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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open-label, retrospective chart review

Study drug and medical condition

• Medical condition to be studied:
  Breast enlargement

  Breast reconstruction

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  Evaluate the safety profile of McGhan breast implants in patients who have undergone breast augmentation or reconstruction surgery between 24 December 2015 and 31 December 2019 in different centers in China
• Data analysis plan:
  Patient demographics, relevant medical history, indication for surgery, implant device characteristics, procedure-specific details, pre- and post-operative treatments, and any additional procedures at or around time of surgery will be summarised using descriptive statistics. The safety analysis will be performed on patients for whom an SAE or AE of Special Interest was recorded. The number and percentage of patients reporting SAEs and AEs of special interest will be presented by system organ class and preferred term.