Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in
women undergoing primary reconstruction or revision of existing breast implants.
- 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
- 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.
- Advanced fibrocystic disease considered to be premalignant without accompanying
- 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.