Medical technology is developing at a lightening pace, along with other types of technology. It is wonderful to know that a hip can be replaced. These new developments are supposed to help us live longer, healthier, more active lives. The advertisements show people hobbled over in pain prior to surgery, only to be bowling and skiing and dancing after their hip replacement surgery. It looks very inviting, and many people have had their hips replaced in hopes they, too, would be able to do all the active things they used to do.
Often, however, the devices being used in humans are inadequately tested and rushed to market. Manufacturers eager to maximize profits often push a product onto the market, with FDA approval, through an accelerated approval process. If the device can be shown to be “substantially the same” as another device that has already been approved, then this accelerated approval can occur.
Sometimes, this rush to market can have disastrous results, leaving those who have used the device with serious injuries or conditions. While this is by no means a complete discussion of hip replacement devices which have created problems, below we discuss metal-on-metal hip implant devices which have been the subject of litigation.
Metal-on-Metal Hip Replacement Devices
There have been some issues with a number of hip replacement devices that have a metal-on-metal design. According to some studies, approximately one in twelve recipients of metal-on-metal hip implants will require revision surgery within five years of the original replacement surgery.
There are two types of metal-on-metal devices: a total hip replacement system, and a “resurfacing” hip system. The problems primarily occur as a result of the metal rubbing on metal – tiny metal fragments are released and that can cause problems.
Some side effects of metal-on-metal implants are:
- Blood test results that show elevated levels of chromium and cobalt caused by metal debris (metallosis)
- Clicking, popping or grinding near the hip implant
- Loosening of the implant that results from bone loss
- Necrosis, or cell death, or the affected tissue
- Misalignment or dislocation (the two parts of the implant move against one another and become misaligned)
- Fracture of the bone around the implant
- Loosening in the hip joint because the implant fails to stay attached to the bone in the correct position
- Death of the bone cell resulting from oxygen supply problems
- Metal debris resulting from component parts move together. Tiny bits of metal shavings spread around the area surrounding the implant and destroy soft bone and tissue.
- Pain, swelling or discomfort in the hip area, or problems walking
- Revision surgery to remove and replace a hip device necessitated by any of the above symptoms
You should know there are some other hip replacement devices, not really considered metal-on-metal design which can still cause similar side effects.
What Can Be Done?
There is a wide variety of treatments for these problems, depending on the severity of the side effect. Sometimes antibiotics are needed to treat an infection, or fluid needs to be drawn off the joint. Sometimes revision surgery is needed to solve the problems. Those with high levels of metals in their blood (metallosis) usually have revision surgery to stop the shedding of the metal particles into their body.
Suffice it to say that if you are experiencing any of these symptoms, you should immediately contact your surgeon to determine if any of the above issues have arisen. They will conduct the appropriate tests and plot a course of action.
Because of the concern of so many problems with metal-on-metal hip replacement devices, the FDA is attempting to closely monitor those patients with these devices. There are over 500,000 people in the U.S. with these types of hip replacements. Additionally, they are reviewing the effectiveness vs. the potential danger of metal-on-metal hip replacement devices.
A few of the devices are no longer on the market, having been completely recalled. The recipients of others are being closely watched to determine if additional action is necessary. Keep in mind that just because a product has been “recalled” it does not necessarily mean you need a revision surgery – it may only mean you need monitoring more closely to prevent issues.
The FDA launched a webpage in 2011 specifically for doctors, patients and others concerned about the metal-on-metal devices. It gives some additional information about monitoring and treatments.
Additionally, the FDA has asked the manufacturers of these products to closely follow up with the patients who have them on a long term basis, to determine whether the risk outweighs the benefit. These studies are ongoing.
This is not to say that EVERY hip replacement is problematic!! Nor is every hip replacement device problematic. There are those who have had no problems with their particular device, and that is a good thing.
It is nearly impossible to determine in advance how someone is going to react to a particular device, as we are all different and have different sensitivities. Certain things such as medications, liver function, a compromised immune system, weight, level of activity and general health can impact whether or not a person will have problems with these devices. It is not a one-size-fits-all problem.
There have been a number of lawsuits filed over these devices, and many are ongoing. In some instances, the cases have been consolidated into Multi-District Litigation, which means the claims are centralized in one court to preserve our precious judicial resources. The rationale is that it will save time and money to have these complex cases handled together.
There are a number of manufacturers who have put these devices into the marketplace, and are subsequently defendants in the litigation. Your doctor will be able to inform you which company manufactured the device you had implanted.
If you or a loved one has had a hip replacement and are having problems with it, the first call should be to your doctor. Then you should seek legal counsel with an attorney experienced in defective medical device litigation. They will be able to guide you in the right direction and advise you if compensation is available for you.