When the FDA approved Motiva SmoothSilk® Round Ergonomix® (‘Ergonomix®’) and SmoothSilk® Round (‘Round’) Breast Implants, the FDA required a Post Approval Study (PAS) to examine use and endpoints not addressed during premarket studies. We need good long term data on numbers of patients that require reoperations, numbers of patients that have complications, numbers of patients that develop issues like leaks or capsular contracture, as well as information about the general health and patient satisfaction over time. Studies like this are an excellent way to obtain long term data.
Information will be collected to analyze long term patient outcomes with Motiva Breast Implants. These types of studies are very important both so that future patients will have more safety data and that surgeons using these devices have quality long term outcome data.
As one of the highest volume Motiva Breast Implant surgeons in the United States I was honored to be invited to be included in this study.
The study works as follows:
For 10 years, patients will be followed after augmentation.
The first step is that the patient decides if they would like to join the study. It is 100% voluntary and there is no requirement for patients to join the study. A detailed consent form is obtained that explains the study in detail. If they choose to contribute to the study, health history and registration forms are completed by the study site on the day of surgery. Data regarding the specifics of the surgery is submitted. The patient will complete a baseline survey. After surgery the implant is registered to a national implant registry.
The next steps involve follow up every year for 10 years. Two online surveys are sent to the patient. One is a health survey and one is a questionnaire. Each will take an estimated 15 minutes to complete. They complete these form online and do not need to come to the office. Regular patient follow up still occurs as it would for all patients.
Patients are reimbursed with a $50 gift card yearly for their participation and a bonus $250 when the 10 years are completed. Patients are not incentivized to join the study with free or discounted surgical fees.
There is also a control group of patients not getting breast implants and also a group of patients having other aesthetic surgical procedures such as liposuction, rhinoplasty, or abdominoplasty.
We are currently enrolling patients in this study. As a breast implant surgeon I believe that high quality data that tracks long term outcomes is very important for the field of aesthetic surgery. If you are interested in enrolling please let us know.