Surgical staplers are generally made of plastic and loaded with a disposable cartridge of surgical staples. The staplers come in both reusable and disposable models. They resemble construction or industrial staplers and are designed to insert and close several staples at once.
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The devices may be used internally to seal tissue during surgery. They are useful in minimally invasive surgery because they require only a narrow opening and can quickly cut and seal tissue and blood vessels. Skin staplers are used externally to close skin under high tension, such as on the skull or the trunk of the body.
Surgical staples offer several advantages over sutures.
Surgical staplers are frequently used to close incisions in the abdomen and uterus during Cesarean deliveries, or C-sections, since the staples allow women to heal faster and reduce scar tissue. Surgeons may also rely on surgical staplers when removing part of an organ or cutting through organs and tissue inside the body.
They are also used to connect or reconnect internal organs within an organ system. The devices are frequently used for surgeries involving the digestive tract, including the esophagus, stomach and intestines, in which a portion of these tube-like structures have been removed and the remaining portions must be reconnected.
Patients must pay special attention to medical staples in the skin to avoid infection. A study reviewed the surgical site infection rate of wound closure using staples versus sutures in elective knee and hip arthroplasties. The researchers found a significantly higher risk of surgical site infection in patients with staples compared to sutures.
Always follow your doctor’s instructions and do not remove any dressings until it’s safe to do so. Rinse the site twice daily to keep it clean. Your doctor will tell you how and when to dress the wound to prevent infection.
When to Call Your Doctor About Surgical Staple Complications
Surgical staples usually remain in place for one to two weeks, depending on the type of surgery and the placement of the staples. In some cases, internal staples may not be removed. They are either absorbed or become permanent additions to hold internal tissue together.
Removing surgical staples from the skin is generally not painful. But they should be removed only by a doctor. Never attempt to remove surgical staples on your own.
Removal requires a sterile setting and a specialized surgical staple remover or extractor. The device spreads one staple at a time, allowing the doctor to gently work it out of the skin.
Usually, a doctor will remove every other staple, and a second appointment is scheduled to remove the rest if the wound has not completely healed.
Surgical staplers work by compressing tissue, connecting two pieces of tissue with staggered rows of B- shaped surgical staples and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.
There are various designs for different types of surgeries, with most categorized as either linear or circular.
When using linear staplers, the surgeon uses the handles at one end to close the “jaws” of the stapler at the other end over the tissue. When the surgeon fires the stapler, a row of staples binds the tissue together and a blade cuts the tissue between the staples. The process seals the open wound to prevent bleeding.
Linear staplers are used to connect tissue during minimally invasive surgeries or to remove an organ. Circular staplers are often used for surgeries involving the digestive tract from the throat to the colon.
Circular staplers fire two staggered rows of staples from a circular cartridge. This circular layout allows the stapler to connect two sections of the intestine, or another tube-like structure, after a portion has been removed. The staples cause tissue to pinch up as rings or donuts between the staples. A built-in blade then slices off the overlaying tissue, sealing the new connection.
Surgeons watch the closed wound for about 30 seconds to make sure the tissue has been squeezed together properly and confirm that there is no bleeding.
Common materials for surgical staples include stainless steel and titanium. These are both strong metals that tend to cause few problems for patients in surgical procedures.
But plastic staples are frequently used for people with metal allergies or to reduce scar tissue.
Staples made from plastic or metals don’t dissolve like many sutures, so extra attention must be paid to prevent infection.
Staples made from polylactide-polyglycolide copolymer are designed to be reabsorbed into the body. They are often used in cosmetic surgery because, like plastic staples, they result in less scaring.
Johnson and Johnson’s Ethicon division and Medtronic are the two largest surgical stapler manufacturers. Together, they produced about 80 percent of the stapler market in , according to an analysis by Future Market Insights. 3M also manufacturers skin staplers sold in the United States.
The devices accounted for close to $2 billion in revenue for manufacturers in , with most sold in North America.
Surgical Stapler Manufacturers and Select BrandsJohnson & Johnson subsidiary Ethicon recalled 92,496 surgical staplers in April over concerns that they might not fire with enough force to completely form staples.
The U.S. Food and Drug Administration branded the recall as a Class I recall, the FDA’s most serious type. The agency warned in a statement that the devices could cause serious injuries or death. Some people who have been injured by malfunctioning devices have suffered serious injuries and filed surgical stapler lawsuits.
