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  • reshamn replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 8 years, 2 months ago

    Apart from the ISO Standard, Carcinogenicity is a crucial test for a biomaterial.Carcinogens are classified according to their mode of action as genotoxic or nongenotoxic carcinogens. The conventional test for carcinogenicity is the long-term rodent carcinogenicity bioassay.There could be even co-carcinogens that do not necessarily cause cancer on their own, but promote the activity of other carcinogens in causing cancer.

    In 2014, FDA sent a very strong warning to physicians and medical device companies, because of the risk involved with laparoscopic power morcellators(LPM) used during different types of laparoscopic (minimally invasive) surgeries like treating uterine fibroids, hysterectomy or myomectomy. These surgeries break up small bits of tissues which might spread cells from uterine cancer. Therefore, a Carcinogenicity is extremely in determining how much of a role can a particular device play when it comes to spreading cancer.