Phase
Condition
N/ATreatment
MemoryGel® Breast Implants
MemoryShape® Breast Implants
Other Aesthetic Surgery
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;
Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
Agrees to answer baseline questions;
Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
Has a valid e-mail address and access to the internet to complete online questionnaires.
Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
Has active infection anywhere in her body;
For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
Is currently pregnant or nursing;
Is planning on undergoing or has undergone bariatric surgery; or
Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline implants) and is at least 22 years of age;
Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
Agrees to answer baseline questions;
Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
Has a valid e-mail address and access to the internet to complete online questionnaires.
Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
Expects to undergo breast implant surgery during the study period;
Has ever had silicone implants anywhere in her body;
Has active infection anywhere in her body;
Has a history of cancer of any kind, except non-melanoma skin cancer;
Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
Is currently pregnant or nursing;
Is planning on undergoing or has undergone bariatric surgery; or
Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
Received MemoryShape Breast Implants for breast augmenation after January 01, 2015 and was at least 22 years old (primary or revision) at the time of surgery OR underwent breast reconstruction (primary or revision) with MemoryShape Breast Implants after January 01, 2015. A women who has since had her MemoryShape Breast Implants explanted may still be enrolled in the study.
Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
Agrees to answer baseline questions;
Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
Has a valid e-mail address and access to the internet to complete online questionnaires.
Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
Had an active infection anywhere in her body at the time of surgery;
For augmentation patients, had a history of cancer (prior to implantation) of any kind, except non-melanoma skin cancer; for reconstruction patients, had a history of cancer (prior to implantation) of any kind, except non melanoma skin cancer or adequately treated breast cancer;
Had a confirmed diagnosis of connective tissue disease or neurological disease prior to implantation OR was being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
Was pregnant or nursing at the time of surgery;
Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or
Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Study Design
Study Description
Connect with a study center
Hedden Plastic Surgery Center
Birmingham, Alabama 35242
United StatesSite Not Available
The Park Clinic
Mobile, Alabama 36606
United StatesSite Not Available
Plastic Surgery of Tuscaloosa
Tuscaloosa, Alabama 35406
United StatesSite Not Available
Advanced Plastic Surgery Institute
Gilbert, Arizona 85295
United StatesSite Not Available
Advanced Surgical Associates
Mesa, Arizona 85297
United StatesSite Not Available
Robles Plastic Surgery
Phoenix, Arizona 85014
United StatesSite Not Available
Berardi Aesthetics and Plastic Surgery
Scottsdale, Arizona 85260
United StatesSite Not Available
Guerra Plastic Surgery Center
Scottsdale, Arizona 85260
United StatesSite Not Available
Mark Malek, MD Plastic Surgery
Scottsdale, Arizona 85260
United StatesSite Not Available
Vanderpool Cosmetic Plastic Surgery
Fayetteville, Arkansas 72703
United StatesSite Not Available
Tehrani Plastic Surgery
Apple Valley, California 92307
United StatesSite Not Available
Jaime Schwartz, MD
Beverly Hills, California 90210
United StatesSite Not Available
Susan E. Downey, MD Inc
Burbank, California 91505
United StatesSite Not Available
Mohebali Plastic Surgery
Corte Madera, California 94925
United StatesSite Not Available
Institute of Cosmetic and Reconstructive Surgery
Fountain Valley, California 92708
United StatesSite Not Available
Newport Beach Center for Plastic Surgery
Newport Beach, California 92660
United StatesSite Not Available
Newport Center for Special Surgery
Newport Beach, California 92660
United StatesSite Not Available
North Coast Plastic Surgery
Oceanside, California 92056
United StatesSite Not Available
Li Plastic Surgery
Ontario, California 91764
United StatesSite Not Available
Summit Plastic Surgery
Redding, California 96001
United StatesSite Not Available
Verve Plastic Surgery
Solana Beach, California 92075
United StatesSite Not Available
Kaweah Delta Health Care District
Visalia, California 93291
United StatesSite Not Available
Park Meadows Cosmetic Surgery
Lone Tree, Colorado 80124
United StatesSite Not Available
David Bogue MD, Plastic Surgery, PL
Boca Raton, Florida 33431
United StatesSite Not Available
The Plastic Surgery Institute of Miami
Coral Gables, Florida 33134
United StatesSite Not Available
University of Miami / Sylvester Comp Cancer Ctr
Coral Gables, Florida 33146
United StatesSite Not Available
