FDA Issues New Warning on Metal-on-Metal Hip Replacement

There are as many as 500,000 Americans estimated to have received metal-on-metal hip replacements.

If you suffer from arthritis, a fracture or another condition that causes everyday pain, and common activities such as walking or getting in and out of a chair are painful and difficult, you may be one of the thousands who have considered hip replacement surgery.

The hip is one of the body’s largest weight-bearing joints. It is a “ball and socket” joint. Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms fail to respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, patients may receive a “metal-on-metal” hip implant, in which the ball and socket of the device are both made from metal.

Imagine two pieces of metal rubbing against each other in your body. The U.S. Food and Drug Administration (FDA) recently confirmed that this would be good reason to be concerned.

The FDA has issued a warning about the potential adverse effects of metal-on-metal hip replacements made of cobalt-chromium-molybdenum alloys. The metal components of the hip replacement devices, which include a metallic ball that rotates in a metallic cup, are designed to slide back and forth against each other when patients with this metallic implant walk or run. However, the FDA has now warned that small metallic particles may rub off the components of such hip replacements.

This type of metal-on-metal hip replacement may cause damage to bone and soft tissue near the vicinity of the implant. The release of the debris can be extremely painful, resulting in a condition referred to as Adverse Reaction to Metal Debris (ARMD). Because this process can result in the implant becoming loose so it drops, revision surgery is required in some patients. The federal agency has also determined that the process of erosion of the metal can result in metal IONS being released into the bloodstream, traveling to other parts of the body.  The IONS can cause additional medical complications when they migrate throughout the body. The FDA has not yet considered what levels of IONS in the body should be considered unsafe.

The FDA has recommended that those who are in need of a hip replacement avoid the metal-on-metal type of replacement and opt instead for implants made of ceramic or polyurethane material, or where only one of the components is metallic, not both.

Toxicity caused by debris from a metal-on-metal hip implant caused the need for the device to be removed from a 66-year-old man who is suing Johnson & Johnson, who manufactured his implant, according to expert testimony at Friday’s trial.

The testimony was heard in Los Angeles Superior Court in the first lawsuit to go to trial involving all-metal hips made by J&J’s DePuy unit. More than 10,000 U.S. lawsuits have been filed since the hips were recalled from the market in 2010.

It was alleged that the manufacturer was aware of the defects in their ASR hip implants, which include the risk of poisoning from cobalt and chromium metal debris, even before it started selling their devices in 2004.

The 66-year-old man’s blood test showed his levels of cobalt and chromium reached as much as seven times normal after he received the ASR hip.

A J&J study presented at the trial showed that the company had estimated that 37 percent of the devices would fail within about five years of implant surgery. (That is about 4 in 10 of its all-metal devices).

More than 10,000 lawsuits have been filed since the hips were recalled from the market in 2010.

The FDA began assessing the safety and risks of all-metal implants after receiving more than 5,000 complaints of adverse reactions, ranging from inflammation and bone fractures to dislocation and heavy metal blood poisoning. Among the devices cited was the Zimmer Durom Cup, which has been the source of increasing litigation in courtrooms across the country. Many patients implanted with the Durom were often forced to undergo painful revision surgery and would seek to hold the manufacturer liable for their pain and suffering.

Despite high failure rates of their all-metal implants and the hip manufacturer temporarily suspending sales of its Durom Cup in July 2008, there has never been an official Zimmer hip replacement recall. The device was released about four weeks later, with revised instructions for orthopedic surgeons.

Following reports of Zimmer hip replacement complications, including loosening, metal grinding and early failure, the FDA issued a safety communication concerning all-metal hip implants on January 17, 2013. The agency has been investigating the risks of these prosthetic devices for several years.

The FDA is now providing updated safety information to patients and health care providers and will continue to gather and review available data on currently marketed metal-on-metal hip implants. Updates will be provided as necessary to patients and health care providers by the agency.

If you or a loved one received a metal-on-metal hip implant and are experiencing pain, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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