A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China

Study Identifier
MED-EPI-PLS-0637
CT.gov Identifier
NCT04261608
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Breast Augmentation
  • Breast Reconstruction
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019
    Exclusion Criteria:
    \-

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Beijing Lidu Plastic Surgery Hospital
    Beijing, Beijing Municipality, China
    Status
    Not applicable
    Location
    Plastic Surgery Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Status
    Not applicable
    Location
    Guangzhou Sogood Medical Cosmetology Hospital
    Guangzhou, Guangdong, China
    Status
    Not applicable
    Location
    The Second People's Hospital of Guangdong Province
    Guangzhou, Guangdong, China
    Status
    Not applicable
    Location
    Changsha Yan Han Medical Plastic Hospital
    Changsha, Hunan, China
    Status
    Not applicable
    Location
    Hunan Yamei Medical Cosmetology Hospital
    Changsha, Hunan, China
    Status
    Not applicable