Motiva Implants® Post-Approval Study

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