In early June, Smith & Nephew PLC pulled from the market a metal liner used in hip replacements following patient reports of fractures, infection and dislocations related to the device. This recall adds to concerns about the safety of metal-on-metal hips.
According to the company, the device is the optional metal liner for its R3 Acetabular System hip devices. The liners were first introduced in 2007, since that time, 7,700 of the liners have been implanted. Most of which were used in stemmed total hip replacements.
The decision to pull the device comes after analysis of clinical results showing that 1.6 patients with the system required revision surgery each year, which is above the 1 percent guideline set by Britain’s National Institute for Health and Clinical Excellence.
Johnson & Johnson, in 2010, recalled metal-on-metal system for like reasons. By some estimates, the marketing of similar devices has been quietly discontinued and the use of metal-on-metal systems has slumped to less than 5% of the hip replacement market.
Generally speaking, metal-on-metal hip implants have been associated with high rates of revision surgery as well as systemic complications due to component erosion and leaching of metal ions both locally and into circulation.
This week, the FDA held an expert advisory panel meeting to discuss the safety of metal-on-metal hip replacements and hip resurfacing systems to determine whether or not it should regulate the devices under more stringent guidelines and premarket review analysis . To date, the panel is yet to make specific recommendations.