7 High-Profile Failures of FDA-Approved Medical Devices
We like to assume that doctors know best. A lot of the time, they do. But they aren’t responsible for making sure that the devices they use on a daily basis, will live up to their promised potential.
It’s up to the FDA to determine whether or not a particular machine or device is ready for use. And even if it is, there can be serious malfunctions in those FDA approved medical devices.
They can inadvertently cause harm to a patient if they are damaged or ineffective. And at the very least, that patient and/or their family deserve compensation.
How can you protect yourself against medical device failures? Keep reading to learn about 6 high-profile failures of medical devices that the FDA approved.
What Happens When a Device Malfunctions?
Before we get into specific devices that have failed, let’s break down what they are and what can happen when they fail.
What are medical devices? Medical devices are instruments, implants, machines, and other devices that medical professionals use in the diagnoses, prevention, and cure for diseases and other ailments.
Many doctors and patients alike depend on medical devices every day in order to keep themselves or someone else alive and well. If a device is not used properly, malfunctions, or fails to do its job in any way, it could be detrimental to a patient.
Soon after someone recognizes the malfunction, there should be a recall, for which there are three types:
- A Class I recall means that the device or product in question could potentially cause death or serious health problems.
- A Class II recall means that the device or product could cause health problems that are potentially reversible.
- A Class III recall means that the device or product is unlikely to cause any health issues.
Once they issue a recall, the manufacturer will either come and fix a part in-house (depending on the defect) or remove the device completely. Now let’s take a look at some of those massive failures.
1. Mesh Implants
Thousands of women suffered complications due to mesh implants. In South Africa, 51-year-old Renate Scheepers had to undergo surgery in order to have the mesh removed from around her bladder, after years of excruciating abdominal pain.
Over 100,000 women all over the world have filed lawsuits against manufacturers saying that these faulty mesh products harmed them.
2. Inadequate Sterilization Instructions
Here is an example of a recall that didn’t require the removal of a device. In January 2014, they issued a recall for a Standard Offset Cup Impactor from Greatbatch.
The steam sterilization recommendation that was provided with the device was not sufficient and did not meet requirements for sterility assurance.
Greatbatch issued new sterilization recommendations to customers, and no adverse effects were reported.
3. Metal-On-Metal Hip Implants
When these hip implants were first introduced, they were advertised as being more durable and better for younger patients who tend to be more active.
However, they have proven to be dangerous. Because the entire device is metal, different components can rub together, leaving bits of metal behind. These shed metal particles can cause anything from inflammation to metal poisoning.
Half of the plates used in New Zealand, for example, were subject to recalls, safety notices, and health problems.
A 44-year-old Mumbai-based salesman who used to sell equipment to hospitals, now suffers from difficulty walking, vision problems, and irregular heart rhythms. These ailments are attributed to his own metal hip, made by Johnson & Johnson.
4. BrainLab Image-Guided Surgery System
IGS (Image-Guided Surgery System) issued a very serious (Class I) recall for their device which showed surgeons where their instruments were, relative to the patient’s anatomy during surgery.
In 2016, they issued a recall because the display may have been inaccurate for each device. Even though it was only being used for minimally-invasive surgeries, the inaccuracies had the potential to be serious or life-threatening.
5. Implantable Defibrillator
U.S. citizen Charlissa Dawn Boyce passed away after a defibrillator that was planted inside her failed to shock her heart back into rhythm. Around 350,000 devices had been implanted and were later subject to a massive recall.
It failed to shock her heart because the batteries failed and turned out to be defective. Even though her family filed a lawsuit, there is nothing that can be done to compensate for the loss of a loved one.
6. Teleflex Tracheal Tube
Teleflex made a tracheal tube that could kink during patient use. However, the FDA designated the recall as a Class I recall.
It was meant to be used for patients that needed help with both short-term and long-term ventilation, without having to change tubes. The Teleflex ISIS HVT was meant to meet the needs of patients requiring both short- and long-term ventilation, without the need to change tubes.
Because of significant defects, however, a recall was issued, and customers were urged to stop using and return the tubes immediately.
What Is Being Done to Remedy These Mistakes?
The FDA medical device approval process is not thorough enough, and they are one of the first ones to admit that.
The FDA is doing an overhaul of the approval process to decrease the number of failures and injury that happened as a result of these many defects.
Will Faulty FDA Approved Medical Devices Affect You?
Not only can FDA approved medical devices have defects, but these defects can affect people’s health and even threaten their lives.
Often times, astronomical medical bills are the result of these devices having to be remedied or removed. People lose money for missed work and families are also affected.
It’s important to get the help and compensation that you need and deserve if you’ve been a victim of a faulty product. Contact the defective medical device attorneys of Farris, Riley & Pitt, LLP for a confidential, FREE consultation so that you can get the compensation you deserve.