South Florida Plastic Surgery
Fort Lauderdale, Florida 33308
United StatesSite Not Available
First Coast Plastic Surgery
Jacksonville, Florida 32257
United StatesSite Not Available
Christopher Craft Cosmetic Surgery
Miami, Florida 33176
United StatesSite Not Available
Imagos Plastic Surgery
Miami, Florida 33173
United StatesSite Not Available
Pierini Esthetic Surgery
Miami, Florida 33166
United StatesSite Not Available
Sean A. Simon, MD
Miami, Florida 33146
United StatesSite Not Available
Southeastern Plastic Surgery
Tallahassee, Florida 32308
United StatesSite Not Available
Dr. Joshua Halpern MD, PA
Tampa, Florida 33607
United StatesSite Not Available
The Swan Center for Plastic Surgery
Alpharetta, Georgia 30005
United StatesSite Not Available
Artisan Plastic Surgery
Atlanta, Georgia 30342
United StatesSite Not Available
North Atlanta Plastic Surgery
Atlanta, Georgia 30342
United StatesSite Not Available
Advanced Aesthetics
Fayeteville, Georgia 30214
United StatesSite Not Available
Advanced Aesthetics
Fayetteville, Georgia 30214
United StatesSite Not Available
Marietta Plastic Surgery
Marietta, Georgia 30060
United StatesSite Not Available
Snodgrass and Robinson Plastic Surgery Specialists
Rome, Georgia 30161
United StatesSite Not Available
The Georgia Institute for Plastic Surgery
Savannah, Georgia 31405
United StatesSite Not Available
Barrington Plastic Surgery
Inverness, Illinois 60067
United StatesSite Not Available
MAE Plastic Surgery
Northbrook, Illinois 60062
United StatesSite Not Available
A New You Plastic Surgery & Laser Center
Oak Lawn, Illinois 60453
United StatesSite Not Available
Iowa Plastic Surgery
Davenport, Iowa 52807
United StatesSite Not Available
AMAE Plastic & Reconstructive Surgery
Birmingham, Michigan 48009
United StatesSite Not Available
Ellen A. Janetzke, MD
Bloomfield, Michigan 48304
United StatesSite Not Available
Partners in Plastic Surgery
Grand Rapids, Michigan 49546
United StatesSite Not Available
The Center for You
Traverse City, Michigan 49684
United StatesSite Not Available
Danielle DeLuca-Pytell, MD, PC
Troy, Michigan 48084
United StatesSite Not Available
Spa Renaissance & Renaissance Plastic Surgery
Troy, Michigan 48083
United StatesSite Not Available
Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville, Minnesota 55337
United StatesSite Not Available
Parkcrest Plastic Surgery
Saint Louis, Missouri 63141
United StatesSite Not Available
Parkcrest Plastic Surgery
St. Louis, Missouri 63141
United StatesSite Not Available
Hankins and Sohn Plastic Surgery
Henderson, Nevada 89074
United StatesSite Not Available
Atlantic Plastic Surgery
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Summit Medical Group
Berkeley Heights, New Jersey 07922
United StatesSite Not Available
Doctors Plastic Surgery
Long Island City, New York 11106
United StatesSite Not Available
Piedmont Plastic Surgery & Dermatology - Blakeney
Charlotte, North Carolina 28277
United StatesSite Not Available
Providence Plastic Surgery & Skin Center
Charlotte, North Carolina 28277
United StatesSite Not Available
Renaissance Plastic Surgery
Concord, North Carolina 28025
United StatesSite Not Available
Piedmont Plastic Surgery & Dermatology - Cox Road
Gastonia, North Carolina 28054
United StatesSite Not Available
Piedmont Plastic Surgery & Dermatology Center - New Hope
Gastonia, North Carolina 28054
United StatesSite Not Available
Piedmont Plastic Surgery & Dermatology - Hickory
Hickory, North Carolina 28602
United StatesSite Not Available
Hunstad Kortesis Center for Plastic Surgery
Huntersville, North Carolina 28078
United StatesSite Not Available
Forsyth Plastic Surgery
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Advanced Surgical Arts Center
Bismarck, North Dakota 58503
United StatesSite Not Available
The Columbus Institute for Plastic Surgery
Columbus, Ohio 43212
United StatesSite Not Available
Carp Cosmetic Surgery
Uniontown, Ohio 44685
United StatesSite Not Available
Tim R. Love, M.D., P.C.
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Paul Glat, MD, PC
Bala-Cynwyd, Pennsylvania 19087
United StatesSite Not Available
Upstate Plastic Surgery
Greer, South Carolina 29650
United StatesSite Not Available
The Center for Dermatology and Plastic Surgery
Alcoa, Tennessee 37701
United StatesSite Not Available
Plastic Surgery Group
Chattanooga, Tennessee 37403
United StatesSite Not Available
Music City Plastic Surgery
Nashville, Tennessee 37215
United StatesSite Not Available
Ciaravino Plastic Surgery
Houston, Texas 77098
United StatesSite Not Available
Premier Plastic Surgery
Draper, Utah 84020
United StatesSite Not Available
Michael D. Marion Plastic Surgery
Lehi, Utah 84043
United StatesSite Not Available
Plastic Surgery of Fredericksburg
Fredericksburg, Virginia 22401
United StatesSite Not Available
Plastic Surgery Center of Hampton Roads
Newport News, Virginia 23606
United StatesSite Not Available
The Hague Center for Cosmetic and Plastic Surgery
Norfolk, Virginia 23510
United StatesSite Not Available
Richmond Plastic Surgeons
Richmond, Virginia 23233
United StatesSite Not Available
Kai Morimoto MD PLLC
Spokane Valley, Washington 99216
United StatesSite Not Available
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