Jacksonville Faulty Hip Implant Attorneys
"Metal on Metal" Hip Implants Raising Concerns
The New York Times reported on March 3, 2010, concerns over "metal on metal" hip implants because the devices are linked to causing severe tissue and bone damage to the hip area, often requiring replacement surgery within a year or two.
About one-third of the half a million hip replacement surgeries performed per year in the United States use the metal on metal implant device. The ball-and-socket device is comprised of metals such as cobalt and chromium because of their durability. However, recent studies have shown that these metals begin to wear and generate high volumes of metallic debris that is eventually absorbed into the patient's body. The absorption of these metals have led to serious and severe inflammatory reactions that trigger pain in the groin area, atrophied tissue in the hip joint, and surrounding bone loss.
Doctors from leading clinics around the country such as Rush University Medical Center in Chicago and the Mayo Clinic in Rochester, Minn., say they have treated a number of patients within the last year with these types of problems, which appear related to the metal debris. The deterioration of tissue and bone loss caused by the metal debris can seriously complicate replacement surgeries, which occur far more frequently than the intended life expectancy of approximately 15 years of the device.
The Journal of Arthroplasty urged doctors to use the metal on metal devices only with "great caution, if at all." Studies conducted thus far show that one in three patients could be adversely affected by these devices and all the major orthopedics makers sell these devices. Several of these companies have issued statements decrying the potential risks and stated that the incidences of metal debris problems were extremely low. If the number is as high as suspected, this could mean thousands of patients in the United States could be seriously affected by these devices and will need to undergo additional surgery.
The United Kingdom medical agency just recently announced (www.aboutlawsuits.com April 20, 2010) they will begin reviewing potential problems with these hip replacement devices due to their growing concerns these devices may be linked to tumors, swelling and other hip damage. The UK reviewing body, The Medicines and Healthcare Products Regulatory Agency (MHRA) is expected to announce an official review of metal hip replacements this week.
Currently, there are approximately 40,000 people in the UK who received the metal on metal hip replacement device. The MHRA is expected to announce that anyone considered at-risk could undergo a blood test in order to detect high levels of metal compounds, which could be a sign the hip device is shedding metals into their blood stream.
In the U.S., the DePuy ASR metal hip replacement is scheduled to be taken off the market because the FDA has received about 300 complaints of similar medical problems associated with the device. Last year, the UK studied 660 patients who had received the DePuy device and found that 3.4 percent suffered from similar adverse reactions related to metal debris.
Many surgeons fear they are just now seeing the tip of the iceberg. Surgeons from Rush University Medical Center have performed about two dozen surgeries within the last year removing the metal on metal devices due to adverse affects from metal debris absorption in their patients. A similar number of patients have had their hip devices removed at the Mayo Clinic for similar reasons. According to Dr. Daniel J. Berry, Mayo's head of orthopedic surgery, Mayo has decreased the use of metal on metal hip devices by 80 percent in favor of other hip devices made out of different materials until more scientific evidence becomes clearer. This decrease of use of metal on metal devices is becoming a general trend when it comes to hip replacement devices.
It is unknown whether some of the manufacturers' devices tend to "shed" more metal debris than others, but some experts argue that because the demand was so high, some of the manufacturers may have rushed to get their product on the market. As a result, some of the devices were most likely poorly designed. There's a mounting defense by the manufacturers pointing fingers at the surgeons, stating in order to meet market demand, the surgical procedure, itself, could be at-fault.
The doctor who helped pioneer hip resurfacing, Dr. Harlan C. Amstutz, says it's a little of both - "It is design-related and it is technique-related." Dr. Amstutz, who developed and sold the hip-resurfacing system to the Wright Medical Group, said he believed the hip resurfacing, which typically uses all metal components, was safe. This procedure, which intentionally preserves more hip bone, was aimed at younger, more active patients (men under 55) because of bone strength and the fact they would probably undergo more hip surgeries in later years.
This was not the case, however, for Gregory Smith, 35, of Milan, Ill. Three years ago, he underwent a hip replacement to correct a congenital hip disorder. He received the metal on metal hip device and immediately began experiencing severe pain and discomfort. Last year, he went to Rush University where Dr. Brett Levine removed the device and replaced it with another device. Mr. Smith described the removal of the original device akin to taking fire out of his body. The tissue around the Mr. Smith's left hip was severely inflamed and some had died. Dr. Levine stated that even though Mr. Smith's original device was installed slightly askew, the misalignment would not have created a serious problem for Mr. Smith had the device not been metal on metal.
Dr. Levine stated he was now replacing metal on metal devices at the rate of one a month.
If you or a loved one has suffered due to hip implant, please contact one of our skilled Jacksonville medical malpractice attorneys today to discuss your case.