A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
- Conditions
- Breast AugmentationBreast Reconstruction
- Registration Number
- NCT04261608
- Lead Sponsor
- Allergan
- Brief Summary
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants who experienced adverse events up to 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Beijing Lidu Plastic Surgery Hospital
🇨🇳Beijing, Beijing, China
Guangzhou Sogood Medical Cosmetology Hospital
🇨🇳Guangzhou, Guangdong, China
The Second People's Hospital of Guangdong Province
🇨🇳Guangzhou, Guangdong, China
Changsha Yan Han Medical Plastic Hospital
🇨🇳Changsha, Hunan, China
Hunan Yamei Medical Cosmetology Hospital
🇨🇳Changsha, Hunan, China
Plastic Surgery Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China