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

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

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

Conditions
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Breast Reconstruction

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


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 reconstruction | Device: Natrelle(TM) Silicone-Filled Breast Implants<br>* Breast implant surgery<br>|
| Experimental: 2<br>Revision-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>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision of augmentation or reconstruction