FDA Safety Warnings and Investigations for Metal Hip Replacements
Some of the dangers of metal-on-metal hip replacements include when the metal ball and the metal socket of the replacement rub against each other, causing the release of metal ions in the hips, and resulting in an inflammatory response. This may initiate the need for a difficult and painful revision surgery to replace the device.
These injuries and conditions which result from a metal-on-metal hip replacement can have numerous negative impacts on a person’s life. For this reason, it is crucial that you contact a Raleigh metal hip replacement lawyer as soon as possible if you have experienced an injury due to your hip replacement. An experienced and qualified attorney can handle your claim and fight for your rights, providing you the time and energy you need to focus on recovery. They understand the hardships that come with any injury, and will work diligently to help you receive the compensation you deserve.
The Role of the FDA
The FDA became involved when the failure rates for the DePuy ASR were astronomically high. The agency received reports from people all across the country that had to undergo revision surgeries very soon after implant. Therefore, the FDA got involved, sent some warning letters, tried to understand the manufacturer’s position with these implants, and determine why they were failing so quickly.
Issuance of Warnings
The FDA issued several safety communication warnings regarding metal-on-metal hip replacements, the dangers associated with them, and urging patients to talk with their doctors about all available options.
FDA warnings are critical because once the FDA is involved, that really sparks the public’s interest in the device. It puts the public on notice of potential issues with the device. It also puts surgeons on notice. If there is a higher than normal failure rate, the FDA puts out safety warnings about the device. The FDA can also issue various levels of recall that take a strong action against the further use of these products.
Failure Rates of Metal Hip Replacements
For the DePuy ASR, the failure rate was extremely high. For the Pinnacle, the failure rate was not nearly as high. The failure rate for the Biomet Magnum M2A was lower than that. However, a failure rate of 7 or 10 percent is too much because of the difficulties related to the initial surgery.
Patient Risk Factors
Patient risk factors associated with metal hip replacements include obesity, age, sedentary lifestyle, and overall poor health before the initial hip is placed. Some people are more susceptible to infection, so this is not the fault of the hip manufacturers when an infection develops during the course of the implant surgery or the healing time.
Metal ion testing is a blood test that checks specifically for elevated cobalt and chromium. The patient’s primary care doctor does the blood test and knows immediately when the results come back whether the levels of cobalt and chromium are elevated.
Other kinds of tests a doctor or other medical professional might conduct include physical examination, which would show if the implant is working properly. Doctors could also do an X-ray or other radiographic studies and imaging to see if the parts are in place. Typically, the blood test to check the cobalt and chromium levels is the first thing a doctor does when a patient with a metal-on-metal hip implant complains of hip pain.
Importance of an Attorney
Having an attorney is extremely important because once you undergo a hip replacement surgery, if you do not have an attorney hired and in place to retrieve the explant, the doctors might dispose of it after the surgery. That can be one of the most important pieces of information in your case that a jury could see.