Mayo Clinic to dramatically reduce use of metal-on-metal hip implants
Safety concerns have prompted the Mayo Clinic in Minnesota to reduce its use of DePuy hip replacements and other metal-on-metal implants by 80%. One orthopedic surgeon with the clinic cited concerns about the safety of hip replacements as the reason for the decreased use of the devices. read more »
FDA planning system to identify faulty devices
The Food and Drug Administration is planning to implement a system designed to identify faulty devices such as failing metal-on-metal hip replacements. The identification system, dubbed “unique device identifier” (UDI), is similar to bar codes and would be tied to a larger database of hospital records. read more »
Hip recalls cost DePuy $271 million in 2012 first quarter
A worldwide recall of the DePuy ASR hip replacement cost DePuy’s parent company more than $271 million in the first quarter of 2012. Johnson & Johnson stated that the costs were related to the recall of the failing metal-on-metal hip implant, as well as personal injury lawsuits related to the device. read more »
FDA warning letter may have led to DePuy recall
A Food and Drug Administration letter sent to DePuy may have played a role in the company’s decision to issue a hip replacement recall, the New York Times reported. The agency’s letter explained concerns over high failure rates while requesting additional safety studies. Research found that 13% of patients who received an ASL hip replacement required revision surgery to correct… read more »
British regulators call for ban on Johnson & Johnson hip implant
Regulators from the U.K.’s Medicines and Healthcare products Regulatory Agency issued a statement urging the ban of a Johnson & Johnson hip implant due to its high failure rate. Nearly 11% of patients with a combination of Johnson & Johnson’s Mitch TRH cup/heads and Stryker’s Accolade femoral stems require a second surgery within four years of receiving the hip replacement,… read more »
Consumer Reports issues recommendation to slow down device approval process
Consumer Reports issued a recommendation urging the Food and Drug Administration to slow down the approval process for medical devices, despite manufacturers’ desire to rush products onto the market. The group alleges that manufacturers pass devices such as metal-on-metal hip replacements through the FDA approval process without receiving adequate testing. read more »
J&J began phasing out DePuy implants after FDA letter
The manufacturer of the recalled DePuy hip replacements began phasing out the implants after a Food and Drug Administration letter requested more safety studies on the device, according to internal company documents. Johnson & Johnson had previously insisted its 2010 recall of the DePuy ASR hip replacement was strictly a business decision and was not instigated by any FDA actions.… read more »
FDA plans expert review of metal-on-metal hip implants
The Food and Drug Administration is planning an expert review of metal-on-metal hip replacements to be held June 27-28. The panel is expected to gather information from researchers, doctors and patients to help the agency decide if it needs to implement new testing and review standards for medical devices like the all-metal hip replacements. read more »
Patients with flawed hip implants could number in hundreds of thousands
The number of patients at risk of metallic poisoning from flawed all-metal hip replacements could be in the hundreds of thousands, according to an investigation by the British Medical Journal (BMJ) and British Broadcasting Company. The report singled out DePuy’s metal-on-metal ASR hip replacements, which were sold both overseas and in the U.S. read more »
Health officials recommend annual checks for hip implant patients
British health regulators have recommended that patients who received a metal-on-metal hip replacement such as the DePuy ASR implants should undergo yearly checks for as long as they have the device. The recommendation for patients with all-metal hip replacements was previously to undergo annual exams for only fiver years. read more »