Post Market Clinical Experience Study of Sientra 207 Breast Implants

Sientra

Status: Terminated

Conditions: Breast Augmentation; Breast Revision-Augmentation

Treatments: Device: Sientra 207 Silicone Gel Breast Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT02905617

CP-1008

Details and patient eligibility

About

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

Full description

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.

Enrollment: 113 patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

113 participants in 2 patient groups

Primary Augmentation

Description:

Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant.

Treatment:

Device: Sientra 207 Silicone Gel Breast Implant

Revision Augmentation

Description:

Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery.

Treatment:

Device: Sientra 207 Silicone Gel Breast Implant