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

Allergan

Status

Completed

Conditions

Breast Reconstruction

Treatments

Device: Natrelle(TM) Silicone-Filled Breast Implants

Study type

Interventional

Funder types

Industry

Identifiers

NCT00691327

910044

Details and patient eligibility

About

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

Enrollment

84,329 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.