When a medical professional advises a patient to consent to the implantation of a medical device, it is because the doctor believes it will improve the health of the patient. The use of these devices is common, and patients trust that they will help with a specific medical condition. Unfortunately, they are not always safe, and it is necessary for the Food and Drug Administration to issue a recall, even if the FDA approved it beforehand. So, what happens when the FDA recalls a medical device?
FDA Recall for Medical Devices
The FDA decides when it is necessary to recall a medical device, drug or food product. There are different levels of recalls, and it can be smart for a patient with a medical device to be aware of how this process works. If you suffered because of a harmful or defective medical device, you could have grounds for a civil claim.
FDA Recall Levels
There are different levels of recalls, and the FDA will decide which one is necessary based on the gravity of the situation and the severity of the potential harm that consumers could suffer. The three levels of recalls are as follows:
Class III FDA Recall
This is the most serious type of recall. It involves devices that are important for sustaining human life, such as pacemakers and bone implants.
Class II FDA Recall
This involves devices that are important for treatment of a specific medical condition, but the issue with the device, such as a wheelchair, will likely not cause serious harm to the patient.
Class I FDA Recall
This level of recall involves devices that are important for treatment but will probably not cause injuries, such as scalpels used in surgery and medical gloves.
What Does it Mean When the FDA Recalls Your Medical Device?
A recall starts when the FDA learns of a problem with a medical device. Sometimes, they learn of a problem through an investigation done by the agency, and sometimes the manufacturer will report a problem when they learn of it. At that point, the FDA will work with the manufacturer to get the product off the market and address issues with patients who already have it.
Experienced Defective Medical Device Lawyers
If you learn there is a recall on a device implanted in your body or used for your medical treatment, it can be frightening and overwhelming. You may want to discuss your options with your doctor and your insurance company regarding removal, replacement or other ways to keep you safe. You may also want to speak with an experienced Texas medical device attorney, especially if you have already suffered adverse effects from the problematic device.