• The primary study outcome is that the Style 410 silicone implant will be determined to be safe device and benefit women who chose to have breast reconstruction, augmentation, or revised previous implant surgery. [ Time Frame: within 10 years of implantation ]
  

• Women will benefit both physically and psychologically from receiving Style 410 silicone implants. [ Time Frame: within 10 years of implantation ]
  

The Food and Drug Administration (FDA) has issued a guidance document requiring that clinical studies be conducted to establish the safety and efficacy of silicone-filled breast implants ("Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses", January 13, 2004). The Inamed Style 410 Silicone-Filled Breast Implant is an experimental device that is available to patients who participate in this clinical study.

After implantation, the study schedule requires follow-up visits at 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years after your surgery. Case Report Forms (CRFs)on Quality of Life and Activity and Lifestyles will be completed by each patient at annual visits. Photographs of the breast/chest area will be taken prior to surgery and one year after surgery. Anyone scheduled for explantation of the study implant(s) for any reason will be asked to obtain a magnetic resonance imaging procedure (MRI) immediately prior to explant surgery, if medically advisable.

Inclusion Criteria:

• Be a female 18 years of age or older,
• Have a condition appropriate for breast augmentation, reconstruction or revision
• Have adequate tissue available to cover the implant(s),
• Complete a screening by your surgeon, and
• Be willing to sign this Informed Consent document which gives you information about your breast implants and confirms your commitment to follow study requirements and acceptance of the potential risks involved.
• Be willing to have a magnetic resonance imaging procedure (MRI) performed immediately prior to explantation, if medically advisable.

Exclusion Criteria:

• Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
• Existing carcinoma of the breast, without mastectomy.
• Abscess or infection in the body at the time of enrollment.
• Pregnant or nursing.
• Have any disease, including uncontrolled diabetes (e.g., Hb AIc > 8%), that is clinically known to impact wound healing ability.
• Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
• Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems).
• Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder).