Breast AugmentationNCT01639053
Sientra Post-Approval Study
An observational study of Breast Augmentation and Breast Reconstruction, run by Tiger Biosciences, LLC. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction, Breast Revision
- How many people
- 5,498 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
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.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Keywords
- Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gel Participants | Not described | |
| Control Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of Sientra Silicone Gel Breast Implants in women
Measured: 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sientra, Inc., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639053
- Sponsor's protocol ID
- CP-1007
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2012
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
- ClinicalTrials.gov ID
- NCT01639053
- Acronym / sponsor ID
- CP-1007
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Keywords
- Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,498 participants (actual)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel Participants | – | – |
| Control Participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term safety of Sientra Silicone Gel Breast Implants in women
Time frame: 10-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Augmentation
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sientra, Inc. study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Augmentation and Breast Reconstruction, run by Tiger Biosciences, LLC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of Sientra Silicone Gel Breast Implants in women (time frame: 10-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.