Faulty hip products were used despite US concerns
Published 18/02/2012 | 05:00
FAULTY hip replacements continued to be used on Irish and other European patients even after a US government watchdog said it needed more information on the products before it could grant a licence.
The latest information has emerged in confidential correspondence on the DePuy hip products, which were at the centre of a worldwide safety recall in 2010. DePuy Orthopaedics, part of Johnson & Johnson's joint replacement section, had to recall products used on 93,000 patients around the world.
A total of 3,282 Irish patients had been fitted with full hip replacements or had hip resurfacing carried out.
The products were recalled and large numbers of the Irish patients -- all of whom must undergo regular testing -- have had to have them removed and undergo further surgery.
Commenting on the confidential correspondence published in 'The New York Times', a spokesman for Johnson & Johnson told the Irish Independent yesterday the Food and Drug Administration (FDA) in the United States had licensed the DePuy hip replacements in 2005.
He said DePuy filed a submission for pre-market approval with the FDA in July 2007 for the hip resurfacing version of the device.
"We received a letter from the FDA in August 2009 indicating that more information was needed in order for the FDA to evaluate the safety and effectiveness of the resurfacing product.
"At the same time that the company received this FDA letter, market demand for hip resurfacing was declining rapidly.
"In weighing the significant resources that would be required to produce the new clinical dataset requested by FDA against the declining market interest in resurfacing, DePuy decided to withdraw the PMA."
He said it was "purely a business decision" based on a declining market.
Both products were licensed for sale in Europe and were mainly used on private patients in Ireland.
Peter McDonnell, a Dublin solicitor acting on behalf of patients, said he strongly advised anyone who is having the faulty hip removed to keep it.
He said the patient can request to retain the prosthesis for evidence for his or her medical and legal team.