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Medical Devices Failures - Is the Trend Growing?

Victor Lewin - Friday, January 30, 2015

As our population ages, bones, joints and other body parts weaken and grow frail with the passage of time. Artificial implants are becoming more and more prevalent in today's society. Along with the increase in artificial implants comes an increase in complaints about a number of the artificial products that are being implanted.

One of the first noteworthy events that brought to light the issue of defective medical devices and implants was the massive recall in 2005 of hip and knee replacement products manufactured by DePuy. Since that recall, other hip implant manufacturers have been the subject of lawsuits and class actions in both Canada and the United States.

With the ever increasing amount of hip and knee replacement surgeries that are performed in hospitals across Canada, the complaints about defective devices are also growing. The implants are known to cause complications, including infection, joint dislocation or even total failure of the device itself as a result of poor manufacturing, design or materials. Due to these problems, numerous individuals in Nova Scotia and other provinces have had to undergo revision surgery, some multiple times.

One must look no further than the lack of clinical evidence about a device's robustness and quality that implant manufacturers choose to submit when their device is made available to surgeons and hospitals. In the past, a failed device would lead to the surgeon or hospital discontinuing the implantation of product and the manufacturer would initiate a recall of its faulty product. However, some devices which have been known to receive numerous complaints, including implants which are the subject of litigation, are never recalled by the manufacturer.

Patients with hip replacement failures usually suffer issues with the device, including:

Fatigue within the device or poor quality design or materials causing breakage

Cracks or fractures near the joint

The device becoming unsecure or loose within the patient's body causing pain/stiffness

As recently as late 2011, the FDA in the United States provided warnings to the public regarding the use of metal-on-metal hip components. These types of products are usually used in total hip arthroplasty surgery. Reported symptoms of issues with metal-on-metal hip implants include pain in the affected area, loss of sensation or a feeling of numbness, difficulty in an individual's gait and ability to walk.

The metal total hip replacement system is made up of three distinct parts:

1) The Femoral Head (a ball of metal)

2) The Femoral Stem (length of metal inserted in to the thigh bone)

3) The Metal Receptacle Cup (implanted in the hip bone)

The selling point of metal-on-metal implants is that they are more durable and have a longer "life" than the plastic or ceramic products also on the market. Due to the reputed "better quality" of the metal devices, surgeons and hospitals are using these types of implants much more frequently and are being suggested to younger patients who may require artificial surgical implants.

Two studies from Britain in late 2011 discuss the metal-on-metal hip devices and note a marked increase in failures. Worringly, the report stated that metal-only devices appeared to have a much higher failure rate than implants constructed of ceramic or plastic. Although the metal versions are touted to be more durable, the study found that approximately 1 in 3 patients required replacement surgery within 6 years of being implanted with the DePuy ASR device.

The second study found that metal devices did not pose any advantage over their ceramic and plastic counterparts and, interestingly, the metal devices may be more prone to require revision surgery than the other types.

As stated, a number of manufacturers have been the subject of numerous lawsuits and class actions. A brief rundown on the class actions Wagners have filed against artificial hip manufacturers follows:

DePuy

Wagners commenced a class action in Nova Scotia on January 10, 2011. The lawsuit was filed as a result of the numerous complaints received by both Health Canada and the United States' FDA. DePuy recalled its ASR XL modular acetabular cup and the ASR hip resurfacing system in August 2010. Failure rates with this particular were approximately 13% after a 5-year study of 40,000 patients in the US was conducted. The usual standard recognized by medical practitioners is usually around 5%.

Wagners filed a similar action in New Brunswick on January 12, 2011.

Wright Medical

Wagners commenced a class action in Nova Scotia on September 13, 2011. The Wright Profemur Hip Implant System is composed of a Profemur Modular Stem (i.e. a Profemur Z stem, Profemur Plasma Z stem, Profemur LX stem, Profemur Tapered stem, Profemur RAZ stem, Profemur TL stem, Profemur Xm stem, or Profemur Renaissance stem) with a Profemur neck and femoral head. This modularity purports to allow orthopaedic surgeons more options for modifying the implant's geometry and should yield better results than conventional hip replacement systems. The device was approved for implantation by Health Canada in February 2001.

In approximately 2009 the Australian Joint Registry reported that the Profemur Z Stem component of the Profemur Hip Implant System had an 11.2% failure rate at the three year interval.

Biomet

Wagners commenced a class action in Nova Scotia on May 1, 2014. The Biomet implant is another metal-on-metal product that was the subject of concerns from as early as 2006 concerning risk of failure and the development of metallosis in the patient. Although the Biomet companies were aware of these concerns, they continued to aggressively market their device for use in implants.

More info can be obtained about these medical device lawsuits from Wagners' website.

As technology continues to evolve and new devices are developed, in addition to the products currently in use, it may well be that competition, poor design and other factors may see a further increase in faulty or defective implant products being used in patients in Nova Scotia and other provinces in Canada.

Wagners continues to monitor problems with implants and other medical devices that are surgically implanted in patients.

If you or someone you know has been affected by a defective hip, knee or other type of implant, you may wish to contact us to determine if you have a case against the device manufacturer.

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