People suffering from serious health issues in Texas and across the nation rely on medical advancements to help them. For those who have heart failure, that might require a heart pump to be implanted. When the person has a specific health concern that can only be addressed by one type of device, they generally do not have a choice. Recently, however, one device has stoked fear about its safety. Those who have had an unexpected adverse reaction need to know what happened and why.
Investigative reports suggest heart pump has safety issues
The HeartMate 3 is a heart pump that has been used for people suffering from heart failure. It is approved by the Food and Drug Administration. Despite that, some have looked at the data regarding its safety and expressed fear. Two are former employees at the FDA.
In the past seven years, there have been over 4,500 incidents with this device. A subsidiary of the manufacturer analyzed the statistics and found that there were no issues in 90% of the cases in which the device was used. Still, there are assertions that the FDA has not been attentive to possible risks.
The HeartMate 3 is currently the only type of device that can be used for this purpose in the United States. Another similar device called HeartWare was removed from the market in 2021 because there was a belief that patients could be harmed. Abbott has dismissed worries about its device.
Two incidents reported by CBS News resulted in lawsuits. In one, a man died after a defect in the HeartMate 3 resulted in him suffering from several medical problems including strokes, organ failure and brain injury. In the other, the patient died when the same type of defect caused him to have strokes.
People impacted by medical device failures may need assistance
With many medical devices – like the HeartMate 3 – people are limited in their options to address potentially fatal health problems. That, however, does not mean the device should not be scrutinized with regulatory agencies and the manufacturers making sure it is safe for people to have implanted.
For people who have suffered a negative outcome from this or any medical device, it is imperative to understand what steps can be taken under medical products liability law. This can be crucial to being compensated for all that was lost and for companies to be held accountable.
