The Health Services Executive (HSE) is expected to order a review of patients in Ireland who were implanted with metal-on-metal hip devices. The HSE is Ireland’s equivalent of the U.S. Food and Drug Administration (FDA).
Metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. In the United States, these devices were approved using the fast-tracked 510(k) approval route, which bypasses clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants.
The all-metal hip implants were created for greater durability and longevity and with the intention that the seemingly stronger metal components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries.
The HSE review comes after last year’s review in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA), which is the medical devices regulatory body in the UK. Some 8,000 patients in Ireland have been implanted with a metal-on-metal device and about 3,500 of those individuals were implanted with DePuy Orthopaedic’s ASR device and have already undergone review, according to TheJournal.ie. DePuy is a unit of Johnson & Johnson.
The DePuy ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System were recalled after data from a medical device registry in the United Kingdom indicated that the devices were failing in about 12 percent of patients within five years. At the time the devices were recalled, some 93,000 patients worldwide received one of the ASR models. Since the recall, the failure rate has been reported to be as high as 40 percent based on Australian joint registry data. At the time of the recall, DePuy officials said that, “more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery,” according to TheJournal.ie.
An HSE spokesperson told TheJournal.ie that, “There are no immediate safety concerns with these implants. This is not a product recall, this is a review.” Letters will be issued to those impacted by the review this week. Also, a new national database in Ireland—the Irish National Orthopaedic Register (INOR)—is scheduled to start logging data on all hip and knee replacement surgeries that take place in Ireland, effective September. Meanwhile, last year’s MHRA alert identified four groups of devices for review, including DePuy ASR hip replacements.
On January 17, the FDA issued a Safety Alert acknowledging risks associated with metal-on-metal hip implant devices and issued new guidelines for all-metal hip patients. The agency advised that people implanted with all-metal devices undergo physical exams, diagnostics imaging, and metal-ion testing, when necessary. In that same alert, the FDA also proposed new, stricter guidelines that would require manufacturers prove that their devices are safe and effective through clinical testing, a method referred to as “premarket approval.”