Abstract:

Ultra-light textiles (knitwear) designed as implantable medical devices for potential uses in urogynaecology (treatment procedures in women incontinence and vagina reconstructions) and general surgery (hernia treatments) are a response to the increasing demand for advanced medical devices in medicine. Chemical profile characterisation of leachable substances is an important factor in the use  of the materials influencing their biocompatibility. The implant is made of undesired chemical substances in the main raw-material, and penetration into the tissue may cause local and/or systemic inflammation in the patient’s body. The characterisation and analysis of such substances is therefore essential to secure the safe use of implants. Most important is the characterisation of the matter that is extractable from the designed medical devices. To serve these purpose, ultra-light textile implants designed for potential use in urogynaecology and general surgery were examined concerning the chemical analysis of the undesired substance contained in the main material which constitutes the base of the implant. It was a goal of the work to set optimal parameters for the examination of chemical characterisation of the leachable implant’s material, bearing in mind their safe clinical use. Analysis of the chemical leachable profile was made in accordance with directives of standard PN-EN ISO 10993-18:2008 and some Polish and European testing procedures.