Edwardsville, ILLess than a month ago, DePuy Orthopedics announced a voluntary recall of approximately 93,000 DePuy implants. Now, patients who received the implants may be wondering if they are at risk of their implant failing. Bob Rowland, partner at Goldenberg Heller Antognoli & Rowland, says patients face two potential problems with their DePuy ASR and ASR XL metal-on-metal hip implants: loosening and dislocation of the device resulting in the need for early hip revision surgery and/or the release of metal debris causing muscle and soft tissue damage.
The lack of depth of the cup in the hip implant leads to repeated loosening and dislocation as the ball slips out of the cup/socket. This failure has been particularly pronounced in women and people of a shorter stature.
Many artificial hips have a ceramic component, but the recalled DePuy replacements have a metal-on-metal design. The normal wear and tear movement of the hip causes pieces of metal to splinter off and be released into the hip joint.
"Every revision surgery is more invasive then the last and increases bone loss. It's not as simple as just replacing the hip—the surgeries become more complicated with each revision"
As a result of the metal-on-metal design, patients could be at risk for metallosis, development of lesions, soft tissue injury and, ultimately, rejection of the implant. Signs that there are problems with the hip replacement device include difficulty walking, popping or crunching sensations while walking, pain when bearing weight and pain when walking or rising from a seated position.
Although Johnson & Johnson (parent company to DePuy Orthopedics) has reportedly announced it will pay for patients to have their hips replaced, they are not covering all the costs associated with failed hip replacements, Rowland says.
"They will only pay for the surgery itself, they're not paying for diagnostic testing to determine if patients have metallosis," Rowland says. "Metallosis is the condition whereby the metal-on-metal rubbing releases metal into the body. Johnson & Johnson isn't offering diagnostic testing, such as blood tests to detect metal ions in the blood. They're also not covering lost wages, follow-up medical care, treatment for metallosis or compensation for patients for pain and suffering. They'll pay to replace the hip, but the patient is left to pay everything else out-of-pocket."
The devices that were recalled include the ASR Hip Resurfacing System, available 2005 through 2009, and the ASR XL Acetabular hip prosthesis, from 2008 through 2009. Rowland says that the typical failure rate for other hip replacements is five to six percent but the failure rate of the DePuy replacements is between 12 and 13 percent. Furthermore, he notes that if a clinical study were undertaken of the DePuy devices, the actual failure rate could be between 20 and 25 percent.
"Another consideration is that, typically, hip replacements last about 15 years before a second replacement surgery is needed," Rowland says. "Premature failure gets that whole process moving faster because a second hip replacement occurs sooner than it should. Every revision surgery is more invasive then the last and increases bone loss. It's not as simple as just replacing the hip—the surgeries become more complicated with each revision.
"Generally, with a second hip replacement there is a greater risk of complications and a greater risk of failure. It sets a whole series of events in motion where a patient is required to have a second and even third surgery within two to five years of the initial implant. Typically, a patient is not expected to undergo a revision for at least 15 years."
Because the statute of limitations varies from state to state, patients who believe they had the DePuy hip replacements should confirm with their doctor that their replacement was indeed a DePuy product. This can be done by speaking with the doctor or by obtaining a copy of the operative report from the surgeon. That report will include a sticker which will identify the manufacturer of the implant.
Due to statute of limitations, as well as the need for early detection of metallosis, patients should not wait until they have a problem with their hip implant before contacting an attorney.
"Don't wait until the device has failed," Rowland says. "We want to start monitoring and obtain a simple blood test to determine if you have metallosis. Patients may not be aware they are suffering from metallosis, and early medical monitoring is key."
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