Motiva Implants® for Breast Enhancement

Not currently recruiting at 45 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of Motiva Implants® (breast implants) for women seeking breast enhancement or reconstruction. It includes women undergoing their first breast augmentation, those needing reconstruction after breast tissue removal (such as after cancer), and those aiming to improve past surgery results. Suitable candidates have sufficient breast tissue to cover the implants and are willing to adhere to study requirements, including attending follow-up visits. As an unphased trial, this study provides a unique opportunity for women to contribute to research that could improve breast implant options and outcomes.

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 prior data suggests that Motiva Implants® are safe for breast enhancement?

A previous study showed that Motiva Implants® had low complication rates. The likelihood of issues, such as implant rupture, was only 0.2%. Capsular contracture, or hardening around the implant, occurred in about 0.4% of cases. Both surgeons and patients reported high satisfaction with the implants. These findings suggest that the implants are generally safe and well-tolerated by most individuals undergoing these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Motiva Implants® for breast enhancement because they offer several innovative features compared to traditional silicone or saline implants. Unlike conventional implants, Motiva Implants® incorporate a unique silicone gel called ProgressiveGel Plus™, which is designed to mimic the natural feel of breast tissue more closely. Additionally, these implants include a built-in microtransponder, known as Q Inside Safety Technology™, allowing for non-invasive verification of implant details without the need for surgery. These advancements aim to improve patient satisfaction and safety, making them a promising option in the field of breast reconstruction and augmentation.

What evidence suggests that Motiva Implants® are effective for breast enhancement?

Research has shown that Motiva Implants® are effective for breast enhancement. Studies have found low complication rates, ranging from 2.8% to 16.67%, depending on the type of surgery. Both patients and surgeons report high satisfaction with the results of these implants. This trial will evaluate Motiva Implants® in various contexts, including primary breast augmentation, revision augmentation, primary breast reconstruction, and revision reconstruction. Clinical data confirm their safety for use in both breast enlargement and reconstruction surgeries. Overall, Motiva Implants® have proven safe and effective in improving breast appearance. ^{1 2 3 6 7}

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.

Exclusion Criteria

I have an infection or abscess.

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

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

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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39331509/

The Study of the Safety and Effectiveness of Motiva ... There were low complication rates for implant-related complications and high surgeon and patient satisfaction.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230005B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Motiva USA performed a clinical study to establish a reasonable assurance of the safety and effectiveness of primary breast augmentation and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03579901

Study of the Safety and Effectiveness of Motiva Implants® This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10004118/

Complication Rates after Breast Surgery with the Motiva ... Short- and medium-term complication rates ranged from 2.8–14.4% and 0.32–16.67%, respectively.

5. motiva.health motiva.health/surgeons-preserve/

Preservé by Motiva Preservé introduces an innovative technique for low-impact breast surgery, preserving the patient's native breast tissues and sensation over time.

6. motivausa.com motivausa.com/

Homepage | Motiva US Breast Implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have ...

7. fortesmd.com fortesmd.com/blog/the-safety-and-durability-of-motiva-implants-what-you-need-to-know/

The Safety and Durability of Motiva Implants: What You ... Included in this statistic are incredibly low instances of implant rupture and capsular contracture, at only 0.2% and approximately 0.4%, respectively, ...