CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
Condition: Breast Augmentation; Breast Reconstruction; Breast Revision
Intervention: The Contour Profile Gel (CPG) breast implants
Intervention description: The CPG mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. The Siltex® shell is textured to provide a disruptive surface for collagen interface. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The gel is made from the same materials as Mentor's standard gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness. The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant which may help the physician ensure proper placement.
The Contour Profile Gel is available in sizes 125cc - 690cc and 4 styles with various projection and height options in this study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1891.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone Gel; Contour Profile Gel; Siltex; CPG Styles

Summary:

      The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's
      Contour Profile Gel (CPG) breast implants 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 determine device safety.
    

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), or 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, spondylarthropathies, 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