A new study urges women and some men to avoid opting for an alternative to a hip replacement procedure, known as metal-on-metal hip resurfacing.
According to a New York Times report on research gleaned from the National Joint Registry of England and Wales found that hip resurfacing in younger women and men with a smaller stature face an “unacceptably high” risk of early failure, compared with a traditional hip replacement. These metal components fit over the bones that make up the hip joint. The procedure aims to preserve more of the thigh bone than would be sacrificed during a total hip replacement procedure. Like all-metal hip implants, hip resurfacing was touted as a viable option for younger recipients because it would require less revision surgeries and potentially delay the need for a total hip replacement.
When two metal components are used in a hip resurfacing procedure, they put patients at some of the same risks that recipients of metal-on-metal hip implants face, sometimes even greater. In fact, metal resurfacing options are included in the same class of medical devices, the class that’s fallen under a negative light since the high-profile recall of the failed DePuy Orthopaedics ASR line of metal-on-metal hip implants.
This new research is published in the journal, The Lancet. Authors, in their “Interpretation” of the data, said, “We recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men. Before further new implant technology is introduced we need to learn the lessons from resurfacing and metal-on-metal bearings.”
The study found that women faced the highest risk of early failure of their hip resurfacing, worse than any type of total hip replacement. For women 55 years of ago, those who received a hip resurfacing with the smallest available femoral head, 42 millimeters, the early (five-year) failure rate is 8.3 percent. That rate drops to 6.1 percent for women receiving the 46 mm femoral head, compared with 1.5 percent of women who receive a metal-on-polyethylene total hip replacement. Similar but lower early failure rates were noted among male recipients of an all-metal hip resurfacing.
Metal-on-metal hip implants have been under increased scrutiny since that 2010 recall on the ASR hip implant. Since then, the Food and Drug Administration domestically has ordered all manufacturers of these devices to conduct full post-market safety studies on these devices and to provide evidence that they’re safe and effective for recipients.
It is the FDA’s flawed 510(k) “fast-track” approval system that’s being blamed – including by this most recent research – for allowing these largely experimental implant and implant component parts onto the market without much scrutiny.