Last updated on May 2019

Memory Gel and Shape Combined Cohort


Brief description of study

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.

Detailed Study Description

The post-approval study will include 2518 women undergoing breast augmentation or reconstruction with 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.

Clinical Study Identifier: NCT02919592

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Plastic Surgery of Tuscaloosa

Tuscaloosa, AL United States
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Jaime Schwartz, MD

Beverly Hills, CA United States
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Artisan Plastic Surgery

Atlanta, GA United States
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Barrington Plastic Surgery LTD

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Newport Center for Plastic Surgery

Newport Beach, CA United States
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Parkcrest Plastic Surgery

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Ontario, CA United States
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Phoenix, AZ United States
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Apple Valley, CA United States
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Barrington Plastic Surgery

Inverness, IL United States
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Marietta Plastic Surgery

Marietta, GA United States
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Ellen A. Janetzke, MD

Bloomfield, MI United States
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Premier Plastic Surgery

Draper, UT United States
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Southeastern Plastic Surgery

Tallahassee, FL United States
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Carp Cosmetic Surgery

Uniontown, OH United States
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Music City Plastic Surgery

Nashville, TN United States
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Greer, SC United States
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Summit Medical Group

Berkeley Heights, NJ United States
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Jacksonville, FL United States
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Sean A. Simon, MD

Miami, FL United States
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Ciaravino Plastic Surgery

Houston, TX United States
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Forsyth Plastic Surgery

Winston-Salem, NC United States
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Park Meadows Cosmetic Surgery

Lone Tree, CO United States
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Mark Malek, MD Plastic Surgery

Scottsdale, AZ United States
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Susan E. Downey, MD Inc

Burbank, CA United States
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Redding, CA United States
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Iowa Plastic Surgery

Davenport, IA United States
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Recruitment Status: Open


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