Who is eligible for clinical trial NCT02724371?

Participants must meet protocol criteria for Breast Reconstruction. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT02724371 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

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 (NCT02724371)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Mentor Worldwide, LLC

🩺 Plain-English Summary (8th-Grade Level)

The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (17 items).

Location: Plastic Surgery Associates of Montgomery — Montgomery, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Subject is female and is at least 18 years old
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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Subject is pregnant at time of enrollment
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (30 Sites)

Plastic Surgery Associates of Montgomery — Montgomery, Alabama
Mosharrafa Plastic Surgery — Phoenix, Arizona
Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB) — Phoenix, Arizona
Andres Plastic Surgery — Scottsdale, Arizona
Adventist Health Bakersfield — Bakersfield, California
Susan E Downey MD, Inc — Burbank, California
Liu Plastic Surgery — Los Gatos, California
Stanford University School of Medicine — Stanford, California
Buckhead Plastic Surgery, P.C — Atlanta, Georgia
Georgia Institute of Plastic Surgery — Savannah, Georgia
The Centre, PC — Mishawaka, Indiana
University of Iowa Hospitals & Clinics — Iowa City, Iowa
The University of Kansas — Kansas City, Kansas
Abbott Northwestern Hospital — Minneapolis, Minnesota
Washington University School of Medicine — St Louis, Missouri
The Mount Sinai Medical Center — New York, New York
Plastic Surgery Institute of Dayton — Centerville, Ohio
The Plastic Surgery Group — Cincinnati, Ohio
The Cleveland Clinic — Cleveland, Ohio
The Ohio State University Plastic Surgery — Columbus, Ohio
Legacy Good Samaritan Medical Center — Portland, Oregon
Paul Glat, MD, PC — Bala-Cynwyd, Pennsylvania
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
The Center for Dermatology and Plastic Surgery at Springbrook — Alcoa, Tennessee
The Plastic Surgery Group PC — Chattanooga, Tennessee

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