NCT00691327CompletedNot Applicable
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan Medical
- Enrollment
- 84,329
- Locations
- 1
- Primary Endpoint
- Local Complications
Study Overview
Brief Summary
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Local Complications
Time Frame: 5 years
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Secondary Outcomes
- Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale(5 years)
Investigators
Study Sites (1)
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