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

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).

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Key information

Conditions

Breast Augmentation Breast Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Lidu Plastic Surgery Hospital, Beijing, Beijing Municipality, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019

Exclusion criteria

Treatment and study plan

Primary outcomes

Number of participants who experienced adverse events

Time frame: up to 4 years

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Feb 10, 2020
Registry last updated: Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed