Motiva Implant Clinical Trial
Dr. Jacob Unger is Enrolling Participants in Nashville, TN
What is the Motiva Study?
- While the FDA has not yet approved Motiva breast implants for use in the United States, the devices have been in use by experienced plastic surgeons for nearly eight years in almost 70 other countries.
- Like all new medical products, the Motiva implants must first be rigorously studied before they can be approved by the FDA for medical use in the United States.
- Dr. Jacob Unger of Maxwell Aesthetics is one of a select group of plastic surgeons nationwide enrolling patients for this ongoing Motiva clinical trial, designed to test the safety and efficacy of Motiva breast implants.
- Participating subjects are not charged for the cost of the implant, and all 10 annual follow-up visits are free. The patient is, however, responsible for all other fees, including for the anesthesiologist, surgeon, and operating room.
What is Different About Motiva Implants?
- Several investigational Motiva implants are available for use in this study, including Motiva Implants Round Plus® and Ergonomix® with or without Q Inside Safety Technology®.
- Motiva has developed certain non-scientifically proven implant features that the company believes set its products apart, including TrueMonobloc®, SmoothSilk Surface®, BluSeal, ProgressiveGel Plus®, ProgressiveGel Ultima®, TrueTissue Technology®, Ergonomix®, and Q Inside Safety Technology®. Feel free to explore these features and innovations in a series of Motiva videos and descriptions.
Who Can Participate?
- This trial is for women at least 22 years old who are seeking primary breast augmentation, primary breast reconstruction, or revision breast surgery.
- To participate in this clinical trial, subjects must meet certain inclusion criteria which can be found by clicking here. Some important requirements to note: You must be a genetic female committed to following the study requirements for all 10 years of its duration, agree to attend all 10 annual follow-up visits, live reasonably close to your participating plastic surgeon, agree to have an MRI if medically indicated, and agree to allow the implants to be sent back to their manufacturer if they are removed for any reason.
Who Cannot Participate?
- This trial has a number of exclusion criteria, and you can find a full description of each by clicking here.
- Some important factors that would exclude subjects from participating in this study are being BRCA1 or BRCA2 positive, being pregnant or actively nursing, and having certain pre-existing medical conditions (including obesity with a BMI >40, severe cardiovascular disease, or HIV).
Is There Any Monetary Compensation?
- Subjects are compensated roughly $200 for attending each annual clinic follow-up visit and filling out patient questionnaires, for a total of $2,150 over 10 years.
- This amount is in addition to a baseline compensation of at least $750 that can be collected upon study completion after all 10 annual follow-up visits have been completed. See this online brochure for more information about compensation.
What Else do I Need to Know?
- In order to help determine the safety of the Motiva implants, other information about you and your health will be collected. That includes information about any past or current medical conditions, as well as any implant complications, such as rupture or infection.
- Your surgeon, Dr. Jacob Unger, has years of experience performing breast surgery. You will work together to determine which implant style and size will get you the look and feel you desire.
- For more information about participating in the Motiva Breast Implant Clinical Trial, please contact Dr. Jacob Unger at Maxwell Aesthetics. You can also read Motiva’s study brochure or visit Motiva’s study website for more information.