Although all medical devices can come with some form of risk, all medical devices for the public use must clearly warn physicians and their patients of all the device’s dangers so they can both make the decision if the risk associated with the device is worth improving the disease or condition it is intended to treat. These warnings are also critical so they may be aware as to what aspects of the patient’s health should be monitored in order to best decrease the risk. A few of these medical devices include:
The U.S. Food and Drug Administration (FDA) approved the DePuy Synthes Attune Knee System in 2010, but reports of device failure quickly flooded in. Patients are experiencing premature device failure requiring painful additional surgeries. Although there has been no recall of the Attune Knee System, the FDA has received hundreds of reports of device failure and patients across the country are demanding answers.
When patients undergo surgery, a blanket is often placed over them. However, in some cases, a special heated blanket called a Bair Hugger is used to maintain the patient’s body temperature. It works by forcing warmed air around the body. Unfortunately, this movement of air can also distribute harmful air particles into the patient and cause a serious or life threatening infection.
When a patient experiences a potential pulmonary embolism, deep vein thrombosis, or other major internal blood clotting event, an IVC filter may be surgically placed inside the patient to prevent this blood clot from damaging the heart and/or lungs. When these devices fail or are not removed within a safe period, they can migrate or break up and cause more damage than a blood clot.
Women who undergo hysterectomies and other surgical procedures involving the uterus may need tissue broken up in order to be removed. In the case of a power morcellator, this tissue is ground up or morcellated with the use of this medical device and removed. However, women who have benign growths that contain a harmful substance can see their risk for cancer dramatically increase with the use of a power morcellator when this substance is released into the uterus.
This form of birth control is permanent and vaginally applied to induce the fallopian tubes to grow blockage in order to not let sperm pass to the eggs. However, this form of birth control contains metal particles that are known to break apart and cause a host of dangerous medical conditions, as well as fail and lead women to falsely believe that they are protected from unwanted pregnancies.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.