Study of the Safety and Effectiveness of Motiva Implants®

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 allrequired 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 isreporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or anuntreated cancer of any type.

• Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulcerationcompromised 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 monthsof enrollment.

• Is taking any drugs that would interfere with blood clotting, or that might resultin 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 highsurgical risk and or significant postoperative complications.

• Has any connective tissue/autoimmune disorder or rheumatoid disease, such assystemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis,among others.

• Has any condition that impedes the use of magnetic resonance imaging (MRI) includingimplanted metal device, claustrophobia or other conditions that would make MRI scanprohibited.

• Has a history of psychological characteristics that are unrealistic or unreasonablegiven 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 studysurgeon, or ICON the Contract Research Organization (CRO) that is helping to conductthe 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.