Medical Devices and Pharmaceutical Drugs

Scientific advancements in the medical and pharmaceutical industries have had a profound impact on the lives of people all over the world. However, it is important to recognize that there are instances where drugs and medical devices have failed or caused harm to people, as evidenced by the numerous reports received by federal regulators every day. 

Our society generally has a great amount of trust in the healthcare system and expertise of our doctors. Thanks to scientific progress, we now have access to remarkable drugs and medical devices that can dramatically improve the quality of our lives—oftentimes saving them.

Nevertheless, it is necessary to acknowledge that not all drugs and devices undergo the extensive testing and scrutiny that they should before being made available to the public. Consequently, there are instances where these products, which were intended to help us, end up causing harm instead.

Medical Devices

Medical devices encompass a wide range of products, including items like hearing aids, hip implants, insulin pumps, and surgical mesh. However, it’s important to note that medical devices undergo different testing procedures compared to pharmaceutical drugs. In fact, it is quite common for new devices to be used on patients without going through human tests beforehand.

Medical devices can receive clearance from the U.S. Food and Drug Administration (FDA), the agency that regulates food and pharmaceuticals in the United States, through a process called 510(k). This process permits a drug manufacturer to release a new device if they can demonstrate that it is “substantially similar” to an existing product already available in the market.

Similar to defective drugs, issues with medical devices might not become apparent until after they have been introduced—sometimes years later. In such cases, manufacturers may issue temporary recalls or remove the device from the market completely.

Medical Device Recalls

In certain situations, medical devices may undergo a product recall if they are found to be defective or are at risk of causing harm. While the FDA plays a role in approving and overseeing medical devices, it rarely initiates recalls by itself. Manufacturers typically take voluntary action to recall their devices once they find issues. In exceptional cases where a pharmaceutical company neglects potential dangers and fails to order a voluntary recall, the FDA may intervene.

By law, pharmaceutical manufacturers are obligated to inform the FDA whenever they initiate a product recall so that it can be publicly announced. There are many reasons for recalling a device, including software malfunction, incorrect labeling or instructions, product defects, high failure rates, or lack of sterility.

According to Stericycle Expert Solutions, a technology firm that tracks consumer recalls, medical device manufacturers issued 1,267 product recalls, affecting more than 441 million individual devices in 2018. Among these recalls, the most common cause was software issues, accounting for 296 recalls, followed by 232 recalls due to mislabeling.

In rare instances, companies have failed to issue a voluntary recall despite receiving more reports of complications related to their devices than expected. And sometimes, instead of initiating a recall, manufacturers will choose to discontinue or withdraw problematic devices from the market.

The FDA has noted a significant rise in medical device recalls over the past decade. According to their report, there was a 97 percent increase in recalls within a span of 10 years, from 604 recalls in 2003 to 1,190 recalls in 2012.

How to Find Out if There’s a Medical Device Recall Notice

If you want to find out if a medical device has been recalled, you can use the FDA’s Medical Device Recalls database. It is a valuable resource for consumers and health care providers. 

Medical Device Health Problems

A defective medical device can result in significant health issues. Implantable products, like hip replacements or pacemakers, often necessitate surgical procedures to replace or remove defective devices.

One example of such failures is metal on metal hip implants, which have been linked to metallosis, a form of metal poison that destroys muscle tissue or bone around the joint and leads to additional complications within the body. Surgical mesh in the hernia, on the other hand, has been associated with issues such as bowel perforation, infection, and chronic pain.

Between 2008 and 2017, the FDA received more than 5.4 million reports of failures, problems, or other issues related to medical devices. Upon reviewing these reports in 2018, the International Consortium of Investigative Journalists discovered that almost 83,000 deaths that possibly resulted from medical devices.

Moreover, reports over the span of a decade highlighted 1.7 million injuries caused by various types of medical devices. More than 25% of these injuries were attributed to six types of devices. Among them, hip replacements and insulin pumps had the highest number of reported injuries.

