Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,788
Sientra, Inc.
Santa Barbara, California, United States
Local Complications
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
Time frame: 10 Years
Satisfaction Determined by Patients
Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree."
Time frame: 10 Years
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