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Delayed Recall Order by TGA Receives Fire


Published on The Australian Therapeutic Goods Administration (TGA) faced criticism for dilly-dallying on the hip replacement recall issue. Thousands of men and women who were given artificial hip implants are pondering their fates as painful revision procedures appeared to be their only relief option, media reports say. In fact, a former gymnast and DePuy advocate filed a lawsuit against the company.

Published in: Health & Medicine
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Delayed Recall Order by TGA Receives Fire

  1. 1. As Published on the DePuy Hip Replacement Recall Website
  2. 2. The Australian Therapeutic GoodsAdministration (TGA) faced criticism fordilly-dallying on the hip replacement recallissue. Thousands of men and women whowere given artificial hip implants arepondering their fates as painful revisionprocedures appeared to be their only reliefoption, media reports say. In fact, a formergymnast and DePuy advocate filed a lawsuitagainst the company.
  3. 3. Surgeons and consumers from different regions ofAustralia slammed the TGA—the Australiancounterpart of the US Food and DrugAdministration—for dragging its foot on thedefective implants imported into the country bydifferent device makers, says the daily newspaperThe Age.Many people who owned defective hip replacementsare reportedly considering to put themselves underthe knife in the run up to December because of thehigh incidence of failures of the artificial devices theyare using.
  4. 4. The sufferers who embracedartificial hips last year havedisclosed astounding rates offailure of over 10%, which rantwice as much as the normalrate of 4%. They ran intorisks that were two times asmuch as they could bear forcorrection surgery, says thepaper. Those defectiveimplants were spread across24 brands of artificial hipprostheses, including theDePuy ASR system of Johnson& Johnson.
  5. 5. A private orthopedic organization supervised by thefederal government, the National Joint ReplacementRegistry has kept tab about 2,700 elderly Australians whoare affected by defective hip replacements in 2010, saysthe daily newspaper The Age.Politicians in Australia have organized a task force toevaluate the damning report of hip replacement failuresas the Senate prepares to disclose its findings on thecontroversy.The National Joint Replacement Registry found in 2006that metal-on-metal hip prosthetics had failure rate of50%. It described the incidence as “higher than normal,”reports Australia’s leading daily newspaper SydneyMorning Herald.
  6. 6. More than 5 in 10 of those implantsplanned for revisions were amongproducts that were listed as trouble-prone, says The Age, quoting numbersfrom the National Joint ReplacementRegistry.The failure rate in hip replacementswas assessed at 4% through 5%. TheTGA reported that DePuy hipprosthetics had a failure rate of 10%.More or less 80,000 in replacementhips and knees are surgically insertedto Australians each year. The DePuyhip replacement recall issue hascaused a national uproar among healthinsurance service providers andconsumer lobbyists who soughtstringent monitoring.
  7. 7. As a metal-on-metal contraption, different hipreplacement system models can last throughnormal wear and tear. However, there is acorresponding risk arising from metal toxicitythat is likely to develop. Hip replacementrecall still affected Johnson & Johnson and twoof its products.