Defective or unsafe medical devices cause millions of dollars in damage, pain, suffering, and even death every year in the United States. When you get an implant or incorporate a medical device into your life, you put a lot of trust into that device and the medical professionals who developed it and implanted it.
Unfortunately, things do not always go as planned, and your medical device can cause you a great deal of pain, revision surgery, time, and money. In those circumstances, you need to involve a Florida medical device attorney who can help you hold the right people accountable for your loss and damage.
What is an Unsafe or Defective Medical Device?
According to the Food and Drug Administration (FDA), a medical device is defined as “an instrument, apparatus, implement, machine, . . . or similar or related article,” that is either
- Intended for use in the diagnosis or treatment of a disease or other condition or
- Intended to affect the structure or function of the body and does not achieve its result through the use of a chemical action (like a drug would do).
Medical devices must go through an approval process with the FDA that is similar to prescription and over-the-counter drugs. However, they can be “fast-tracked” through this process if they can show that the device is substantially similar to other medical devices. Unfortunately, in some cases, just because a device is already on the market does not make it safe. There are many situations where medical devices that the FDA deems similar enough for approval that actually turns out to be very dangerous.
Some examples of known unsafe medical devices include:
- Implanted defibrillators
- Surgical or vaginal mesh
- Hip implants
- Knee implants
- Intrauterine contraceptive devices (IUDs)
- Bladder slings
However, just because your medical device is not on this list does not mean that you should rule it out as a potential cause of your pain, discomfort, or other long-term medical problems.
Consequences of Dangerous Medical Devices
Some medical devices can lead to damage and injuries that you must endure for the rest of your life. You may have to go through revision surgeries, chronic pain, additional medical care, and a variety of other negative consequences. Some of the most common results of an unsafe medical device include:
- Worsening symptoms
- Revision surgery
- Loss of mobility or use of a particular body part
- Permanent disability
All of these potential problems often lead to additional medical bills, pain and suffering, rehabilitation or retraining costs, lost wages, and more.
In some cases, medical devices can lead to death, which causes unspeakable harm to families and other loved ones. The long-term effect of the loss of a loved one is immeasurable and includes things like lost companionship, friendship, love, and other unquantifiable losses. For many families, it also means the loss of a breadwinner and the reality of covering unexpected large medical bills and funeral costs.
Who is Legally Responsible for Dangerous or Defective Medical Devices?
There are a variety of individuals or entities that may be to blame for the creation and implementation of a defective or dangerous medical device. The blame depends on why the problem arose in the first place. For example, the manufacturer may be responsible if they knowingly pushed through an unsafe device with the FDA. Those who sold the device or recommended it to you (like salespeople, doctors, or other medical professionals) could be to blame if they knew that the device was likely to harm, rather than help you. Even the laboratory that tested the device could be partially responsible if they did not thoroughly examine the device for risks before it reached you.
Call a Medical Device Attorney for Help
Because medical devices are products, they fall under the wide umbrella of products liability in Florida. However, these cases are often much more serious or severe compared to the average product liability case because they involve a device that is implanted inside of you.
A medical device lawyer can help you decide what your legal options are if you or a loved one are facing injuries and damage because of a medical device. Give our team a call today to learn more.