criteria

I have an infection or abscess.

I am not on medication that affects blood clotting or increases surgery risks.

I have a condition like lupus, scleroderma, or rheumatoid arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary breast augmentation, primary breast reconstruction, or revision surgery using Motiva Implants®

Surgery and immediate recovery

Follow-up

Participants are monitored for safety, effectiveness, adverse events, reoperations, patient satisfaction, physician satisfaction, and quality of life

10 years

Treatment Details

Interventions

• Motiva Implants®

Trial Overview The safety and effectiveness of Motiva Implants® are being tested in women undergoing primary breast augmentation or reconstruction, as well as those having revision surgeries. The study monitors how these silicone gel-filled implants perform over time.

Participant Groups

Group I: Revision Reconstruction Experimental Treatment 1 Intervention

Revision surgery to correct or improve the results of a previous breast reconstruction.

Group II: Revision Augmentation Experimental Treatment 1 Intervention

Revision surgery to correct or improve the results of a previous breast augmentation

Group III: Primary Breast Reconstruction Experimental Treatment 1 Intervention

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.

Group IV: Primary Breast Augmentation Experimental Treatment 1 Intervention

Subjects age 22 and over, indicated to increase breast size

Who Is Running the Clinical Trial?

Motiva USA LLC

Lead Sponsor

Trials

2

Recruited

910+

References

1. England pubmed.ncbi.nlm.nih.gov

Six-Year Prospective Outcomes of Primary Breast Augmentation With Nano Surface Implants. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A single surgeon's experience with Motiva Ergonomix round SilkSurface silicone implants in breast reconstruction over a 5-year period. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A Single Center's Clinical Experience With Ergonomix Breast Implants. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Expert Consensus on the Use of a New Bioengineered, Cell-Friendly, Smooth Surface Breast Implant. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Motiva Ergonomix Round SilkSurface Silicone Breast Implants: Outcome Analysis of 100 Primary Breast Augmentations over 3 Years and Technical Considerations. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Complication Rates after Breast Surgery with the Motiva Smooth Silk Surface Silicone Gel Implants-A Systematic Review and Meta-Analysis. [2023]

7. Sweden pubmed.ncbi.nlm.nih.gov

Short-term treatment outcomes and safety of two representative brands of the fifth-generation silicone gel-filled breast implants in Korea. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

High-Resolution Ultrasound-Assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-Based Augmentation Mammaplasty Using a Bioengineered, Cell-Friendly, Smooth-Surface Device in Korean Females. [2023]