On Track Of Becoming Costliest Recall Ever Is metal-On-Metal Hip Replacement
With already about 5,000 complaints received by the US Food and Drug Administration (FDA) so far this year, the growing issue on metal-on-metal hip replacement is about to become the costliest and biggest medical device predicament ever. Since its announcement last year, the DePuy hip replacement recall had spawned thousands of complaints. Some 75 percent of the complaints received by the FDA involves the DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson (J&J).
Approximately a year ago, DePuy announced a worldwide recall of its ASR XL Acetabular System and Hip Resurfacing Platform after failing at a higher-than-expected rate. In the complaints, patients reported having symptoms such as:
• Pain around the hip joint
• Difficulty walking
• Swelling around the implant area
• Rash that is a sign of dying tissue
Those symptoms may indicate more severe problems such as:
• Loosening, when the implant does not stay attached to the bone in the right position.
• Fracture, where the bone around the implant may have broken.
• Dislocation, where the two parts of the implant that move against each other are no longer aligned. This happens because tissue around the joint becomes inflamed and weakened, and can't hold it in place.
• Damage to the nerves, tissues and muscles near the implant area
The number of patients with metal-on-metal implants is estimated at 500,000 with hip replacements considered as one of the most common procedures in the U.S. According to DePuy, there are about 93,000 patients worldwide who are using the ASR. According to a New York Times analysis, DePuy's recall of its two hip systems could cost the company about a billion dollars. Other hip makers aside from DePuy which were targets in a May FDA probe are Biomet Inc. and Zimmer Holdings Inc.
According to a Reuter report, DePuy is now facing more than 2,000 lawsuits in state and federal court in the United States and have hired the services of Broadspire Services Inc. to administer patient claims for out-of-pocket medical costs associated with the recall. The Broadspire Services Inc., on behalf of insurance companies and employers, manages workers compensation and other medical claims. The move was highly criticized as a means to save J&J and DePuy the money.
With the number of complaints on hip replacement this year so far higher than the combined number of complaints received in the past four years, the hip replacement recall is touted to be bigger than the Medtronic recall of its Sprint Fidelis lead in 2007.
Approximately a year ago, DePuy announced a worldwide recall of its ASR XL Acetabular System and Hip Resurfacing Platform after failing at a higher-than-expected rate. In the complaints, patients reported having symptoms such as:
• Pain around the hip joint
• Difficulty walking
• Swelling around the implant area
• Rash that is a sign of dying tissue
Those symptoms may indicate more severe problems such as:
• Loosening, when the implant does not stay attached to the bone in the right position.
• Fracture, where the bone around the implant may have broken.
• Dislocation, where the two parts of the implant that move against each other are no longer aligned. This happens because tissue around the joint becomes inflamed and weakened, and can't hold it in place.
• Damage to the nerves, tissues and muscles near the implant area
The number of patients with metal-on-metal implants is estimated at 500,000 with hip replacements considered as one of the most common procedures in the U.S. According to DePuy, there are about 93,000 patients worldwide who are using the ASR. According to a New York Times analysis, DePuy's recall of its two hip systems could cost the company about a billion dollars. Other hip makers aside from DePuy which were targets in a May FDA probe are Biomet Inc. and Zimmer Holdings Inc.
According to a Reuter report, DePuy is now facing more than 2,000 lawsuits in state and federal court in the United States and have hired the services of Broadspire Services Inc. to administer patient claims for out-of-pocket medical costs associated with the recall. The Broadspire Services Inc., on behalf of insurance companies and employers, manages workers compensation and other medical claims. The move was highly criticized as a means to save J&J and DePuy the money.
With the number of complaints on hip replacement this year so far higher than the combined number of complaints received in the past four years, the hip replacement recall is touted to be bigger than the Medtronic recall of its Sprint Fidelis lead in 2007.
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