Medical implant manufacturers and the NHS are at risk of having to face thousands of new hip replacement negligence claims after the Medicines and Healthcare products Regulatory Agency (MHRA) issued a new safety alert about metal-on-metal artificial hips.
The MHRA has told health care professionals that some 56,000 patients must have X-rays and blood tests to determine whether they have been adversely affected by the metal-on-metal hips, which could be far more toxic than first thought.
Wear and corrosion in metal-on-metal implants can lead to tiny metal iron particles entering the soft tissue area around the artificial hip, causing various problems for patients, including metallosis, and aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL).
To date, tens of thousands of recipients of the metal-on-metal hips have been negatively affected by them, with some even developing tumours from toxins.
DePuy a manufacturer of MoM hip implants, which is owned by Johnson & Johnson, is currently facing a trial in October this year, where some 600 patients will be taking action against it for complications arising from their hip replacements. In 2013, NHS hospitals were told to stop fitting most metal-on-metal hip replacements.
A year before that, the MHRA released guidelines advising that larger implants should be checked for life, with tests being performed to check for metal particles in the patient’s blood. However, it’s new guidelines are calling for speedier and wider testing.
In an updated note on metal-on-metal hips, the MHRA said that it had continued to monitor the performance of metal-on-metal hip joint articulations “for the occurrence of soft tissue reaction associated with these devices”.
It said that the majority of patients with MoM hip replacements currently have well-functioning hips. However, some patients will develop progressive soft tissue reactions to the wear debris associated with MoM articulations. Data from the 13th Annual Report of the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, published in 2016, continued to show a risk of adverse soft tissue reaction to particulate debris.
“MHRA’s clinical orthopaedic experts have also observed that soft tissue necrosis may occur in both asymptomatic and symptomatic patients, and believe early detection of these events should give a better revision outcome should this becomes necessary,” it added.
Dr Neil McGuire, MHRA’s clinical director of medical devices said: “Although the majority of patients with these metal on metal devices have well-functioning hips, it is known some may develop soft tissue reactions related to their implant. The clinical advice we have received indicates patients will likely have the best outcomes if these problems are detected early, monitored and treated if necessary.”