800 Participants Needed

Motiva Implants® for Breast Enhancement

Recruiting at 43 trial locations
AV
RM
LV
Overseen ByLaura Vindas, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Motiva USA LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.12345

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.12367

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.12389

Are You a Good Fit for This Trial?

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.
See 3 more

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Revision ReconstructionExperimental Treatment1 Intervention
Revision surgery to correct or improve the results of a previous breast reconstruction.
Group II: Revision AugmentationExperimental Treatment1 Intervention
Revision surgery to correct or improve the results of a previous breast augmentation
Group III: Primary Breast ReconstructionExperimental Treatment1 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 AugmentationExperimental Treatment1 Intervention
Subjects age 22 and over, indicated to increase breast size

Find a Clinic Near You

Who Is Running the Clinical Trial?

Motiva USA LLC

Lead Sponsor

Trials
2
Recruited
910+

Citations

Six-Year Prospective Outcomes of Primary Breast Augmentation With Nano Surface Implants. [2020]
A single surgeon's experience with Motiva Ergonomix round SilkSurface silicone implants in breast reconstruction over a 5-year period. [2023]
A Single Center's Clinical Experience With Ergonomix Breast Implants. [2022]
Expert Consensus on the Use of a New Bioengineered, Cell-Friendly, Smooth Surface Breast Implant. [2021]
Motiva Ergonomix Round SilkSurface Silicone Breast Implants: Outcome Analysis of 100 Primary Breast Augmentations over 3 Years and Technical Considerations. [2021]
Complication Rates after Breast Surgery with the Motiva Smooth Silk Surface Silicone Gel Implants-A Systematic Review and Meta-Analysis. [2023]
Short-term treatment outcomes and safety of two representative brands of the fifth-generation silicone gel-filled breast implants in Korea. [2021]
Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study. [2022]
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]
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