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RECRUITING
NCT06510205

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

Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.

View on ClinicalTrials.gov

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 different number of participants for each license.

Official title: MNT202401: Post Market Clinical Follow up for Mentor Breast Implants

Key Details

Gender

FEMALE

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

6111

Start Date

2024-07-14

Completion Date

2034-12-31

Last Updated

2026-07-07

Healthy Volunteers

No

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.

Locations (4)

Sichuan Huamei Zixin Medical Aesthetic Hospital

Chengdu, China

Yunnan Huamei Meilai Cosmetology Hospital

Kunming, China

Shenzhen Yixing Medical Cosmetology Hospital

Shenzhen, China

Shenzhen Junke Medical Cosmetology Clinic

Shenzhen, China