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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35133
• EU PAS number:
  EUPAS32613
• Study ID:
  35133
• Official title and acronym:
  A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  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 status:
  Ongoing

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 20/11/2019

Study start date

Planned: 01/04/2020

Actual: 01/04/2020

Date of final study report

Planned: 30/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

China McGhan Breast Implant PASS Protocol_Final_V1.0_20Nov2019_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

MED-EPI-PLS-0637