Motiva Implants® Post-Approval Study

Launched by MOTIVA USA LLC · Apr 14, 2025

Keywords

ClinConnect Summary

The Motiva Implants® Post-Approval Study is looking into the safety and effectiveness of Motiva breast implants after they have been approved for use. Researchers want to gather information about how well these implants perform in real-life situations, focusing on the experiences of women who have received them. The study is not yet recruiting participants, but it will be open to women aged 22 and older who are either seeking breast augmentation for the first time or who need to replace their current implants to improve their results.

To participate, eligible women must be in good health and have enough tissue to cover the implants. They should be willing to follow the study's requirements, including undergoing certain medical tests if needed. However, some women may not qualify, especially those with certain medical conditions, infections, or a history of specific diseases. Overall, participants can expect to contribute valuable information that may help improve breast implant safety and performance for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria Motiva Implants®:
• • Female
• • Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation
• • Patient has adequate tissue available to cover implant(s)
• • Willingness to follow all study requirements
• • Signs an Informed Consent
• • Agrees to have device returned to the Sponsor, if explanted
• • Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised
• Inclusion Criteria Control group:
• • Is 22 years of age or older
• • Female
• • Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)
• • Signs an Informed Consent
• • Willingness to follow all study requirements
• Exclusion Criteria Motiva Implants®:
• • Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2
• • Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)
• • Has an active infection anywhere in their body
• • Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment
• • Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
• • Has any medical condition such as obesity (BMI \>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
• • Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others
• • Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
• • Has been implanted with any non-FDA approved breast implant
• • Has been implanted with any silicone implant other than breast implants
• • HIV positive (based on medical history)
• • Has been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
• Exclusion Criteria Control group:
• • Has a history of silicone implants (anywhere in the body)
• • Plans to undergo silicone breast implant surgery during the course of the study
• • Has an active infection anywhere in their body
• • Has a history of cancer (except skin cancer)
• • Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
• • Has any medical condition such as obesity (BMI \>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
• • Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others