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FDA Recognizes Known Dangers of Metal-on-Metal Hip Implants

The FDA said yesterday that metal-on-metal hip implants can cause pain and soft-tissue damage. This was not news to the many victims of the medical device industry's failure to properly test these devices before placing on the market and selling them for their own profit. Unfortunately, this news simply confirms what the victims and those of us who represent the victims already knew. Metal on metal hip implants are dangerous products. According to the Newsday article, The FDA also said that "surgeons should select a metal-on-metal hip implant for their patient only after determining that its benefits outweigh that of an alternative hip system." 

Many of us saw the article in the New York Times on Wednesday, which alerted readers that the FDA was seeking to tighten regulations on these devices. The New York Times reported, as a result of the vast failures of these devices "thousands of patients have been forced to undergo painful and costly operations to replace the devices."

The target of the FDA's "tightening" is the approval process for a new medical device known as 510(k). Using this approval method, a manufacturer can have a device approved for sale by claiming that the new device is "substantially similar" to a device that the FDA has already approved under its strict pre-market approval process. This way, the manufacturer can have a device put on the market relatively quickly and without rigorous testing, and devices, such as the DePuy ASR hip, are sold to patients without even having been tested in an actual person. The result is that the manufacturers can sell and make profits on their products quicker and without spending money to make them safe - to the great risk and detriment to the public.

Jonathan B. Acklen, Esquire

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