Biotechnology

Breast cancer detection and survival among women with cosmetic breast implants: Systematic review and meta-analysis of observational studies

Health Canada is responsible for ensuring that medical devices are supported by comprehensive evidence demonstrating their safety and effectiveness, which is accomplished in part by surveillance of any health consequences of such devices used in the Canadian population. In this study led by Laval University, Health Canada collaborated to assess potential impacts of Breast implants which are considered a medical device. There is strong evidence that cosmetic breast implants do not increase the risk of breast cancer. However, there is concern that implants might impede the early identification of breast cancer, and that successful treatment of breast cancer may be less likely if the patient has breast implants. Several studies have previously sought to determine whether these risks are real, but individual studies have typically had small numbers of patients, making it difficult to form firm conclusions. In this study Health Canada collaborated with several Canadian universities and government research institutions to methodically select previous research studies examining these associations, and use statistical techniques to combine data across those studies. The resulting analysis includes data from a much larger number of individuals, increasing the robustness of the conclusions. The study found that breast cancers are detected at a more advanced stage in women with cosmetic breast implants, possibly because they are more difficult to detect at an early stage. Additionally, women with cosmetic breast implants who were then diagnosed with breast cancer had a reduced chance of survival, compared with women diagnosed with breast cancer but who did not have breast implants. This study strengthens the evidence that cosmetic breast implants may impair diagnosis of, and survival from, breast cancer. Health Canada can use the results of this study to better understand potential risks associated with cosmetic breast augmentation. Results of this research are published in the British Medical Journal, 2013, 346, f2399, doi: 10.1136/bmj.f2399.

Early Murine Immune Responses from Endotracheal Exposures to Biotechnology-Related Bacillus Strains

The Bacillus bacteria are a group that is used in biotechnology applications, but also cause problems such as food poisoning and other infections.  The bacteria can form dormant spores, which are resistant to environmental conditions and can germinate and replicate at a rapid rate.  As Health Canada is responsible for the health risk assessment of biotechnology microorganisms, this study was aimed at developing new scientific tools and contributing knowledge to inform risk assessment.  This study examined different strains of Bacillus bacteria, as well as commercial products containing larger numbers of spores, for their capacity to cause immune system effects in mice following inhalation.  The dormant spores of all the strains examined caused very few effects even one week after exposure, but the replicating bacteria caused mice to show strong immune and systemic effects just two hours after exposure. The Bacillus spores were found to produce few effects compared to the effects of replicating Bacillus bacteria.  This early screening approach was successful in distinguishing the adverse effects of the different Bacillus strains, and may be useful in assessing the relative hazard potential of other biotechnology-related bacteria to inform risk assessment and support safe handling practices.  This study was published in Toxicological and Environmental Chemistry (2011 Feb), 93(2):314-331.

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