Objective: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies.
Methods: The (TPLC) database of the US Food and Drug Administration (FDA), the (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data.
Background: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events.
Objectives: To categorise contraindications to sclerotherapy based on the available scientific evidence.