Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
Condition: Breast Augmentation; Breast Reconstruction; Breast Revision
Intervention: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Intervention description: The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 955.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone gel; Contour Profile Gel; Siltex®

Summary:

      The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's
      Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction,
      or revision. Safety information on the rate of capsular contracture, rupture, and infection
      will be collected, and used to help determine device safety.

      Approximately 1000 patients at approximately 60 medical centers across the United States were
      enrolled in this research study. These patients were implanted with silicone breast
      prostheses and will be monitored for 10 years to collect information on risks associated with
      the implant surgery as well as changes in the way these patients feel about themselves.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is genetic female, 18 years of age or older

          -  A candidate for:

               -  Primary breast augmentation (general breast enlargement)

               -  Primary breast reconstruction (for trauma, loss of breast tissue due to
                  mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital
                  deformity, including asymmetry)

               -  Revision surgery (previous augmentation or reconstruction with silicone-filled or
                  saline-filled implants)

          -  Signs the Informed Consent

          -  Agrees to return device to Mentor if explant necessary

          -  Agrees to comply with follow-up procedures, including returning for all follow-up
             visits

        Exclusion Criteria:

          -  Subject is pregnant

          -  Has nursed a child within three months of study enrollment

          -  Been implanted with any silicone implant other than breast implants (e.g. silicone
             artificial joints or facial implants)

          -  Confirmed diagnosis of the following rheumatic diseases or syndromes: 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 (except
             reconstruction subjects)

          -  Subject in Augmentation cohort and has diagnosis of active cancer of any type.
             (Exception is low-grade non-metastasizing skin cancer)

          -  Infection or abscess anywhere in the body

          -  Demonstrates tissue characteristics which are clinically incompatible with implant
             (e.g. tissue damage resulting from radiation, 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 which could lead to significant postoperative
             adverse events

          -  Demonstrates characteristics that are unrealistic/unreasonable with the risks involved
             with the surgical procedure

          -  Premalignant breast disease without a subcutaneous mastectomy

          -  Untreated or inappropriately treated breast malignancy, without mastectomy

          -  Are HIV positive

          -  Work for Mentor or the study doctor or are directly-related to anyone that works for
             Mentor or the study doctor

          -  Implanted metal or metal devices, history of claustrophobia or other condition that
             would make a MRI scan prohibitive