Question

Collagen is a ubiquitous material in extracellular matrix (ECMs) and its derivatives are used in human medicine. One derivative, the spongy material Gelfoam™, is used in surgical procedures. A soluble form of collagen is used as a dermal filler. Both of these were approved by the FDA over a decade ago. How do these products differ chemically? What issues might arise in today’s regulatory environment for obtaining approval for these materials?

Answer 1

Gelfoam is a medical device which is applied to bleeding surface to prevent and stop bleeding. It is water insoluble, non -elastic and pororous prepared from porcine gelatin skin.It is capable of absorbing.It is mainly used in surgical procedure.

Dermal fillers/ injectible fillers are soft tissue fillers which are used to avoid wrinkles temporarily. They are made up of sugar molecules or hyaluronic acid or collagen from pig , cows etc . and also of synthetic polymers such as polylactic acid and calciumhydroxylapatite.

Both of them can cause adverse effect which can be short term, long term or permanent on human and there are various risk associated with their uses. so they are approved for some uses only.

Some risks associated with them which might be a problem for obtaining approval for them are as follows:

Dermal fillers: itching, swelling, pain, bruises,soreness, allergies, necrosis, movement of fillers from the site of injection, damage to skin etc.

Gelfoam:Gelfoam is always recommended for preventing and stopping bleeding only, If used for other purposes it can cause necrosis, fever, abscess or nodule formation.pain etc.