In the United States in 2009, one million patients received either a hip or knee implant, creating a highly lucrative business worth $6.7 billion to medical device companies. No guarantees are offered on implants. Early detection of defective implants rarely occurs, due to the lack of a national implant registry.
200,000 to 300,000 of annual surgeries are for the replacement of the hip joint. The recent recall of the ASR XL Acetabular System, a metal-on-metal implant made by DePuy Orthopedics, has raised major concerns about the safety of artificial devices, how they’re tested, and how their real performance is tracked.
Since 2008 there have been three Major Hip Recalls
The DePuy device was recalled on August 26, 2010 when the failure rate reached that of 12-13%. (The standard is 5 %.) It is disturbing to know that this was TWO years after the first complaints were filed in 2008 with the FDA.
Other hip recalls showing the slow pace of recalls include the:
-Trident PSL and Hemispherical Acetabular hip replacement cups made by Stryker Corporation, recalled in January 2008. These implants were left on the market 3 years after reports of numerous defects and complications.
- Durom Cup sold by Zimmer Holdings on July 24, 2008. These cups were used from 2006 to 2008 in 12,000 surgeries before they were finally recalled due to loosening.
Other Metal-on-Metal Hips being investigated
There are other metal-on-metal hips on the market that have not been recalled, but are currently being investigated by the FDA. If you have a metal-on-metal hip you should consider checking with your physician to make sure everything is OK.
Joint Registries Do Well in Other Countries
Other countries, especially Australia, Britain, Norway, and Sweden have joint registries that help create more accurate performance statistics. Because of this doctors can make better product choices for their patients. Experts estimate that because the U.S. lacks this, the risk of a revision surgery doubles.
In May 2008, for example, When Zimmer received the first complaints about the Durom cup the company refused to perform a recall until it examined 1,300 patient records. If there had been a searchable index containing information such as:
- Patient name,
- Surgeon,
- Hospital,
- Type of procedure,
- Date of surgery,
- Type of implant with identifier (serial number or bar code),
that lengthy review would not have been necessary.
What is being done about it here in the U.S.?
Plans are underway for a pilot American Joint Replacement Registry. Medicare officials have refused to assist with a registry because of a lack of resources for data collection in the past There are also concerns about funding; initially and long-term.
It has been noted that failed medical devices contributes enormously to U.S. health care costs, and experts agree. This fact was not addressed by the reform legislation that was passed back in March 2010. In fact, due to the new law levies and excise taxes on implant sales, joint replacements may become even more expensive.
Unfortunately, these additional costs will be passed on to private insurers, consumers, and finally back to the taxpayers because Medicare pays for about half of the joint implants in the U.S. The pain and suffering by people whose hips are failing and the climbing costs of those failures could be addressed easily and effectively with a coherent national record-keeping system.
If you’ve suffered a premature failure of a metal hip replacement device, contact a DePuy hip recall lawyer to protect your interests and discuss the possible legal options that may be available to you.
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