Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
Condition: Breast Reconstruction; Breast Augmentation; Breast Revision
Intervention: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Intervention description: Two types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1008.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Reconstruction; Breast Augmentation; Revision; Silicone breast implants; Round low-bleed

Summary:

      The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round
      Low-Bleed Silicone Gel-filled 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 centers across the United States will be enrolled in this
      research study. These patients will be implanted with silicone breast prostheses and
      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 and at least 18 years old

          -  A candidate for:

          -  Primary breast augmentation (for post-lactational mammary involution or general breast
             enlargement)

          -  Primary breast reconstruction (for cancer, trauma, surgical loss of breast or
             congenital deformity)

          -  Revision surgery (previous augmentation or reconstruction with silicone-filled or
             saline-filled implants)

          -  Signs the Informed Consent

          -  Agrees to follow the procedures for explant analysis

          -  Agrees to comply with follow-up procedures, including returning for all follow-up
             visits

        Exclusion Criteria:

          -  Patient 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, infections arthritis, spondylarthropathies, any
             other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue
             syndrome

          -  Currently has a condition that could compromise or complicate wound healing (except
             reconstruction patients)

          -  Patient in Augmentation cohort and has diagnosis of active cancer of any type

          -  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

          -  Implanted metal or metal devices, history of claustrophobia or other condition that
             would make a MRI scan prohibitive