Motiva Implants for Breast Augmentation

(Motiva PAS Trial)

Overseen By Sofia Chaves-Chen, PharmD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Motiva USA LLC

Must not be taking: Blood thinners

Disqualifiers: Breast disease, Obesity, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

2400 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

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 might cause significant complications after surgery.

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

Research shows that Motiva Implants® are designed with advanced technology to improve both the look and safety of breast augmentation. Studies have reported positive outcomes over several years, indicating that these implants are effective for enhancing breast appearance. ^{1 2 3 4 5}

Is it safe to use Motiva Implants for breast augmentation?

Motiva Implants have been studied for safety, showing some early complications like seroma (fluid buildup) in a small percentage of cases, but overall, they have a good safety profile compared to other implants. They are designed to reduce historical complications associated with breast implants. ^{1 2 5 6 7}

What makes Motiva Implants unique for breast augmentation?

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 augmentation. This novel design is part of the fifth generation of silicone gel-filled implants, which distinguishes them from older, more traditional implants. ^{1 2 3 5 8}

What is the purpose of this trial?

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 Criteria

This clinical trial is open to individuals seeking breast implants for aesthetic surgery. Specific eligibility criteria are not detailed, but typically participants must be in good health and have realistic expectations about the outcomes of implant surgery.

Inclusion Criteria

I am female.

Willingness to follow all study requirements

Signs an Informed Consent

Exclusion Criteria

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

Implanted with any silicone implant other than breast implants

Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline (Preoperative)

Collection of baseline data before the surgical procedure

1 week

Operative

Surgical procedure for breast augmentation or revision

1 day

Postoperative

Postoperative data collection and monitoring

10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Treatment Details

Interventions

• Motiva Implants®

Trial Overview The study focuses on the use and safety of Motiva Implants®, which are silicone gel-filled breast implants. It aims to collect data on their performance and patient experiences after they've been marketed.

Participant Groups

Group I: Revision Augmentation Experimental Treatment 1 Intervention

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

Group II: Primary Augmentation Experimental Treatment 1 Intervention

Subjects age 22 and over, indicated to increase breast size

Group III: Control Group Experimental Treatment 1 Intervention

Aesthetic procedure other than breast implant surgery

Who Is Running the Clinical Trial?

Motiva USA LLC

Lead Sponsor

Trials

2

Recruited

910+

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

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. 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]