Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
3613 participants
INTERVENTIONAL
2016-09-01
2031-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary Breast Augmentation
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
MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Revision Breast Augmentation
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
MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Primary Breast Reconstruction
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
MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Revision Breast Reconstruction
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
MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Other Aesthetic Surgery
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Other Aesthetic Surgery
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)
Interventions
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MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Other Aesthetic Surgery
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)
Eligibility Criteria
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Inclusion Criteria
2. Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
4. Agrees to answer baseline questions;
5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
6. 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
7. Has a valid e-mail address and access to the internet to complete online questionnaires.
1. 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;
2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
3. Agrees to answer baseline questions;
4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
5. Has a valid e-mail address and access to the internet to complete online questionnaires.
1. 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.
2. Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
4. Agrees to answer baseline questions;
5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
6. 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
7. Has a valid e-mail address and access to the internet to complete online questionnaires.
Exclusion Criteria
2. 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;
3. 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;
4. Is currently pregnant or nursing;
5. Is planning on undergoing or has undergone bariatric surgery; or
6. 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.
1. Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
2. Expects to undergo breast implant surgery during the study period;
3. Has ever had silicone implants anywhere in her body;
4. Has active infection anywhere in her body;
5. Has a history of cancer of any kind, except non-melanoma skin cancer;
6. 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;
7. Is currently pregnant or nursing;
8. Is planning on undergoing or has undergone bariatric surgery; or
9. 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.
1. Had an active infection anywhere in her body at the time of surgery;
2. 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;
3. 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;
4. Was pregnant or nursing at the time of surgery;
5. Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or
6. 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.
18 Years
FEMALE
No
Sponsors
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Mentor Worldwide, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Mentor Worldwide, LLC
Locations
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Hedden Plastic Surgery Center
Birmingham, Alabama, United States
Plastic Surgery of Tuscaloosa
Tuscaloosa, Alabama, United States
Advanced Plastic Surgery Institute
Gilbert, Arizona, United States
Advanced Surgical Associates
Mesa, Arizona, United States
Robles Plastic Surgery
Phoenix, Arizona, United States
Berardi Aesthetics and Plastic Surgery
Scottsdale, Arizona, United States
Guerra Plastic Surgery Center
Scottsdale, Arizona, United States
Mark Malek, MD Plastic Surgery
Scottsdale, Arizona, United States
Vanderpool Cosmetic Plastic Surgery
Fayetteville, Arkansas, United States
Jaime Schwartz, MD
Beverly Hills, California, United States
Susan E. Downey, MD Inc
Burbank, California, United States
Mohebali Plastic Surgery
Corte Madera, California, United States
Institute of Cosmetic and Reconstructive Surgery
Fountain Valley, California, United States
Newport Beach Center for Plastic Surgery
Newport Beach, California, United States
Newport Center for Special Surgery
Newport Beach, California, United States
North Coast Plastic Surgery
Oceanside, California, United States
Li Plastic Surgery
Ontario, California, United States
Summit Plastic Surgery
Redding, California, United States
Verve Plastic Surgery
Solana Beach, California, United States
Kaweah Delta Health Care District
Visalia, California, United States
Park Meadows Cosmetic Surgery
Lone Tree, Colorado, United States
David Bogue MD, Plastic Surgery, PL
Boca Raton, Florida, United States
The Plastic Surgery Institute of Miami
Coral Gables, Florida, 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
Sean A. Simon, MD
Miami, Florida, United States
Pierini Esthetic Surgery
Miami, Florida, United States
Imagos Plastic Surgery
Miami, Florida, United States
Christopher Craft Cosmetic Surgery
Miami, Florida, United States
Southeastern Plastic Surgery
Tallahassee, Florida, United States
Dr. Joshua Halpern MD, PA
Tampa, Florida, United States
The Swan Center for Plastic Surgery
Alpharetta, Georgia, United States
Artisan Plastic Surgery
Atlanta, Georgia, United States
North Atlanta Plastic Surgery
Atlanta, Georgia, United States
Advanced Aesthetics
Fayetteville, Georgia, United States
Marietta Plastic Surgery
Marietta, Georgia, United States
Snodgrass and Robinson Plastic Surgery Specialists
Rome, Georgia, United States
The Georgia Institute for Plastic Surgery
Savannah, Georgia, United States
Barrington Plastic Surgery
Inverness, Illinois, United States
MAE Plastic Surgery
Northbrook, Illinois, United States
A New You Plastic Surgery & Laser Center
Oak Lawn, Illinois, United States
Iowa Plastic Surgery
Davenport, Iowa, United States
AMAE Plastic & Reconstructive Surgery
Birmingham, Michigan, United States
Ellen A. Janetzke, MD
Bloomfield, Michigan, United States
Partners in Plastic Surgery
Grand Rapids, Michigan, United States
The Center for You
Traverse City, Michigan, United States
Spa Renaissance & Renaissance Plastic Surgery
Troy, Michigan, United States
Danielle DeLuca-Pytell, MD, PC
Troy, Michigan, United States
Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville, Minnesota, United States
Parkcrest Plastic Surgery
St Louis, Missouri, United States
Hankins and Sohn Plastic Surgery
Henderson, Nevada, United States
Atlantic Plastic Surgery
Portsmouth, New Hampshire, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Doctors Plastic Surgery
Long Island City, New York, United States
Piedmont Plastic Surgery & Dermatology - Blakeney
Charlotte, North Carolina, United States
Providence Plastic Surgery & Skin Center
Charlotte, North Carolina, United States
Piedmont Plastic Surgery & Dermatology - Cox Road
Gastonia, North Carolina, United States
Piedmont Plastic Surgery & Dermatology Center - New Hope
Gastonia, North Carolina, United States
Piedmont Plastic Surgery & Dermatology - Hickory
Hickory, North Carolina, United States
Forsyth Plastic Surgery
Winston-Salem, North Carolina, United States
Advanced Surgical Arts Center
Bismarck, North Dakota, United States
The Columbus Institute for Plastic Surgery
Columbus, Ohio, United States
Carp Cosmetic Surgery
Uniontown, Ohio, United States
Tim R. Love, M.D., P.C.
Oklahoma City, Oklahoma, United States
Paul Glat, MD, PC
Bala-Cynwyd, Pennsylvania, United States
Upstate Plastic Surgery
Greer, South Carolina, United States
The Center for Dermatology and Plastic Surgery
Alcoa, Tennessee, United States
Plastic Surgery Group
Chattanooga, Tennessee, United States
Music City Plastic Surgery
Nashville, Tennessee, United States
Ciaravino Plastic Surgery
Houston, Texas, United States
Premier Plastic Surgery
Draper, Utah, United States
Michael D. Marion Plastic Surgery
Lehi, Utah, United States
Plastic Surgery of Fredericksburg
Fredericksburg, Virginia, United States
Plastic Surgery Center of Hampton Roads
Newport News, Virginia, United States
The Hague Center for Cosmetic and Plastic Surgery
Norfolk, Virginia, United States
Richmond Plastic Surgeons
Richmond, Virginia, United States
Kai Morimoto MD PLLC
Spokane Valley, Washington, United States
Countries
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Other Identifiers
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MEN-15-003
Identifier Type: -
Identifier Source: org_study_id