The recall affected two models of the company’s Endo-Surgery Intraluminal Staplers used in gastrointestinal tract surgeries.
Ethicon reported that two patients had been injured by the devices, according to the FDA. In both cases, the devices misfired, cutting portions of the rectum. Misfires or other malfunctions can prolong operations or require doctors to perform unplanned surgery to correct the damage.
The FDA warned that the misfires could increase complications from surgical staplers, including the risk for bleeding, infection, permanent damage to organs.
In , Ethicon recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads. The devices were used in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries.
The company reported that an inspection had found the surgical staplers’ cartridges may not insert a complete line of staples when fired.
Medtronic issued two recalls of its Endo GIA staplers and staple cartridges from select production lots, or batches, in and . Both recalls involved possible missing components. The company said the defects could affect staple alignment and lead to serious complications.
At least five people were injured by staplers included in the recall, according to the company. The recall involved defects in staple cartridges that were spotted during the manufacturing process. The company reported “no confirmed complaints” about the devices from doctors or patients.
The U.S. Food and Drug Administration began tightening restrictions and reporting safety concerns over surgical staplers in . It issued new guidance for using the devices to doctors and hospitals, took steps to reclassify certain surgical staplers from low- to moderate-risk devices and reported tens of thousands of previously unknown cases of stapler malfunctions and injuries.
The new classification would require premarket review and clearance of the devices from the FDA before manufacturers could sell them.
The FDA actions followed a series of surgical stapler problems coming to light earlier in . Kaiser Health News reported that more than half of all surgical stapler malfunctions from through , 56,000 of them, had been reported to a hidden FDA database instead of a database accessible by the public.
The FDA consolidated the two databases so all the reports could be viewed by the public. The total number of reported surgical stapler malfunctions over the eight-year period rose from 41,000 to nearly 110,000.
Surgical staplers are medical devices that may be used in place of sutures to close surgical wounds or incisions. The staplers themselves are often made of plastic and can either be disposable or reusable. However, they don’t look like regular office staplers. Instead, they’re similar in appearance to commercial-grade construction staplers. As for the staples, they’re often made out of either steel or titanium for maximum strength.
In general, surgical staplers are used for larger surgical wounds both internally and externally that stitches may not be able to handle. The C-section is a common procedure for which surgical staples are used, as it may help reduce scar tissue and healing time. Staples may also be used to connect or reconnect organs within an organ system — such as after removing a part of the digestive tract to reconnect it.
Some doctors prefer staples over sutures, arguing that they are faster (staples are placed instantly) and easier to use than sutures. The FDA also lists low infection risk and minimal tissue reaction as advantages of this method. Additionally, surgical staple strength may offer advantages for larger surgical wounds.
Caring For Surgical Staples
Surgical staples must be removed (discussed below). However, they remain in your body for up to two weeks, depending on the procedure.
Caring for surgical staples correctly during this time is vital to healing properly and minimizing the chance of complications occurring.
Surgical Staple Removal
Unlike sutures, the body does not absorb most surgical staples (excluding the polylactide-polyglycolide copolymer staples). Internal staples are sometimes designed to be left inside the body permanently, or an absorbable type of staple is used.
Aside from these cases, a doctor must remove the staples after sufficient healing has occurred. Removal is usually not painful, but patients should not attempt to do so themselves. Removal must be performed in a sterile environment, and doctors use a special tool to remove them.
Despite the benefits of surgical staplers discussed above, patients may encounter numerous problems during the staple application, post-op recovery, or removal. These include:
Opening of the wound
Poor staple application (too much or too little force)
Incorrect staple placement location
Jammed, misfired staple, or failure to fire a staple
Damaged, broken, or malformed staples
Using incorrectly-sized staples given the application
Failure to remove a staple that is designed to be removed
Allergic reaction to staple material
Any of these and other problems could increase recovery time and pain during recovery at best. At worst, they expose the patient to significant health risks.
Given the potential problems posed by surgical staplers, they can lead to numerous serious injuries. This is especially true considering that surgical staples are often used inside the body. Even the smallest error could have a dramatically negative impact on the patient.
Some major and even life-threatening complications surgical staples may contribute to include:
Allergic reactions to staple material
Blood clots
Fistula
Infection/sepsis
Internal organ or tissue damage/tearing
Internal bleeding
Despite the various risks and problems surgical staples can post to patients, the FDA currently considers surgical staplers for internal use as Class I (low-risk) devices (although that may change). This is the lowest-risk category of medical devices.
