The potential carcinogenicity of orthopaedic implants - a scoping review

Background: Every year, hundreds of thousands of patients receive an orthopaedic or dental implant containing metals such as cobalt, chromium and titanium. Since the European Chemicals Agency (2020) classified pure cobalt metal as a Category 1B carcinogen, manufacturers of products containing ≥ 0.1% of this metal must perform a risk assessment and justify that there are no viable alternatives. The up-classification of cobalt metal to a carcinogen without good evidence that its use in implants is carcinogenic may cause unnecessary concern to the many patients who have, or may require such implants. Although in vitro and animal studies have shown such metals to be carcinogenic, human epidemiological studies have not been definitive. In addition, although many advances have been made in the past few decades with regard to the materials used in implant metals, no recent review of their carcinogenic effects have been published.

Methods: This scoping review aims to summarise epidemiological studies conducted in recent years (from 2010 to present) to outline the carcinogenic effects of orthopaedic metal implants that have been published. This encompasses implants of different materials and surfaces, including metal, polyethylene and ceramic orthopaedic implants, cemented and cementless joint replacement surgeries, and surgical techniques such as resurfacing and total joint replacements that are currently in use and the potential carcinogenicity related to their use. Research papers with various study designs published in the English language were included. Studies were excluded if participants had a prior history of cancer before receiving orthopaedic implants and if they focused solely on the carcinogenicity of metals or materials not related to orthopaedic implants.

Results: A total of 16 studies, encompassing over 700,000 implant patients, were identified through PubMed and have been included in this review. In long term follow-up of up to 17.9 years, no increased risk of all-site cancer was seen in these patients. However, an increase in site-specific cancers, namely prostate, melanoma and haematological cancers have been identified. Specifically, an increase in prostate cancer was identified in three studies.

Conclusion: Based on the summarised evidence, there is no consistent evidence to show that patients with any type of orthopaedic implant has an increased risk of cancer, although slight (non-statistically significant) increases in prostate cancer was observed and this, in particular, deserves longer-term surveillance.