Motiva Study
Study on the safety and efficacy of Motiva Implants®
Establishment Labs is a global breast implant and medical device company that designs, develops, manufactures and markets an innovative product portfolio of advanced silicone-filled breast implants and body contouring implants.
Since its approval in 2010, Motiva Implants® have been implanted in women in more than 60 countries, including the United Kingdom, Sweden, Germany, Switzerland, Austria, Japan, Australia and South Korea.
Motiva Implants ® are not approved for commercial distribution in the USA.
Motiva Implants ®
The Motiva Implants® Round test product and the Motiva Implants Ergonomix® test product are filled to 100% of the volume.
Several technologies are offered:
- SmoothSilk®/SilkSurface®
- TrueMonobloc®
- BluSeal®
- ProgressiveGel Plus™ or ProgressiveGel Ultima™
- Q Inside™ Security technology
Together with each patient, the examining specialist determines the appropriate style and size of the implant.
ProgressiveGel PLUS™ |
ProgressiveGel Ultima™ |
Creates a natural looking contour |
Look and feel of a natural breast |
Balance between elasticity and strength of the gel |
Elastic and soft gel |
Full chest in the upper area |
Adapts to the natural shape of the breast |
Younger, more active appearance |
A more natural look and feel |
Clinical study
We invite you to voluntarily participate in a 10-year research study on breast implants. The purpose of this study is to determine the safety and efficacy of the test products (Motiva Implants®, SmoothSilk® Round, and Ergonomix®) in women with primary breast augmentation, primary breast reconstruction, and revision surgery.
- INCENTIVES FOR PATIENTS
All patients participating in the study will receive the Motiva Implants® to be tested free of charge. - REPARATION/COMPENSATION
The costs of visits to the doctor for all follow-up appointments are covered by Motiva USA. In addition, patients are reimbursed for all annual follow-up examinations and for completing questionnaires within this framework. - TRUST FUND
After the follow-up ensuing the first year, a trust fund will be established for each patient participating in the study; the patients will be fully reimbursed after completion of the 10-year study.
Inclusion criteria
- Genetic woman.
- Patient is 22 years or older and wishes to undergo one of the following procedures: primary breast augmentation, primary reconstruction or revision surgery.
- Patient has sufficient tissue material to cover the implant or implants.
- Willingness to comply with study requirements, including consent to meet all required follow-up appointments and signing the informed consent form.
- Consent to return the product to Establishment Labs in case of explanation.
- Willingness to undergo magnetic resonance imaging (MRI) if medically indicated.
Exclusion Criteria
- Presence of a disease of the breast considered to be precancerous in one or both breasts or a mutation of BRCA1 or BRCA2 known from history without previous bilateral mastectomy or untreated cancer of any kind.
- Presence of insufficient or unsuitable tissue (e.g. due to radiation damage, ulceration, circulatory disorder or a history of wound healing disorder).
- Presence of an abscess or infection.
- Existing pregnancy or current breastfeeding, or delivery or breastfeeding within 6 months prior to study enrollment.
- Use of any medication that may interfere with blood clotting or be associated with increased risk or significant postoperative complications.
- Presence of health problems such as obesity (BMI > 40), diabetes, autoimmune disease, chronic lung disease or severe cardiovascular disease that may be associated with an unacceptably high risk of surgery and/or risk of postoperative complications.
- Presence of a connective tissue disease / autoimmune disease or disease from the rheumatic form such as systemic lupus erythematosus, discoid lupus, scleroderma or rheumatoid arthritis.
- Existence of circumstances that speak against a magnetic resonance imaging (MRI) examination, including metal implant, claustrophobia or other complaints that would make an MRI examination impossible.
- A history of psychological characteristics that would be unrealistic or unacceptable given the risk of surgery.
- Inserted implants without FDA approval.
- Inserted silicone implants that are not breast implants.
- HIV-positive (according to medical history).
- Diagnosis of anaplastic large cell lymphoma (ALCL).
- Working for Establishment Labs, Motiva USA or any of their subsidiaries, for the study surgeon or ICON, the contract research organization (CRO) assisting in the conduct of the study, or a direct relationship to a person working for Establishment Labs, Motiva USA or any of their subsidiaries, for the study surgeon or CRO.
Please contact your surgeon if you need an explanation of terms unknown to you or have questions.