Hip implant makers neglect product testing before hitting the market

Date: Jan 19, 2014

A new study, conducted by UK researchers and published in the British Medical Journal, has found that nearly a quarter of all hip implants on the market have "no evidence for their clinical effectiveness".

In other words, these hip implant products made their way to surgeons and into the bodies of patients without ever being tested for their efficacy. This could pave the way for a number of medical negligence lawsuits, especially if the invasive surgery for the non-effective implant caused any complications.

The report found these implants are approved without a single study on how much they could benefit the patient, nor what damage they could cause. The study was conducted on the back of a number of lawsuits arising from hip replacements that went awry. Most commonly, hip implants, which are advertised to last as long as two decades before they need to be replaced, had to be altered or replaced shortly after the original surgery.

For the past few years there have been recalls for thousands of these devices, but for many it was already too late.

Experts assert patients are reluctant to receive hip implants

The ongoing studies and lawsuits are having a powerful effect on the medical device market. In the BMJ report, experts stated the public's concern over hip implants is mounting.

"Medical device regulation has been the subject of recent debate," the researchers said.

"Both professional and public confidence in the system is at a low point. This is particularly true in orthopaedics, where the premature failure of some metal-on-metal hip replacements has added considerably to the global burden of hip revision."

Several adverse health problems can arise after patients receive a faulty hip implant. Metal-on-metal hip implants, regardless of which manufacturer issues them, have proven to cause serious problems. The most common complaints are related to problems arising when metal debris is absorbed into the body, due to the metal components of the joint rubbing together.

This can cause metallosis, certain types of cancers and metal blood poisoning, and it often leads to further surgeries to correct the problems.

"This study shows that a considerable proportion of prostheses available to orthopaedic surgeons have no readily available evidence of clinical effectiveness to support their use," the report concluded.

"Concern exists about the current system of device regulation, and the need for a revised process for introducing new orthopaedic devices is highlighted."

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