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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Augmentation and Breast Reconstruction
• Intervention / Treatment: Device: Mentor Breast implants

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: +86 15692105615; Email: ygu51@its.jnj.com

Study Locations

• China
  • Chengdu, China, 610000
    • Recruiting
    • Sichuan Huamei Zixin Medical Aesthetic Hospital
  • Shenzhen, China, 519000
    • Recruiting
    • Shenzhen Junke Medical Cosmetology Clinic
  • Shenzhen, China, 518000
    • Recruiting
    • Shenzhen Yixing Medical Cosmetology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All populations receiving Mentor breast implants

Description

Inclusion Criteria:

1. Women who have received Mentor breast implants per product instructions;
2. Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
3. Participants must be at least 22 years old at the time of their implantation surgery.

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mentor Group; Who recieves Mentor breast implants per request	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast implant related AEs	Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Scale assessment	Zero means you have no pain, while 10 represents the most intense pain possible.	1 month after surgery
Customer Satisfaction Score measurement	Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied.	Up to 5 years after surgery

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
• Investigators: Study Director: Huimin Wu, Shenzhen Junke Medical Cosmetology Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Estimated): June 30, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MNT202401 (Other Identifier: Johnson & Johnson Medical (Shanghai) Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No