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The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.
The post-approval study will include 2218 women receiving MemoryShape or MemoryGel Breast Implants. Four cohorts will be included: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction. For the purpose of assessing rheumatological and neurological signs and symptoms, a control group of 300 women will be selected from the participating investigators' practices, who are undergoing an aesthetic surgery other than breast implant surgery. Breast implant patients and the concurrent control group patients will be followed for 10 years. Baseline and operative data will be collected at the beginning of the study, and follow-up data will be collected annually for 10 years through online questionnaires.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Breast Augmentation
MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
Parkcrest Plastic Surgery
Mentor Worldwide, LLC
Published on BioPortfolio: 2016-09-29T23:08:21-0400
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) occasionally requires post-approval studies to help monitor the safety, effectiveness, and r...
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