Hip replacement recall - Challenge of repairing broken trust

THERE are anxious times ahead for thousands of hip replacement patients in Ireland as they await tests to see if they have been implanted with faulty components.

The prospect of having to undergo further painful surgery and the lengthy rehabilitation that follows will cause huge dismay. But so too will the realisation that this is not the first recall of hip replacement products by international manufacturers in recent times.

There were two such recalls in 2001, by Sulzer Orthopaedics and St Gobain Desmarquest, and two more incidents in 2008, involving a suspension of production by Zimmer Inc and the recall of products by Stryker Corporation.

Problems with the DePuy product that is currently under scrutiny were first highlighted over a year ago and the components were withdrawn in Australia as far back as last December and in the US last April.

Five recalls in less than a decade should have signalled an unusually high failure rate in what by now is a very common surgical procedure. It should have rung alarm bells among health authorities worldwide about manufacturing processes that now seem at best sloppy and at worst criminally careless.

So why weren’t standards tightened up after the 2001 recalls? And why did the DePuy recall happen in a piecemeal fashion? If there had been five recalls of breast implants inside a decade, the medical devices industry would probably have been called before Senate hearings in the US while weeping Hollywood actresses testified about their personal traumas.

The majority of hip implant recipients, however, are older people, many of whom will have struggled along gallantly in increasing pain and discomfort for years before finally getting their surgery.

Up to a few years ago, it was not uncommon for a hip patient in crippling pain to wait two or three years to even get an appointment with an orthopaedic consultant in some parts of the country.

Having endured a major operation and complied with the rigorous exercise regime that goes with it, patients were unlikely to complain if they didn’t feel entirely happy with the results or if, after a while, some of the pain and discomfort returned. Even if they did complain, was anyone listening? These are old folk, after all. They’ve got to expect to be creaky and achy. At their time of life they should be grateful society considered them worth the investment of hospital time and money.

Attitudes may not have been quite as cavalier as that but there are definitely questions to be asked about the quality control in place within the companies responsible for the recalls and why they were allowed to slip so often with so muted a response.

In the meantime, the priority must be to have all patients who have been fitted with the DePuy parts scheduled for testing as soon as possible and, where necessary, offered corrective surgery without undue delay. That will be a challenge for the Health Service Executive at a time when resources and manpower are already fully stretched.

But what’s happened is an insult to patients who put their faith in surgery and to the surgeons whose careful work was undone by clumsy manufacturing.

Mending damaged hips will be only half the job – repairing broken trust may prove the trickier procedure.

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Saturday, September 18, 2021

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