After a handful of medical device manufacturers shelled out $8 billion in damages for over 100,000 women worldwide who claim they were injured by faulty vaginal mesh implants, many members of the public started wondering how many more patients got injuries from defective medical devices but their case never went to trial.
With over 1.7 million injuries and 83,000 deaths tied to defective medical devices every year, the global numbers must be so high that one can deem injuries caused by medical devices a worldwide “epidemic.”
Even in the United States, not all medical device injuries make it to the National Electronic Injury Surveillance System (NEISS), which gets the data from emergency departments’ ‘adverse event’ reports at a select number of hospitals. Since experts believe that the numbers may be four times higher than what’s officially reported, medical device injuries are now considered an “underrecognized public health problem.”
The situation is even more dire in the developing world where no such reporting systems are set in place. For instance, in Asia, Africa, and South America, there is little to no oversight of these devices as authorities prefer to leave that task to their European counterparts or the US Food and Drug Administration (FDA).
Very Sobering Findings
According to the first global investigation into medical device harm, governments worldwide have failed to protect millions of patients from serious harm and injury through lax oversight and controversial testing standards vouched by a multi-billion dollar industry.
The International Consortium of Investigative Journalists, which is behind the investigation, found that in most parts of the world, medical implants, even the most complex ones, need to meet lower safety testing standards than regular drugs do to be approved for a market. Patients who were maimed or severely injured by faulty devices claim that no one had warned them of the risks.
Investigators believe that chief reason that has led to this situation is device makers’ profits. When one country rejects their offer or force them to recall their products, they just move on to the next. The industry also spends billions of dollars on lobbying efforts to get regulators to approve their products faster and with little disregard of international safety standards.
It is estimated that medical device manufacturers have collectively spent billions to put a lid on scandals about their faulty products, fraud, and corruption. For instance, Johnson & Johnson has so far paid $4.3 billion and counting to U.S. patients who claim that they were severely injured by the drug maker’s defective surgical staplers, hips, and mesh implants.
Most Dangerous Medical Devices
The most dangerous medical devices that have so far hurt or put the life at risk of millions of people include:
- Mesh implants: Over 100,000 women have sued transvaginal mesh implant makers for sustained injuries caused by faulty medical devices and won; Tens of thousands more might be crippled by mesh-related complications and not even know it .
- Replacement hips: Faulty hip replacements from Johnson & Johnson have been linked to complications and even poisoning of thousands of users. Over 500,000 patients had had these devices implanted before the products were massively recalled.
- Cardiovascular devices: Although cardiovascular devices account for 32% of adverse effects by therapeutic area, the investigative process into these products’ failure is less transparent and robust than the investigation of plane crashes because of the industry’s lack of transparency. Around 350,000 faulty defibrillators were implanted into patients before being recalled worldwide due to serious battery issues in 2016.
You can check out the link for a laundry list of medical devices that often have cases brought against them. When you believe that you were injured by a faulty medical device, if there’s one such mass tort case, you no longer have to prove that the device was defective. You’ll only have to bring evidence of your injuries and causation to get full compensation.
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