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Local Man Says Hip Replacement Poisoned Him
Tony Stauffer's Metal-On-Metal Hip Replacement Made By Depuy
POSTED: 6:54 pm PDT August 8, 2011
UPDATED: 3:03 pm PDT August 9, 2011
SAN DIEGO -- Some San Diegans have discovered that their hip replacements have poisoned them."It's been a nightmare," said 62-year-old Tony Stauffer.Four years ago, Stauffer – who has been active all his life – underwent hip replacement surgery. He opted for a new metal-on-metal hip from the company Depuy that was supposed to last three decades.His recovery took six months but eventually, he felt like his old self."Like all similar hip surgeries, it's excruciatingly painful," said Stauffer, "Then, I think I have my life back. I think I won't have to ever have to go through this again."Stauffer was wrong. Less than three years later, his hip started to swell and he suffered a host of other symptoms."My hair started to fall out," he said. "My fingernails became brittle. I got skin rashes."A recall announcement from Depuy revealed what was happening to Stauffer: his joint movement was shaving off metal flakes. Those flakes caused metal poisoning, which inflamed his joint and damaged his muscles."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."Stauffer was not the only one. About 93,000 people received the hip implant around the world.Attorney John Gomez represents Stauffer and dozens of local patients who have filed suit. Gomez claims Depuy did not act on complaints and did not do enough research."Rather than really testing their product [and] making sure it was safe….they rushed it to market," said Gomez.In fact, the hip was never tested in humans, thanks to an FDA fast-tracking process which allows for approval for implants similar to predecessors."That is unbelievable," said Stauffer.Stauffer said the FDA must listen to recent calls for reform in the approval process.Early this year, Stauffer had the hip removed and endured another painful recovery."The message I want to send is one of responsibility," he said. "I suffer the consequences of them being in a hurry."The FDA released this statement to 10News:
"On May 6, the FDA issued letters to 21 manufacturers of these hip systems ordering them to conduct what we call postmarket surveillance studies on 145 hip systems that have been cleared for marketing in the U.S. FDA explained at the time that it needed more data to better understand metal ion concentrations and adverse events associated with the systems. Some of our questions are related to reports that describe a small number of patients who may have developed symptoms or illnesses elsewhere in the body including effects on the heart, nervous system and thyroid gland that may be due to the patient's reaction to metal ions released by the implant or by particles from the implant."In response, Depuy provided a statement, which read in part:
"Depuy's top priority is and always has been patient safety. We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, Depuy has worked to provide patients and surgeons with the information and support they need.The company has made detailed recall information available on www.depuy.com and has created a help line for patients to have their questions answered and submit claims for reimbursement. We encourage patients to call the ASR help line at 1-888-627-2677.Depuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. Depuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. ASR patients should contact the ASR help line at 1-888-627-2677 for assistance.In August 2010, Depuy issued a voluntary recall of the ASR hip system after receiving new information from the UK National Joint Registry as part of the company's ongoing surveillance of post-market data concerning the ASR hip system. After reviewing this data, Depuy decided it was in the best interests of patients to voluntarily recall the ASR hip system. This data showed a five-year revision rate of approximately 12% for the ASR hip resurfacing system and approximately 13% for the ASR XL Acetabular system, which was not in line with data previously reported to Depuy."
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