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

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

Conditions
-----------------
Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction

Intervention / Treatment
-----------------
* Device: Natrelle(TM) Silicone-Filled Breast Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Primary augmentation | Device: Natrelle(TM) Silicone-Filled Breast Implants<br>* Breast implant surgery<br>|
| Experimental: 2<br>Primary reconstruction | Device: Natrelle(TM) Silicone-Filled Breast Implants<br>* Breast implant surgery<br>|
| Experimental: 3<br>Revision-augmentation | Device: Natrelle(TM) Silicone-Filled Breast Implants<br>* Breast implant surgery<br>|
| Experimental: 4<br>Revision-reconstruction | Device: Natrelle(TM) Silicone-Filled Breast Implants<br>* Breast implant surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Complications | By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale | Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied | 10 years |