Thousands of Americans undergo hip replacement surgery each year, making it one of the more common procedures in medicine today. In total, more than half a million hip implantations have taken place in the country.

One of the most popular devices used in these surgeries is a metal-on-metal device from DePuy known as the DePuy ASR hip replacement. However, the DePuy ASR hip replacement device has been hit with a number of lawsuits from plaintiffs alleging that they suffered from device failure and other serious complications.

DePuy ASR Hip Replacement

The DePuy ASR hip implant device was released onto the market after approval by the U.S. Food and Drug Administration (FDA) in 2005.

Unfortunately, metal-on-metal implants like the DePuy ASR device have been connected with serious complications. Patients have reported a high rate of device failure, metallosis (metal poisoning), dislocation, and device dissociation. Thousands of patients have filed lawsuits against DePuy over such injuries.

The FDA issued a recall of the DePuy ASR hip replacement in August 2010. In total, the recall affected around 93,000 units distributed around the world.

According to hip implant lawsuits, certain side effects are serious enough to necessitate revision surgery, which brings on its own risks and further expenses. Some lawsuits have resulted in substantial settlement money of thousands of dollars. So far, DePuy and its parent company Johnson & Johnson have agreed to pay more than $2.5 billion in ASR-related litigation.

The FDA Approval Loophole

While the U.S. Food and Drug Administration (FDA) is known to carefully examine products before approval, lawsuits claim that the DePuy ASR hip replacement did not actually undergo the normal FDA approval process before hitting the market, and instead skipped clinical trials altogether via a significant loophole.

The loophole in question is the FDA 510(k) regulatory pathway, which allows manufacturers like DePuy to skip the regular approval process (including clinical trials and some testing) if they can show that the new device is “substantially equivalent” to other devices already given approval. However, this loophole has allegedly let faulty products into market.

Hundreds of thousands of patients have already been implanted with metal-on-metal devices like the DePuy ASR hip replacement.

An article published in the New England Journal of Medicine asked that the FDA close this loophole. The DePuy ASR hip replacement, public health experts wrote in the article, had an unusually high rate of revision surgery due to early device failure rates.

“As thousands of Americans are painfully learning, there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts,” the experts wrote.

Dr. Tony Nargol, who works at a hospital in England, claims that he tried to warn DePuy that metal-on-metal implants like the DePuy ASR hip replacement could cause serious damage, including extremely damaged flesh surrounding the device in some of the worst cases.

If you or someone you love has suffered complications from a metal-on-metal hip implant like the DePuy ASR hip replacement or have had to undergo revision surgery due to complications, you may be able to file a lawsuit. Of course, filing a lawsuit cannot take away the pain and suffering caused by device complications, but it can help to alleviate the financial burden from medical expenses and lost wages.