Post Market Clinical Experience Study of Sientra 207 Breast Implants

Tiger Biosciences, LLC.113 enrolled

Overview

A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Breast Augmentation Breast Revision-Augmentation

Interventions

Sientra 207 Silicone Gel Breast ImplantDEVICE

The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.

Eligibility

Sex: FEMALEMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age, 2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12. Exclusion Criteria: 1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery 2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

Locations (1)

Sientra, Inc.

Santa Barbara, California, United States

Outcomes

Primary Outcomes

Investigator Overall Satisfaction Questionnaire

The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Time frame: 3 months

Investigator Overall Satisfaction Questionnaire

Time frame: 6 months

Investigator Overall Satisfaction Questionnaire

Time frame: 12 months

Data from ClinicalTrials.gov

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