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

Last updated: May 22, 2025
Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mentor Breast implants

Clinical Study ID

NCT06510205
MNT202401
MNT202401
PMS-MTR-202301
  • Ages 22-100
  • Female

Study 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. 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 a minimum of 300 subjects per license, with participation from three or more medical institutions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women who have received Mentor breast implants per product instructions;

  2. Participants must possess the ability to comprehend the study procedures, giveconsent for the use of their preoperative and surgical data, and agree to take partin postoperative follow-up assessments. Additionally, they should possess thenecessary civil capacity, be capable of reading and writing, and willingly provideinformed consent by signing the consent form.

  3. Participants must be at least 22 years old at the time of their implantationsurgery.

Exclusion

Exclusion Criteria:

  • Not applicable

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Mentor Breast implants
Phase:
Study Start date:
July 14, 2024
Estimated Completion Date:
December 31, 2034

Connect with a study center

  • Sichuan Huamei Zixin Medical Aesthetic Hospital

    Chengdu, 610000
    China

    Active - Recruiting

  • Shenzhen Junke Medical Cosmetology Clinic

    Shenzhen, 519000
    China

    Active - Recruiting

  • Shenzhen Yixing Medical Cosmetology Hospital

    Shenzhen, 518000
    China

    Active - Recruiting

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