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FDA Wants Expert Advice on DePuy Hip Implants

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Washington, DCThe Food and Drug Administration (FDA) will be asking an advisory panel of experts to take a closer look at metal-on-metal implants, as calls for action were made following a large hip replacement recall, Reuters reported.

According to the news outlet, the advisory panel will be held on June 27–28, and the panel of experts will examine the various hip replacements that are on the market, including DePuy implants that have come into question due to several lawsuits against the company.

Though the FDA metal device investigation is nothing new, it signals that the agency may be ready to subject the hip replacements to stricter scrutiny.

The investigation initially gained attention in August 2010, when DePuy, a division of Johnson & Johnson, recalled 93,000 XL Acetabular metal-on-metal hips. This device was allegedly experiencing a failure rate of roughly 13 percent.

The news outlet reported that following this recall, the FDA ordered manufacturers to collect more post-implant data. Since this point, the agency has been investigating the safety of this type of hip replacement device and trying to see if they should undergo more rigorous testing and premarket review.

A release from the FDA noted that evidence suggests such a review may be necessary due to the alleged failure rate of 13 percent. A recent study from the National Joint Registry of English and Wales found that 6 percent of people with the implants needed additional surgery. This represents a much higher risk than those who received ceramic or plastic versions, as only 1.7 to 2.4 percent of these individuals required further medical procedures.

The news outlet reported that as the FDA investigation continues, people with such a device will learn more about their legal fate. The panel of experts could lend an opinion that will prove positive for people who have faulty replacements.

The French Tribune reported that a total of 28 people out of 507 patients from New Zealand have filed international cases against the hip replacement company, as the manufacturer of the device was targeted due to allegedly faulty products.


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