March 22, 2012 — The New York Times has obtained an internal document from 2009 that shows the U.S. Food and Drug Administration (FDA) asked DePuy Orthopaedics to provide additional safety data about its ASR hip implants. The FDA cited device safety concerns and problems with the safety information that DePuy provided to the FDA. A few weeks later, DePuy decided to phase out the metal-on-metal hip implants and sell its inventories. One year later, when stocks of the devices were nearly depleted, DePuy recalled defective hip implants because of high failure rates. The devices also leaked toxic metals into nearby tissues and bone.
The Times obtained the letter from the FDA to DePuy under the Freedom of Information Act. In the letter, the FDA asked DePuy to provide added safety data. The agency was concerned that blood tests from some patients had shown a high concentration of toxic metal ions. The FDA officials were also concerned that a safety study from Australia had shown that the device was prematurely failing at high rates, which indicated it was performing more poorly than safety data submitted by DePuy to the FDA. In conclusion, the FDA decided not to approve the devices for sale in the U.S. A few weeks after DePuy received this letter, the company decided to gradually phase out the metal-on-metal hip implants.
The letter is evidence that there was concern about the safety of the ASR hip implant more than one year before DePuy decided to recall it. During this year, the company began slowly phasing out the devices and sell the remaining stock. In May 2010, nine months after the FDA letter, a company executive wrote “we are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow.” Three months later, with the stockpile of ASR hip implants nearly depleted, DePuy issued the recall.
DePuy claims that the phase-out was due to slowing product sales, and not safety concerns from the FDA or independent studies. Company executives have insisted that internal company data showed that the ASR and Pinnacle hip implants performed comparably to competing hip implants, until August 2010, when the company decided to recall the products.
When the Times revealed that there was proof that DePuy had received the FDA letter, DePuy’s chief executive said that any suggestion that the FDA had concluded that there were safety issues with the device was “simply untrue.”
In an eight-year period, around 93,000 patients were implanted with the ASR device, about one-third of them in the U.S. The devices had a high rate of premature failure and could also leak particles of metallic debris into the body. Many people who have been implanted with the devices have suffered tissue and bone damage around the implant, broken implants, and other severe side effects. DePuy is now facing at least 5,000 defective hip implant lawsuits brought by people who have been injured by the devices and are seeking compensation and justice for their injuries.
Currently, there is concern about the safety of all metal-on-metal hip replacements, which are currently implanted in around 500,000 Americans. Though the use of metal-on-metal devices is being phased out in Europe, they are still popular in the U.S. Several studies have shown that the metal-on-metal design has higher rates of complications compared to plastic or ceramic designs. Experts are now calling for a complete ban of the metal-on-metal design, because the risk of this design outweigh its benefits.
The FDA initially approved the metal-on-metal hip replacements through a loophole which allowed the device to reach the U.S. marketplace without undergoing clinical safety studies because they were “substantially similar” to devices already on the market. The FDA is now facing a whistleblower lawsuit brought by scientists who allege that the FDA placed them under surveillance after they warned Congress that the FDA was approving unsafe medical devices and placing the public at risk.
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