Memory Gel and Shape Combined Cohort
- Conditions
- Revision Breast AugmentationRevision Breast ReconstructionPrimary Breast AugmentationPrimary Breast Reconstruction
- Interventions
- Device: MemoryShape® Breast ImplantsProcedure: Other Aesthetic SurgeryDevice: MemoryGel® Breast Implants
- Registration Number
- NCT02919592
- Lead Sponsor
- Mentor Worldwide, LLC
- Brief 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.
- Detailed Description
The post-approval study will include a maximum of 3500 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 with 300-480 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 3613
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary Breast Augmentation MemoryShape® Breast Implants Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants Revision Breast Augmentation MemoryShape® Breast Implants Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants Other Aesthetic Surgery Other Aesthetic Surgery Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise) Revision Breast Augmentation MemoryGel® Breast Implants Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants Primary Breast Reconstruction MemoryShape® Breast Implants Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants Primary Breast Reconstruction MemoryGel® Breast Implants Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants Revision Breast Reconstruction MemoryShape® Breast Implants Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants Primary Breast Augmentation MemoryGel® Breast Implants Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants Revision Breast Reconstruction MemoryGel® Breast Implants Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
- Primary Outcome Measures
Name Time Method 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications 10 years
- Secondary Outcome Measures
Name Time Method Rates of lactation complications 10 years Effectiveness 10 years Patient satisfaction rates
Rates of occurrence of connective tissue disease 10 years Rates of occurrence of rheumatological signs and symptoms 10 years Rates of occurrence of neurological signs and symptoms 10 years Rates of occurrence of suicide 10 years Rates of MRI confirmed rupture 10 years Rates of occurrence of cancer 10 years
Trial Locations
- Locations (78)
Artisan Plastic Surgery
🇺🇸Atlanta, Georgia, United States
North Atlanta Plastic Surgery
🇺🇸Atlanta, Georgia, United States
Ciaravino Plastic Surgery
🇺🇸Houston, Texas, United States
Imagos Plastic Surgery
🇺🇸Miami, Florida, United States
Christopher Craft Cosmetic Surgery
🇺🇸Miami, Florida, United States
Advanced Surgical Arts Center
🇺🇸Bismarck, North Dakota, United States
Li Plastic Surgery
🇺🇸Ontario, California, United States
Newport Beach Center for Plastic Surgery
🇺🇸Newport Beach, California, United States
Mohebali Plastic Surgery
🇺🇸Corte Madera, California, United States
Summit Plastic Surgery
🇺🇸Redding, California, United States
Verve Plastic Surgery
🇺🇸Solana Beach, California, United States
Susan E. Downey, MD Inc
🇺🇸Burbank, California, United States
Newport Center for Special Surgery
🇺🇸Newport Beach, California, United States
North Coast Plastic Surgery
🇺🇸Oceanside, California, United States
Institute of Cosmetic and Reconstructive Surgery
🇺🇸Fountain Valley, California, United States
Park Meadows Cosmetic Surgery
🇺🇸Lone Tree, Colorado, United States
David Bogue MD, Plastic Surgery, PL
🇺🇸Boca Raton, Florida, United States
Sean A. Simon, MD
🇺🇸Miami, Florida, United States
Pierini Esthetic Surgery
🇺🇸Miami, Florida, United States
MAE Plastic Surgery
🇺🇸Northbrook, Illinois, United States
Partners in Plastic Surgery
🇺🇸Grand Rapids, Michigan, United States
Barrington Plastic Surgery
🇺🇸Inverness, Illinois, United States
A New You Plastic Surgery & Laser Center
🇺🇸Oak Lawn, Illinois, United States
Danielle DeLuca-Pytell, MD, PC
