RR Phantom
Location : Wasted Space Job/hobbies : Cayman Islands Actuary
| Subject: OZschwitz: Regulator dithering put hundreds of hip patients at risk Fri Nov 11, 2011 10:57 pm | |
| 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At the next meeting, in December 2009, when it was announced the implants were to be withdrawn, the minutes show the TGA came under fire from members about the lack of meetings and for being ''too weak and too slow'' in dealing with implants experiencing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.
Read more: http://www.smh.com.au/national/health/regulator-dithering-put-hundreds-of-hip-patients-at-risk-20111111-1nbrw.html#ixzz1dSaMEorn
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