New Study Suggests Lack of Pre-Market Testing in Hip Implants

A new study published last month in the British Journal of Medicine suggests that nearly 25% of all artificial hip implants do not receive proper testing prior to hitting the market.

According to researchers from the U.K., many hip implant systems receive approval for patient use without conducting any clinical studies to gage their effectiveness and to determine the potential risks the products may pose to patients.

The study comes after thousands of patients have filed a hip replacement lawsuit after experiencing severe complications from implants. While the average hip replacement system is expected to last 15 to 20 years, many patients have been forced to undergo painful revision surgery shortly after receiving the implant. Many manufacturers have issued a hip replacement recall when products were found to be dangerous and defective years after they hit the market.

Numerous issues experienced by patients have been identified through hip implant registry systems, in place in the U.K., Australia, and other countries to monitor the effectiveness of implants.

The most recent study was conducted using data from the National Joint Registry of England and Wales (NJR). Researchers found that “24% of all hip replacement implants available to surgeons in the U.K. have no evidence for their clinical effectiveness.” Of the 10,617 hip implants and components implanted in U.K. patients in 2011, 8% of those procedures were performed with untested parts. The study contains a list of all of the untested devices.

Confidence in hip implants at all-time low

In the study, researchers noted that people are becoming vary on the effectiveness of hip implants.

“Medical device regulation has been the subject of recent debate,” noted the researchers. “Both professional and public confidence in the system is at a low point. This is particularly true in orthopaedics, where the premature failure of some metal-on-metal hip replacements has added considerably to the global burden of hip revision.”

One of the most well-known instances of metal-on-metal hip replacement system failure is that of the DePuy ASR implant. The company issued a recall in August 2010, after a study suggested failure rates could be as high as 12 to 13 percent. Registry data later suggested actual rates of failure could actually be up to 30 percent.

Thousands of patients filed a hip replacement lawsuit against the company, after being forced to undergo early revision surgery. DePuy Orthopaedics, a division of Johnson & Johnson, has agreed to a settlement that could cost between $2.4 billion to $4 billion. The settlement will go into effect if all DePuy ASR plaintiffs join the settlement agreement.

Complications lead to hip replacement recalls

Patients have experienced a variety of serious complications with multiple metal-on-metal implants produced by many different manufacturers.

The safety of a number of products besides the DePuy Pinnacle and ASR systems has been questioned, including Biomet Magnum, and the Wright Medical Conserve Cup, leading to similar litigation. Allegations include complaints of a defective design that releases metal debris into the body as the metal parts rub against each other. This leads to metallosis, metal blood poisoning in the body, tumors, and high rates of failure.

In the U.S., the FDA has been under fire for their fast-track process for many artificial hip systems, under their controversial 510k clearance system. The process provides medical device manufacturers the ability to introduce new products without substantial clinical trials, if they’re able to prove the device is markedly similar to another approved device on the market. Critics argue that medical device manufacturers have taken advantage of the system by introducing substantially new devices, under the false pretense that they’re extremely similar in nature to a previously approved device.

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