Breast AugmentationNCT06510205
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
An observational study of Breast Augmentation and Mammaplasty, run by Johnson & Johnson Medical (Shanghai) Ltd. at 4 sites in China.
Trial summary
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Augmentation, Mammaplasty
- What is being tested?
- Mentor Breast implants
- Type of treatment
- Medical device
- How many people
- 6,111 participants
- Where
- 4 sitesChina
- Study dates
- 14 Jul 2024to 31 Dec 2034
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All populations receiving Mentor breast implants
Who may be able to join
- Women who have received Mentor breast implants per product instructions;
- Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
- Aged not less than 18 years at the time of implantation surgery (for products with registration license Guoxie Zhujin 20223130323, the participant's age should be not less than 22 years).
Who cannot join
- Not applicable
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Sichuan Huamei Zixin Medical Aesthetic Hospital
Chengdu, 610000
- Recruiting
Yunnan Huamei Meilai Cosmetology Hospital
Kunming, 650000
- Recruiting
Shenzhen Yixing Medical Cosmetology Hospital
Shenzhen, 518000
- Recruiting
Shenzhen Junke Medical Cosmetology Clinic
Shenzhen, 519000
About this study
Official title: MNT202401: Post Market Clinical Follow up for Mentor Breast Implants
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll different number of participants for each license.
- Conditions
- Breast Augmentation, Mammaplasty
- Being tested
- Mentor Breast implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentor Breast implantsDevice
Mentor breast implants are circular or waterdrop-shaped devices with shells made of successive cross-linked layers of silicone elastomer. The shell is filled with Mentor's proprietary formulation of silicone gel.
Mentor breast implants are available in smooth and textured shells, both supplied in sterile form.
| Study group | Role | What they receive |
|---|---|---|
| Mentor Group | Who recieves Mentor breast implants per request Receives: Device: Mentor Breast implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast implant related AEs
Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years
Measured: Up to 5 years
Secondary outcomes (2)
Numerical Pain Scale assessment
Zero means you have no pain, while 10 represents the most intense pain possible.
Measured: 1 month after surgery
Customer Satisfaction Score measurement
Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied.
Measured: Up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start14 Jul 2024
- Primary completion30 Jun 2034 (estimated)
- Study completion31 Dec 2034 (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
- 6,111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huimin Wu, Study director, Shenzhen Junke Medical Cosmetology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510205
- Sponsor's protocol ID
- MNT202401
- Other IDs
- PMS-MTR-202301
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MNT202401: Post Market Clinical Follow up for Mentor Breast Implants
- ClinicalTrials.gov ID
- NCT06510205
- Acronym / sponsor ID
- MNT202401
- Conditions
- Breast Augmentation, Mammaplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,111 participants (estimated)
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 30 Jun 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 19 Jul 2024 (actual)
- 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.
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll different number of participants for each license.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mentor Group | – | Device: Mentor Breast implantsWho recieves Mentor breast implants per request |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All populations receiving Mentor breast implants
Key inclusion criteria (3 listed)
- Women who have received Mentor breast implants per product instructions;
- Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
- Aged not less than 18 years at the time of implantation surgery (for products with registration license Guoxie Zhujin 20223130323, the participant's age should be not less than 22 years).
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentor Breast implantsMentor breast implants are circular or waterdrop-shaped devices with shells made of successive cross-linked layers of silicone elastomer. The shell is filled with Mentor's proprietary formulation of silicone gel. Mentor breast implants are available in smooth and textured shells, both supplied in sterile form. | Device | Mentor Group |
Primary outcome
Breast implant related AEs
Time frame: Up to 5 years
Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years
2 secondary outcomes
Numerical Pain Scale assessment
Time frame: 1 month after surgery
Customer Satisfaction Score measurement
Time frame: Up to 5 years after surgery
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 28 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Huimin Wu study director
Shenzhen Junke Medical Cosmetology Clinic
4 sites 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 Mammaplasty, run by Johnson & Johnson Medical (Shanghai) Ltd. at 4 sites in China.
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 1 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: looking for participants now, as of the sponsor's last update on 28 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 4 sites in China. 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?
Contact Study Contact (+86 15692105615, ygu51@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast implant related AEs (time frame: Up to 5 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 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.