Retrieval studies testing retrieved biotextiles

Abstract The biocompatibihty, biofunctionahty and biostability of a prosthesis, its degradation and the host response are determined throngh an implant retrieval stndy.This chapter focnses on varions aspects of analyzing retrieved biotextile implants. Sample preparation techniques, analytical test methods and different test standards are reviewed. Some precautions and the limitations of implant retrieval studies are also discussed. 

The focus of this chapter has been the study of retrieved biotextile implants. While similar issues are relevant to all types of implantable devices, most of the tests and protocols described in this chapter are exclusively for biotextile implants. A biotextile retrieval study can serve a number of different purposes, such as ... 

As mentioned earlier, biotextile retrieval studies can be carried out in animals (preclinical trials) as well as in human subjects (clinical trials). Retrieval studies using animal models are usually planned studies where the device to be tested is implanted in the animal for a fixed duration after which it is harvested and studied for the desired characteristics. 

Table 8.2 Material test procedures for a biotextile retrieval study...

Sequence of test procedures for biotextile retrieval study. 

The various tests to be considered when planning a biotextile retrieval study are summarized in Table 8.2. The sequence of the test procedures to be followed for biotextile retrieval analysis is shown in Figure 8.4. 

Thus, biotextile retrieval studies provide an important tool to test a device s performance in vivo and to ensure that the product is safe and efficacious during clinical use. 

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