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NCT Number: NCT06510205

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

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.

Recruiting

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Key information

Conditions

Breast Augmentation Mammaplasty

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Sichuan Huamei Zixin Medical Aesthetic Hospital, Chengdu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Not applicable

Treatment and study plan

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.

Primary outcomes

  1. Breast implant related AEs

    Time frame: Up to 5 years

    Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary outcomes

  1. Numerical Pain Scale assessment

    Time frame: 1 month after surgery

    Zero means you have no pain, while 10 represents the most intense pain possible.

  2. Customer Satisfaction Score measurement

    Time frame: Up to 5 years after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

+86 15692105615

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Medical (Shanghai) Ltd.

Industry

Registry information

Official study title

MNT202401: Post Market Clinical Follow up for Mentor Breast Implants

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Jul 19, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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