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6,111 women to track breast implant safety over 5 years

NCT ID NCT06510205

Knowledge-focused Sponsor: Johnson & Johnson Medical (Shanghai) Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study follows 6,111 women in China who received Mentor breast implants to monitor safety and satisfaction over five years. Researchers will record any implant-related side effects, pain levels, and how happy patients are with their results. The goal is to gather real-world data to guide future product improvements.

What this could mean

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

Active substance
Mentor breast implants (silicone gel-filled, smooth or textured shells)
What this could lead to
If successful, this study could provide real-world safety data to improve future breast implant designs and patient care.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to other populations or implant types.

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

About 6,111 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2034

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

All populations receiving Mentor breast implants

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Women who have received Mentor breast implants per product instructions; 2. 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. 3. 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). Exclusion Criteria: * Not applicable

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As listed by the trial registrant

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

Breast augmentation Breast augmentation and breast reconstruction Mammaplasty

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shenzhen Junke Medical Cosmetology Clinic

    RECRUITING

    Shenzhen, 519000, China

  • Shenzhen Yixing Medical Cosmetology Hospital

    RECRUITING

    Shenzhen, 518000, China

  • Sichuan Huamei Zixin Medical Aesthetic Hospital

    RECRUITING

    Chengdu, 610000, China

  • Yunnan Huamei Meilai Cosmetology Hospital

    RECRUITING

    Kunming, 650000, China

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