Over 300,000 people in the United States undergo hip replacement surgery each year. Hip replacement surgery involves the replacement of a damaged hip joint with an artificial implant. The degree of the replacement, such as total or partial implants, depend upon the degree of damage to the existing hip. The surgery is usually a last resort for people that have already tried alternative treatments such as anti-inflammatory drugs; cortisone shots; physical therapy, and crutches. Signs of a deteriorating hip include pain when walking or climbing stairs and painful aching during the night.
Replacement implants come from many different materials such as, plastic, ceramic and metal. Metal hip replacement devices are used primarily for total hip replacement and hip resurfacing procedures. A metal hip replacement consists of a ball component and a socket component, both of which are made from metal. The support for the metal-on-metal device was predicated on the fact that the materials would be more durable than alternatives and therefore last longer.
The use of metal hip replacement devices has been thought to avoid debris wear that is often seen in alternative devices made from plastic and polyethylene.
The six leading manufacturers of metal hip replacement devices are; Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer.
Metal hip replacement devices have been available for hip replacement surgery in the United States for several decades and have been available for hip resurfacing procedures since 2006.
The first to use a metal-on-metal implant on a regular basis was English surgeon George McKee. In 1953, he began by using a cemented hemiarthroplasty used for neck of femur fracture treatment with a new cobalt-chrome socket as the new acetabulum. This implant had a good survival rate, however, the method became unpopular by the mid-1970’s.
However, metal implants have experienced a revival. In the past, concerns were raised regarding the bearings used and their potential to generate metal ions that had a risk of cancer as well as associated hypersensitivity reactions and aseptic loosening (the failure of the bond between the implant device and the bone). Those concerns dissipated once the cause for the aseptic loosening was found to be attributed to poor design and improper implantation techniques rather than the metal materials themselves.
Recent information about the wear of certain metal hip replacement devices has raised concerns about their use. Materials made of metal give off small particles of debris. Further, metal can corrode which gives off metal ions. The debris can then enter the space that surrounds the implant, as well as enter the patient’s bloodstream. Such an action can cause a reaction in some patients like pain or swelling around the hip and other parts of the body.
The Food and Drug Administration (FDA) has become concerned over the use of metal hip replacement devices because pain and swelling cases have been reported. On January 17, 2013, the FDA issued an updated public health communication about metal hip replacement devices. The communication stated that metal hip implants have unique risks in addition to the general risks of all hip implants. The unique risks were found to exist because the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.
As it stands, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body that would produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal particles.
In general, metal hip systems are not meant to be implanted in patients:
- Who have kidney problems
- Who have a known allergy or sensitivity to metals
- Who have a suppressed immune system
- Who are currently receiving high doses of corticosteroids such as prednisone
- Who are women of childbearing age
When a hip replacement device is created and presented to the FDA for approval, the FDA does not require clinical trials if the device is similar to an already on-market product. This can lead to hazardous devices being implanted into the bodies of patients. Dating back to 2003, six hip replacement manufacturers have recalled a total of 578 implant components.
When a recall is made, it can fall under three potential categories; Class I, Class II, and Class III. Class I recalls are the most serious and harmful. The FDA states Class I recalls as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls are described by the FDA as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recalls are for problems that are unlikely to cause patient harm. The FDA describes a Class III recall as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Hip replacement manufacturer, DePuy, had 150 Class II hip replacement device recalls with a major portion being due to a high failure rate due to metal components.
Zimmer, another hip replacement manufacturer, had 104 Class II hip device recalls with a large portion being due to a metal grain structure anomaly where the material had an improper assurance of proper fatigue strength.
These products were allowed to reach the marketplace due to the FDA’s 510(k) clearance rules which allow for the release of medical devices as long as substantially similar devices are already widely available. This provision allows manufacturers who already produce metal-on-metal and other hip devices to offer largely untested hip implants for sale.
If you have suffered adverse health effects as a result of a faulty, metal hip replacement device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled Denver defective medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.