Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Allergan

Status

Completed

Conditions

Breast Reconstruction

Revision of Augmentation or Reconstruction

Breast Augmentation

Treatments

Device: Natrelle(TM) Silicone-Filled Breast Implants

Study type

Interventional

Funder types

Industry

Identifiers

NCT00689871

020056

Details and patient eligibility

About

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

Enrollment

715 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female, age 18 years or older
Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
Seeking primary breast reconstruction
Seeking breast revision-augmentation
Seeking breast revision-reconstruction
Adequate tissue available to cover implants
Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

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., HbAIc > 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)
Are not willing to undergo further surgery for revision, if medically required