What side effects are associated with this type of intervention?

Common side effects of breast implants, including those similar to Motiva Implants® used for augmentation or reconstruction, include capsular contracture (hardening of the tissue around the implant), implant rupture or leakage, infection, changes in nipple or breast sensation, and implant displacement. Some patients may also experience pain, swelling, or asymmetry. Long-term complications can include the need for additional surgeries to address these issues.

What prior FDA approvals exist?

The FDA has approved several types of breast implants for augmentation and reconstruction, including saline-filled and silicone gel-filled implants. Notable approvals include silicone gel-filled implants from manufacturers like Allergan and Mentor, which have been widely used for both cosmetic and reconstructive purposes. These implants are designed to mimic the natural feel of breast tissue and have undergone rigorous testing for safety and efficacy. Motiva Implants® are being studied for similar applications, aiming to provide safe and effective options for women undergoing primary breast augmentation, reconstruction, or revision surgery.

What other types of research exist?

Promising novel alternatives to Motiva Implants® for breast augmentation or reconstruction include: 1) Autologous fat grafting, which uses the patient's own fat for a more natural look and feel. 2) Composite breast augmentation, combining implants with fat grafting for enhanced results. 3) B-Lite® lightweight breast implants, which are designed to reduce the weight of traditional implants while maintaining volume. 4) 3D-printed custom implants, tailored to the patient's anatomy for a personalized fit. These alternatives offer various benefits such as reduced risk of complications, more natural aesthetics, and personalized treatment options.

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Silicone gel-filled breast implants

Motiva Implants® for Breast Enhancement

N/A

Waitlist Available

Research Sponsored by Motiva USA LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Genetic female

Patient is seeking one of the following procedures: Primary Breast Augmentation, Primary Breast Reconstruction, Revision Augmentation, Revision Reconstruction

Must not have

Has an abscess or infection

Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, common side effects from similar procedures may include pain at the implant site, infection potential around the implant area, changes in nipple sensation, rupture risk of the implant material leading to additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am genetically female.

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

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I have enough tissue to cover the breast implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection or abscess.

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

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

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I am HIV positive.

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I have been diagnosed with anaplastic large cell lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.

Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.

Secondary outcome measures

Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline

Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture

Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)

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Trial Design

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast implants, such as those studied in the Motiva Implants® trial, involve the surgical insertion of silicone or saline-filled implants to enhance or reconstruct breast tissue. This procedure is used for primary breast augmentation, reconstruction post-mastectomy, or revision surgeries. The implants help restore or improve the breast's shape and volume, which is significant for patients seeking aesthetic enhancement or reconstruction after breast cancer surgery. The type of implant and surgical technique chosen can affect the overall outcome, recovery process, and potential complications, underscoring the importance of thorough consultation with a healthcare provider.