Your regulators will protect you -- NOT
SURGEONS continued to insert trouble-prone hip implants, placing hundreds of patients at risk for 18 months after manufacturers informed health officials of the product's "unacceptable" failure rate.
Documents filed with a Senate committee inquiry reveal three years of hesitation by a regulatory agency, at one point under pressure from medical device companies, after evidence emerged of the high rate of repeat surgery involving the Johnson & Johnson DePuy implants. Records of an expert group advising the Therapeutic Goods Administration (TGA) show the group failed to meet for 18 months after Johnson & Johnson advised the government of the implant's "unacceptable" revision rate in May 2008.
At the next meeting, in December 2009, when it was announced the implants were to be withdrawn, the minutes show the TGA came under fire from members about the lack of meetings and for being "too weak and too slow" in dealing with implants experiencing high failure rates.
Johnson & Johnson has revealed it has "reimbursed" $21 million in claims from more than 3500 patients fitted with DePuy implants. The company is also facing two separate class actions over the implants.
Official estimates show about 5570 DePuy implants have been placed in patients in Australia and so far more than 430 have had to be removed and replaced in what are difficult, costly and painful operations. The documents submitted to the Senate community affairs inquiry show after the failure rate emerged, the company in September 2007 agreed with the TGA to "restrict supply" of the products to surgeons who had undergone specific training.
Johnson & Johnson was reported by the TGA in May 2008 to have said the overall use of DePuy products had dropped dramatically. But figures from the National Joint Replacement Registry show implants of the "resurfacing" product had fallen from 183 to 131 in the three years from 2007.
A separate DePuy hip product also came under suspicion but this was at first blamed on other components and 1210 of these products were implanted in 2008, 31 more than the previous year. Both products were removed from the market in December 2009 after persistent evidence of high failure rates.
Bob Lugton, who has had to have his DePuy hip replaced and lost significant mobility as a result, is campaigning for more rigorous regulation.
The disclosures by the TGA were "depressing", the retired engineering executive said. Surgeons had also been reluctant to notify patients of the emerging risk of the implants. he said.
The president of the Australian Orthopaedic Association, Graham Mercer, said the majority of surgeons altered their choice of implants due to the results of its national registry but there would always be those "who think they know better".
Dr Mercer said Johnson & Johnson trained some surgeons "but the revision rate remained unchanged".
A TGA spokeswoman would not comment on the issue yesterday, saying it would await the outcome of the inquiry.