UnknownNot Applicable

Sientra Post-Approval Study

United States5,498 participantsStarted 2012-04

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Long-term safety of Sientra Silicone Gel Breast Implants in women

Timeframe: 10-years

Trial details

NCT IDNCT01639053

SponsorTiger Biosciences, LLC.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03

View on ClinicalTrials.gov More Breast Augmentation trials