Motiva Implants for Breast Augmentation

(Motiva PAS Trial)

Recruiting at 19 trial locations

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

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® for breast augmentation, focusing on their performance after market release. The study includes different groups: individuals receiving implants for the first time, those undergoing revision surgery to correct or enhance previous implants, and those having other aesthetic procedures. Women seeking to increase breast size or improve results from a prior augmentation may qualify if they have sufficient tissue to cover the implant and agree to follow study requirements. As an unphased trial, this study allows participants to contribute to ongoing research and potentially improve their aesthetic outcomes.

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

Previous studies have shown that Motiva Implants are very safe. Research indicates that problems with the implants are rare. For instance, the chance of an implant breaking is just 0.2%, and the chance of scar tissue forming around the implant (capsular contracture) is about 0.4%. Reports from patients and surgeons indicate high satisfaction, suggesting the implants are well-accepted.

Motiva Implants are already available on the market, having passed several safety checks. However, breast implant surgery is not recommended for women with active infections or those with existing or pre-cancerous breast conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Motiva Implants® because they offer a fresh take on breast augmentation. Unlike traditional silicone or saline implants, Motiva Implants® boast a unique gel technology called ProgressiveGel Plus™, which aims to provide a more natural look and feel. Additionally, these implants incorporate a less invasive insertion technique, potentially leading to a quicker recovery and less scarring. These features make them a standout option for individuals seeking primary or revision breast augmentation.

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

This trial will evaluate the effectiveness of Motiva Implants® for breast augmentation. Studies have shown that Motiva Implants® are effective for breast enlargement. In one study, only 6.1% of patients required additional surgery to adjust or fix the implants. Another study confirmed the implants' safety and effectiveness over six years, demonstrating long-lasting results. These implants also use a special method that helps maintain the natural feel and sensation of the breast. Overall, research has proven that Motiva Implants® are both safe and effective for increasing breast size. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Implanted with any silicone implant other than breast implants

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

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

The Study of the Safety and Effectiveness of Motiva ... There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort ...

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/PMC6452326/

Six-Year Prospective Outcomes of Primary Breast ... The results of this long-term, follow-up study demonstrate the safety and effectiveness of the Motiva silicone breast implants in primary breast ...

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. 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, ...

7. 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 ...