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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-000937
    NCT ID: NCT02724371
    Sponsor Protocol Number: MEN-15-001

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Mentor MemoryGel® larger size ultra high profile breast implants for patients who are undergoing primary or revision reconstruction surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Female and at least 18 years old
  • A candidate for
    • Primary breast reconstruction 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  with surgically absent breast tissue  
      • Previous reconstruction with silicone-filled or saline-filled implants 
      • 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
  • Understands and signs the Informed Consent
  • Agrees to return device to Mentor if device is removed
  • 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

  • Pregnant at time of enrollment
  • 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
    • Any connective tissue disorder
    • Rheumatoid arthritis
    • Crystalline arthritis
    • Infectious arthritis
    • Spondyloarthropathies
    • Any other inflammatory arthritis
    • Fibromyalgia
    • Chronic fatigue syndrome
  • Currently has a condition that could compromise or complicate wound healing
    • 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
  • 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 an MRI scan prohibitive
  • History of claustrophobia or other condition that would make a MRI scan prohibitive

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alanna Rebecca, M.D.

Open for enrollment

Contact information:

Debra Ryan CCRP

(480)342-1208

Ryan.Debra29@mayo.edu

.
CLS-20318088

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