Last updated on October 2018

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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William Hedden, MD

Hedden Plastic Surgery Center
Birmingham, AL United States
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Diane Z Alexander, MD

Artisan Plastic Surgery
Atlanta, GA United States
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Michael J. McNeel, MD

Marietta Plastic Surgery
Marietta, GA United States
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Richard Greco, MD

The Georgia Institute for Plastic Surgery
Savannah, GA United States
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William Stefani, MD

Spa Renaissance & Renaissance Plastic Surgery
Troy, MI United States
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David Caplin, MD

Parkcrest Plastic Surgery
Saint Louis, MO United States
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Peter Hyans, MD

Summit Medical Group
Berkeley Heights, NJ United States
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Steven Carp, MD

Carp Cosmetic Surgery
Uniontown, OH United States
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Tim Love, MD

Tim R. Love, M.D., P.C.
Oklahoma City, OK United States
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Paul Glat, MD

SGM Physician Research Consortium, LLC
Bala-Cynwyd, PA United States
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Mark Brzezienski, MD

Plastic Surgery Group
Chattanooga, TN United States
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Joshua Olson, MD

Advanced Plastic Surgery Institute
Gilbert, AZ United States
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Ramon A. Robles, MD

Robles Plastic Surgery
Phoenix, AZ United States
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Joseph Berardi, MD

Berardi Aesthetics and Plastic Surgery
Scottsdale, AZ United States
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David Bogue, MD

David Bogue MD, Plastic Surgery, PL
Boca Raton, FL United States
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Jason Altman, MD

The Plastic Surgery Institute of Miami
Coral Gables, FL United States
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Don R Revis, Jr, MD

South Florida Plastic Surgery
Fort Lauderdale, FL United States
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Jose Perez-Gurri, MD

Imagos Plastic Surgery
Miami, FL United States
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Christopher Craft, MD

Christopher Craft Cosmetic Surgery
Miami, FL United States
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Joshua Halpern, MD

Dr. Joshua Halpern MD, PA
Tampa, FL United States
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Christopher Pelletiere, MD

Barrington Plastic Surgery LTD
Inverness, IL United States
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Christopher Pelletiere, MD

Barrington Plastic Surgery
Inverness, IL United States
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Michael Epstein, MD

MAE Plastic Surgery
Northbrook, IL United States
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David Klein, MD

Renaissance Plastic Surgery
Concord, NC United States
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D'arcy Honeycutt, MD

Advanced Surgical Arts Center
Bismarck, ND United States
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Howard Heppe, MD

Plastic Surgery of Fredericksburg
Fredericksburg, VA United States
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Darrin Hubert, MD

Richmond Plastic Surgeons
Richmond, VA United States
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Alvaro Testa, Jr, MD

Advanced Surgical Associates
Mesa, AZ United States
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Joseph G. Bauer, MD

The Swan Center for Plastic Surgery
Alpharetta, GA United States
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Marc Malek, MD

Mark Malek, MD Plastic Surgery
Scottsdale, AZ United States
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Jaime Schwartz, MD

Jaime Schwartz, MD
Beverly Hills, CA United States
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Thomas D. Toohey, MD

Newport Center for Plastic Surgery
Newport Beach, CA United States
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Samir Shah, MD

A New You Plastic Surgery & Laser Center
Oak Lawn, IL United States
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Angela Steele

Hankins and Sohn Plastic Surgery
Henderson, NV United States
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Miguel A. Yanez, MD

Piedmont Plastic Surgery & Dermatology - Blakeney
Charlotte, NC United States
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Parag Butala, MD

Piedmont Plastic Surgery & Dermatology - Cox Road
Gastonia, NC United States
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Benson Timmons, IV, MD

Piedmont Plastic Surgery & Dermatology Center - New Hope
Gastonia, NC United States
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Steven A. Siciliano, MD

