The bad news just keeps on coming in for manufacturers of metal-on-metal hips. This morning, Johnson & Johnson ($JNJ) and Stryker ($SYK) are feeling the heat from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). The health body is urging surgeons to stop using metal-on-metal hip devices made by these companies, because of a higher revision rate versus competing offerings.
The MHRA further tells surgeons to monitor those patients who may have received the Mitch TRH cup/heads, made by Johnson & Johnson's (J&J) Finsbury Orthopaedics unit, used in combination with Accolade femoral stems made by Stryker.
According to data from the England and Wales National Joint Registry, the combination had a revision rate of 10.7% after four years of implantation. The body has deemed this number unacceptable.
"Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely," explained Susanne Ludgate, clinical director of the MHRA, in a release.
She added that the health regulator had started investigating safety concerns in February. The following month, the U.K.'s National Joint Registry of England and Wales--the biggest artificial joint registry in the world--called on doctors to stop using the implants. The recommendation came after a new study analyzing data from more than 400,000 hip replacements showed that 6% of those patients receiving all-metal implants needed their joints fixed or replaced, versus 1.7% to 2.3% of patients who received ceramic or plastic joint implants.
Metal hips have been excoriated in the press and by regulatory bodies over the past year or so due to the potential for health problems. In May, the FDA called on a number of companies--including J&J and Stryker--to investigate whether their hip implants raise the level of metal in patients' blood to dangerous levels.
Last winter, Sens. Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) got into the game after looking into the safety issues involving a number of devices, including the hips. They sent a letter to J&J regarding its DePuy metal-on-metal hip implant, which has been recalled.
The FDA is heeding calls to look into hip safety. Over the course of a two-day meeting in June, the agency will solicit expert feedback on exactly what risks--and potential benefits--these devices can provide.
- get the MHRA release