Motiva Implants® Post-Approval Study

Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures

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.

Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.

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