🇺🇸Troy, Michigan, United States
AMAE Plastic & Reconstructive Surgery
🇺🇸Birmingham, Michigan, United States
Iowa Plastic Surgery
🇺🇸Davenport, Iowa, United States
Piedmont Plastic Surgery & Dermatology - Cox Road
🇺🇸Gastonia, North Carolina, United States
Gryskiewicz Twin Cities Cosmetic Surgery
🇺🇸Burnsville, Minnesota, United States
Forsyth Plastic Surgery
🇺🇸Winston-Salem, North Carolina, United States
Parkcrest Plastic Surgery
🇺🇸Saint Louis, Missouri, United States
Piedmont Plastic Surgery & Dermatology - Blakeney
🇺🇸Charlotte, North Carolina, United States
The Columbus Institute for Plastic Surgery
🇺🇸Columbus, Ohio, United States
Piedmont Plastic Surgery & Dermatology - Hickory
🇺🇸Hickory, North Carolina, United States
Carp Cosmetic Surgery
🇺🇸Uniontown, Ohio, United States
Paul Glat, MD, PC
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Plastic Surgery of Fredericksburg
🇺🇸Fredericksburg, Virginia, United States
Kai Morimoto MD PLLC
🇺🇸Spokane Valley, Washington, United States
Premier Plastic Surgery
🇺🇸Draper, Utah, United States
Michael D. Marion Plastic Surgery
🇺🇸Lehi, Utah, United States
Kaweah Delta Health Care District
🇺🇸Visalia, California, United States
University of Miami / Sylvester Comp Cancer Ctr
🇺🇸Coral Gables, Florida, United States
South Florida Plastic Surgery
🇺🇸Fort Lauderdale, Florida, United States
First Coast Plastic Surgery
🇺🇸Jacksonville, Florida, United States
Advanced Aesthetics
🇺🇸Fayetteville, Georgia, United States
Marietta Plastic Surgery
🇺🇸Marietta, Georgia, United States
Spa Renaissance & Renaissance Plastic Surgery
🇺🇸Troy, Michigan, United States
Piedmont Plastic Surgery & Dermatology Center - New Hope
🇺🇸Gastonia, North Carolina, United States
Plastic Surgery Center of Hampton Roads
🇺🇸Newport News, Virginia, United States
Richmond Plastic Surgeons
🇺🇸Richmond, Virginia, United States
Plastic Surgery of Tuscaloosa
🇺🇸Tuscaloosa, Alabama, United States
Hedden Plastic Surgery Center
🇺🇸Birmingham, Alabama, United States
Mark Malek, MD Plastic Surgery
🇺🇸Scottsdale, Arizona, United States
Jaime Schwartz, MD
🇺🇸Beverly Hills, California, United States
The Plastic Surgery Institute of Miami
🇺🇸Coral Gables, Florida, United States
The Swan Center for Plastic Surgery
🇺🇸Alpharetta, Georgia, United States
Dr. Joshua Halpern MD, PA
🇺🇸Tampa, Florida, United States
Snodgrass and Robinson Plastic Surgery Specialists
🇺🇸Rome, Georgia, United States
Southeastern Plastic Surgery
🇺🇸Tallahassee, Florida, United States
Ellen A. Janetzke, MD
🇺🇸Bloomfield, Michigan, United States
Doctors Plastic Surgery
🇺🇸Long Island City, New York, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
Atlantic Plastic Surgery
🇺🇸Portsmouth, New Hampshire, United States
Tim R. Love, M.D., P.C.
🇺🇸Oklahoma City, Oklahoma, United States
The Hague Center for Cosmetic and Plastic Surgery
🇺🇸Norfolk, Virginia, United States
The Georgia Institute for Plastic Surgery
🇺🇸Savannah, Georgia, United States
The Center for You
🇺🇸Traverse City, Michigan, United States
Advanced Plastic Surgery Institute
🇺🇸Gilbert, Arizona, United States
Robles Plastic Surgery
🇺🇸Phoenix, Arizona, United States
Advanced Surgical Associates
🇺🇸Mesa, Arizona, United States
Berardi Aesthetics and Plastic Surgery
🇺🇸Scottsdale, Arizona, United States
Music City Plastic Surgery
🇺🇸Nashville, Tennessee, United States
Guerra Plastic Surgery Center
🇺🇸Scottsdale, Arizona, United States
Vanderpool Cosmetic Plastic Surgery
🇺🇸Fayetteville, Arkansas, United States
Upstate Plastic Surgery
🇺🇸Greer, South Carolina, United States
Hankins and Sohn Plastic Surgery
🇺🇸Henderson, Nevada, United States
Plastic Surgery Group
🇺🇸Chattanooga, Tennessee, United States
The Center for Dermatology and Plastic Surgery
🇺🇸Alcoa, Tennessee, United States
Providence Plastic Surgery & Skin Center
🇺🇸Charlotte, North Carolina, United States