Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Mentor Worldwide, LLC
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
