Tens of millions of Americans undergo surgery each year and tens of thousands of them end up with surgical staples. Too often, those surgical staplers malfunction in some way and result in surgical staple injuries leading to surgical staple lawsuits, or can even lead to death.
The U.S. Food and Drug Administration (FDA) put out an open letter last year acknowledging an uptick in the use of surgical staplers for internal use – not just to close external incisions – and announced it was working on several initiatives to increase the safety of their use.
Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, the agency said, especially after the recall of certain staplers last year.
In its letter of March 8, 2019, the FDA said it planned to draft new labeling recommendations for stapler manufacturers and to hold a public advisory committee meeting to discuss, among other things, reclassifying the devices in order to exert more control over their testing and labeling.
In April of this year, the agency formally proposed the reclassification. The matter is still pending.
The FDA classifies medical tools and devices based on their potential danger to patients. Currently, surgical staplers are classified as Class I devices. Other Class I devices include tongue depressors and surgical trays. These devices are deemed to be of minimal risk to patients. As surgical staplers have the potential to cause life threatening injuries, the FDA may change the classification to Class II or Class III. Items in these classes are subject to stricter regulation than items in Class I.
Injuries Caused by Surgical Staplers
Internal surgical staplers are a tool of efficiency. Using them to secure and connect tissue and organs can take significantly less time than traditional internal suturing, and that means patients have shorter procedures and are exposed to less anesthesia. Conversely, the staples and staplers can fail.
Between January 2011 and April 2018, the FDA said it received in excess of 41,000 public individual medical device reports documenting the internal use of surgical staplers and staples. The outcomes of those cases included 32,000 malfunctions, more than 9,000 serious injuries, and 366 deaths. When the agency took “nonpublic” reports into account, the total number of injuries and malfunctions rose to 110,000, Kaiser Health News revealed.
The secret database may have made it difficult for doctors and patients to make informed decisions on whether to use these medical devices. According to doctors who experienced issues with surgical staplers, looking through medical databases to find out if these malfunctions were common yielded few results.
Patients have also described feeling alone due to the secrecy surrounding stapler malfunctions. One woman who spoke to the Tampa Bay Times recalled feeling like the only person who had gone through what she had. After surgical staples that were used to seal her colon during surgery failed, she suffered from a colon leak which required additional surgeries and a prolonged recovery.
She decided to file a lawsuit against the manufacturer of her staples after it was revealed that a database full of surgical staple injury cases had been hidden from public view. Had it been known that surgical staplers had the potential to cause life threatening injuries and potentially wrongful death, she and other patients may have chosen another surgical method.
Among the most common and least serious of the reported malfunctions and injuries are “opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue),” the FDA’s letter said.
Even simple malfunctions can lead to longer surgical procedures and in some cases necessitate additional surgical interventions. Those, in turn, put patients at greater risk for bleeding, infection, sepsis, damage to internal tissue and organs, the recurrence of some cancers, and death, the agency noted.
“Often used in minimally invasive surgeries, [staples] are meant to both cut tissue and vessels and then quickly seal them,” the article by Kaiser Health News said. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.
Ethicon Stapler Recall
Ethicon, a Johnson & Johnson subsidiary, is one company that has been subject to multiple surgical stapler recalls over concern of surgical staple injury. Several cases of reported surgical staple injury prompted the FDA to announce a Class I recall – the most serious class of recall – of several surgical staplers manufactured by Ethicon in October 2019. The FDA posted the recall notice on its website.
Most recently, four of Ethicon’s Echelon Flex Endopath staplers were recalled due to a potential flaw in the jaw of the device that could lead to malformed staples, the FDA said.
Mass Device explained how Ethicon is handling the alleged defects associated with the Ethicon Echelon Flex Endopath 60mm staplers. According to Mass Device, the recall affected other countries in addition to the United States, such as those in Europe. Reportedly, Ethicon related a statement notifying the public that the defective staplers were distributed in Germany, Luxembourg, Switzerland, Denmark, the Netherlands, and Belgium. The news source says those included were manufactured from August 1, 2019 on.
Ethicon has since halted the production of defective lots, and has since taken steps to identify the source of the defect and figure out how to prevent it from occurring again.
The October recall came on the heels of another class I recall of Ethicon staplers issued in May 2019, the regulator society reported.
The previous recall of Ethicon surgical staplers involved a different kind of device. Where the Echelon Flex Endopath are linear staplers, the previously recalled staplers are circular staplers. The circular staplers that were subject to Class 1 recall were the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and the Endo-Sugery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples.
According to the FDA, an investigation into the alleged issues with the circular staplers indicated that the problems could have been associated with a change in the manufacturing process for the devices. This change to the process reportedly led them to produce malformed staples, which could cause injury to patients, explains the FDA. Reportedly, the change was implemented in March 2018, and the new process was in use through March of the following year. There were 94,496 devices included in that recall.
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