Motiva Breast Implant Clinical Trial
Motiva breast implants are considered an investigational device in the US and Canada and subjects will be participating in an FDA approved clinical trial.
What is a Breast Implant Clinical Trial?
A clinical trial is a research study that allows manufacturers to evaluate the safety and efficiency of their new product. In order to get a new breast implant onto the market, manufacturers must first enroll subjects in clinical trials across the country as an investigational study. Although the study is investigational, the implants are not experimental. Many implants in clinical trials are approved in other countries and often have been in use for years prior to their US debut.
How do I take part in the Clinical Trial?
Each applicant will be reviewed based on the specific inclusion and exclusion criteria to determine if they are a candidate for the lengthy trial period. You will still need to come into our office and sit down for a consultation prior to the surgery. Dr. Epstein will discuss the Motiva Implants with you to determine size and shape/implant type.
Am I A Candidate for the Motiva Implant Clinical Trial?
The inclusion criteria is as follows:
- Genetic female.
- Patient is seeking one of the following procedures: Primary Breast Augmentation: age 22 or over, indicated to increase breast size. Primary Breast Reconstruction: to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly. Breast Implant Revision Surgery: (removal and replacement of breast implants) revision surgery to correct or improve the results of a previous breast augmentation or reconstruction surgery.
- 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 if medically advised.
Exclusion Criteria is as follows:
- Has any breast disease considered to be pre-malignant, or an untreated cancer of any type without mastectomy or has medical history reporting mutations in BRCA1 or BRCA2 of both breasts or one breast.
- 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 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.
Will I be receiving free surgery?
Although implants are often part of the surgery cost, Motiva Implants are provided free of charge at the day of surgery. You will be responsible for the cost of the surgery and any routine surgical appointments following. You will also receive compensation for being part of the trial which will be awarded after each annual visit. Visit our Patient Information page to learn more.
Does this clinical trial consist of Only one surgery?
As a participant in the Motiva clinical trial, you will undergo breast augmentation surgery with Dr. Epstein in Stony Brook, Long Island. By participating in the trial, you are committing to coming back each year to visit with Dr. Epstein for the course of 10 years. This does not require additional surgeries but could involve additional testing including MRIs. Additional surgeries may be required if there are complications or if a patient desires to go bigger or smaller in volume.
Are there any risks Specific to Motiva Silicone Gel Breast Implants?
- RFID microtransponder Q Inside Safety Technology – The implant may or may not contain a transponder with a radiofrequency identification device (RFID) for traceability purposes. Risks identified for the microtransponder will be addressed by compliance with special controls established for the device. In rare cases, a suspicion of microchip failure could be identified because no electronic serial number is obtained in the reading with the Motiva Q inside Reader Standard, in this case the site investigators will communicate the sponsor to further analyze and verify the reason of the suspected failure.
- Blue pigment – The barrier layer of the Motiva implants includes a blue silicone pigment to enable visual recognition of this layer by surgeons and quality inspectors. The pigment content represents less than 0.05% of the barrier layer material and less than 0.008% of all shell layers.
- Unknown Risks- Concerns include immunological and neurological disorders, carcinogenicity and connective tissue disorders due to the relationship between silicone and certain diseases
- Connective Tissue Disease, Cancer, Neurological Disease