A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
NCT ID: NCT02724371
Last Updated: 2025-11-10
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
400 participants
INTERVENTIONAL
2016-04-01
2029-01-31
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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 Larger Size MemoryGel Ultra High Profile Breast implants
Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
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 Larger Size MemoryGel Ultra High Profile Breast implants
Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
Interventions
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Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A candidate for:
* Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction \[tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement\] to replace breast tissue post-mastectomy)
* Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
* Subject understands and signs the Informed Consent
* Subject agrees to return device to Mentor if device is explanted
* Subject agrees to comply with follow-up procedures, including returning for all follow-up visits
* Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width
Exclusion Criteria
* Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
* Currently has uncontrolled diabetes (at time of screening or enrollment)
* Has nursed a child within 3 months of study enrollment
* Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
* Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection
* Infection or abscess anywhere in the body
* Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
* Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
* Anatomic or physiologic abnormality that could lead to significant postoperative adverse events
* Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
* Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment
* Anticipated need for use of ADM/mesh at the time of implant or implant exchange
* Subject is HIV positive
* Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
* Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive
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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Plastic Surgery Associates of Montgomery
Montgomery, Alabama, United States
Mosharrafa Plastic Surgery
Phoenix, Arizona, United States
Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
Phoenix, Arizona, United States
Andres Plastic Surgery
Scottsdale, Arizona, United States
Adventist Health Bakersfield
Bakersfield, California, United States
Susan E Downey MD, Inc
Burbank, California, United States
Liu Plastic Surgery
Los Gatos, California, United States
Stanford University School of Medicine
Stanford, California, United States
Buckhead Plastic Surgery, P.C
Atlanta, Georgia, United States
Georgia Institute of Plastic Surgery
Savannah, Georgia, United States
The Centre, PC
Mishawaka, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
The University of Kansas
Kansas City, Kansas, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Mount Sinai Medical Center
New York, New York, United States
Plastic Surgery Institute of Dayton
Centerville, Ohio, United States
The Plastic Surgery Group
Cincinnati, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Plastic Surgery
Columbus, Ohio, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, United States
Paul Glat, MD, PC
Bala-Cynwyd, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Center for Dermatology and Plastic Surgery at Springbrook
Alcoa, Tennessee, United States
The Plastic Surgery Group PC
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
UVA Health System
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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MEN-15-001
Identifier Type: -
Identifier Source: org_study_id