NASHVILLE, Tenn., Jan. 29, 2019 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration oversees the investigation and approval not only of medicines, but also devices used for plastic surgery procedures, including breast implants. As a plastic surgeon experienced in breast augmentation based in Nashville, TN, Dr. Jacob Unger at Maxwell Aesthetics has been chosen as an investigator in an ongoing clinical trial Study of Safety and Effectiveness of the Motiva Implants®, a device currently used around the world but not yet approved for medical use in the United States.
As part of his role as an investigator, Dr. Unger is enrolling Nashville-area women into the clinical trial. Subjects who are accepted and participate in the clinical study will receive the Motiva Implants® investigational devices and 10 yearly follow-up visits at no cost. Other surgery-related costs, such as the anesthesiologist and operating room costs, will still be billed to clinical study participants. Participants will also receive an average of $200 for each of their annual visits over the ten years following their surgery, along with $750 from a trust fund, when the study and all 10 yearly visits are completed.
Dr. Unger is the only surgeon participating in this study in Tennessee. In all, there are currently only 22 sites in North America where trial subjects are being recruited.
To be considered for the trial, women must be at least 22 years old and desire primary breast augmentation or reconstruction, or breast revision to alter the results of a prior augmentation surgery. Other inclusion and exclusion criteria are available on the official Motiva study page.
The Motiva Implants® investigational devices incorporate new technology and are already sold in more than 60 countries outside the United States. For this study, the devices in question include Motiva’s Round Plus and Ergonomix® with or without Q-Inside Safety Technology®.
Maxwell Aesthetics has long been a practice that women choose for breast augmentation surgery. Dr. Unger is a board-certified plastic surgeon and member of the American Society for Aesthetic Plastic Surgery who has worked and studied breast surgery in the United States and Europe.
Find out more about the Motiva Implants® Clinical study at Maxwell Aesthetics. For more information, call 615.932.7700. Maxwell Aesthetics is located at 2020 21st Avenue, South Nashville, TN, 37212. CONTACT: 615.932.7700