Breast Augmentation, Mammaplasty
Conditions
Brief 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.
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.
Sponsors
Johnson & Johnson Medical (Shanghai) Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast implant related AEs | Up to 5 years | Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Scale assessment | 1 month after surgery | Zero means you have no pain, while 10 represents the most intense pain possible. |
| Customer Satisfaction Score measurement | 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. |
Countries
China
Contacts
CONTACTStudy Contact
STUDY_DIRECTORHuimin Wu
Shenzhen Junke Medical Cosmetology Clinic
Outcome results
None listed