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

NCT06510205 | Recruiting

• 2 other identifiers: MNT202401PMS-MTR-202301
• Study Type: observational
• Target: 6,111
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Breast Augmentation; Mammaplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Numerical Pain Scale assessment

  1 month after surgery

• Customer Satisfaction Score measurement

  Up to 5 years after surgery

Study Arms (1)

Mentor Group

Who recieves Mentor breast implants per request

Device: Mentor Breast implants

Interventions

Mentor Breast implants DEVICE

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.

Mentor Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Per product instruction for use(IFU)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All populations receiving Mentor breast implants

You may qualify if:

• Women who have received Mentor breast implants per product instructions;
• 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.
• Aged not less than 18 years at the time of implantation surgery (for products with registration license Guoxie Zhujin 20223130323, the participant's age should be not less than 22 years).

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Johnson & Johnson Medical (Shanghai) Ltd.: lead

Study Sites (4)

Sichuan Huamei Zixin Medical Aesthetic Hospital

Chengdu, 610000, China

RECRUITING

Yunnan Huamei Meilai Cosmetology Hospital

Kunming, 650000, China

RECRUITING

Shenzhen Yixing Medical Cosmetology Hospital

Shenzhen, 518000, China

RECRUITING

Shenzhen Junke Medical Cosmetology Clinic

Shenzhen, 519000, China

RECRUITING

Study Officials

• Huimin Wu

  Shenzhen Junke Medical Cosmetology Clinic

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

+86 15692105615; ygu51@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 19, 2024
• Study Start: July 14, 2024
• Primary Completion (Estimated): June 30, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)