RecruitingNCT06510205

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

MNT202401: Post Market Clinical Follow up for Mentor Breast Implants

Sponsor

Johnson & Johnson Medical (Shanghai) Ltd.

Enrollment

6,111 participants

Start Date

Jul 14, 2024

Study Type

OBSERVATIONAL

Conditions

Mammaplasty Breast Augmentation

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

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).

Exclusion Criteria1

Not applicable

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Interventions

DEVICEMentor 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.