Tag: Injuries

Beware of faulty medical devices
Do not think that the medical device–be it an artificial hip, a pacemaker or mesh–your doctor proposes to implant is safe because the Food and Drug Administration (FDA) has approved its use. As I’ve written before on Just Care, there is a fair chance that you could be at serious risk. Fred Schulte reports for Kaiser Health News on the 28,000 lawsuits against medical device companies for selling faulty products, misleading providers about their products, failing to disclose product defects as required by law, paying physicians illegal kickbacks, and more.

You rarely read or hear about medical device companies, but many are multi-billion dollar businesses. Like pharmaceutical companies, they are operating in a health care market that allows them to charge exorbitant prices for products that sometimes add little value or worse, cause serious harm. Despite the need for a more stringent FDA approval process of certain devices and a registry to ensure awareness of dangerous medical devices, the industry has done a brilliant job of keeping this from happening.

One reason dangerous devices are in use lies with the FDA’s approval procedures. It allows medical device companies to design and distribute many new devices without testing. If they are substantially equivalent to another product already approved, they do not need to go through an approval process. But, the line between substantially equivalent and different enough as to be defective is blurry.

It’s also often hard to know whether a device is safe even though there is a public database that is supposed to store information about faulty medical devices. The problem lies with the FDA, which also keeps a private database of information on medical device malfunctions and injuries that for some reason it does not deem fit for the public database. It literally keeps hundreds of thousands of incident reports secret. Consequently, doctors keep using these dangerous devices–artificial hips, pacemakers, mesh, etc.–on unsuspecting patients.

And, physicians often rely on medical device salespeople when implanting a device. They often work in tandem with medical device salespeople to learn about them. While that might make sense in theory, it can be harmful to patients if the physician is not super sure of what he or she is doing. The sales reps are not legally required to have medical training or credentials.

In one case, a surgeon relied on a Life Spine rep’s assurance that the surgeon would have the implants he needed mid-surgery to address a spinal issue, but he did not. The patient is claiming that, as a result, the surgeon implanted the wrong device and she suffered physical harm. Meanwhile, Life Spine, the sales rep and the surgeon are pointing fingers at one another, refusing to take responsibility for the harm.

It’s still not possible to do the needed research to determine the frequency with which implants cause harm or which implants are dangerous. It’s also not possible to know which implants are the safest. A public FDA website at which reports of serious injuries from a medical device are posted has the following caveat: It could include “incomplete, inaccurate, untimely, unverified, or biased data.”

Now, six multi-district federal cases have consolidated the more than 28,000 patient suits charging that medical devices caused injuries. For the health and safety of Americans, the federal government should be putting in place a smart and wholly transparent way to track injuries, a more robust approval process for devices, and a means of removing defective products from the market swiftly.

Here’s more from Just Care:
August 10, 2021
How to avoid unintentional injuries
As we age, the risk of unintentional injuries rises. A new Centers for Disease Control study looks specifically at unintentional injuries among older adults. Older people can and should take precautions to help prevent avoidable injuries.

Each year, about 60,000 older adults die from unintentional injuries. In 2019, the majority of them, 34,000, died from falls. About 8,000, 13 percent, died from motor vehicle accidents. A tiny fraction, 3,000, died from accidental drug overdose or poisoning.

On top of that, an even larger number of older adults experience unintentional non-deadly injuries, with grave health consequences. They might experience severe brain injury and inability to care for themselves.

In 2018, 2.4 million older adults visited the emergency room. More than 700,000 of them ended up hospitalized. More than 90 percent of those visits were caused by falls.

Women are more prone than men to experience an unintentional injury. They are more likely to end up in the emergency department and to be hospitalized for a fall than men. But, men are more likely to die from an unintentional fall.

The likelihood of falling increases with age, with one in four older adults falling each year. But, the likelihood of being in a motor-vehicle crash declines. The researchers posit that people tend to drive less as they age.

You can prevent these unintentional injuries. Falls do not have to be part of aging. Talk to your doctor.

Sometimes, exercise to improve balance and strengthen muscles can make all the difference between suffering from an unintentional injury and not. Physical therapy visits can also help; Medicare covers medically necessary physical therapy. Eye exams, which Medicare generally does not cover, can detect and correct poor vision. Good vision can help in preventing avoidable injuries.

Your doctor should also check your feet at least once a year to ensure you have the right footwear to minimize your risk of falling. Medication reductions can also help, particularly reducing use of benzodiazepines, opioids and anti-depressants.

Visit this Just Care post to learn how to make your home safer.

Here’s more from Just Care:
May 10, 2021
What are the most common injuries in U.S.?

Amino, Inc. a health care data insights firm, looked at 244 million claims in its database between 2012 and 2016 to determine the most common injuries in the U.S. for which people receive medical attention. As it turns out, almost one in six doctor visits include a physical injury diagnosis. Amino also identified different predominant injuries in different states, ones that are disproportionately frequent.

No matter which state you live in, having an “open wound”–essentially a cut–and “bruising” are the two most frequent injuries for which people receive medical attention. Colorado is the one exception, with falls as its most common injury. Curiously, bruises rank at the top in the northeast, south, California and Oregon and open wounds rank at the top everywhere else. You’re left wondering what explains this difference and whether this difference is more about doctor labeling than anything meaningful.

Behind open wounds and bruising, injuries that are disproportionately frequent in different states vary widely. Some of the variation is easier to understand than other variation. In Idaho, Utah, Wyoming, Colorado, New Mexico and Nevada, suffocation is more common, perhaps because they are mountain states, and suffocation is related to oxygen deficiency. People in Hawaii tend to have a higher incidence of near-drowning diagnoses. Nebraska, Wyoming, Montana are a few of the states with a higher than normal proportion of “animal-drawn vehicle accident” diagnoses. New York residents are more likely than people in other states to get treatment related to an “unarmed fight or brawl.”

Who knows why, but motor vehicle accidents are more common in Tennessee, Arizona and California than in other states. Head injuries are more common in Florida. People in Massachusetts have disproportionately more concussions.

February 14, 2017