ABSTRACT
Implantation studies are a type of assay unique to medical devices and biomaterials, having been specically devised for those situations where an exogenous (and usually man-made) construct or material is enclosed in the body or partially entered into it by a breached surface. It is intended to assess the effects of devices (usually polymers or elastomers) that have xed surfaces in direct contact with living tissue (not including the skin). The effects of concern may be either short or long term, with a range of responses over the course of the host body and the device interacting with each other, expressed as alterations in various indicators of local tissue tolerance. Longerterm studies are conducted for long-term implants, and they focus more on broader systemic effects and potential carcinogenicity. Common tissues assessed are muscle, subcutaneous, and bone, but others such as brain, ocular, dental, and heart may be assessed as well. The whole eld of implantation biology (which studies these interactions) is an extremely complex and active one (Greco, 1994; Black, 2000; Guelcher and Hollinger, 2006; Long et al., 2012; Raner et al., 2012; Kumar et al., 2015).
