Now Enrolling Subjects in the Motiva Silicone Filled Breast Implant Trial
Motiva Breast implants are not approved by the FDA for use in the United States. Like all drugs and medical devices, such approval only occurs after a rigorously audited study. That trial is underway and Dr. Teitelbaum is one of about twenty-five selected plastic surgeons nationwide offering these implants to a limited group of patients. The study commenced in April 2018 and will conclude in 10 years after enrollment is complete, which is expected to be by the end of 2018.
Participating patients will receive the breast implant devices without cost for the patient, but all other associated costs such as the fees for the surgeon, anesthesiologist, laboratory tests, and operating room remain the same. Patients will also receive compensation throughout the study according to the trial plan, over the ten year period when completing their annual visits.
There has been substantial experience with these implants in over 65 countries outside of the United States since their introduction in 2010. There has also been excellent data about these implants published in prominent journals. However, the following must be emphasized: potential Motiva Implant study patients need to assume that little is yet conclusively known about the safety and effectiveness of these particular implants in the US. Indeed, that is the very point of doing this
Motiva breast implants are considered an investigational device in the USA and subjects will be participating in an FDA approved clinical trial.
Before You Read On: Study Requirements
A woman can only receive these implants if she participates in this 10-year clinical trial. While there is financial compensation for participating, there is also a very long list of requirements and restrictions. A few of those are: patients must be over 22 years old; a genetic female; make a commitment to comply with the numerous study requirements; be willing to undergo an MRI if requested, agree to have implants returned to the manufacturer if they are ever removed; and must live
close to a participating physician’s office and guarantee returning for annual follow-ups for ten years. See below in FAQ section for a complete list of inclusion and exclusion criteria.
What are the Inclusion Criteria for the United States Motiva Study?
- Genetic female.
- Patient is seeking one of the following procedures:
- Primary Breast Augmentation: age 22 and 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 sign the informed consent.
- Agrees to have device returned to Establishment Labs if explanted.
- Willing to undergo Magnetic Resonance Imaging (MRI) evaluation if medically advised.
What are the Exclusion Criteria?
Subjects will not be allowed to enter the study if they have any of the following 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(s), 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).
- 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.
How many Motiva Implants have been used?
The exact number is not available, but Motiva implants are sold globally. In 2018 the countries using the most Motiva implants were Brazil, Sweden, and Germany, and are sold in over 65 countries. They are rapidly gaining popularity in countries that are the most sophisticated about plastic surgery, such as South Korea and Brazil.
Possible Advantages of Motiva Implants
Remember that until the trial is complete we will not know for sure what, if any, advantages there are. But there already is substantial experience with these implants globally and it looks like the two biggest advantages are 1) a better feel and 2) a lower chance of capsular contracture. Colleagues are describing this implant as feeling and moving more naturally than other breast implants. Patients who have switched to Motiva from other implants describe them as feeling more comfortable
and like they are a part of their own body. Capsular contracture is the build-up of thick and tight scar tissue around breast implants and this remains a common reason for revision surgery. Surgeons are anecdotally describing that their rates of this are very low with this implant. More significantly two publications in major journals show the incidence of capsular contracture to be lower than with any other implant to date.
The reason that these implants feel good is that they use a gel with different viscoelastic properties and match it to a shell that is able to stretch in unison with it. So there is no sense of their being a bag that is filled with something else. The low capsular contracture rate seems to be due to their advanced surface technology, which has better biocompatibility at its interface with the tissues.
One unique innovation is that these implants can also be ordered with or without a tiny “radio frequency” micro-transponder buried within them. This allows a surgeon in the future to scan outside your body and find out exactly the type, size, serial number, and manufacturing date of your implants.
There are videos on the Motiva Implants global website, not specifically addressed to the US market that show some of the differences with this implant.
For additional videos about the Motiva Implant please visit: http://motivaimplants.com/products/videos/
When did the company start?
Establishment Labs, the manufacturer of Motiva Implants ™ was incorporated in 2004 in Costa Rica, which is a manufacturing hub for many many American medical device companies, including heart valves and another breast implant manufacturer. The company entered the European breast market in 2011 and its products are available throughout the world.
Multiple Levels of Clinical Evidence Indicate Superior Safety
A Word About Dr Teitelbaum and New Breast Implants
Dr. Teitelbaum is an international authority on breast implants. He is the only surgeon in the United States to have participated in the clinical trials of Sientra, Allergan, and Mentor cohesive/gummy bear breast implants. He wrote the official surgeon educational materials for the introduction of the Mentor and Allergan implants to US surgeons, including a detailed video demonstrating ideal surgical techniques. A breast implant clinical trial requires a plastic surgeon, their office,
and each patient to follow very specific protocols and he and his personnel already have extensive experience and expertise in this area.
