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NCT06510205From ClinicalTrials.govRecruiting

The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population

MNT202401: Post Market Clinical Follow up for Mentor Breast Implants

  • Breast Augmentation
  • Mammaplasty

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Johnson & Johnson Medical (Shanghai) Ltd.
Enrolment target
6,111
Started
14 July 2024
Main results due
30 June 2034
Study sites
4
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(4)

  • Sichuan Huamei Zixin Medical Aesthetic Hospital

    Chengdu, China

    Recruiting

  • Yunnan Huamei Meilai Cosmetology Hospital

    Kunming, China

    Recruiting

  • Shenzhen Yixing Medical Cosmetology Hospital

    Shenzhen, China

    Recruiting

  • Shenzhen Junke Medical Cosmetology Clinic

    Shenzhen, China

    Recruiting

Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06510205. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor B | Trialion