The FDA will examine the risks and benefits of metal-on-metal hip implants in a 2-day panel in Maryland tomorrow and Thursday (June 27-28). The agency is convening the meeting of scientific and medical experts in light of evidence that metal-on-metal hip implants fail at a higher rate than implants made of ceramic or plastic. As part of the meeting, the FDA is allotting some time for the public to comment. The panel will discuss failure rates of metal-on-metal hip implants, as well as when and how patients should undergo imaging and ion testing to measure the metal’s effect on surrounding tissue.
More than 500,000 patients in the U.S. have received metal-on-metal hip implants, most of which were implanted between 2003 and 2010.
Lisa McGiffert, campaign director for Consumers Union’s Safe Patient Project and people who have been harmed by metal-on-metal hip implants are attending the panel both to gain and deliver insight on these safety issues. You can view a free webcast of the panel on both days—the links to the webcast are on the FDA website here.
Here’s a mini lesson for those less familiar with metal-on-metal hip implant systems. Metal-on-metal hip implants are medical devices in which the “ball and socket” are both made from metal. Because the metal ball and the metal cup slide against each other during walking or running, metal particles may wear off the device and invade the bloodstream. Metal ions can damage the bone and tissue surrounding the implant and joint. Under these circumstances, patients may have to undergo a painful or difficult revision surgery to remove or replace the implant.
Bloomberg reported last week that FDA had received nearly 16,800 adverse event reports for metal-on-metal hip implants between 2000 and 2011. The most reported problem was revision surgery to remove or replace the implant (14,131 reports) followed by 8,704 reports of pain. It’s clear that too many people have suffered from metal-on-metal hip implants. Behind these unacceptable statistics, the FDA should be mindful of real people’s stories while they hold this important meeting.
Dwight Schrag traveled from his home state of Washington to Maryland to present his wife’s video testimony to the FDA panel. His wife, Mary, received a Johnson & Johnson DePuy ASR metal-on-metal hip implant in 2006 that led to severe health problems and was recalled by the manufacturer in 2010. Dwight is all too familiar with the havoc that metal-on-metal hip implants can wreak and wants to prevent other patients from being harmed. Dwight told us:
“Due to the toxic device’s metal debris and tissue rejection (metallosis) the ASR cup never attached to the bone. My wife had to attach a support belt around to her hips every morning to alleviate pain so she could walk. X-rays didn’t reveal the fact that the implant was not attached. Toxic metal debris did even greater damage to my wife than the implant itself. She developed neurological memory loss, severe heart arrhythmia (heart rate spikes), nerve, tissue, and muscle damage, giant cells formation (fluid sacks) around the metal joint, hearing (tinnitus) and vision loss, foggy memory, depression, severe disabilities due to instability and inability to sleep due to constant pain. My wife has not fully recovered and will be permanently disabled. She cannot walk further than a hundred feet unassisted. Every day she is in severe, ongoing pain due to loss of tissue, muscle and nerve damage in the implant region of her groin. Multiple surgeries were tried to correct the pain during the four year period, causing further disabilities, but none worked. Eventually it became a life or death battle to get the thing out.”
Mary Schrag had to get her implant removed in 2010, just four years after it was first implanted and four months after it was recalled. For people like Mary and Dwight, this FDA panel examining the safety of metal-on-metal hips is far overdue.
According to Dwight, “There’s no possible medical reason to implant something as toxic and harmful as this in a human body. Medical patients are not Guinea Pigs to be experimented upon. It’s an atrocity and human tragedy beyond description.” Dwight’s wife’s story was recently featured in an Associated Press story on the FDA’s meeting.
More than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process where a new device is reviewed for its “substantial equivalence” to devices that are already on the market. This flawed device approval process allows devices like Mary Schrag’s metal-on-metal hip to be sold without clinical testing, and puts future medical device patients at risk.
Consumers Union’s Safe Patient Project has urged lawmakers to require stricter safety testing for all high risk and implantable devices and prohibit recalled devices from being used as the basis for determining substantial equivalence for new devices. However, the final FDA User Fee Bill just passed by the House and Senate doesn’t include these common sense reforms due to heavy lobbying by the medical device industry. On the plus side, the final bill does include a provision that makes it easier for the FDA to re-classify medical devices with a history of harming patients, which may allow the FDA to require stricter testing of subsequent devices of the same type.
In May 2011, the FDA asked metal-on-metal hip implant makers to conduct post-market studies to collect more safety data on these devices, including data related to metal ion concentrations in the bloodstream. But more than a year later, as the New England Journal of Medicine recently reported, “the FDA and manufacturers had reached agreements on study protocols for less than a quarter of the devices, most of the study plans had not been finalized, and it was unclear whether any studies had begun.” The newly passed FDA User Fee Bill will require future studies like this to begin no later than 15 months of being ordered by the FDA. While the FDA waits for these device makers to provide them with new safety data from these studies, more patients will continue to receive these potentially dangerous implants.
This FDA panel examining metal-on-metal hip implants comes after thousands have reported harm. We hope this meeting will prompt the FDA to take stronger action to protect patients. You can follow our live tweets tomorrow and Thursday at @CUsafepatient.