FDA Communication, February 09, 2011

All artificial hip replacement systems have risks related to implant or material wear. Metal-on-metal hip (MoM) replacement systems have unique risks in addition to the general risks of all hip implant systems.

In April 2010, the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific recommendations for patients implanted with MoM hip replacements. The recommendations included blood tests and imaging for patients with painful MoM hip implants.

There are several differences between the U.K. and U.S. regulatory systems and some of the U.K. data may not be directly applicable to the experience in the US. For example, some of the devices available in U.K. are not marketed in U.S. Therefore; the frequency of reactions, in the U.S. is unknown. For this reason, FDA is in the process of gathering additional information about adverse events in people with metal-on-metal hip implants.

At the current time, there is no evidence to support the need for checking metal ion levels in the blood or special imaging if patients with MoM hip implants have none of the signs or symptoms described above and the orthopaedic surgeon feels the hip is functioning properly. The FDA is recommending that asymptomatic patients with MoM hip implants continue to follow-up with their orthopaedic surgeon as prescribed.

If patients with MoM hip implants develop any concerns, it is very important for them to make appointments with their orthopaedic surgeons promptly for further evaluation.

If patients with MoM hip implants develop any new or worsening symptoms outside of their hips, or if they are referred to doctors to evaluate new conditions, they should let the doctors know that they have MoM hips.

From the February 11, 2011, American Academy of Orthopedic Surgeons

Communication blast

“FDA issues communication on metal-on-metal hip components.

The U.S. Food and Drug Administration (FDA) has posted a public health communication about metal-on-metal (MOM) hip components used in total hip arthroplasty (THA). The communication addresses recent concerns about MOM hip implant systems, and provides specific information for orthopaedic surgeons on these devices, including their effectiveness and general considerations before, during, and after arthroplasty. In addition, the communication provides information for other healthcare professionals regarding treatment to patients with a MOM implant, as well as for patients who have or are considering MOM implants.

AAOS appreciates this thorough and well-considered look at the concerns surrounding the use of these implants. With the patient’s safety, health, and quality of life always in mind, the members of the AAOS will continue to work with device makers and agencies such as the FDA to share knowledge and communicate any potential concerns.”

Because the amount of information exceeds the capacity of my Blog to learn more, go to WWW.FDA.GOV/medical devices and enter metal on metal hip February 09, 2011

For the week of February 21, 2011, you will learn about stem cells and the hip as there are lots of patients considering a hip replacement as well as many recipients of hip resurfacing on one side who are deciding what to do about the other hip

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