Medical products are designed to save lives, but each year in the United States, thousands of drugs and medical devices are recalled. Here are a few cases that might surprise you.
Medtronic Minimed Insulin Pumps
There are approximately 1.45 million men, women, and children in the United States with Type 1 diabetes, and nearly 330,000 of these people use insulin pumps to regulate their blood sugar. In 2020, insulin pumps created by the company Medtronic were recalled after causing over 2,000 injuries and one death. The medical devices were recalled after an issue was found with the retainer ring meant to hold the product’s insulin cartridges.
Many of the devices that were distributed across the United States had a retainer ring that was broken or missing completely. This piece of the device was meant to regulate the amount of insulin that was delivered to the body, so, as a result, many devices ended up either giving patients too much or too little insulin, with resulted in many people having severe reactions. The company ended up fixing the issue and continuing production of their insulin pumps.
Believe it or not, this common drug was recalled in 1982, not because of an issue with the batch or any harmful side effects, but rather because of the packaging that the medicine came in. This recall came after the Chicago Tylenol Murders. Homicide investigators found that many Tylenol packages had been tampered with in Chicago stores. Whoever committed the crime had opened the bottles as well as the capsules inside, replacing the medicine they contained with cyanide.
This act resulted in the death of seven Chicago residents in just one week, in addition to a handful of victims of copycat murders. To prevent any further deaths, Tylenol immediately recalled all of its products from stores and warned consumers to throw out any recently purchased bottles of the drug. This event caused many drug companies to switch from capsule-style medications and also pushed the FDA to require tamper-proof bottles for all drugs being sold over the counter.
More than 3 million people in the United States have a pacemaker implanted to help regulate their heartbeat. These devices are incredibly common and help to save countless lives, but unfortunately, they are also some of the most commonly recalled medical devices on the market. There were three separate pacemakers recalled in 2021 alone, each having issues with the battery depleting prematurely. In 2017, however, more than 500,000 of the pacemakers designed by the medical device company, Abbott, were recalled for a very unusual reason.
The company found that these devices had a potential cyber-security issue. They found that the devices could be hacked by a third party, who could then control the pace that they set, either making them slow down or speed up. Thankfully, the manufacturers caught the problem before there were any real cases of this issue happening and were able to update the pacemakers to prevent it, successfully keeping their patients out of harm’s way.
There was once a time in the United States when drug manufacturers were not required to prove the effectiveness of their products before putting them on the market. They were also not required to track or report any side effects that they discovered after releasing the drug. This all changed in 1962, because of the drug Thalidomide. This drug was never actually legally
approved to be sold in the United States, but this did not stop doctors from recommending it as a sedative or a treatment for the common cold and flu symptoms, or prescribing it to more than 20,000 expecting mothers to combat morning sickness and other harsh pregnancy symptoms.
By 1961, the drug was found to have caused severe birth defects in approximately 10,000 children–nearly half of the children that were exposed to it while in the womb. It was promptly recalled by the FDA, which made amendments to the Federal Food, Drug, and Cosmetic Act in response. While this was incredibly tragic, it did prove a need for a stronger presence of toxicology testing in medicine, saving countless lives in the future.
Nearly a decade after the Thalidomide debacle, the FDA recalled Diethylstilbestrol, another drug commonly prescribed to pregnant women. The drug was originally thought to prevent miscarriages and other common pregnancy complications by aiding in the mother’s production of estrogen, however, it was proved to be ineffective in the 1950s. Despite this, doctors kept prescribing it until the 1970s, when it was found to have caused rare vaginal tumors in girls who had been exposed to the drug in utero.