Unfortunately, the number of reports received by the FDA may only represent a small portion of the actual issues with medical devices. The FDA requires medical facilities to promptly report any problems associated with medical devices to both the agency and the medical device manufacturer within 10 days. However, during an FDA investigation in 2015 involving 17 major hospitals, gaps in reporting were discovered. The investigation revealed that six of the hospitals failed to report patient deaths and injuries accurately, while five others did not meet the reporting deadlines for injuries.

In a more recent investigation conducted by Kaiser Health News in 2019, it was revealed that the FDA allowed medical device companies to submit reports regarding injuries and malfunctions through an alternative database. This “hidden database” was not available to the medical professionals or the public. It’s estimated that more than 1.1 million incident reports were funneled through this secretive database since 2016.

Prescription Drugs

According to the Centers for Disease Control and Prevention, almost 50% of Americans take at least one prescription medication, and about 25% use at least three. 

The FDA maintains that our country has one of the safest drug supply networks. However, it’s important to understand that all medications come with risk, and some drugs can be extremely dangerous, even leading to death.

Before a new drug product is approved for use, it has to go through three rounds of testing on humans. However, these drug trials often involve a small number of people, which means that adverse health consequences may not be detected during the testing phase. In some cases, side effects may not surface until thousands—sometimes millions—of people have been taking them. 

A study published in the Journal of the American Medical Association in 2017 revealed that nearly one-third of FDA-approved prescription drugs had undisclosed side effects when they became available on the market between 2001 and 2010. As a result, some drug manufacturers issue a voluntary recall or amend their products, while the FDA issued a safety alert and required pharmaceutical companies to include a black box warning, the agency’s consumer warning. 

Even after an adverse health problem is identified, numerous drugs continue to be available for purchase and use on the market. This means that some medications are still being sold and prescribed to patients even though there are known issues or risks associated with them. 

It is important to recognize potential consequences and the need for continued vigilance in monitoring the safety and effectiveness of drugs.

Nexium and Prilosec

One example of a medicine with serious side effects is proton pump inhibitors (PPIs). These medications, like Nexium and Prilosec, have been linked to harmful effects, such as kidney disease, bone fractures, and heart attacks. Despite numerous lawsuits filed against the drug manufacturers, these medications are still available for purchase without a prescription.

Abilify

Another problematic drug is Abilify, an antipsychotic prescribed for disorders like schizophrenia and bipolar disorder. While uncommon, some individuals taking Abilify experience severe side effects, including problematic behaviors like compulsive shopping, binge eating, gambling, and sex addictions.

The FDA first alerted Americans about the impulse-control problems associated with Abilify in 2016—nearly 14 years after the medicine was initially approved for use. This highlights the delayed recognition of these risks and the continued availability of the prescription despite its potential harm.

Adverse Events

Since 1968, the FDA has received more than 16 million adverse event reports. These incidents document the negative reactions experienced by people who used medications or medical devices. 

In 2018 alone, the FDA’s public database revealed that more than 9 million of these reports were considered serious. Furthermore, approximately 1.6 million of these reports were linked to deaths. 

These numbers highlight the importance of closely monitoring and addressing the concerns of drugs and medical devices to protect patient safety.

Prescription Drug Recalls

When the FDA discovers new potential drug risks, it takes action by releasing a safety alert. Additionally, it mandates that new warnings be included in patient medication guides. This is done to ensure that both healthcare providers and patients are aware of the potential risks and can make informed decisions.

However, if the risks of a drug product are determined to be greater than its potential benefits, the drug may go through a market withdrawal. This can be initiated by the drug company itself or by an FDA recall. The purpose of a recall is to withdraw the drug from circulation in order to safeguard public health and prevent further harm.

Blood Pressure Medication Recall Example

In 2018 and 2019, several pharmaceutical companies had to recall several batches of blood pressure medications, including Irbesartan, Valsartan, and Losartan. The reason for these recalls was due to the presence of tiny amounts of N-Nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are chemicals known to cause cancer. 

