Sientra Post-Approval Study

Sientra

Status: Active, not recruiting

Conditions: Breast Reconstruction; Breast Revision; Breast Augmentation

Study type: Observational

Funder types: Industry

Identifiers

NCT01639053

CP-1007

Details and patient eligibility

About

This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.

Enrollment: 5,498 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Genetic female with US residency
2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
3. Agrees to Sientra study requirements

Exclusion criteria

1. Has an active infection anywhere in body
2. Has active cancer without adequate treatment
3. Currently pregnant or nursing
4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

Trial design

5,498 participants in 2 patient groups

Gel Participants

Control Participants