Due to advances in modern medicine and technology, doctors can solve many problems that were impossible to fix years ago. If you have a car accident, or fall from a bicycle, bones and joints can be injured. Sometimes, joints just wear out. No matter what the cause, your doctor may have suggested that you have your hip replaced. The surgery may have seemed successful and after some time your hip may have felt like new. Hospital and surgeon bills were paid by your insurance. So what is the problem?
Hip Replacement Recall
After some period of time, you may have begun experiencing pain and discomfort. Maybe your hip is popping or clicking? Is this normal? Is this what you expected? No. Hip replacement implants that are “metal on metal” have been recalled and caused problems for many people. As a result, thousands of lawsuits were filed against many of the manufacturers of the devices. The manufacturers are setting aside literally billions of dollars to settle these lawsuits. They are also recalling these implants because of the problems that they are causing.
Traditionally, hip implants involved metal-on-polyethylene or ceramic-on-polyethylene devices. Studies have shown that the newer metal-on-metal implants offer few advantages over the older devices. The British Medical Journal (“BMJ”) reported that statistically metal-on-metal implants required repeat surgery more than the traditional method. The BMJ article was based upon a study performed the U.S. Food and Drug Administration (“FDA”). The study compared metal-on-metal and ceramic-on-ceramic with metal-on-polyethylene or ceramic-on-polyethylene devices. It was revealed that metal-on-metal implants had a larger failure rate than the traditional implants.
Hip Implant Failures
Many of the implant failures reported:
Decreased mobility
Pain in the hip
Groin or thigh
Inflammation and swelling
Loosening of the device
Bone damage
Infections
Nausea
Metal poisoning
An indication that the hip replacement implant has failed is when any of these symptoms appear within five years of the surgery. Pain, inflammation, and swelling may be normal some time after the surgery, but not for years afterward.
A hip implant device consists of a ball and socket that replaces the body’s original equipment. Due to the nature of the implant, it is not unexpected that the ball and socket will wear against each other. With the metal-on-metal implant, tiny particles of metal can be generated. This does not affect every patient, but some patients cannot tolerate the particles of metal. The reaction may cause fluids to collect around the joint and in the muscles around the joint. While the patient may not initially experience any discomfort, untreated fluids may eventually cause pain and swelling around the joint, and in the long term, cause damage to nerves, muscles, or bones around the joint.
Replacement surgery is not what the patient expected. If the implant needs to be replaced, the patient must now endure additional pain and recovery, as well as the expense of unnecessary surgery.
In addition to the need of replacement surgery, the patient may be subjected to metal poisoning. Lawsuits against some of the manufactures have alleged that, after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient’s blood and tissue and bone surrounding the implant.
In an FDA Safety Communication: Metal-on-Metal Hip Implants, dated January 17, 2013, the FDA advised:
“Metal-on-metal hip implants have unique risks, in addition to the general risks, of all hip implants. In metal-on-metal hip implants, 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 around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”
Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).
Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.”
What Should You Do?
If you have had a hip replacement implant, the FDA advises that you and your doctor take the following course of action:
If you are experiencing problems, you should have your hip examined by your doctor once every six months. If you are not experiencing problems, you should have your hip examined once every one to two years. If you are having problems, talk to your doctor about soft tissue imaging, such as MRI, CT, or ultrasound to examine the surgical area. You might also think about testing for metal ion levels. According to the FDA, the most reliable test results are available for cobalt in EDTA-anticoagulated blood. Symptoms of an adverse impact of metal ions are:
General hypersensitivity reaction (skin rash)
Cardiomyopathy
Neurological changes including sensory changes (auditory, or visual impairments)
Psychological status change (including depression)
Renal function impairment
Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold
So who and what are some of the hip implant devices that have had problems and been subjected to lawsuits? Some of them are:
Johnson & Johnson’s DePuy ASR and Pinnacle
Smith & Nephew’s Birmingham
Zimmer Durom
Biomet Hip Systems
Stryker Rejuvenate
Wright Medical Pro Femur
Wright Conserve plus
Stryker ABG II
Biomet M2a Magnum
In order to determine if you are eligible to receive some of the billions of dollars available from the manufacturer, you should contact the qualified personal injury attorneys at The Kyle Law Firm. Contact us for a free consultation today.
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