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Ten-Year watch on silicone gel breast implants

NCT ID NCT01639053

NEW Disease control Sponsor: Tiger Biosciences, LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 22, 2026

Summary

Researchers are following thousands of women for ten years to track how Sientra silicone gel breast implants perform in everyday use. Participants include women having breast augmentation, reconstruction after cancer surgery, or revision of previous implants. The study collects long-term safety information after the implants reached the market, rather than testing them against another treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sientra silicone gel breast implants
What this could lead to
If the implants hold up well over ten years, the study could give women and surgeons clearer long-term safety information when choosing breast implants.
What could go wrong
This is an observational postapproval study, not a controlled experiment, so it can describe what happens but cannot prove the implants cause or prevent any outcome. Implant safety questions often take many years and large numbers of women to answer, and results may not apply to other implant brands.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

5,498 people

The number who actually took part.

Start date

Apr 2012

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction. Control participants are candidates for and undergo aesthetic surgery other than implantation with Silicone Gel Breast implants.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast augmentation Breast reconstruction Breast revision

Contacts and locations

Locations

  • Sientra, Inc.

    Santa Barbara, California, 93117, United States

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