Ensayos clínicos

Inclusion Criteria

• Female and at least 18 years old
• A candidate for
  • Primary breast reconstruction 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  with surgically absent breast tissue  
    • Previous reconstruction with silicone-filled or saline-filled implants 
    • 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
• Understands and signs the Informed Consent
• Agrees to return device to Mentor if device is removed
• 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

• Pregnant at time of enrollment
• 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
  • Any connective tissue disorder
  • Rheumatoid arthritis
  • Crystalline arthritis
  • Infectious arthritis
  • Spondyloarthropathies
  • Any other inflammatory arthritis
  • Fibromyalgia
  • Chronic fatigue syndrome
• Currently has a condition that could compromise or complicate wound healing
  • 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
• 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 an MRI scan prohibitive
• History of claustrophobia or other condition that would make a MRI scan prohibitive