Study of the Safety and Effectiveness of Motiva Implants®

Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.

Inclusion Criteria

• Genetic female.
• Patient is seeking one of the following procedures:

Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction

• Patient has adequate tissue available to cover implant(s).
• Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
• Agrees to have device returned to Establishment Labs if explanted.
• Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.

Exclusion Criteria:

• Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
• Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
• Has an abscess or infection.
• 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 any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
• 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 anaplastic large cell lymphoma (ALCL).
• Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.