Long-term safety evaluation of Mentor breast implants in Chinese women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Sichuan Huamei Zixin Medical Aesthetic Hospital
  Chengdu, China Recruiting
• Yunnan Huamei Meilai Cosmetology Hospital
  Kunming, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improved Breast Enlargement Using Your Own Fat Tissue

  This study tests a temporary device to help your own fat grafting for breast enlargement stay in place and keep volume after surgery.

  Recruiting 4Tissue · Edegem and 1 other locations · NCT07869641

• Breast implant study to see how Luna implants perform after surgery

  This study tests whether Eurosilicone Luna breast implants stay intact and keep their shape over 10 years in women aged 18–65 undergoing cosmetic or reconstructive breast surgery.

  Recruiting at 2 sites GCA (Eurosilicone) · Villefranche-sur-Saône and 1 other locations · NCT07679594

• Autologous Free Dermal Graft Support in Vertical Scar Breast Reduction

  This study tests whether using a patient’s own skin graft to support the lower pole helps keep the breast shape after a vertical scar breast reduction.

  Recruiting Cumhuriyet University Hospital · Sivas, Sivas · NCT07657962

• SPSIP Block to Help Pain After Breast Reduction Surgery

  A randomized trial tests whether adding an ultrasound-guided SPSIP block can lower opioid use in the first 24 hours after bilateral breast reduction surgery.

  Recruiting Cumhuriyet University Hospital · Sivas, Sivas · NCT07657949

• Bilateral rhomboid intercostal block to reduce pain after breast implant surgery

  This trial will test whether adding an ultrasound-guided bilateral rhomboid intercostal block to general anesthesia reduces pain and tramadol use after elective bilateral breast implant surgery in adults aged 18–65.

  Recruiting Aydin Adnan Menderes University · Aydin, Efeler · NCT07448246

• Nipple reconstruction with cross-linked hyaluronic acid after mastectomy

  This trial will test whether adding a cross-linked hyaluronic acid injection to areola micropigmentation helps women who had a mastectomy achieve better nipple projection, appearance, and satisfaction.

  Recruiting Germans Trias i Pujol Hospital · Badalona, Barcelona · NCT07008339

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.