Dermal fillers are aesthetic devices that can be injected permanently or non-permanently to restore volume and aesthetic appearance to a particular area of the body. They have become increasingly popular because they are effective and non-invasive options for facial rejuvenation. Increased demand for filler treatments in the coming years will provide considerable financial incentive for the development of safer, cheaper, and better products.
Dermal fillers are high-risk medical devices that must undergo pivotal clinical investigations, with a design and scope similar to that of Phase III studies for drug/medicinal product approval. Safety concerns and complicated approval regulations in the US and Europe must be considered and addressed. This paper discusses types of dermal fillers, common complications and side effects, and nuances of the regulatory approval process.
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