Medical devices have been in existence long before modern medical science came into practice. The first-ever recorded use of medical devices dates back to the Neolithic Age (7000 BC) in the form of flint-tipped dental drills.
During the ancient ages, there were scarcely any regulatory measures involved before a medical device was used by healthcare providers. Today, the scenario is completely different. A regulatory body called the Food and Drug Administration, or FDA is responsible for ensuring the safety and effectiveness of medical devices.
Essentially, this agency (a part of the Department of Health and Human Services or HHS) gave the FDA the charge to carry out trials before a new medical device entered the market. However, this is a double-edged sword mainly because it is commonplace to find unsafe devices.
In this article, we will discuss whether a loophole in the FDA approval process is behind the commercialization of defective/dangerous medical devices.
FDA Regulation of Medical Devices
All the regulations involved in the approval process of medical devices can be found in the Federal Register (FR). This register defines the level of control exercised by the FDA over individual medical devices and the regulatory requirements for each.
First, every medical device manufacturer needs to ensure that their product matches the definition of a medical device (as described under Section 201(h)). If yes, their device will be assessed based on the US Federal Food, Drug, and Cosmetic Act (FD&C) of 1938.
This Act allows the FDA to oversee the safety of drugs, food products, cosmetics, and medical devices. The device will be tested on humans for its safety and efficacy. The regulatory body’s review teams will verify all data submitted by the manufacturer before giving a verdict for approval or rejection.
Besides the product’s safety and efficacy, the FDA regulates the packaging and post-market surveillance. This means every medical device manufacturer must reveal all information regarding the product’s side effects and complications.
If new risks are discovered during post-market clinical trials, the FDA must be notified of those too. The FDA review team includes medical officers, project managers, pharmacologists, statisticians, chemists, and microbiologists.
FDA’s approval for substantiate review begins after the device manufacturer submits their acceptance application. Then, the clinical trial process begins. The standard review time is 10 months, but the approval may be granted within six months of conducting clinical trials.
The Limits Involved in FDA Control
When a medical device is approved by the FDA, it means that the said device’s substantiated review has been conducted. After review, it was found that the device fulfilled all of the claims made in the acceptance application.
However, there are certain risks and limits involved. In other words, some devices are approved by the agency after which major complications come to light. In many cases, the sad discovery is also made that the device manufacturer was aware of the complications all along. Yet, they chose to keep them a secret from the public (even healthcare providers).
One example would be that of the Paragard intrauterine device or IUD. This device was commercialized in 1988 and is the only FDA-approved copper-based IUD. It works on the principles of generating an immune response within the body. The copper released through the device makes it extremely difficult for a sperm to fertilize an egg.
The device’s manufacturers, Teva Pharmaceuticals and Cooper Surgical, claimed that the Paragard IUD could prevent conception for 10 years. Did the FDA find the device to be effective? Yes, but many women suffered major complications at the time of device removal.
According to TorHoerman Law, these complications included device breakage and migration, infection, infertility, organ perforation, and pain/discomfort. Women with such injuries required surgical interventions (though the Paragard IUD is a non-surgical device).
This is why the victims started filing a Paragard lawsuit against the manufacturers. Later, it was found that the defendants were aware of the design defects but failed to address them. Additionally, no warning was issued to the public or healthcare providers. Currently, over 2,400 lawsuits are awaiting settlements.
The first Bellwether trials in this litigation are about to be held in 2024. After the trial is over, the plaintiff’s counsel will have a better idea of individual settlement amounts. On average, it is estimated that the payouts will range between $10,000 and $400,000.
The Paragard IUD case is just one among numerous cases where the medical device’s complications are discovered after the FDA approval process has taken place. The agency’s purview has its limits – it can conduct a recall after post-market surveillance but the process often comes at the cost of individuals’ health (sometimes lives).
Recent Cases of Loopholes in the Approval Process
The limitations of the FDA may have deadly consequences, but they’re not the loophole we’re talking about. Recently, a study conducted by Yale University found that manufacturers have found a way to have their unsafe medical devices enter the market.
This has to do with the fact that most FDA approvals are based on device similarity. In other words, if a new device is more or less similar to the ones already available, the manufacturer is allowed to bypass the clinical testing procedure. They are approved based on previous trials.
The shocking discovery this study made was that some of these new devices shared similarities with those that have been recalled. If a device was approved based on a previously recalled device, the chances of the new device being recalled (under Class I) increased 6x.
This meant the new devices could have serious consequences from the viewpoint of patient safety and health. In the final analysis, was the regulatory body’s review team aware of such loopholes? The Yale researchers found that they were aware of this problem for years. Simply illustrating the effects of such an issue will not offer any concrete solution.
This loophole requires action on the part of the Congress. The research team concluded that this is not an FDA issue, but one that concerns the laws governing the FDA’s actions.