Surgical staples are critical tools for surgeons, used often during minimally invasive operations to replace older style sutures in closing incisions.
But some patients, like Angelo Paolozzi, are alleging in class-action lawsuits that sometimes, these staples can lead to further complications — a risk he believes more people should know about.
The 56-year-old says the staples used to hold his bowel together after a surgery for diverticulitis -- the inflammation of pouches in his intestines -- failed, triggering a life-threatening infection.
“I was starting to get a fever,” he told CTVNews. “I was very distended, so everything was filling in to my cavity, my stomach cavity.”
In order to solve the problem caused by the staples, he had to go into emergency surgery. He said that a doctor told him, “If we don’t operate tonight, you might not be here tomorrow.”
He ended up having to spend a month in hospital – but survived.
“I was angry at the same time as being sad and upset and scared, as I didn't know what was happening to me,” he said. "I'm in a bed with all these tubes in me and I'm cut right open and I had a colostomy bag at that point because they had to put one in — I wasn't expecting anything like that.”
There have been more than 1,100 reports to Health Canada about internal surgical staple malfunctions, linked to injuries, bleeding and other complications requiring additional surgery and even deaths in some cases.
But Paolozzi said it took him more than a year to figure out that staples were even the cause of his infection.
“My wife looked at all the medical records,” he said. “We wanted answers and that's where we saw that it stated that 80 per cent of the staples let go, and that is what caused all the everything to come out of my intestine into my stomach.”
He says people need to be more aware that this can happen.
He has filed a class-action lawsuit alleging the device used in his surgery didn’t "eject or properly close,” and that the maker, Covidien, which is owned by Medtronic, failed to adequately warn physicians or consumers of the risk.
And he’s not the only one who has experienced this.
Lois Ruscheinski is the plaintiff in a similar B.C. class-action lawsuit.
A surgical stapler was used during her hernia repair surgery in 2017. Shortly after her procedure, her blood pressure dropped and her blood count was low -- indicating she was bleeding internally.
She was rushed into emergency surgery, where doctors discovered that the staple line in her bowel had opened and she was bleeding from multiple locations.
She had to get three units of blood and had to stay in hospital for several days.
“Anything could have happened, and yeah, I think I could have died from this and it was kind of scary,” she told CTV News in a phone interview from her home in Surrey, B.C.
Lawyer Jill McCartney told CTV News that she has seen more examples of people suffering injury after staples were used in a surgery.
“Sometimes when people contact us, they've had additional surgeries because they've had to go back in after a surgery, or something's gone wrong and had to do repair work,” she said.
And the effects can be huge.
“We're seeing people with significant pain, people with significant hospitalizations and people having to have multiple surgeries to try to address these problems. And in the end, they're often left with ongoing problems of pain and scarring and far more invasive procedures than they had anticipated at the outset.”
There have been several voluntary surgical staple recalls in Canada in recent years, with the U.S. Food and Drug Administration (FDA) also reporting so many cases involving "serious injuries, [and] patient deaths” linked to device malfunctions.
Two months ago, it reclassified the staplers as a higher risk device and ordered companies to conduct more testing. The agency also outlined more recommendations for health-care providers to cut down on adverse events associated with surgical staples.
But experts caution millions of surgeries are safely done with staples. And they’re improving all the time.
“It's really important to know that surgical staplers are used routinely every day throughout the country, throughout the world,” Dr. David Urbach, surgeon-in-chief and medical director of perioperative services at the Women's College Hospital, told CTV News.
“There are tens of thousands of people having surgery using surgical staplers for internal use. And by and large, they're very, very reliable, and they're very useful for surgical procedures.”
He said that just like any tool, they can occasionally misfire or not seal off tissue reliably, and that usually surgeons can recognize an issue at the time of surgery and correct it before a problem develops.
“But it's important to know that complications can occur after any type of surgery, even when devices do function properly,” he added.
“I think surgeons and other health care providers who use medical devices like surgical staplers really benefit from knowing some of the pitfalls and some of the details about how they can be used most effectively, [and] most safely.”
Medtronic, the maker of Paolozzi’s device, responded to CTV News in an email.
“The safety profile of Medtronic’s internal staplers has been established through decades of real-world use and study,” the company stated. “Complications are infrequent and in most cases are related to inherent risks associated with the underlying surgical procedure. We will defend this lawsuit in court.”
The maker of Ruscheinski’s device, Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, also responded in an email.
“We have received the notice of civil claim filed with the Supreme Court of British Columbia and will vigorously defend this matter,” the statement reads. “Patient and product safety is the top priority for Ethicon. Surgical staplers are widely used in the operative care of patients to improve surgical outcomes. Ethicon adheres to high quality and safety standards in surgical stapler development. Surgical staplers are safe and effective when used in accordance with their instructions for use.”
Paolozzi said he understands that staples are an important tool for surgery.
“Staples is the proper procedure to do it as long as it's a proper product and it's done properly,” he said. “I don't see an issue with using staples in the future.”
Who he blames for his situation is the company behind the staples used on him.
“They should be held responsible if a company is selling a product […] and stating that it's good for all surgeries,” he said.
As part of the lawsuit, he and his wife are seeking special damages in the amount of $500,000 for every person who has undergone a surgical procedure using the company’s staples.
He wants to talk about his case to raise awareness, since it took him so long to discover that staples caused his complications.
“I didn't know until about a year and a half ago, roughly,” he said.
He added that the doctors advised him before the original surgery that there may be issues if they accidentally hit the intestine during surgery, but there were no warnings about the staples themselves.
“I am on the mend, but I'm always constantly going to have issues,” he said.
“I’m always going to have pain throughout my life. It's never going to go away.”
If other patients are in the dark about what caused their post-surgical complications, he hopes his story can help by drawing attention to this common medical device.
“I want it to be out there,” he said. “So this way if they've had the same [experience] or something similar, at least they can investigate more.”
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