Study of the Safety and Effectiveness of Motiva Implants®

Motiva Implants® Silicone Gel-filled Breast Implants, SmoothSilk® both Round and Ergonomix®,
have not been approved by FDA, and the purpose of this study is to collect scientific
evidence of the safety and effectiveness of these implants. Motiva Implants® have been
approved for commercial distribution in over 60 countries, including the United Kingdom,
Sweden, Germany, Switzerland, Austria, Japan, Australia, Brazil, and South Korea.

This clinical study is a multicenter, single arm study. The population consist of 750
patients in four cohorts and an MRI subpopulation of 250 patients to verify the rates of
rupture.

Safety will be assess by incidence, severity, method of resolution, and duration for all
complications on a per implant and per subject basis. And effectiveness will be measured by
and overall patient satisfaction, and co-primary endpoints for breast measurements. As
secondary endpoints physician satisfaction and three quality of life questionnaires annually
and at 1,2,4,6,8 and 10 years respectively.

Patients will be follow up through a 10 year period to guaranty the safeness of the devices,
patients will attend a baseline visit and from the day of subjects will be asked to make
visits at the following time periods after the surgery: 3-6 weeks, 1, 2, 3, 4, 5, 6, 7, 8, 9
and 10 years. Each investigator will perform an evaluation of the status of the implant and
will examined the presence of any post-surgical complications.

Specifically, for primary augmentation subjects, breast measurements and 3D imaging and for
all subjects' photographs, an evaluation of your nipple and breast sensitivity will be
performed.

It is the investigator´s choice if additional 3D imaging will be performed for subjects in
the revision augmentation, primary reconstruction and revision reconstruction cohorts at any
or all of the annual study visits.

A review of the subjects current medications, continued cancer therapy (if applicable),
mammography results (if applicable), and MRI scan at visits 1, 2, 4, 6, 8, and 10 (for MRI
sub-study subjects) could also be conducted. In addition, study investigators will evaluate
the breasts for capsular contracture and any other complications that may arise, annually and
in unscheduled visits.

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.