Sea Girt

Researchers are studying the safety and performance of Motiva Implants®, silicone gel-filled breast implants used for breast augmentation and revision procedures. This prospective, non-randomized, multicenter study collects data before surgery, during the operation, and annually for up to 10 years. The study also compares the incidence of connective tissue disease signs and symptoms in participants with Motiva implants to a control group undergoing other aesthetic surgeries. Participants receive either Motiva Implants® during breast augmentation or revision surgeries or undergo other aesthetic procedures like liposuction, rhinoplasty, or face-lifts in the control group. The study includes monitoring of implant performance and safety, with some participants possibly undergoing CT, ultrasound, or MRI evaluations if recommended. Participants agree to return explanted devices to the sponsor, and they must follow all study requirements throughout the study period. During the 10 years of follow-up, participants have yearly assessments to gather operative and postoperative data. Researchers evaluate safety and effectiveness, tracking any signs of connective tissue diseases and other outcomes related to the implants or aesthetic procedures. The study monitors participant health and implant status through imaging and clinical evaluations to provide long-term safety information.