While Dr. Teitelbaum believes that breast implants have a meaningful effect on the result of a breast augmentation, he also believes that other factors have an even greater effect, such as patient education, proper planning, implant size and dimension selection, precise surgical technique, anesthesia, etc. So whether you get this implant or another implant from Dr. Teitelbaum, it is his expertise as a breast surgeon that will make the biggest difference in achieving outstanding
Motiva Implant Sizing Charts - Motiva implants available in the US clinical trial
Dr. Teitelbaum and Motiva Implants
Dr. Teitelbaum embraces new technology only after careful consideration. It was only after visiting the factory several times, using the implants overseas, and speaking to European colleagues who had been using the implants that he decided to become a paid advisor on the Motiva Medical Advisory Board and to use these implants in the US clinical trial. He has lectured about Motiva Implants to surgeons in Central America, and Europe, and was one of the central figures in designing the
experimental protocol for this study.
The Motiva Design Philosophy
Dr. Teitelbaum does not consider these implants to be revolutionary, but rather evolutionary. The founders of the company saw multiple areas in which they felt the design and manufacturing processes could be improved.
Motiva Implants can be thought of as taking a standard breast implant and making tweaks and improvements to many steps of the design and manufacturing process. Silicone has been used and tested for decades. The manufacturing process is essentially a well improved version of what other companies are using.
An example of this is that most of the other manufacturers use implants that are built with components that were designed at different times for different purposes. But the Motiva Implants are designed from the ground up, with a shell surface, shell, and filler that are each matched in their characteristics to work together.
What are the key features and innovations of Motiva Implants?
The following are marketing terms used by Motiva for their breast implants. They are provided for thoroughness and interest but they should not be taken as medically proved issues. There are videos on the Motiva Implants global website, not specifically addressed to the US market http://motivaimplants.com/products/videos/ which demonstrate some of these features.
- TrueMonobloc(R) – Refers to matching the strength and elasticity of all parts of the implants so that it behaves as a single, natural unit.
- SmoothSilk® Surface – designed to be highly biocompatible and provoke a minimal response in the tissue surrounding the implant, as well as having surface characteristics that diminish to some degree the growth of bacteria (biofilm).
- BluSeal™ - one of the layers of a breast implant shell minimizes silicone diffusion. This is a very important component of an implant and so Motiva gave theirs a blue tint so that surgeons could verify its presence.
- ProgressiveGel™ Plus – the gel in the round implant which helps maintain upper pole fullness
- ProgressiveGel™ Ultima™ - the gel in the Ergonomic implant which is designed to adopt a more anatomic shape with the softest feel.
- TrueTissue Technology™ - using specially designed silicone gel characteristics so that the implant has a compression resistance and feel that mimics a woman’s own body
- Ergonomix™ -probably the most unique implant made by Motiva that is designed to achieve maximum projection in the lower pole of the breast implant
- Q inside Safety Technology™ - the first breast implant to have a radiofrequency micro-transponder embedded within it so that in the future surgeons can wave a reader on the outside of a patient’s body and receive detailed information about the implant
Is The Trial Right For You?
This trial is for people who believe that there are advantages to the implant, while at the same time appreciating that they are not yet proven. They must be willing to comply with all the requirements, and in particular absolutely commit to the ten annual follow-up visits. The economic compensation may be an incentive, but this is a serious issue and your decision needs to be based on something more than that.
The Disadvantages of Motiva Implants
No disadvantages relative to other implants have yet been shown, but until the trial is completed and the data analyzed no one can say that there are not any.
Some surgeons have described to Dr. Teitelbaum that they have the impression that Motiva Implants have a greater tendency to drop than other implants. If this is true – and it is hard to know because these things are usually subtle and hard to measure – it may be because the Motiva Implants are less reactive than other implants, and so the membrane the body makes around them is thinner and more pliable than usually occurs with other implants. That may be one reason why they feel so
soft, but it may also allow the pressure of the implant to push out on the breasts. This seems to be more of an issue with breasts that are already weak and stretched, and Dr. Teitelbaum will continue to evaluate whether this is an issue and how to manage it.
The radiofrequency chip is very exciting technology, but since it has metal within it there can be interference with MRI’s, creating a small area of the breast that the MRI cannot see. Motiva is working with radiologists to understand the significance to this and how to see the area with an ultrasound. If you are considering the chip Dr. Teitelbaum will discuss any updates with you.
Is this implant experimental?
Although Motiva Implants® are only available in the US as investigational devices in a clinical trial, these devices have been commercialized since 2010 and has obtained regulatory approval in over 60 countries. They would not be considered experimental through much of the world where they are already approved.
What kind of implants are available on this study?
There are two implants available: one is a round implant with a relatively firm gel that helps to create a rounder shape with more upper fill. The other is the Ergonomix implant which is what Dr. Teitelbaum expects to use for most of his patients. The principle behind it is to give the natural shape of a teardrop implant, but to do so without the risk of rotation and with a softer gel since the Ergonomix implants are round.
What scientific data is available about results with Motiva Implants?
In 2017 a study of 5813 patients was published, and it showed a very low complication rate compared to other studies. This was an independent study, not subject to the rigors of FDA oversight. It was published in an important peer – reviewed journal.
Breast Augmentation with Motiva Implants® - Information for the Patient
Aumento Mamario Con Implantes Motiva® Informoación Para El Paciente
Preliminary 3-Year Evaluation of Experience
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