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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.
Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
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.
Official title: Post-Market Clinical Follow-up for Mentor Breast Implants
Key Details
Gender
FEMALE
Age Range
22 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2024-07-14
Completion Date
2034-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
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 (3)
Sichuan Huamei Zixin Medical Aesthetic Hospital
Chengdu, China
Shenzhen Yixing Medical Cosmetology Hospital
Shenzhen, China
Shenzhen Junke Medical Cosmetology Clinic
Shenzhen, China