Failure of Medical Device Industry to Protect Patients

Written By Benjamin L. Vanasse

A recent report released by the International Consortium of Investigative Journalists (ICIG) called the “Implant Files” underlines the dangers associated with medical devices and the failure of the medical device industry to focus on protecting patients. This worldwide investigation looks at numerous aspects of the medical device industry and found a startling lack of transparency about the safety of these devices. Too often, medical devices are rushed to the market without a full and adequate investigation into the potential dangers of the device. In the U.S., the average time for a new device to be approved through the FDA’s premarket approval process has dropped by 200 days since 1996. It is difficult to properly assess just how many people have been injured from medical devices.

Unsafe Medical Devices Statistics

According to data from the FDA, there have been more than 80,000 deaths and 1.7 million injuries possibly linked to medical devices in the past decade. However, much of this reported data depends on the transparency of the FDA and the medical device industry. In one of the more particularly troubling cases, the ICIG “Implant Files” reports that for years, the FDA allowed breast implant companies to bury evidence of ruptures and other injuries as routine events that did not require public disclosure. In 2017, the FDA instituted more rigorous reporting rules, and suspected breast implant injuries jumped from an average of fewer than 200 per year through 2016 to 8,242 in the first half of 2018.

Hernia Mesh

Another medical device that has been linked to a number of injuries is surgical mesh that is used in hernia repair surgery. Elective incisional hernia repair is one of the most commonly performed general surgical operations in the United States. The FDA estimates that there are more than 1 million hernia repairs each year. Surgical hernia mesh is typically used to treat inguinal or groin hernias. Hernias have a high rate of recurrence, and a common treatment involves the use of surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Despite these supposed benefits, a number of people have suffered adverse events due to defective surgical mesh. Common complications include pain, infection, inflammation, bleeding, hernia recurrence, migration or movement of the implant, bowel perforation and obstruction, and the need for additional surgeries. There have already been more than 50,000 lawsuits filed in the U.S. related to hernia mesh procedures.

Too often, the medical device industry puts profits over patient safety. The industry spends hundreds of millions of dollars developing close relationships with doctors and hospitals, in addition to spending vast sums of money on lobbying to influence deregulation, making it easier to get newer products on the market. It is time for the medical device industry to learn that patient safety must always be its number one priority.