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

Not Applicable

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
3	Natrelle(TM) Silicone-Filled Breast Implants	Revision-augmentation
1	Natrelle(TM) Silicone-Filled Breast Implants	Primary reconstruction
2	Natrelle(TM) Silicone-Filled Breast Implants	Revision-reconstruction

Primary Outcome Measures

Name	Time	Method
Local Complications	5 years	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale	5 years	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied