A coalition of patient, consumer, and public health groups urged the FDA today to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold. The FDA recently announced that it granted approval for the new device after a small study of only 10 women and 144 men, under a process that is not as rigorous as the process the law requires for devices that are life-saving or life-sustaining.
In a letter to FDA Commissioner Margaret Hamburg, the groups maintain that the device should have been classified as high risk and subject to stricter testing because it is implantable and life sustaining, and would result in serious injury or death if it doesn't work correctly. The medical device in question is the endovascular suturing system, which is used in patients who have experienced complications following an endovascular graft used to treat aneurysms.
"This decision by FDA sets a bad precedent for approving new devices," said Lisa McGiffert, Director of Consumers Union's Safe Patient Project. "Medical devices intended to save lives should require the FDA's most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands of patients at risk of serious harm, similar to what we have seen with recalled metal hips and surgical mesh." By law, high-risk devices are supposed to be reviewed through the FDA's premarket approval (PMA) process, which requires a comprehensive evaluation, including scientific clinical studies, to ensure the device's safety and effectiveness. However, the FDA reviewed the device under the de novo process, which is intended for low and moderate risk medical devices that are not substantially similar to devices already on the market. The de novo process is not as rigorous as the process the law requires for devices that are life-saving or life-sustaining.
The FDA has been criticized by public health experts and consumer advocates because many medical devices have been recalled as potentially lethal after having been approved by the FDA without scientific clinical trials proving that the devices were safe or effective. In a scathing report issued last summer, the well-respected Institute of Medicine (IOM) urged the FDA to trash its current system, which approves more than 95% of medical devices on the basis that they are "substantially equivalent" to older medical products on the market. The IOM urged the FDA to instead require all devices to be proven safe and effective, and to rely more on a rarely used "de novo process" for determining the safety and effectiveness of devices that are low or moderate risk. The PMA process was to continue to be used for high-risk devices.
"FDA has responded to the Institute of Medicine's recommendation by starting to beef up the de novo process, but instead of selecting a moderate risk device, as the law requires, the FDA inappropriately used the de novo review process for a device that is obviously intended to save lives. To get around the law, the FDA is claiming that the product is not life-saving and therefore does not need to be tested by rigorous clinical trials and inspections, as is required for life-saving devices," explains Dr. Diana Zuckerman, president of the National Research Center for Women & Families.
The Coalition letter asks the FDA Commissioner to rescind the agency's approval of this product and instead require it to be reviewed through the more rigorous Premarket Approval (PMA) Process. In addition, it asks that the Commissioner "provide an explanation of how these devices, which repair an aortic endograft, do not satisfy the criteria that the FDA sets for high-risk devices that they "sustain or support life, are implanted, or present potential unreasonable risk of illness or injury" if it were to fail.
A complete copy of the patient safety coalition's letter follows: February 29, 2012 Margaret A. Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Dear Commissioner Hamburg, We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the use of the de novo process for high-risk medical devices.
We have previously expressed our strong concerns about the low standards of the 510(k) premarket clearance process for medical devices. Although intended for low- and moderate-risk devices, too many devices that are high-risk are cleared through the 510(k) process and later found to cause life-threatening adverse events. The law requires that class III medical devices for which general and special controls cannot provide reasonable assurance of safety and effectiveness be reviewed through the premarket approval (PMA) process. The Food and Drug Administration (FDA) defines Class III devices as those that "sustain or support life, are implanted, or present potential unreasonable risk of illness or injury."http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm.
Nevertheless, we have documented numerous examples where such devices were reviewed under the less stringent 510(k) process.
Very few devices go through the de novo process, which is intended for moderate-risk devices found to be not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or to a device which was subsequently reclassified into class I or class II. We agree with the Institute of Medicine that the de novo process makes more sense than the 510(k) process for some moderate-risk devices. However, the Center for Devices and Radiological Health has announced its approval under the de novo process of an endovascular suturing system "used in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion."http://www.accessdata.fda.gov/cdrh_docs/reviews/K102333.pdf.
The endovascular suturing system, which was categorized as a class III device and is intended for the repair of aortic endografts, is obviously a permanent implantable device that is intended for a life-sustaining purpose, for which general and special controls would not provide reasonable assurance of safety and effectiveness. It is a clear example of a medical device that should be reviewed under the PMA process. It is not in the interests of public health that the FDA is planning to reclassify this product as class II through the de novo process, thus bypassing the PMA process. While the "special controls" applied through the de novo process are more rigorous than the standards for clearance through the 510(k) process, they are considerably less stringent than the PMA process and fail to provide a reasonable assurance of the safety and effectiveness of this high-risk device.
Finally, we note that the limited clinical testing of the endovascular suturing system was inadequate to prove the safety or efficacy of this implanted device for most patients, since it included only 10 women (and 144 men), no comparison control group, and only one year of follow-up. (No information about racial or ethnic diversity is publicly available).
Therefore, we urge the FDA to rescind its final rule (21 CFR Part 870) classifying the endovascular suturing system into class II (special controls) and instead require a PMA application for this device with more rigorous clinical testing. In addition, we ask that you provide an explanation of how these devices, which repair an aortic endograft, do not satisfy the criteria that the FDA sets for high-risk devices that they "sustain or support life, are implanted, or present potential unreasonable risk of illness or injury" if it were to fail.
Thank you for considering our comments and responding to our inquiry in this very important matter.
Sincerely, American Medical Women's Association Center for Medical Consumers Community Access National Network Consumers Union Jacobs Institute of Women' Health National Consumers League National Research Center for Women & Families / Cancer Prevention and Treatment Fund National Women's Health Network Our Bodies Ourselves Public Citizen U.S. PIRG WoodyMatters Cc: Dr. Jeffrey Shuren The Honorable Tom Harkin The Honorable Herb Kohl The Honorable Michael Enzi The Honorable Henry Waxman The Honorable Rosa DeLauro SOURCE Consumers Union -0- 02/29/2012 CO: Consumers Union ST: District of Columbia IN: HEA MEQ SU: AVO EXE PRN -- DC61941 -- 0000 02/29/2012 15:56:20 EDT http://www.prnewswire.c