Holly Kelly Ennis
FDA Holds Panel Hearing Regarding Problems with Metal Implants
On November 13-14, 2019, the FDA Immunology Device Panel of the Medical Devices Advisory Committee held a two day meeting to discuss the adverse events relating to metal-containing implants, including metal hip components, the Essure device and spinal fusion implants. The panel heard from over 50 presenters including physicians, patients harmed by metal-containing medical devices, as well as from industry touting the safety of their products. The purpose of the meeting was to discuss the risks of immunological responses to metal placed in the body. Although it is claimed that adverse reactions affect only a minority of implant patients, millions of metal-containing medical devices are implanted into patients. Accordingly, this "minority" represents hundreds of thousands of patients. The devastating damage can include severe pain, neurological damage, cognitive impairments and autoimmune disease. Additionally, there is little scientific research on autoimmune and allergic responses to metal-containing implants.
The hearing lasted two days, the first day focusing on metal-containing implants surgically implanted and the second day on dental implants. Both patients and physicians strongly urged the FDA to require implant manufacturers to fully disclose all of the components used in medical devices so that patients and physicians have a full and complete understanding of what is to be often permanently implanted in the body. Physicians will be better able to screen for potential allergeric and immunological responses in patients with certain metal sensitivites and can make appropriate implant decisions accordingly. Patients also strongly urged that device labels disclose the risks associated with metals, and to require manufacturers to send letters to physicians nationwide alerting them to the threat of adverse reactions to metal.
Some of the most impactful testimony came from Dr. Steven Tower, the orthopedic surgeon featured in the Netflix documntary, The Bleeding Edge. Dr. Tower suffered from a failed hip implant sustaining severe necrosis of the tissue surrounding his implant as well as severe cobalt poisoning, causing neurological issues. Tower testified that the problem is not just limited to metal-on-metal hip implants but can occur with many popular hip designs as well as other implants. He said the hip implant patient's symptoms closely resemble the problems suffered by thousands of women implanted with the Essure sterilization device, which was removed from the market following thousands of adverse event reports and lawsuits related to its complications. Tower sharply criticized the FDA for its prior handling of hip implants, charging that the agency has been, "asleep at the switch" and had put the interests of industry over patient safety. Madris Tomes, an expert on FDA adverse event reports, testified that metal-on-metal hips were by far the most common cited product concerning immune and allergic reactions to devices, followed most frequently by the Essure device. Sue Francis, a ceramic-on-polymer hip implant recipient pleaded with the FDA to enforce strict labeling of metal composition in medical devices with additional labeling for device coatings, which can also trigger allergic or autoimmune responses. "Doctors need to know what they're putting in patients," she said. "Protect us, the patients and the doctors, and do not be complicit in the manufacturer's incomplete labeling," she implored the FDA panel.
The FDA panel's general charge or task is to examine risks associated with an increasing number of implant devices, espeically hip and other joint replacement devices. Although reactions to these devices are claimed to be proportionately rare, the sheer volume of hip, knee, cardiac and other surgically implanted devices is on the rise, thus contibuting to an increasing potential for injury. The FDA is notoriously slow to action. In 2012 the FDA held a two-day advisory committee meeting to address failure rates from metal-on-metal hips implants, which led to a restriction on these products. However, since metal-on-metal hips represent just one type device which can cause the allergic and autoimmune responses, we are truly no further along than we were 7 years ago at this time. According to Aron Yustein, the FDA hopes the knowledge gained can be used to help mitigate potential risks by allowing for more informed patient selection and follow-up, including new diagnsotic tests, designs and adaption. However, it remains unclear how this new knowledge will be obtained. Currently, most testing is inadequate to identify a patient at risk for an allergic or immune reaction prior to be implanted. Because so much remains unkown about the reason for adverse reactions to implants, the panel found it difficult to give the FDA any more clarity regarding the utility of available diagnositc and prognostice tests for pre-and post-procedural patient assesment and managment.
Following the two day meeting, it is imperative that all packaging for medical implants must list the specific elemental compositons of each device. It is absolutely essential that physicians and patients have a clear and complete understanding of what specific materials are being implanted and the risk factors this imposes on each individual patient. Patients also demanded that letters be sent to physicians nationwide explaining the potential risks and injuries associated with metal implants so that physicians will be educated and can more quickly recognize and address adverse reactions relating to a metal implants. Further, it is essental that adequate allergic or immune response testing be performed pre-operatively to assess a patients's risk for a heightened or prolonged response to a metal implant. The Panel should have its official recommendations made public in the next few months. Patients should file their comments and recommendations to the Public Docket to be reviewed by the Panel, no later than December 16, 2019 at: https://www.regulations.gov/docket?D=FDA-2019-N-3767.