I Guarantee this Device Won’t Fail!

Posted on: September 13th, 2013 by admin 2 Comments

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A metal-on-metal hip implant. Copyright Corin.
A metal-on-metal hip implant. Copyright Corin.

Imagine you are a patient considering whether to have an artificial joint surgically inserted to relieve your debilitating hip pain. The orthopaedic surgeon provides you with a pamphlet from the implant manufacturer, which says that the device is guaranteed to be free of defects for one year. You also speak to a sales representative from the company who assures you that your new hip is “guaranteed to last at least ten years.” Is this a realistic scenario?

It transpires that none of the major orthopaedic implant manufacturers — DePuySmith & NephewStrykerWright MedicalZimmer — offers a warranty to protect patients if the implant fails and needs to be replaced. They argue, probably with some justification, that the longevity of an implanted hip joint depends on factors beyond their control, including the patient’s weight, the surgeon’s skill and whether the patient followed post-operative guidelines on physical activity. However, there are certainly cases where failure can result from a defect in the implant materials or, as in the case of metal-on-metal hip implants, a poor design.

A failed hip joint awaiting revision. Copyright NHS.
A failed hip joint awaiting revision. Copyright NHS.

The USA is renowned for litigation and American consumers are now starting to flex their collective muscles. The Consumers Union has recently challenged the manufacturers of hip and knee implants to provide warranties to have a defective device replaced at no cost. Lisa McGiffert, director of the Safe Patient Project, has said: “Patients have a right to know how long medical device manufacturers are willing to stand by their products.”

Consumers Union has just sent letters to all the manufacturers, urging them to provide a 20-year warranty, including: (1) the full cost of replacing the flawed implant (device, surgeon and hospital costs); (2) a clear system for making the claim; (3) does not eliminate a patient’s right to sue; (4) provides full explanation if a claim is denied; and (5) does not disqualify a patient who has a disease unrelated to the device’s failure.

While it seems highly unlikely that the companies will comply with these recommendations, some of which — like the 20-year warranty period — are unrealistic, there are some actions manufacturers can take to mitigate the risk of a failed implant. First, they can take out insurance with a company like Medmarc; and second, instead of hiding behind their FDA certification, they can place in the public domain all the evidence to show that their implants are both safe and effective. These would be steps in the right direction.

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2 Responses

  1. Eb Blignaut says:

    Hi Kit -see the forwarded e-mail with its hip-joint joke. With no medical aid I wonder whether the state will ever cover these replacements? I can’t see why companies should not guarantee their products for 20 years – it is not a long time and stainless steel and modern plastics/ceramic products should easily last that long.
    Any carry-over to breast issues?
    Regards
    Eb

    • Kit Vaughan says:

      Thanks for the feedback, Eb. The problem with guaranteeing a device like a hip joint, is that the person receiving it may already be in their 70s or 80s. The other problem is that, unlike your motor car, the hip joint cannot readily be given a service to confirm that all mechanical components are in working order. An implant is a Class III device (much higher risk if it malfunctions) whereas our imaging systems are Class II. We will definitely offer a guaranty for the PantoScanner range of products but it won’t be as long as 20 years.