The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mentor Breast implants.
- Who it may be relevant to
- Registry conditions: Breast Augmentation, Mammaplasty. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MNT202401: Post Market Clinical Follow up for Mentor Breast Implants
Overview
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.
Interventions
- 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.
Primary outcome measures
- Breast implant related AEs [Time frame: Up to 5 years]
Secondary outcome measures (2)
- Numerical Pain Scale assessment [Time frame: 1 month after surgery]
- Customer Satisfaction Score measurement [Time frame: Up to 5 years after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Sichuan Huamei Zixin Medical Aesthetic Hospital — Chengdu
- Yunnan Huamei Meilai Cosmetology Hospital — Kunming
- Shenzhen Yixing Medical Cosmetology Hospital — Shenzhen
- Shenzhen Junke Medical Cosmetology Clinic — Shenzhen
Identifiers
NCT: NCT06510205 · MNT202401 · PMS-MTR-202301