Hip replacement implant manufacturers are facing at least four Canadian class action lawsuits filed by plaintiffs who claim the devices failed prematurely and caused them pain. According to a report from CBC.com, the hip implant lawsuits also allege that many defective devices were rushed to market, with too little testing to ensure their safety in patients.
Health Canada, the agency that regulates medical products in that country, allows devices like hip implants to be approved via “fairly rudimentary, small studies” conducted “over a short period of time without a control group,” CBC.com said. When devices are modified, Health Canada is more flexible than it is with a modified form of a drug, which would require a new clinical trial.
“The risk to people has been huge in relation to the benefit, particularly bearing in mind that there were effective products on the market that were working for decades before these new products came out. In this case, newer was not better,” one plaintiffs’ attorney told CBC.com.
The fairly quick approval of hip implants by Health Canada may be playing a role in the large number of recalls issued by manufacturers in recent years, CBC.com said. According to the agency, of 33 manufacturers with active licences, 12 have conducted recalls related to hip replacements in the past five years.
As anyone who reads this blog knows, newer hip implants – especially all-metal varieties – have also caused problems in the U.S. Last May, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, including DePuy Orthopaedics, Zimmer, Stryker, Biomet and Wright Medical, to conduct post-market studies of their devices to determine if they were shedding dangerous amounts of metallic debris in patients. The FDA’s order followed the August 2010 worldwide recall of DePuy’s ASR hip implant, after it was found that it failed prematurely in an unusually high number of patients. The ASR, as well as an all-metal version of DePuy’s Pinnacle hip implant has been named in lawsuits by U.S. patients.
In November, a study of hip implants commissioned by the FDA found that new versions, including all-metal designs, offered no benefits over older types of implants. It also found that people who received all-metal hip implants were more likely to require repeat surgery than those who received traditional implants.
As is the case in Canada, hip implants introduced to the U.S. are often brought to market fairly quickly. The FDA allows manufacturers to gain approval for hip replacements through its 510(k) clearance protocols when a device can be shown to be “substantially” equivalent to products already on the market. Such approvals don’t require human clinical trials.