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Legal issues with warranties
To the editor:
I read the Commentary in the June 2014 issue of Orthopaedics Today Europe about warranties of implants (Manufacturer warranties of implants to patients may be a future consideration).
This might be critical from a legal point of view for surgeons. Joint implants, as are any risk class III medical devices, are intended for life-long use in the body. Maintenance, one major requirement for long-term proper function of high-tech products from engines to entire factories, is in fact impossible for joint implants since this leads to revision surgery.
Consequently the implant has to remain in place until it fails, which is inevitable for a certain proportion of patients. The fact that the average age for primary implantation is decreasing, the number of young patients treated with arthroplasty is increasing and the increased life expectancy leads to increased demands on the implants.
If an implant is accepted to be safe and durable, then it might be used preferably for younger high demand patients, as we have observed with ceramic-on-ceramic implants, for example.
So crude revision rates do not necessarily reflect the quality of an implant since confounders by the patient’s profile, the surgical technique used or the surgeon’s expertise might have a relevant impact on the average outcome figures.
One consequence of offering warranties is that the expected failure rate is at least predictable enough to execute potential claims. On the other hand, high risk medical devices are regulated by a legal framework that requests high quality standards.
If a manufacturer detects and accepts some quality deficiency in one of its implants, then it would have to recall the implant from the market according to present and future legislation in Europe. As we know from the past, recalls have significant consequences for the manufacturer; some are no longer in existence after such an incident.
If patients request benefits from a warranty, then the manufacturer has significant incentives to deny that implant quality is one reason for failure. A most likely alternative reason for failure is malpractice by the surgeon.
Warranty is what everybody looks for and health care is no exception. It is proven to be a great marketing tool. However, the circumstances in arthroplasty, legal framework and the large variety of factors that impact outcome create a difficult environment to execute a warranty. The surgeon as the one dealing face-to-face with the patient might be in an uncomfortable position in the end.
Gerold Labek, MD
Innsbruck, Austria