Piedmont Plastic Surgery & Dermatology - Hickory
Hickory, NC United States
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Stephanie A. Stover, MD

Pierini Esthetic Surgery
Miami, FL United States
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Christie Pajor, RN

Snodgrass and Robinson Plastic Surgery Specialists
Rome, GA United States
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Andrew Gear, MD

Providence Plastic Surgery & Skin Center
Charlotte, NC United States
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George A. Lawson, III, MD

Forsyth Plastic Surgery
Winston-Salem, NC United States
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James E. Lovett, III, MD

Upstate Plastic Surgery
Greer, SC United States
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Peter J. Vonu, MD

Plastic Surgery Center of Hampton Roads
Newport News, VA United States
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Susan E. Downey, MD

Susan E. Downey, MD Inc
Burbank, CA United States
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Jeremy Z. Williams, MD

Park Meadows Cosmetic Surgery
Lone Tree, CO United States
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Sean A. Simon, MD

Sean A. Simon, MD
Miami, FL United States
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Joseph M. Gryskiewicz, MD

Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville, MN United States
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Jason I. Altman, MD

Doctors Plastic Surgery
Long Island City, NY United States
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Michael E. Ciaravino, MD

Ciaravino Plastic Surgery
Houston, TX United States
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Robert H. Schnarrs, MD

The Hague Center for Cosmetic and Plastic Surgery
Norfolk, VA United States
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Ross Bunch, MD

Plastic Surgery of Tuscaloosa
Tuscaloosa, AL United States
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R. Douglas Vanderpool, MD

Vanderpool Cosmetic Plastic Surgery
Fayetteville, AR United States
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Ali Tehrani, MD

Tehrani Plastic Surgery
Apple Valley, CA United States
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Khashayar Mohebali, MD

Mohebali Plastic Surgery
Corte Madera, CA United States
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Thuan Nguyen, MD

Institute of Cosmetic and Reconstructive Surgery
Fountain Valley, CA United States
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Nirav B. Savalia, MD

Newport Beach Center for Plastic Surgery
Newport Beach, CA United States
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Gregory Park, MD

North Coast Plastic Surgery
Oceanside, CA United States
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Ka Ming Li, MD

Li Plastic Surgery
Ontario, CA United States
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Alex N. Lechtman, MD

Kaweah Delta Health Care District
Visalia, CA United States
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Joshua Der

University of Miami / Sylvester Comp Cancer Ctr
Coral Gables, FL United States
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David N. Csikai, MD

First Coast Plastic Surgery
Jacksonville, FL United States
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Ben Kirbo, MD

Southeastern Plastic Surgery
Tallahassee, FL United States
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Amy K. Alderman, MD

North Atlanta Plastic Surgery
Atlanta, GA United States
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Joseph Raniere, Jr., MD

Advanced Aesthetics
Fayetteville, GA United States
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Mohammad Ali, MD

AMAE Plastic & Reconstructive Surgery
Birmingham, MI United States
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Ellen A. Janetzke, MD

Ellen A. Janetzke, MD
Bloomfield, MI United States
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Dennis Hammond, MD

Partners in Plastic Surgery
Grand Rapids, MI United States
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Steven Thomas, MD

The Center for You
Traverse City, MI United States
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Danielle DeLuca-Pytell, MD

Danielle DeLuca-Pytell, MD, PC
Troy, MI United States
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Lawrence N. Gray, MD

Atlantic Plastic Surgery
Portsmouth, NH United States
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Bivik Shah, MD

The Columbus Institute for Plastic Surgery
Columbus, OH United States
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Stephen M. Becker, MD

The Center for Dermatology and Plastic Surgery
Alcoa, TN United States
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Michael Burgdorf, MD

Music City Plastic Surgery
Nashville, TN United States
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Richard D. Fryer, MD

Premier Plastic Surgery
Draper, UT United States
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Michael D. Marion, MD

Michael D. Marion Plastic Surgery
Lehi, UT United States
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