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 (Athena)

A Study of the Safety and Effectiveness of the Mentor Smooth and Textured Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Reconstruction, Revision Breast Reconstruction
• Intervention / Treatment: Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant

Detailed Description

Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Plastic Surgery Associates of Montgomery
  • Arizona
    • Phoenix, Arizona, United States, 85028
      • Mosharrafa Plastic Surgery
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
    • Scottsdale, Arizona, United States, 85260
      • Andres Plastic Surgery
  • California
    • Bakersfield, California, United States, 93301
      • Adventist Health Bakersfield
    • Burbank, California, United States, 91505
      • Susan E Downey MD, Inc
    • Los Gatos, California, United States, 95032
      • Liu Plastic Surgery
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Buckhead Plastic Surgery, P.C
    • Savannah, Georgia, United States, 31405
      • Georgia Institute of Plastic Surgery
  • Indiana
    • Mishawaka, Indiana, United States, 46545
      • The Centre, PC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
  • Ohio
    • Centerville, Ohio, United States, 45458
      • Plastic Surgery Institute of Dayton
    • Cincinnati, Ohio, United States, 45227
      • The Plastic Surgery Group
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43212
      • The Ohio State University Plastic Surgery
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19087
      • Paul Glat, MD, PC
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Alcoa, Tennessee, United States, 37701
      • The Center for Dermatology and Plastic Surgery at Springbrook
    • Chattanooga, Tennessee, United States, 37403
      • The Plastic Surgery Group PC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Health
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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 Names: UHP-L Breast Implant
Experimental: 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	Device: 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 Names: UHP-L Breast Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation	10 years
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture	10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection	10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement	10 years

Collaborators and Investigators

• Sponsor: Mentor Worldwide, LLC
• Investigators: Study Director: Medical Director, Mentor Worldwide, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimated): March 31, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MEN-15-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No