Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.

Inclusion Criteria:

• Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
• Females seeking revision augmentation or revision reconstruction, where problems exist
• Have any of the following conditions or situations present:
• Post mastectomy surgical removal of the breast for cancer or other disease;
• Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
• Severe ptosis requiring reconstruction;
• Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
• Adequate tissue available to cover implants.
• Saline-filled implants are not an appropriate choice.

Exclusion Criteria:

• Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
• Existing carcinoma of the breast, without mastectomy.
• Abscess of infection in the body at the time of enrollment.
• Pregnant or nursing.
• Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
• Show tissue characteristics which are clinically incompatible with mammaplasty.
• Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
• Are not willing to undergo further surgery for revision, if medically required.
• Diagnosis of lupus or scleroderma.