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

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