Dozens of dangerous medical devices are released on the market every year by unscrupulous manufacturers who care only about their profit. The main loophole used to bypass the vigilant eyes of the Food and Drug Administration (FDA), is the infamous Premarket Notification [510(k)]. This process is often used to rapidly grant approval to a product by providing evidence that establishes a set of similarities to another one currently marketed. However, some inherent flaws in this accelerated pathway let many dangerous or defective devices slip through the cracks, jeopardizing the safety of many U.S. citizens.

What is FDA 510(k) Fast Track Program and why it is dangerous?

The FDA approves many high-risk medical devices through a fast-track Premarket Approval (PMA) pathway known as the Premarket Notification 510(k). Simply known as “the 510k, this process is a premarketing submission used to demonstrate that the device is safe and effective enough to be marketed without further testing. It shortens the time it takes before the instrument is released to the public, and it shares many similarities with the process used to approve generic medications.

However, this fast-track process is often abused by many deceitful companies who want to skip the many complex clinical trials they are required to plan before a product is approved. The 510(k) regulatory pathway is, in fact, used to bypass the long testing phases whenever a medical device is “substantially equivalent” to others already found on the market. Only the first device, known as the “primary predicate,” requires being coupled with substantial evidence about its safety before it receives FDA’s clearance. All the others can just jump on the winner’s bandwagon to avoid undergoing more rigorous testing.

Another major issue with this shortened pathway is the fact that once a medical device is approved, it is very hard to remove it from the market. If a primary predicate is, in fact, recalled there’s a significant chance that the other products that have been approved because of their proven similarities could be harmful as well. However, each medical instrument and brand is dealt with separately, and may still stay on the market for an indefinite amount of time regardless of its dangerousness.

A brief history of the Premarket Notification 510(k)

In the wake of a scandal that saw many women die after using a defective contraceptive device, in 1976 the Congress expanded the FDA’s authority. Specific laws were passed to include the oversight of medical devices which were now classified in the actual three-tiered class system, and the PMA process was enacted. In order to speed up the approval of certain instruments used in clinical practice, the fast-track 510k pathway was also introduced. This process aimed at offering the American public a good compromise between consumer access and patient safety. The idea was to rapidly provide a response to the many medical concerns that lacked a proper treatment option, with cutting-edge medical care. When it was originally conceived, however, the 510k was thought to be used just for non-critical medical tools used in everyday practice such as surgical gloves, thermometers or bandages.

Starting in the early 2000s, a vast deregulation era ended up with the FDA granting approval to almost every product through the fast-track PMN process, giving birth to many controversies. In its 2011 Consensus Report, the prestigious Institute of Medicine (IOM) expressed its concerns over the entire device regulatory system and concluded that the FDA should overhaul it to ensure proper patients’ safety. A study brought to the attention of the Congress showed, in fact, that, among all the Class I devices recalled between 2005 and 2009, 71 percent of them received clearance through the 510k pathway. After an in-depth investigation in which they reviewed 35 years of documented 510(k) approvals, researchers from the IOM recommended the FDA to abandon this process and switch to the more reliable Federal Food, Drug, and Cosmetic Act (FFDCA).

After many years of debate, in 2014, the FDA issued a somewhat negligible change to the 510(k) guidelines and removed the option to give approval to the so-called “split-predicate” devices. Some instruments may have the same technological features of a predicate device, while the intended use of a different one. In these instances, a manufacturer could try to receive clearance by submitting it as a split-predicate product. This option has been now eliminated as it is “inconsistent” with the approval process, although companies who want to market a device for more than one use can still use multiple similar predicate devices to prove its substantial equivalence. But is the current process really effective in supporting public health? Although their goal was to promote clinical innovation, are the policymakers and regulatory agencies adequately protecting the patients’ safety?

The three medical device Classes

Not all devices could be approved trough the 510k, though. Only those products that are classified as either Class I and II can, in fact, skip the more rigid controls required to provide clearance to the Class III medical devices. This last category includes all those instruments who pose the highest risk for the patient’s health, such as pacemakers or drug-eluting coronary stents. Note that, to date, an impressive 90 percent of total devices are associated with an allegedly low-to-moderate risk and are thus defined as Class I or II. However, recent experiences taught us a very hard lesson about the potentially catastrophic consequences of a poorly tested medical device classified in one of these two categories.

