A San Diego man says his ordeal with a <"http://www.yourlawyer.com/topics/overview/DePuy-Hip-Implant-Recall-Johnson-and-Johnson">DePuy ASR hip implant has been a nightmare. According to a report from 10News in San Diego, 62-year-old Tony Stauffer thought the DePuy ASR hip implant he received four years ago would last 30 years, but three years after his surgery, he began to suffer the effects of metal poisoning. Stauffer, who is among the hundreds who have filed lawsuits against DePuy Orthopaedics over the defective metal-on-metal hip implants, was finally forced to have his device removed earlier this year.
Any regular reader of this blog is probably familiar with the safety problems associated with DePuy’s line of ASR metal-on-metal hip implants. The DePuy ASR Hip Resurfacing System was recalled last year, along with the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Before they were recalled, 93,000 ASR hip implants were implanted in patients worldwide.
DePuy ASR hip implant lawsuits allege the all-metal devices allow microscopic shards of cobalt and chromium to make their way into the bloodstream, leading to dangerous levels of metal in blood and body tissues. As weâ€™ve reported in the past, this can lead to even more serious long-term health problems including tissue breakdown, bone loss, and even the formation of non-cancerous tumors.
That’s what Stauffer says happened to him. He told 10News that three years after receiving his DePuy ASR hip implant, his hip started to swell and he suffered hair loss, rashes and other health problems. Last year, he learned that his implant was among those recalled by DePuy.
“My orthopedic surgeon’s first words [were], ‘We have to get that out of there,'” said Stauffer. “I felt angry I had to go though this again.”
The DePuy ASR hip implant was approved through by the U.S. Food & Drug Administration’s (FDA) much-maligned 510(k) process, which does not require human testing. As we reported last week, the Institute of Medicine just called on the FDA to scrap the 510(k) process, saying it offered patients no assurance of safety. A study published last month in the journal Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009 because they could cause serious health problems or death, 80 had undergone 510(k) approvals. Many of those devices were recalled because of concerns the product could kill or seriously harm a patient.
Stauffer told 10News that it was “unbelievableâ€ that DePuy was able to bring the ASR hip implant to market without human tests. He agreed that the FDA must listen to recent calls for reform in the approval process.
“The message I want to send is one of responsibility,” he said. “I suffer the consequences of them being in a hurry.”
The problems with the ASR and other all-metal hip implants have prompted more FDA scrutiny of the devices. As we reported previously, the FDA recently asked DePuy Orthopaedics and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining if these devices are shedding dangerous amounts of metallic debris in patients.