Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced adverse events | up to 4 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Retrospective chart review study where data will be collected from all eligible patients who consecutively underwent breast implant surgery with McGhan single lumen gel-filled Breast implants from 24 December 2015 to 31 December 2019.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jie Luan, Professor | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Lidu Plastic Surgery Hospital | Beijing | Beijing Municipality | China | |||
| Plastic Surgery Hospital Chinese Academy of Medical Sciences |
Not provided
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. | View source |
| To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link. | View source |
Not provided
Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
Not provided
Not provided
Not provided
Not provided
| Beijing |
| Beijing Municipality |
| 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 |