This past spring, the FDA issued a warning affecting the millions of patients each year that undergo routine gastrointestinal, gynecologic, or thoracic surgeries, where surgical staples are used to suture internal organs.
According to the agency, the misuse or misfiring of the surgical staple devices can have dire consequences on a patient’s initial success, recovery or need for future procedures.
And, while the initial warning was shocking enough, more concerning was a report issued months after by independent researchers that suggested twice as many injuries may have actually occurred in patients, only to be covered up in secret FDA reports by the manufacturers.
Surgical staples have been in commercial use since the early 1960s and have been used in more than 10 million patients undergoing internal thoracic cavity surgeries. Some of the more common types of procedures they are utilized in include:
In such procedures, the staples play an important role in suturing internal organs to prevent internal bleeding, blockage and perforation.
According to the FDA, surgical grade staples and their implant tools are prone to failure in many procedures if staff are not properly trained on their use, or if the devices themselves are defective.
On March 8, 2019, the agency sent a warning letter to doctors advising that over a seven-year review period, they had received more than 41,000 reports of surgical stapler complications. Of these, more than 9,000 resulted in severe injury and almost 400 resulted in patient death.
Some of the risks to patients from surgical staples include:
In response to the dangers, the FDA took two courses of action: in April they ordered the recall of a popular surgical stapler device made by Johnson & Johnson’s subsidiary Ethicon; in June they proposed reclassifying all stapler devices to allow greater safety regulation.
Although the prospect of 41,000 or more patients affected by a dangerous medical tool was daunting, a report that surfaced in May showed that the problem was even more urgent than originally thought.
At that time, an independent study by Keiser Health found that at least 56,000 additional cases of surgical stapler complications had been filed with the FDA between 2011 and 2018 through a private manufacturer reporting portal. However, they were never disclosed to the public and weren’t disclosed as part of the original FDA warning.
In fact, the Kaiser Health investigation found that since 2016, over 1 million patient injuries have been hidden in the “alternative summary reporting” database rather than the MAUDE system that is made available to the public.
The revelation of more than double the number of patient side effects being hidden from the public, and the prospect of a reporting system that served only manufacturers at the expense of American patients shook the system and led to calls for reform.
At the very least, the reports are proof that stapler manufacturers knew for years that thousands of patients were experiencing surgical complications from their devices, yet did nothing to warn consumers.
In the months since the FDA and Kaiser Health reports surfaced, lawyers around the country have begun investigating lawsuits on behalf of those injured.
If you or a family member suffered complications with a surgery, repeat surgery or injury due to surgical staple malformations or defects, you may qualify for a case.
Lawyers are currently filing claims against stapler manufacturers like Medtronic, Covidien, Johnson & Johnson and Ethicon for selling defective devices and covering up the dangers.
Unfortunately, they expect that thousands of patients will eventually come forward once the cause of their surgical complications is discovered.
If you have questions about your surgery or injury, or would like to speak directly with a lawyer about your case, contact DrugNews today.
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