Class action lawsuits against the makers of hip replacement systems are mounting in Canada as well as the United States. Different hip implant manufacturers are named in the lawsuits, and some of the plaintiffs allege that their hip replacement surgery made them feel worse, not better.
At least four class action lawsuits have been filed against various artificial hip manufacturers in Canada and several others have been filed in the United States, all alleging the hip implants are defective and require revision surgery to remove and replace the devices.
Most lawsuits are focused on a newer version of implants that some say were allowed to be sold before they were adequately tested. Traditional hip implants are made with ceramic or plastic parts, but newer versions are made with all metal parts. While designed to be more durable and withstand more wear and tear than implants made with other materials, some of the all-metal implants have shown a disappointing track record, failing at a faster rate than devices made with plastic or ceramic parts.
Some critics put blame on regulators who rush approvals on new devices that are similar to ones already on the market. Both Health Canada and the Food and Drug Administration (FDA) in the United States have accelerated approval processes that have allowed these newer hip implants on the market without clinical trials to test for safety and efficacy. As a result, the general population becomes a test market without its consent.
Unlike with clinical trials, tracking problems with specific medical devices is difficult, especially when the situation is not controlled. No joint registry exists in the United States, and the registry in Canada is optional. When problems are eventually identified with a specific device, recalls are often ordered. Health Canada has reported that of the 33 medical device manufacturers with active licenses, 12 have conducted recalls related to hip replacements in the past five years.
Regulators say the expedited approval process for so-called moderate-risk medical devices gets innovative medical devices on the market faster and speeds technological advances. But is it worth it when the quality of human life is at stake?