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.
Study Type
OBSERVATIONAL
Enrollment
5,000
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.
Sichuan Huamei Zixin Medical Aesthetic Hospital
Chengdu, China
RECRUITINGShenzhen Yixing Medical Cosmetology Hospital
Shenzhen, China
RECRUITINGShenzhen Junke Medical Cosmetology Clinic
Shenzhen, China
RECRUITINGBreast implant related AEs
Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years
Time frame: Up to 5 years
Numerical Pain Scale assessment
Zero means you have no pain, while 10 represents the most intense pain possible.
Time frame: 1 month after surgery
Customer Satisfaction Score measurement
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.
Time frame: Up to 5 years after surgery
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