Testing of medical devices in Illinois may be insufficient

When medical devices do not perform as expected it can cause serious health issues in unsuspecting patients in Chicago, and in the worst of cases it could even lead to death. For example, in a recent Food and Drug Administration review and investigation of a contraceptive device known as Essure, thousands of patients have reported serious health issues related to the device, including pain, muscle fatigue and punctured fallopian tubes. These health effects have been reported as severe and debilitating.

Essure is only one example of a defective medical device that could have a severe effect on a patient’s health. The FDA has also reported that a particular heart device meant to stop patients from suffering a stroke actually caused some patients to endure blood loss and punctured patients’ hearts, which in some cases proved fatal. In addition, a medical device known as laproscopic power morcellator that was used in the treatment of fibroids located in a woman’s uterus in fact spread cancer.

According to one think tank, the standards currently in place for clinical trials on medical devices are insufficient. Although drugs must be submitted at least two double-blind and random tests before they can be placed on the market, this is not the case for medical devices, which only need to go through a less stringent clinical trial, some of which may be conducted by the manufacturer itself.

In fact, according to one study, between the years of 2005 through 2009, as many as 80 percent of recalled medical devices that posed a serious or life-threatening danger were not subject to a clinical trial at all prior to being made available to consumers. In addition, while one report indicates that recalls of medical devices during the years of 2002 to 2013 has increased two-fold, the approval process has not been made more stringent as a result, and some claim it is actually easier than ever to be granted approval.

These reports are indeed disturbing. Patients in Chicago should not have their health and lives put at risk by medical devices that are supposed to heal them. When a defective medical device leads to death, Chicagoans may find they have suffered a great loss, emotionally and financially. However, they may find that a consultation with a attorney regarding medical products liability is helpful.

Source: Pacific Standard, “How Medical Device Companies Test Products Out on Patients – After They’re Released,” Jenny J. Chen, Oct. 8, 2015