For many people, the decision to use a medical device as treatment for a debilitating condition is a no-brainer. After all, these devices have been approved by the Food and Drug Administration; what could go wrong? Sadly, hundreds of thousands of patients have been disappointed by a flawed regulatory system that rushes medical products onto the market without sufficient oversight. In Georgia, a woman named Doris Jones found herself at death’s door when a medical scan at the emergency room found a broken IVC Filter clogging her arteries. That filter was meant to soothe her ailment; instead, it nearly killed her.
Jones and 3,000 other patients filed separate lawsuits against Bard, the manufacturer. Those lawsuits have since been consolidated into a multi-district litigation (or MDL) in Arizona. Around the country, hundreds of thousands of people have filed lawsuits for injuries caused by defective medical devices that have been rushed onto the market without sufficient clinical testing.
Over 100,000 Composix Kugel mesh patches – manufactured by a subsidiary of Bard and used to treat ventral hernias – have been recalled after at least one person died due to a broken memory coil ring.
That’s not to mention that more than 20,000 lawsuits pertaining to defective transvaginal mesh devices have been consolidated in West Virginia. And in Arizona, hundreds of hernia mesh implant lawsuits are filed on a weekly basis due to the product’s tendency to meld with the flesh.
Nonetheless, the FDA has been devolving its regulatory capacity, favoring a laxer system. A recent report found that more medical devices were released onto the market in the first quarter of 2018 than in any other quarter going back to 2005. The agency recently exempted five different devices from regulatory oversight. Those devices are:
- Specific home genetic tests
- Sex therapy vibrators
- A basin for an endoscope disinfectant
- Certain mass spectrometry tests
- An ultraviolet water purifier
And last month, the FDA reiterated its devotion to the “least burdensome” regulations for medical device manufacturers, saying that it would not require certain risky devices to undergo human testing prior to being sold on the market. The agency proposed instead a data mining program that would allow regulators to actively surveil medical records. This, the FDA suggests, will allow the agency to determine levels of risk more efficiently.
The FDA, under current statutes, is permitted to exempt devices deemed less risky. The result: in July, 2017, nearly 1,000 devices were exempted. Once exempted, these products don’t have to go through the premarket notification process, otherwise known as 510(k). Most products (specifically those classified as Class II devices) go through the 510(k) process, which requires companies to show that the device in question is “substantially equivalent” to other products already on the market. Manufacturers can thus bypass all clinical trials. In other words, they don’t have to prove empirically that the particular device is safe.
Dr. Jeffrey Shuren, the director of the Center for Radiological Devices and Health at the FDA, said the following: “The system for the most part works fairly well.” He continued, “[B]ut that does not discount the importance about being vigilant about addressing safety issues particularly as technologies continue to evolve.”
Diana Zuckerman, a public health advocate at the National Center for Health Research, suspended her judgement: “The fact that the FDA is now going to change the process — on the one hand it’s terrible so maybe any change is for the better. But the track record over there is not good.” She added, “The devil is in the details.”
The Institute of Medicine has called the 510(k) process “the weakest and most nonsensical program in the FDA.” And in a 2017 report, the Government Accountability Office (GAO) placed, once again, the FDA’s oversight of medical equipment on a High-Risk List – the FDA has been on the list since 2009. In addition, the Department of Health and Human Services Office of Inspector General has designated the FDA’s oversight programs as one of the top 10 management challenges.
If the FDA doesn’t change its tune on regulations, medical devices will probably continue to fail, costing people their livelihood and in some cases their lives.