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Memory Gel and Shape Combined Cohort

2016-09-29 23:08:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Primary Breast Augmentation

Intervention

MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery

Location

Parkcrest Plastic Surgery
St. Louis
Missouri
United States
63141

Status

Recruiting

Source

Mentor Worldwide, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-29T23:08:21-0400

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