Sientra Post-Approval Study

U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01639053

Enrollment

5498

Registered

2012-07-12

Start date

2012-04-30

Completion date

2025-03-31

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation, Breast Reconstruction, Breast Revision

Keywords

Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Long-term safety of Sientra Silicone Gel Breast Implants in women	10-years

Countries

United States

Outcome results