Expired Study
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Indianapolis, Indiana


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


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.



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Indianapolis, Indiana
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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