Why Does the FDA Allow So Many Dangerous Medical Devices to Be Sold?
Last month, the Food and Drug Administration (FDA) put a halt to the sale of pelvic mesh devices, citing its own inability to predict the devices’ safety and functionality in the long-term. The problem is pelvic mesh devices like those halted have been available on the medical market for decades, and practically countless people have already suffered health complications because of them, and at least 80 people have died due to complications. It raises the questions as to why the FDA took so long to recognize their dangers and why they ever allowed them for widespread sale if they never confidently knew their long-term safety.
Unfortunately, this question does not loom over pelvic mesh devices only. This is only one of many incidents in which it seems the FDA has negligently let a defective or dangerous medical device sit on the market for years and years. In a quite recent example, the FDA chose not to ban a breast implant that has been linked to a rare cancer called breast implant associated anaplastic large cell lymphoma (BIA-ALCL), or just breast implant illness. The Administration has seemingly set aside medical research and expert testimonies that urge the ban of certain types of breast implants – but why?
Again, citing breast implant complications and illnesses is only the smallest glimpse at the full scale of the problem. According to the International Consortium of Investigative Journals, who studied reports of defective medical devices the world over, more than 80,000 people have died and nearly 2 million more were injured by a defective medical device between 2007 and 2017. To put that into different terms, that equates to more than 20 deaths and about 550 injuries a day.
It all once again begs the question: “Why has the FDA failed so often to catch or ban dangerous medical devices?”
“Similar” Products May Require No Testing
The first cause – of what is likely many – of the FDA’s apparent failings is a bizarre loophole that lets medical device manufacturers to sidestep product testing if they have made a new product that is “similar” to a preexisting one that was approved. All sorts of medical devices can use this detour, too, including those meant to stay in a patient indefinitely. Several years ago, the Institute of Medicine actually told the FDA to close up these similar product loopholes, but the agency did not.
Products on the Market “Disappear”
When a medical device is brought to the market for sale and patient use, the product manufacturer and the FDA are still supposed to keep close tabs on how it is performing. However, and predictably, this is often not exactly the case.
A medical device that reaches the market tends to “disappear” shortly after as new products roll in, distracting from those that came before. In other cases, medical providers are not given accurate tools to report on how their patients are reacting to a medical device, or they simply do not know they should be looking for unreported side effects. Furthermore, some product manufacturers have gone out of their way to conceal injury and malfunction reports, undermining what efforts the FDA had been making to track problems.
An Industry That “Regulates” Itself
Perhaps the most glaring issue with the FDA and why dangerous medical devices are so common is that the medical device industry is practically regulating itself – or not – due to its close ties with the FDA. Approximately one-third of FDA funding actually comes from medical device manufacturers and Big Pharma. The funds are not being provided for nothing in exchange, though. The FDA will only keep getting funding from the medical device industry if it upholds its promise to “approve devices with as little delay as possible.” With manufacturers having such an influence on the FDA, can we really act shocked when we discover that inspections and regulations met less than the utmost safety standards?
Medical device manufacturers aren’t just paying to keep the lights on at the FDA, either. They are also lobbying Congress tenaciously, spending about $30 million each year in lobbying efforts. It is a smart move on their part, too. The FDA is largely dependent on Congressional decisions, so padding pockets in the Capitol Building is a logical place for them to build their foundation.
(You can learn more about the problem of the FDA failing to catch and control dangerous medical devices by clicking here and reading a recent opinion piece posted by The New York Times.)
Decof, Barry, Mega & Quinn Stands for Justice & The People
As it is now, the unfortunate truth is that we cannot fully rely on the FDA to protect us from dangerously defective or faultily designed medical devices. Therefore, when an injury, illness, or wrongful death does occur, you should turn to a team of personal injury, product liability, and medical malpractice attorneys you can trust to do what is always in your best interests. At Decof, Barry, Mega & Quinn, we are proud to be the name the people of Rhode Island turn to when they need legal guidance and moral support. Since 1975, we have been taking legal fights to defendants of all strengths and sizes for people just like you, accruing more than $1 billion in recoveries for our clients across the years.
If you or a loved one were hurt due to a defective medical device, call our Rhode Island defective medical device attorneys at (401) 200-4059 to arrange an initial case evaluation.