Abstract
Devices and materials intended for clinical applications as medical and implant devices should be evaluated to determine their biocompatibility in physiological systems. This article presents results from cytotoxicity assay of L929 mouse fibroblasts culture, tests for skin irritation, intracutaneous reactivity and sensitization, and material implantation tests for the novel copper/low-density polyethylene nanocomposite intrauterine device (nano-Cu/LDPE IUD) with potential for future clinical utilization. Cytotoxicity test in vitro was conducted to evaluate the change in morphology, growth and proliferation of cultured L929 mouse fibroblasts, which in vivo examination for skin irritation (n = 6) and intracutaneous reactivity (n = 6) were carried out to explore the irritant behavior in New Zealand White rabbits. Skin sensitization was implemented to evaluate the potential skin sensitizing in Hartley guinea pigs (n = 35). The materials were implanted into the spinal muscle of rabbits (n = 9). The cytotoxicity grade of the nano-Cu/LDPE IUD was 0–1, suggested that the composite was nontoxic or mildly cytotoxic; no irritation reaction and skin sensitization were identified in any animals of specific extracts prepared from the material under test; similarly to the control sides, the inflammatory reaction was observed in the rabbits living tissue of the implanted material in intramuscular implantation assay. They indicated that the novel composite intrauterine device presented potential for this type of application because they meet the requirements of the standard practices recommended for evaluating the biological reactivity. The nano-Cu/LDPE IUD has good biocompatibility, which is biologically safe for the clinical research as a novel contraceptive device.
Highlights
The intrauterine device (IUD) is a safe, long-acting and effective method of contraception [1,2]
The aim of the present study is to evaluate the biocompatibility of this novel nano-Cu/low-density polyethylene (LDPE) IUD, such as cytotoxicity on L929 mouse fibroblasts by MTT assay in vitro, skin irritation, the guinea pig maximization test (GPMT) for skin sensitization, and muscle implantation in vivo, which may help us to examine the feasibility and safety of applying it as contraceptive device and to determine whether the material meets the biocompatibility standards for implantable medical products
At 1 and 3 d period, there were no significant differences between the extracts of nano-Cu/LDPE IUD (50%, 25%, 12.5% and 6.25%, v/v) and negative control (p..05)
Summary
The intrauterine device (IUD) is a safe, long-acting and effective method of contraception [1,2]. Use of the IUD has many side effects, such as pelvic pain, bleeding and spotting, etc. The novel nano-Cu/LDPE IUD consists of high-quality copper nanoparticles and LDPE powders, synthesized by heating and evaporation methods [6]. Previous studies on this novel composite IUD, including material characteristics [7,8,9,10,11], corrosion behavior [6,12], contraceptive efficacy and clinical performance [13], antifertility effectiveness and influence on the endometrial environment [14,15], it is indicated that the nano-Cu/LDPE composites could greatly improve the performance of IUDs
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