Issues with Stryker Hip Replacement Can be Devastating
January 25th, 2018 by Cutter Law
The thought of having a metal-on-metal hip implant—such as one made by Stryker or DePuy Orthopaedics—fail typically brings up concerns about pain, loss of mobility, and the necessity for revision surgery. But according to an article in The New York Times, failure of an all-metal hip device can cause serious health problems, as well. Companies that manufacture metal-on-metal hip implants now face lawsuits from patients who allege they weren’t adequately warned about the risks associated with the devices. Meanwhile, the U.S. Food and Drug Administration (FDA) is coming under fire for failure to adequately regulate new medical devices.
Patient Allegedly Suffered Serious Health Problems Caused by Hip Implant Device
The New York Times article opens with the story of Dr. Stephen Tower, a doctor who not only provided hip implant surgery, but had a metal-on-metal hip device implanted in his right hip in 2006. He received a DePuy ASR XL, but concerns about the DePuy device are similar to those regarding Stryker metal-on-metal hip implants.
A few years after his implantation surgery, Dr. Tower was in “excruciating pain” and had revision surgery to replace the hip implant.
“When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.”
According to a letter he wrote to Senator Begich in 2013, Dr. Tower’s blood cobalt level was 200 times the normal amount. Prior to his revision surgery Dr. Tower experienced “progressive problems with memory, cognition, mood, sight, hearing, and had progressive breathlessness with exercise.”
Given that according to Consumers Union in 2011 almost 500,000 Americans received a hip replacement, concern about ongoing issues with metal-on-metal hip devices is widespread.
FDA Under Fire for 510(K) Provision
Despite numerous metal-on-metal hip implant devices being recalled or facing lawsuits thanks to early failure rates, the FDA continued to allow them to be approved for the market without rigorous testing. This is thanks to the 510(k) provision which allows any manufacturer to claim their device is substantially similar to a device that was already approved. Even if the already approved device has shortcomings—such as an early failure rate—manufacturers just have to show that their new device is similar to one already on the market, opening the door for new devices that have the same serious issues as previous implants.
Stryker Tops List of Recalls
Although The New York Times focuses on the DePuy ASR XL, it’s Stryker who has the highest number of hip device recalls. Between November 1, 2002, and July 23, 2013, Stryker issued 231 hip device recalls, according to Consumers Union. Of those, 53 recalls were classified as Class III, which are likely to cause serious harm to patients.
Among the reasons for recalling the Stryker devices:
- Labeling issues
- Manufacturing issues
- Packaging issues
Consumers Union was concerned enough about issues with the metal-on-metal hip devices, including those offered by Stryker, that they wrote a letter to each manufacturer in 2013, requesting all manufacturers offer a warranty for their hip and knee replacement devices (as of 2013, only Biomet offered a warranty and that was only for one partial knee replacement).
Stryker Hip Replacement Lawsuits
As of January 16, 2018, there were 1,880 Stryker hip replacement lawsuits consolidated for pretrial proceedings in MDL 2441. Those Stryker lawsuits allege patients were not adequately warned about the risks associated with metal-on-metal hip replacements.
If you or someone you love was injured by a Stryker hip replacement device, including the Stryker ABC II Hip Implant, contact Cutter Law today. Our attorneys are experienced at litigating against medical device manufacturers and are committed to helping you receive the full compensation you’re entitled to.
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