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

Not Applicable

Completed

• Conditions: Breast Reconstruction

• Registration Number: NCT00691327
• Lead Sponsor: Allergan Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-30
• Results First Submitted QC: 2013-12-30
• Results First Posted: 2014-02-12
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84329

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local Complications	5 years	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale	5 years	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied