Medicines and Healthcare products Regulatory Agency (MHRA)
Hip Replacement Safety Alert
On 22 April 2010 the Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety notice on all metal-on-metal (MoM) hip replacements. This follows after concerns that patients experiencing unexplained hip pain may actually be suffering from a soft tissue reaction to the replacement hip.
A number of patients who have undergone hip replacement using the MoM joints have had reactions such as soft tissue necrosis. Devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient's body; this can cause inflammatory reactions that cause pain in the groin, death of tissue in the hip joint and loss of surrounding bone.
The MHRA although not recalling all UK patients who have undergone an arthroplasty using a metal hip joint, are urging all orthopaedic departments and surgeons to put systems in place by 17 June 2010 to ensure that patients are reviewed at least annually for five years postoperatively and more frequently where there is a presence of symptoms.
The MHRA have recommended that patients with painful MoM replacements should be referred for tests including blood metal ion measurements and MRI or ultrasound scanning. It is recommended that where there is a presence of a soft tissue reaction, fluid collections or tissue masses then revision surgery should be considered early to give a better outcome.
The MHRA have issued this advice to all trusts in England, Scotland, Wales and Northern Ireland and the Care Quality Commission and is continuing to monitor the situation.
Interestingly MoM replacements have been a concern in other countries for a number of years, particularly in Austria where metal-on-metal articulation was abandoned 5 years ago. A recent editorial in a medical journal for orthopaedic surgeons, The Journal of Arthroplasty, urged doctors to use the metal-on-metal devices only with "great caution, if at all."
If you or someone you know has been affected by this, please contact us and our experts may be able to help.