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

NCT06510205 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Breast Augmentation and Breast Reconstruction

Interventions

DEVICE

Mentor Breast implants

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.

Sponsors & Collaborators

  • Johnson & Johnson Medical (Shanghai) Ltd.

    lead INDUSTRY

Principal Investigators

  • Huimin Wu · Shenzhen Junke Medical Cosmetology Clinic

Eligibility

Min Age
22 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-14
Primary Completion
2034-06-30
Completion
2034-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510205 on ClinicalTrials.gov