Surgical staplers are used in gastrointestinal surgeries across the country. In fact, they have been in use for over half a century. However, over 92,000 of them have been recalled recently due to documented evidence of their causing significant injuries and death.
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Injuries linked to surgical staplers include internal organ damage, uncontrolled internal bleeding, and infection, all potentially life-threatening.
It’s clear that the use of surgical staples can present dangers to patients. The U.S. Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) data indicates that over 41,000 adverse event (AE) reports were received between and the end of March . In it, there are 32,000 reports of surgical staplers malfunctioning, and 9,000 serious injuries to patients caused by surgical staplers. Over 350 fatalities have been reported.
Even more disturbingly, those reports don’t include more than 56,000 reports submitted to the FDA in the same time frame. These reports only became public knowledge when Kaiser Health News reported on their existence.
As a result of the Kaiser Health News report, the FDA announced that it will be reviewing surgical stapler safety.
Surgical staplers are used to close incisions and wounds, rather than sutures.
However, malfunctions, improper use, and defects in the design have apparently caused numerous patients to suffer injuries and complications after surgery. These can be long-term, permanent, or even require additional surgery and ongoing treatment to rectify.
Injuries associated with surgical staples include:
The AEs indicate that the most frequent malfunctions are:
Affected patients and their loved ones (if a patient has died) do have recourse. If you suffered an injury or complication due to issues with surgical staples, you can seek compensation for damages from the manufacturers via a legal claim.
Surgical staplers are manufactured by Ethicon (a division of Johnson & Johnson), 3M Corporation, Covidien, Stryker Medical, Tyco Medical Group, and U.S. Surgical.
Possible compensation for damages include:
Questions about whether you are eligible to file a surgical stapler lawsuit? If you or a loved one has been injured or suffered complications from the use of surgical staples, by any manufacturer, call Chaffin Luhana today. We are experienced in product liability law as it applies to surgical staples, and are dedicated to fighting for the rights of patients who have been victimized by defective medical products.
If you want to learn more, please visit our website medical staplers.
If you’ve been following medical device safety issues this year, there’s a good chance you’ve seen the headlines about patient injuries and deaths related to internal surgical staplers. The devices are commonly used in many high-risk surgical procedures. Misuse and malfunction of surgical staplers can lead to serious complications—as we’ve seen during our own research and accident investigations.
The stapler cases we investigate tend to be associated with serious injuries or fatalities, some of which could have been prevented. The overall adverse event rate is low relative to the number of times staplers are used; however, cases of preventable death are chilling. This has led ECRI Institute to thoroughly research and evaluate staplers and to publish safety hazards to our members. In fact, surgical staplers have appeared twice on our annual list of Top 10 Health Technology Hazards— first in and again in .
So, why is this decades-old technology in the news now? And, more importantly, what can you do to keep patients safe?
A recent report by the U.S. Food & Drug Administration (FDA) summarized 109,997 problem reports submitted for surgical staplers and staples since . This figure includes reports submitted to FDA's publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database, as well as those submitted to its "hidden" Alternative Summary Reports (ASR) database.
Of these, there were 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. Also in this report were results from a systematic literature review including 207 surgical stapler studies on malfunctions during use—some of which resulted in hemorrhage and/or conversion to an open procedure.
The considerable evolution of surgical staplers over recent years and the uncovering of these reports prompted the FDA to consider reclassifying the devices. FDA convened a Medical Devices Advisory Committee meeting in late May, and invited me to present ECRI Institute’s surgical stapler surveillance data to a panel of independent experts.
The outcome was agreement that internal surgical staplers should be reclassified as Class II devices, instead of the more lightly regulated Class I. Accordingly, FDA has begun identifying "special controls" that can be shown to reduce risks with the use of surgical staplers—a necessary step for a device to be upclassified from Class I to Class II.
While this reclassification—and, more importantly, the implementation of effective special controls—should be a step forward to improve patient safety, this process will take time. Fortunately, hospitals and providers don't need to wait.
By understanding how staplers work, recognizing how complications occur, and involving various stakeholders in patient safety efforts, hospitals and providers can make a difference.
Staple and cut mechanism
Internal surgical staplers are available in different designs for different applications. Linear staplers, for example, are used to seal and transect (staple and cut) internal tissue during endoscopic surgical procedures, such as organ removals, as well as for bariatric and other gastric surgeries. Circular models are most commonly used for GI anastomoses.
Linear designs consist of a handle and shaft with jaws at the end that can be closed on the tissue of interest (picture the jaws of an alligator). The surgeon clamps onto the tissue and then fires the stapler. This action deploys rows of staples into the clamped tissue on either side of the intended cut line, followed immediately by a knife that transects the tissue in between those staple lines. In this way, the stapler seals the tissue on either side of the cut to prevent hemorrhage. Circular models, by comparison, include a circular anvil that is compressed against the end of a cartridge to seal and cut the tissue of interest.
Complications
Bleeding or GI leaks can occur if a staple line is incomplete or does not hold. Such problems may be immediately apparent, or they may not appear until sometime later, leading to severe symptoms long after the patient has been closed up and sent for recovery. Patient harm in these events can range from no injury to fatality. We've found that, in most cases, the stapler actually functions as intended. The adverse consequences instead result from clamping on another instrument or clip, clamping on tissue that is too thick or too thin, or some other form of misuse. Poor staple line integrity can also occur with diseased, necrotic, or ischemic tissue.
Four steps to reduce harm
Here are key recommendations that we advise hospitals and providers to take now.
Reclassification by FDA and the identification of special controls is a step in the right direction. But it is just a step; and FDA is just one of the stakeholders with a role to play. Manufacturers can continue to improve device designs, building in more "forcing functions" that reduce the risks of use. And healthcare facilities can implement measures like those outlined above to prevent patient harm.
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