Post-Approval Study of Motiva SmoothSilk Round and Ergonomix Breast Implants For Women Undergoing Primary or Revision Breast Augmentation and Other Aesthetic Procedures

What this Trial Is About

This research aims to evaluate the use and safety of Motiva Implants in people undergoing breast implant procedures. The study focuses on collecting and assessing safety and effectiveness data about these implants after they have been approved and are in general use. It includes participants who have primary breast augmentation, revision breast augmentation, or other aesthetic surgeries, with a focus on female patients aged 22 and older. Participants will receive Motiva Implants as part of their breast surgery or undergo other aesthetic procedures. The study is prospective and non-randomized, with data collected at baseline before surgery, during the operation, and annually for up to 10 years after surgery. Participants who have revision surgery or other aesthetic procedures without implants are also included as control groups to compare outcomes. During the study, participants will have various assessments including medical imaging such as CT, ultrasound, or MRI if medically advised. Researchers will monitor for connective tissue disease signs and symptoms, reproductive complications, cancer diagnoses, local complications, and patient satisfaction over 10 years. The impact of RFID on imaging will also be assessed. Participants will be followed for up to 10 years, providing long-term data on the safety and performance of Motiva Implants.

Motiva Implants® Post-Approval Study