New safety concerns over knee replacements

 

The long-term safety and effectiveness of millions of knee replacement implants is unknown, highlighting inherent problems in the regulation and monitoring of medical devices, according to a leading surgeon.

Andrew Carr, professor of orthopaedic surgery at the University of Oxford, warned that surgeons are being hindered by a lack of reliable information as the demand for knee implants grows.

There are more than 15 companies producing dozens of slightly different knee implants that UK surgeons can pick from depending on patient characteristics and surgical preference. Unlike medicines, companies are not required to clinically test medical devices in patients – they must only prove that a knee, hip or breast implant is safe and durable outside the body in order to gain the required kitemark.

Writing in The Lancet, Professor Carr points out that an aging population and increase in obesity rates means the dramatic rise in knee implants looks set to continue. "Widespread surveillance of existing implants is urgently needed alongside the carefully monitored introduction of new implant designs as part of well-conducted large-scale randomised trials," he wrote.

There were 76,780 knee replacements in 2010, a 30 per cent increase in five years, according to the National Joint Registry, which monitors the failure rate of implants by analysing data submitted from surgeons. However, the information on the registry is organised into groups of similar components per brand, making it difficult to monitor individual products.

A small variation can lead to significant improvements or problems in safety and effectiveness, say experts.

Jill Paterson, from Leigh Day solicitors, is currently representing 25 Australian patients involving one knee implant which failed quickly leading to pain and inflammation. “While we don't want to stifle innovation, it is too easy to put something out in the market without testing it properly. The hip and PIP disasters are making people look at this again.”

Carr's warning comes a week after 50,000 patients were told they would need annual blood tests to monitor for toxic effects of metal hip replacements - previously declared safe and effective by manufacturers and regulators. Lawyers acting for almost 2,000 PIP breast implant patients, implanted with non-medical silicon enhancements, will this Friday seek court approval for a type of group action.

Dr Susanne Ludgate, clinical director of the MHRA, said: “The National Joint Registry (NJR) is a key source of information on the long-term safety and performance of knee joint replacements and is the largest such registry in the world. The NJR assists surgeons in making choices and regulators in monitoring performance.

“Since April 2003 all knee joint replacement operations in England and Wales have been recorded in the NJR. In 2010 81,979 knee joint replacements took place in England and Wales.

"Knee replacements transform the lives of many patients who in the past were subject to increasingly severe pain and progressive lack of mobility.”

Arts and Entertainment
The Doctor and Clara have their first real heart to heart since he regenerated in 'Deep Breath'
TV
Life and Style
Apple showed no sign of losing its talent for product launches with the new, slightly larger iPhone 6 making headlines
techSecurity breaches and overhyped start-ups dominated a year in which very little changed (save the size of your phone)
Arts and Entertainment
Jamie Oliver
filmTV chef Jamie Oliver turned down role in The Hobbit
News
The official police photograph of Dustin Diamond taken after he was arrested in Wisconsin
peopleDownfall of the TV star charged with bar stabbing
PROMOTED VIDEO
Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
Arts and Entertainment
Jeremy Clarkson, left, and Richard Hammond upset the locals in South America
tvReview: Top Gear team flee Patagonia as Christmas special reaches its climax in the style of Butch and Sundance
News
people
Sport
Ashley Barnes of Burnley scores their second goal
footballMan City vs Burnley match report
Arts and Entertainment
Peter Mayhew as Chewbacca alongside Harrison Ford's Han Solo in 'Star Wars'
film
News
i100
Arts and Entertainment
Man of action: Christian Bale stars in Exodus: Gods and Kings
film
Arts and Entertainment
Tracy Emin's 1998 piece 'My Bed' on display at Christie's
artOne expert claims she did not
Arts and Entertainment
Catherine (Sarah Lancashire) in Happy Valley ((C) Red Productions/Ben Blackall)
TV
News
Hackers revealed Oscar-winning actress Lawrence was paid less than her male co-stars in American Hustle
people
Arts and Entertainment
Clueless? Locked-door mysteries are the ultimate manifestation of the cerebral detective story
booksAs a new collection of the genre’s best is published, its editor explains the rules of engagement
Sport
Robin van Persie is blocked by Hugo Lloris
footballTottenham vs Manchester United match report
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Business Manager

    £32000 - £40000 per annum: Recruitment Genius: A Business Manager is required ...

