Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
84,329
Breast implant surgery
Unnamed facility
Indianapolis, Indiana, United States
Local Complications
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Time frame: 5 years
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
Time frame: 5 years
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