Today I’d like to follow up on my recent blogs discussing the U.S. Food and Drug Administration’s (“FDA”) 18-member advisory panel designed to investigate the efficacy and safety of metal-on-metal (“MoM”) hip implants.
As you have read, the advisory panel held meetings on June 27th and 28th for the chief purpose of determining whether new guidelines and monitoring recommendations were needed to ensure the safety and proper use of MoM hip devices. The MoM hip implants have been marketed during the last ten years as a safer and more reliable alternative to the traditional ceramic and plastic versions. Moreover, it was urged by the device community that, because the MoM device allegedly lasts longer than the alternatives, it was particularly attractive for surgery in younger patients.
Now, after two days of presentations where little decisive information was released, the overwhelming opinion of those having attended the panel’s presentation is that “there are few reasons to continue using metal-on-metal hip implants . . . .” In light of “growing evidence that the devices can break down early and expose patients to dangerous metallic particles,” health experts have officially come out against future use of the implants. As the chair of the panel, Dr. William Rohr boldly asserted, “I do not use metal-on-metal hips, and I can see no reason to do so.”
Approximately 400,000 Americans undergo hip implant surgery each year, many of whom suffer from arthritis. Of those 400,000 surgeries, approximately 27% used MoM devices in 2010—down from approximately 40% in 2009. Notwithstanding the decrease in use among practitioners, MoM surgeries present a real danger to patients in need of hip replacement. Unfortunately, the current data supporting high failure rates and adverse health consequences was collected in the UK; the FDA and other U.S. entities are still collecting and analyzing independent data. In response to a proposed future research period of five to ten years, the President of the National Research Center for Women & Families opined,”[k]eeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical . . . . If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
Source: Fox News