Heart surgeries are typically high-risk procedures that are intended to be either life-saving or life-enhancing. When artificial devices are involved in these treatments, the risk associated with having them performed invariably increases.
This increase is largely due to the potential of having substandard or defective components break or fail post-treatment. Medical devices have made revolutionary advances in healthcare.
However, when they do not perform or last as intended, the results can be devastating. In many instances, broken or failed heart valve implants can be directly traced to negligence or other shortcomings on the part of the medical device manufacturer.
Why Medical Device Manufacturers Are Often Accountable for Implant Failures
When medical device manufacturers design and sell defective implants, they wind up harming the very people that their devices are meant to help.
Sadly, many companies within this industry are slow to admit problems with their products, even after numerous adverse events have been reported.
Rather than recalling their devices after multiple failed procedures, some of these entities launch massive cover-up campaigns and continue bringing their defective products to market.
As a result, surgeons continue recommending and using these same products in treatments, and injuries and fatalities continue to mount.
The Dangers of Seeking Expedited Device Approvals From the FDA
There are instances in which medical device manufacturers can get around the often lengthy process of having their products approved for use and sale.
The Food and Drug Administration (FDA) has a system of expedited approvals for pharmaceutical products and medical devices similar in nature to those that have been approved and used before.
When demand warrants expedited approval, some companies are able to sidestep stringent testing measures to have their goods brought to market early. This loophole allows them to profit from their designs and research, even when there is still much research left to perform.
Companies that seek expedited design approvals through the FDA’s Breakthrough Device Program or its Expedited Access Pathway, often do so to the detriment of consumers.
The Impact of Defective Heart Valves
Valve-related complications following heart surgery can have severe consequences. Some of the risks that these procedures entail include:
- Arrhythmia (abnormal heart rhythms)
- Breathing problems
- Heart Attack
- Lung problems
Your best chance for a fair prognosis following failure or breakage of a defective heart valve implant is when it breaks early.
Patients who have not already been discharged from the hospital at the time of the breakdown will likely deal with far fewer complications. Due to the importance of these devices, when they malfunction, problems can develop and escalate quickly.
Replacement and Repair Surgeries
Among some of the most common problems resulting from defective heart valve implants are leaks. When these occur, people often suffer from severe fatigue, breathing issues, chest pain, and infection.
Secondary surgeries must be scheduled immediately to avert further problems and to restore normal functioning to the heart. Patients may be willing to take on the risks and hardship associated with initial heart valve surgery.
However, few are prepared for the mental, emotional, and physical stress of taking on a second one. When working with a defective device lawyer to determine the magnitude of damages caused, a person will often consider the added pain and suffering that secondary treatments require.
Defective medical devices can cause tremendous problems for patients, especially when these devices are used in heart surgeries.
In the best scenarios, timely and life-saving interventions can be made to mitigate damages and prevent additional problems. In others, failure to report and recall defective products has led to severe injuries and death.
Seeking compensation holds companies liable for their negligence and prioritization of profits over patient health. It additionally allows injured parties and their families to receive the compensation they need and deserve.