Last updated on September 2017

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 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.

Clinical Study Identifier: NCT02919592

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William Hedden, MD

Hedden Plastic Surgery Center
Birmingham, AL United States
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Christopher A Park, MD

The Park Clinic
Mobile, AL United States
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Jaime Schwartz, MD

The Roxbury Institute
Beverly Hills, CA 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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Samir Shah, MD

A New You
Oak Lawn, IL United States
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William Stefani

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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Bill G. Kortesis, MD

Hunstad Kortesis Center for Plastic Surgery
Huntersville, NC 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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