    Recruitment Genius: Operations Manager

    £45000 - £55000 per annum: Recruitment Genius: This is an exciting opportunity...

    Recruitment Genius: Panel & Cabinet Wireman

    £20000 per annum: Recruitment Genius: Panel Wireman required for small electro...

    Recruitment Genius: Electronics Test Engineer

    £25000 - £27000 per annum: Recruitment Genius: An SME based in East Cheshire, ...

    Day In a Page

    A timely reminder of the bloody anniversary we all forgot

    A timely reminder of the bloody anniversary we all forgot

    Who remembers that this week we enter the 150th anniversary year of the end of the American Civil War, asks Robert Fisk
    Homeless Veterans appeal: Former soldiers pay their respects to a friend who also served

    Homeless Veterans appeal

    Former soldiers pay their respects to a friend who also served
    Downfall of Dustin 'Screech' Diamond, the 'Saved By The Bell' star charged with bar stabbing

    Scarred by the bell

    The downfall of the TV star charged with bar stabbing
    Why 2014 was a year of technological let-downs

    Why 2014 was a year of technological let-downs

    Security breaches and overhyped start-ups dominated a year in which very little changed (save the size of your phone)
    Cuba's golf revolution: But will the revolutionary nation take 'bourgeois' game to its heart?

    Will revolutionary Cuba take 'bourgeois' golf to its heart?

    Fidel Castro ridiculed the game – but now investment in leisure resort projects is welcome
    The Locked Room Mysteries: As a new collection of the genre’s best is published, its editor Otto Penzler explains the rules of engagement

    The Locked Room Mysteries

    As a new collection of the genre’s best is published, its editor explains the rules of engagement
    Amy Adams on playing painter Margaret Keane in Tim Burton's Big Eyes

    How I made myself Keane

    Amy Adams hadn’t wanted to take the role of artist Margaret Keane, because she’d had enough of playing victims. But then she had a daughter, and saw the painter in a new light
    Ed Richards: Parting view of Ofcom chief. . . we hate jokes on the disabled

    Parting view of Ofcom chief... we hate jokes on the disabled

    Bad language once got TV viewers irate, inciting calls to broadcasting switchboards. But now there is a worse offender, says retiring head of the media watchdog, Ed Richards
    A look back at fashion in 2014: Wear in review

    Wear in review

    A look back at fashion in 2014
    Ian Herbert: My 10 hopes for sport in 2015. Might just one of them happen?

    Ian Herbert: My 10 hopes for sport in 2015

    Might just one of them happen?
    War with Isis: The West needs more than a White Knight

    The West needs more than a White Knight

    Despite billions spent on weapons, the US has not been able to counter Isis's gruesome tactics, says Patrick Cockburn
    Return to Helmand: Private Davey Graham recalls the day he was shot by the Taliban

    'The day I was shot by the Taliban'

    Private Davey Graham was shot five times during an ambush in 2007 - it was the first, controversial photograph to show the dangers our soldiers faced in Helmand province
    Revealed: the best and worst airlines for delays

    Revealed: the best and worst airlines for delays

    Many flyers are failing to claim compensation to which they are entitled, a new survey has found
    The stories that defined 2014: From the Scottish independence referendum to the Ice Bucket Challenge, our writers voice their opinions

    The stories that defined 2014

    From the Scottish independence referendum to the Ice Bucket Challenge, our writers voice their opinions
    Stoke-on-Trent becomes first British city to be classified as 'disaster resilient' by the United Nations

    Disaster looming? Now you know where to head...

    Which British city has become the first to be awarded special 'resilience' status by the UN?