Clinical Research Directory

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