NOW ENROLLING SUBJECTS
MOTIVA® SILICONE FILLED BREAST IMPLANTS CLINICAL TRIAL
Motiva® breast implants are a new device not yet FDA approved, and so are not yet commercially available in the US. Only after a carefully designed and formally executed clinical study performed in the US can the FDA be asked to approve them. Dr. Minniti is one of approximately thirty doctors in the US participating in this trial and offering these implants to a limited group of patients. Patients will be prepared to participate in this trial for ten years after enrolling, and this trial is designed to evaluate the performance and safety of these implants.
Enrollment is expected to be completed by the end of 2018. Patients who meet all inclusion criteria, do not have any exclusion criteria, and enroll in the study will receive the breast implants at no cost, but all other costs involved: including fees for the surgeon, anesthesiologist, operating room, and laboratory tests. Patients will also receive monetary compensation throughout the study on a yearly basis, when completing their annual visits.
Motiva® breast implants are considered investigational devices in the US, and enrollees are participating in a clinical trial reviewed by the FDA. Although these implants have been commercially available since 2010, and are currently sold in over 60 countries, their safety and effectiveness in the US has not been established, hence the reason for this study.
• Genetic female, age 22 or older.
• Patient is seeking:
o Primary breast augmentation to increase size.
o Primary breast reconstruction to replace breast tissue after cancer surgery.
o Revision breast implant surgery for either augmentation or reconstruction.
• Patient has adequate tissue available to cover implants
• Patient is willing to follow all study requirements including signing an informed consent and attending all required follow up visits.
• Patient agrees to allow the study device to be returned to Establishment labs if ex-planted.
• Willing to undergo a Magnetic Resonance Imaging (MRI) scan if medically advised.
Subjects will not be allowed to enter the study if they have any of the following:
• Has any breast disease considered pre-malignant, is reporting mutations in BRCA1 or BRCA2 without previous bilateral mastectomy, or has an untreated cancer of any type.
• Has inadequate or unsuitable tissue (e.g., radiation damage, ulceration, compromised circulation, 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, chronic lung disease, 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, discoid lupus, scleroderma, Sjogren’s syndrome, rheumatoid arthritis, or any other variant.
• Has any condition that impedes the use of an MRI including metal devices or implants, or claustrophobia.
• 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.
• Is HIV positive.
• Works for Establishment Labs, Motiva® USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization that is helping to conduct the study, or are directly related to anyone that works for Establishment labs, Motiva® USA, ICON or any of their subsidiaries, or the study surgeon.
MOTIVA® INVESTIGATIONAL DEVICES
AND THEIR DESIGN FEATURES
Motiva® implants are made out of a silicone-based elastomer outer shell with a silicone gel filler. These implants are designed with changes to the physical characteristics of the shell and the gel, as well as the option of a radiofrequency micro- transponder.
There are two types of Motiva® implants that are available; a round device with a relatively firm and stable gel, and a device called Ergonomix™, with softer, more flowing gel designed to replicate a shaped or teardrop implant without the risk of rotation. Below is a list of marketing terms used by Motiva® to describe various features of their breast implants.
• ProgressiveGel™ Plus. The gel in the round implant which is designed to maintain upper pole fulness.
• ProgressiveGel™ Ultima. The gel in the Ergonomix™ implant which is designed to allow a more anatomic shape and the softest feel.
• SmoothSilk® Surface. The outer surface of the shell designed to optimize biocompatibility and minimize tissue reactivity, as well as minimize the attachment and growth of bacteria (biofilm).
• BluSeal™. A layer within the outer shell designed to minimize silicone oil diffusion and a visual indicator of shell integrity.
• TrueMonobloc®. Describes the integration of the physical characteristics of the shell and inner gel, which allows them to behave in a unified fashion.
• TrueTissue Technology™. Describes the physical characteristics of the silicone gel which mimics the compression and resistance of breast tissue.
• Q Inside Safety Technology™. The first radiofrequency micro-transponder embedded within the shell which allows a receiver to display data regarding the implants size, shape, and serial number.
POSSIBLE DISADVANTAGES OF MOTIVA® IMPLANTS
Some surgeons have reported that Motiva® implants tend to drop more than other implants. Only after the completion of this trial can any new information be obtained.
POSSIBLE ADVANTAGES OF MOTIVA® IMPLANTS
Until the trial is complete we will not know for sure what, if any, advantages there are. Global experience thus far seem to indicate the potential advantages include
1. A better feel to the implant
2. Lower risk of capsular contracture
3. Lower risk of re-operation.
The possible reason for Motiva® implants’ more natural feel is due to the changes that have been made in the physical qualities of both the outer shell and the inner gel filling. The shell is more elastic (stretchy) than other silastic shells, and the gel has been designed to possess both more solid (cohesive) and more liquid (lower viscosity) qualities. Further the shell and gel have been designed to interact optimally with one another. Lower rates of capsular contracture may be due to the unique outer shell surface texturing, which may be less irritating and more biocompatible with surrounding tissue.
Finally, there is an optional radio frequency micro transponder that can be read with a hand-held receiver, giving any surgeon information about the implant’s type, size, serial number, and date of manufacture.
A FINAL WORD FROM DR. MINNITI
Dr. Minniti is a cosmetic breast specialist with nearly two decades of experience. He was an early adopter of shaped, highly cohesive silicone gel implants that became available in the US in 2012, and became the biggest user of these devices for aesthetic purposes in Los Angeles.
The Motiva® breast implant is made of the same materials as other silicone gel implants currently available in the US. They differ in their physical characteristics and design. Based on other studies outside the US and data from commercial use in 60 countries, it appears that these implants have an improved risk profile compared to current implants in the US. Although this information needs to be confirmed in a tightly controlled clinical trial in the US, Dr. Minniti expects these implants to perform very well.
This trial is for women who also believe in the advantages of these new implants but know that they still need to be proven in the US. Although financial compensation is offered as incentive, it should not be the only reason to consider entering this FDA clinical trial.