In 1996, the U.S. Supreme Court observed that the regulatory agency usually spent more than 1,200 hours on every PMA request, compared to an average of just 20 hours for each 510(k) submission. The Court obviously concluded that the 510(k) was a significantly less rigorous safety testing, but what about the so-called “dangerous” Class III devices? According to a study published in 2015 in the Journal of American Medical Association (JAMA), for 28 high-risk devices, the FDA only issued 33 studies to grant its approval. But to make things even worse, only 13 percent of these studies reached completion between 3 and 5 years after the device got clearance. The Yale University researchers suggested that the evidence required to prove a device’s safety and effectiveness seemingly shifted from premarket to continual studies that are performed through the entire product life cycle, like an endless experiment on actual patients, regardless of potential risks.

Dangerous medical devices – consequences and famous cases

If a device is not properly tested or it’s not safe enough to be used, the patients may suffer horrifying consequences. Among the most famous cases, the defective Stryker and DePuy hip replacement corroded and broke causing heavy metal poisoning (metallosis) in about 6,000 subjects out of the 15,000 who received an implant between 2010 and 2012. The titanium-made metal-on-metal hips received FDA clearance without any additional clinical testing since, again, the “substantial equivalence” to earlier devices seemed sufficient to the regulators.

After receiving more than 3,000 adverse reaction reports in just two years, in 2011 the regulatory agency issued a systematic review to assess the dangerousness of the transvaginal meshes used for bladder support and prolapse repair. Eventually, the FDA’s investigators concluded that the medical device originally labeled as a “moderate risk” one, was linked with serious complications such as mesh erosion, organ perforation, chronic infections and other forms of permanent damage.

REFERENCES

  1. Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. 2015;314(6):604-612. doi:10.1001/jama.2015.8761.
  2. David Voreacos and Jef Feeley. November 3, 2014. Stryker to Pay More Than $1 Billion for Recalled Devices.
  3. Prime M, et al. The National Joint Registry of England and Wales. 1; 34: 107-110. doi: 10.3928/01477447-20101221-2
  4. Supreme Court of the United States, in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
  5. S. Food and Drug Administration (FDA). Overview of Medical Device Classification and Reclassification. www.fda.org. (Accessed November 2016)
  6. S. Food and Drug Administration (FDA). 510(k) Clearances. www.fda.org. (Accessed October 2016)
  7. S. Food and Drug Administration (FDA). 510(k) Submission Process. www.fda.org. (Accessed November 2016)
  8. S. Food and Drug Administration (FDA). UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication. www.fda.org. (Accessed September 2016)
  9. Institute of Medicine of the National Academies. (July 2011). Medical Devices and the Public’s Health. The FDA 510(k) Clearance Process at 35 Years. (Accessed November 2016)
  10. United States Government Accountability Office (GAO). (June 2011). Report to Congressional Requesters MEDICAL DEVICES. FDA Should Enhance Its Oversight of Recalls. (GAO-11-468).
  11. Ehrenreich B., Minkin S., Dowie M. The Charge: Gynocide. The Accused: The U.S. Government. Mother Jones, November / December 1979 issue.
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Dr. Claudio Butticè, Pharm.D., is a clinical and hospital pharmacist who worked for several large public hospitals in Southern Italy, as well as for the humanitarian NGO Emergency. He is an accomplished medical writer who wrote as an author in several encyclopedias, including The SAGE Encyclopedia of Cancer and Society (2015), The SAGE Encyclopedia of World Poverty (2015), ABC-CLIO Encyclopedia of Science and Technology (in press), and other sociology and anthropology reference textbooks. He’s also a medical writer and journalist who wrote for online magazines such as The Ring Of Fire, Digital Journal, Business Insider and Techopedia. Dr. Butticè holds a Master’s degree in Pharmacy from the University of Palermo.