Implants such as pacemakers and cardiac stents are essential lifesaving devices. But other surgical implants were defective and could constitute examples of products liability related to medical devices because of inadequate government oversight.
Surgeons engaged in almost 1.4 million procedures to replace hips, knees, shoulders, elbows, finger joints, toe joints and ankles in 2014. This could go up to four million procedures in 2030, according to a professional estimate. Along with these metal and plastic implants, there were implants for cardiac pacemakers, transplants for hearts and livers and organic transplants implanting a graft from a deceased donor.
Regulation was lax. Class I and some class II devices are exempt from approval and need only registration with the FDA. More invasive or complex devices only require 90 days-notice to the FDA before marketing. These devices, unlike drugs, do not have to undergo clinical trials.
Class III devices must go through a pre-market approval process where the manufacturer must show reasonable assurance of their safety and effectiveness. But an updated version of a device sold in 1976 may be released without a new clinical trial if the manufacturer finds that it is a substantial equivalent to the existing device.
For these reasons, the FDA did not require clinical testing for 400 moderate to high risk implants that it approved between 2008 and 2013. These included stents, hip replacements, surgical mesh and filters for a large vein that carries blood to the heart.
The 21st Century Cures Act, enacted in 2016, also restricts FDA oversight. Manufacturers may receive approval without FDA participation by submitting case reports, observational studies and subgroup analysis.
The FDA received approximately 16,000 reports of deaths related to medical devices in 2015. The GAO also reported that 99 percent of these adverse events were not reported at first and more serious events are less likely to be reported. One expert believes that were 1.6 million fatalities.
Studies of stent implantation in 2012 found 7,000 patients received no benefit for the elective implantation of this device. In 2004, a recall of two types of cardiac stents affected 96,000 patients because design flaws could cause heart attacks, perforations and death. In 2013, 33,000 substandard vena-cava filters were recalled because these devices caused blood clots from reaching the heart instead of preventing them.
Victims of defective devices may need legal assistance. An attorney can help pursue compensation.