Many people depend on medical devices to help make their lives easier. But when those devices fail, they can cause serious injuries. When this happens, the person may need to undergo more treatment or surgeries to fix the problem. After that’s done, they may have medical expenses and other costs that they are now responsible for.
In order to prevent injuries or complications due to a defective medical device, it can help to know which devices have a history of being defective, are under a current recall, or are being investigated by the federal government. Here are some of the most common defective medical devices in 2019 as well as some information about product recalls that may help keep you and your family informed:
Defining a Medical Device Recall
According to the U.S. Food & Drug Administration (FDA), medical devices are recalled when one of two things happen. There can be a correction, which is where the medical device issue is being fixed where it is used or sold. There can also be a removal, where the medical device is taken away from where it is used or sold. The devices have to be taken off the market when they’re in violation of FDA law, which typically includes the devices being a health risk or having some type of known defect.
It is important to note that when a product is recalled, you don’t have to immediately stop using it. If you ever have any questions about a medical device, call your doctor and speak to them first. A recall could mean the device needs to be looked at and an adjustment or repair may need to be made.
Both manufacturers and distributors can issue a voluntary recall, where they learn that there’s an issue with their device so they inform the FDA and take the appropriate measures to take the product off the market. The FDA can also issue recalls, which may happen if the company refuses to initiate a recall themselves.
Recalls have different levels of severity. A Class I recall means that the product could cause significant health problems or fatalities. Class II means that the product can cause health problems, but they may be reversible. There is still a slight chance the health problems could be serious or result in death. Class III is for recalls where there isn’t a big chance that the product will cause health issues.
Common Defective Devices
Now that you know more about recalls, let’s look into common defective devices that have been investigated so far in 2019:
Many people each year undergo surgeries for implants. Common ones are hip or knee implants, and surgical mesh. Those who get implants may suffer if the product is defective, which could mean it breaks down over time or doesn’t stay in place. People commonly get surgical mesh to repair a hernia. But defective hernia mesh can be dangerous. It may cause an infection or pain, and could even cause a hernia recurrence. When implanted devices are defective, the patient will likely need corrective surgery to fix the problem.
While surgical implants and mesh are the most common types of defective devices, you can stay informed about the current recalls of the year. The FDA keeps an updated list of recently recalled items. Some recent recalled products include:
- Sterile Saline and Sterile Water for Inhalation. Made by Medex Cardio-Pulmonary, also called Smiths Medical, has recalled this device because the containers can leak. If this happens, there’s a risk of exposure that could cause an infection.
- Dual Chamber Implantable Pulse Generators (IPGs). Medtronic, Inc. has recalled these pacemaker devices because it’s possible there’s a circuit error that prevents it from pacing the patient’s heartbeat.
- Vial2Bag Fluid Transfer Systems. West Pharmaceutical Services Inc. recalled their device because it could malfunction in a way that prevents it from transferring medicine from a vial to the IV bag before getting to the patient. This could mean the patient isn’t getting the proper dosage, which can be dangerous.
What Are Possible Symptoms of a Defective Medical Device?
While the concept of a defective medical device can be scary, it’s important you know the signs to look out for what may indicate that something is wrong. This way, you can identify symptoms and get to your doctor as quickly as possible.
If the implant or other type of device is causing considerable pain, preventing you from staying mobile, or you notice bruising or bleeding, then it’s possible there is an issue with the device. It could have come out of place, has an internal issue, or is failing to work as it should.
DiPiero Simmons McGinley & Bastress, PLLC Can Represent You
If you’ve suffered from an injury from a defective medical device that has serious affected your life, you may be able to file a product liability claim against the manufacturer or corporation that is responsible for putting the product into your surgeon’s hands. You deserve to have a legal team that will represent your rights and fight for you to get the compensation you need. With our help, we’ll do everything we can to get you on the path to recovery. Set up a free consultation by contacting us today.