According to an initial investigation conducted by the FDA, it is believed that the contamination occurred due to changes made during the manufacturing process. Additionally, reports indicate that the factories in China and India, where these drugs were manufactured, had a history of problems, even before the discovery of NDMA and NDEA contamination.

It is worth noting that the recall of Valsartan alone has affected millions of Americans who were using the medication.

Top 5 Reasons for Drug Recalls

In a 2016 study published in the American Journal of Health-System Pharmacy, researchers examined the primary causes behind drug recalls. The top 5 reasons for a recall notice were:

1. Contamination: This refers to situations where drugs were found to be contaminated with harmful substances, such as bacteria or foreign particles.
2. Mislabeling: Drug recalls were also commonly prompted by cases where the labeling on the medication was incorrect or misleading, potentially causing confusion or misadministration.
3. Adverse reaction: Recalls occurred when it was discovered that the drug caused unexpected or harmful reactions in patients, leading to health risks or complications.
4. Defective product: Instances where the drug itself was flawed or had manufacturing defects were another significant reason for recalls. These defects could affect the drug’s quality, safety, or effectiveness.
5. Incorrect potency: Recalls were also issued when it was determined that the drug’s potency or strength deviated from the intended or labeled amount, potentially leading to ineffective treatment or adverse effects.

Identifying the reasons for drug recalls helps regulators and healthcare professionals address these issues and ensures the safety and effectiveness of medications.

Drug Recall Classifications

An FDA recall is categorized based on the level of risk the drug poses to the public’s safety.

There are three different classifications for drug recalls, which are as follows:

Class I Recall 

A Class I Recall is the most pressing and urgent type of recall. It is used for drugs that are considered dangerous or flawed, and have the potential to cause severe health issues or even death.

Class II Recall

A Class II Recall is used when a drug has the potential to cause temporary or reversible health issues, or when there is a slight risk of a more serious problem occurring. It signifies a situation where the drug may pose a moderate threat, but is not considered as severe as a Class I recall.

Class III Recall

A Class III Recall is the least severe category of recalls. It pertains to products that have violated FDA regulations regarding labeling or manufacturing, but are not expected to result in any significant health issues or adverse effects.

While not all recalls are announced in the news, the FDA ensures that all recalls are made available to the public through weekly enforcement reports that are posted online. These reports provide information such as the name of the drug, the classification of the recall, and the reason behind it. 

Generally, if a defective drug is widely distributed or poses a significant health risk, the public is notified about the recall to ensure their safety and well-being.

How to Protect Yourself

Thankfully, there are steps you can take to lower your chances of experiencing an injury related to pharmaceutical drugs or medical devices.

One crucial step is to have a conversation with your doctor before taking any new medications or scheduling surgery. By discussing the potential risks and benefits, you can make an informed decision. Seeking a second (or even third) opinion can also be wise in certain situations.

When it comes to medications, it is important to inform your doctor about your complete medical history and provide a list of all the medications you are currently taking. This includes drugs that are available over the counter, as well as any vitamins or supplements. 

U.S. News and World Report has a few additional suggestions to help lower your risk:

1. Analyze the drug label carefully and acquaint yourself with the drug’s side effects 
2. Report any new symptoms that appear after starting a medication
3. Discuss alternative options with your doctor if you suspect that a drug is causing unwanted side effects
4. Ask your doctor about the possibility of safely reducing the number of medications you are prescribed

To check if a medical device or medication has been recalled, you can visit the FDA website dedicated to Recalls, Market Withdrawals, & Safety Alerts.

If you or a loved one experiences adverse effects from a medication or encounters complications associated with a medical device, you have the option to report these issues to the FDA’s MedWatch program. This program allows you to submit a report online, via fax, or through a phone call. Alternatively, you can obtain a printable form to bring to your doctor, who can assist in providing the necessary clinical information for the report.

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