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Scientists and medical professionals are constantly working toward innovations to provide us with cures and treatments for many common medical issues. While it’s great to have so many options created so quickly, sometimes quality is sacrificed in the process, leading to more than 1,000 recalls of drugs and medical devices each year in the United States. Here are a few examples of products that were recalled after being deemed unsafe.
1. Medtronic Minimed Insulin Pumps
Medtronic insulin pumps were devices that were used to deliver insulin to children and adults diagnosed with Type 1 diabetes. These life-saving medical devices were recalled in 2020 after causing more than 2,000 injuries and one death. The product was recalled because the retainer ring that held the device’s insulin cartridges in place was found to be broken or missing on many pumps issued nationwide. This greatly impacted the device’s ability to regulate the amount of insulin that was being pumped, either delivering too much or too little to patients, causing serious reactions and having the potential to become fatal. The issue has since been fixed and the company is continuing production of their improved insulin pumps.
Before 1962, manufacturers in the United States were not required to prove the effectiveness of the drugs they produced before putting them on the market, nor were they required to track and disclose any side effects that they discovered after releasing them. This changed, however, after the 1961 recall of the drug Thalidomide. This drug was created to be a tranquilizer or sedative, but eventually was used more commonly to treat common cold and flu symptoms and was recommended to many pregnant women by their doctors as a means to help with morning sickness.
It’s estimated that this drug was prescribed to nearly 20,000 pregnant women, despite never legally being approved for sale in the United States. In 1961, the drug was recalled after it was discovered to have caused severe birth defects in nearly half of the cases in which it was used. This led to amendments in the Federal Food, Drug, and Cosmetic Act, and sparked a conversation on the importance of toxicology testing in medicine.
Unfortunately, Thalidomide wasn’t the only drug that pregnant women suffered side effects from in the mid-1900s. Another drug that expecting mothers were commonly prescribed by their doctors was Diethylstilbestrol. This drug was meant to prevent miscarriages and other serious pregnancy complications by aiding in the production of estrogen. The drug was proven to be ineffective in the 1950s but was still prescribed by doctors until the early 1970s when it was discovered to be a carcinogen that caused rare vaginal tumors in girls who had been exposed to it in the womb. The drug was promptly recalled, and the manufacturers were forced to pay more than a billion dollars in compensation to the victims and their families.
4. Abbot Pacemakers
One of the biggest recalls in recent history was of pacemakers created by the medical device company, Abbott. The company recalled nearly half a million pacemakers after they realized they had a cyber-security flaw. The company realized that the pacemakers had the potential to be hacked and controlled by a third party. Once they had been hacked, the pacemakers could then be remotely controlled, either sped up or slowed down, by the third party.
Thankfully, the company realized this problem existed before the issue occurred, and was able to create an update in the pacemakers that prevented them from being hacked, protecting their patients from potential harm. While this recall was fairly harmless, it is shocking how common recalls are on pacemakers. In the year 2021 alone, the FDA issued Class 1 recalls on three separate models, all of which were due to issues with the batteries in the devices.
The Tylenol recall of 1982 is potentially one of the most shocking recalls of all time. The FDA decided that the drug was unsafe, not because of any impurities in one of the batches or because of any associated side effects, but because of the packaging. This decision came after many bottles of Tylenol were found to have been tampered with, leading to the deaths of seven Chicago residents in just one week.
These deaths were quickly ruled as homicides as investigators discovered that the medicine inside the capsules had been removed and replaced with cyanide. This serial homicide inspired many copycat murders and forced the recall of the common household drug. It is because of this horrific event that we now have tamper-proof packaging on medications, and fewer drugs are made in capsules.