Long-term safety evaluation of Mentor breast implants in Chinese women
Post-Market Clinical Follow-up for Mentor Breast Implants
This study is trying to see how safe Mentor breast implants are for Chinese women by looking at their pain levels and satisfaction over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 22 Years to 100 Years |
| Sex | Female |
| Sponsor | Johnson & Johnson Medical (Shanghai) Ltd. Industry-sponsored |
| Locations | 3 sites (Chengdu and 2 other locations) |
| Trial ID | NCT06510205 on ClinicalTrials.gov |
What this trial studies
This observational study collects safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. It aims to assess postoperative pain and participant satisfaction levels, gathering insights into clinical experiences to inform future product development. The study plans to enroll at least 300 subjects across multiple medical institutions in China, ensuring a diverse representation of experiences with the implants.
Who should consider this trial
Good fit: Ideal candidates are women aged 22 and older who have received Mentor breast implants and can provide informed consent.
Not a fit: Patients who have not received Mentor breast implants or are under 22 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that enhances the understanding of Mentor breast implants' long-term effects, leading to improved patient outcomes.
How similar studies have performed: Other observational studies on breast implants have shown success in evaluating safety and satisfaction, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu and 2 other locations
- Sichuan Huamei Zixin Medical Aesthetic Hospital — Chengdu, China (Recruiting)
- Shenzhen Yixing Medical Cosmetology Hospital — Shenzhen, China (Recruiting)
- Shenzhen Junke Medical Cosmetology Clinic — Shenzhen, China (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: ygu51@its.jnj.com
- Phone: +86 15692105615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.