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

Johnson & Johnson (J&J)

Status: Enrolling

Conditions: Breast Augmentation and Breast Reconstruction

Treatments: Device: Mentor Breast implants

Study type: Observational

Funder types: Industry

Identifiers

NCT06510205

MNT202401

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 22 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Mentor Group

Description:

Who recieves Mentor breast implants per request

Treatment:

Device: Mentor Breast implants