Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of the device are both made from metal.
Metal-on-metal total hip replacements were introduced for their supposed advantages over conventional devices, such as low rates of wear and increased stability. However, concerns about all-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip devices, after it was found that they were failing in about 12 percent of patients within just five years of implantation.
The U.S. Food & Drug Administration (FDA) began studying all-metal hip implants shortly after the DePuy ASR hip implant recall to determine if the devices are shedding dangerous levels of metal ions into patients’ surrounding tissues and blood stream.
Now, in latest news, according to a new report made public by the US Food and Drug Administration (FDA), all-metal hip implants need be linked to both soft tissue damage and pain.
Because of this, it is likely that individuals who were fitted with metal-on-mental hip implants will at one point require additional surgeries in order to have their implants removed and replaced with new ones.
Despite the fact that all-metal hip implants are supposedly sturdier than other options patients have at their disposal, it looks like the disadvantages might sometimes outweigh the benefits.
Thus, the FDA claims that these implants can lose metal at points where two components connect. This translates into the implant itself becoming prone to failure, and into bone and soft tissue damage.
“Metal release will cause some tiny metal particles to wear off of the device into the space around the implant,” reads the official FDA website.
Furthermore, “Wear and corrosion at the connection between the metal ball and taper of the stem may also occur. Some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream.”
For the time being, the FDA is unable to say how each patient will respond to his/her being fitted with one such metal-on-mental hip implant.
As well as this, they lack information concerning the ways in which various concentration levels of metal pieces lost in a patient’s body or bloodstream will affect their health, causing additional health problems, and what those health problems would be.
“Different people will react to these metal particles in different ways. At this time, it is not possible to predict who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be,” the FDA says.
Therefore, they advise that each patient who is looking into the possibility of having his/her hip fitted with a metal implant take the time to discuss both the risks and the benefits with a surgeon.
The FDA also recommends that people fitted with all-metal hip implants who do not display any adverse effects (i.e. skin rash, cardiomyopathy, auditory, or visual impairments, psychological status change, renal function impairment, thyroid dysfunction) still present for follow-up consultations at least one every one-two years.[hr]