This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,400
Breast Surgery
Aesthetic procedure other than breast implant surgery
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants
Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey
Time frame: 10 Years
Investigate the incidence of Reproductive Complications, Cancer Diagnoses, Local Complications in Motiva implanted participants compared to the incidence in control participants, where data collection allows; and investigate patient satisfaction
Analysis of Patient-Reported safety and satisfaction collected through a Follow-Up Questionnaire and 5-point Likert scale
Time frame: 10 Years
Assess the impact of RFID on imaging
Frequency of imaging impact among participants implanted with devices containing RFID
Time frame: 10 Years
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J. Gerald Minniti, M.D., F.A.C.S.
Beverly Hills, California, United States
RECRUITINGAESTHETX Center
Camp Pendleton, California, United States
RECRUITINGAlign Surgical Associates Inc
San Francisco, California, United States
RECRUITINGSchwartz Aesthetic Institute
Westlake Village, California, United States
RECRUITINGThe Center for Cosmetic Surgery
Denver, Colorado, United States
RECRUITINGAdvanced Plastic Surgery, LLC
Washington D.C., District of Columbia, United States
RECRUITINGCareaga Plastic Surgery
Coral Gables, Florida, United States
RECRUITINGRenee Burke Plastic Surgery, Aesthetics, & Med Spa
South Barrington, Illinois, United States
RECRUITINGCaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, United States
RECRUITINGThe Wall Center for Plastic Surgery
Shreveport, Louisiana, United States
RECRUITING...and 14 more locations