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. 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 you are a candidate for the lengthy trial period. Please contact our office to schedule a consultation and learn more about participating in the clinical trial.
As part of the Motiva Clinical Trial, our practice was also selected to participate in an MRI Sub-Study. The MRI Sub-Study population will be a subset of the study population selected to obtain MRIs at 1, 2, 4, 6, 8, and 10 years. It will be used for the analysis of rupture. Motiva USA will cover the cost of the MRIs. Any patient not chosen as part of the Sub-Study will be responsible for the cost of their own MRIs done outside of the research study.