NCT06510205

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

Post-Market Clinical Follow-up for Mentor Breast Implants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd. · Industry
• Sex: Female
• Age: 22 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-14
• Primary completion: 2034-06-30
• Completion: 2034-12-31
• First posted: 2024-07-19
• Last updated: 2026-04-13

Locations

3 sites across 1 country: China