An observational study in Breast Augmentation and Mammaplasty, sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. Recruiting at 4 sites in China. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Johnson & Johnson Medical (Shanghai) Ltd. · Observational
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.
All populations receiving Mentor breast implants
Exclusion Criteria:
Who recieves Mentor breast implants per request
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.
Breast 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
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Johnson & Johnson Medical (Shanghai) Ltd.