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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Reconstruction, Revision Breast Reconstruction

Intervention / Treatment
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* Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Breast Reconstruction<br>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<br>* 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.<br>* Other names: UHP-L Breast Implant;|
| Experimental: Revision Breast Reconstruction<br>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<br>* 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.<br>* Other names: UHP-L Breast Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |