Post Market Clinical Experience Study of Sientra 207 Breast Implants
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 6/17/2018 |
| Start Date: | August 2016 |
| End Date: | December 2019 |
| Contact: | Sientra, Inc. |
Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast
Implants
Implants
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.
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