To put that into perspective, surgical staplers are in the same class of tools as bandages, tongue depressors, and non-electric wheelchairs. To be fair, handheld surgical instruments generally fall under Class I. However, the number of reported surgical stapler/staple malfunctions, injuries, and even deaths make some question why the device is still in Class 1.
41,000 adverse events pertaining to surgical staplers and staples were reported to the FDA’s database from January 1, , to March 31, :
366 deaths
Over 9,000 serious injuries
Over 32,000 malfunctions
However, on March 7, , Kaiser Health News (KHN) reported that the FDA withheld valuable information from the public — and even from doctors — regarding negative incidents pertaining to medical devices, including surgical staples. It turns out that the total number of surgical stapler incidents from - totaled 110,000.
The FDA has proposed reclassifying surgical staplers from Class I to Class II in light of these issues. Such a reclassification would require special controls surrounding the use of these devices. Additionally, the FDA would have to perform a premarket review of any new surgical stapler or staple product before the manufacturer can begin selling it.
Surgical Stapler Manufacturers
Here are the big surgical stapler manufacturers:
Covidien (part of Medtronic)
Ethicon US (part of Johnson & Johnson)
3M
B. Braun Melsungen AG
Cardica
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Care Fusion Corporation
CONMED
Frankenman International
Meril Life Science
Purple Surgical
Smith & Nephew
Stryker
U.S. Surgical
Welfare Medical
Reach Surgical
Zimmer Biomet
Here are some major surgical stapler recalls, along with the reason for the recall:
– Echelon 60mm Endoscopic Linear Cutter Reloads Black (Manufactured by Ethicon)-Potential for reload damage that could cause staples to misfire
– Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads (Manufactured by Ethicon)-It was discovered that some staplers may not always insert a full line of staples when the device is fired
– EEA Hemorrhoid and Prolapse Stapler Sets With DST” Series Technology (Manufactured by Medtronic)-Potential for improper welding of the yellow staple guide to the instrument, which can result in improper staple formation and subsequent injury.
– Endo GIA “Auto Suture” Universal Articulating Loading Unit (Manufactured by Medtronic)-Missing components that could affect staple alignment contribute to injuries in five patients.
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– Endo GIA Articulating Reloads with TriStaple Technology (Manufactured by Medtronic)-Staplers had missing components that could affect staple alignment in devices.
– Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples, Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples (Manufactured by Ethicon)-Device can misfire and injured two patients.
Here are some major lawsuits initiated and won by plaintiffs over surgical stapler issues.
$5 Million in Damages For Wrongful Death Related
In , a Pennsylvania family brought a lawsuit alleging that one of their loved ones died because a surgical stapler failed to seal the surgical area properly during a gastric bypass procedure.
The jury in the case awarded $5 million in damages to the family.
$80 Million Awarded in Stapler Misfire Case
A California woman named Florence Kuhlmann and her husband John Perkins brought a lawsuit alleging a stapler misfire led to injuries that required two weeks of hospital care and permanent colostomy bag use.
The jury awarded Kuhlman $80 million in total — $70 million of which were punitive damages.
$5.5 Million Settlement For Wrongful Death Related to Surgical Staplers
A man named Ryan Strange sued several parties for the death of his wife, April Strange, after she underwent surgery where a surgical stapler was used:
Memorial Medical Center in Springfield, Illinois
Southern Illinois University School of Medicine’s group practice doctors
Covidien (now part of Medtronic)
The surgical staples used failed to properly seal the wound and cut a blood vessel, which caused April to lose a substantial amount of blood and eventually die.
All parties agreed to share in the $5.5 million settlement, with Covidien paying $250,000.
Medical device manufacturers are required to meet specific safety standards in the design, manufacture, and use of their products to protect both medical practitioners and patients. If they fail to do so, they can be held legally liable by individuals who experience injury from the manufacturer’s device.
Here are some potential monetary damages you may be awarded in a successful surgical stapler injury lawsuit:
Lost wages
Lost ability to earn future income
Loss of consortium
Loss of enjoyment of life
Past and future medical expenses
Pain and suffering
Funeral expenses for stapler injury-related deaths
Punitive damages won from the manufacturer
Keep in mind that lawsuits about surgical staplers and staples have statutes of limitations. This means you have a limited time under which the law allows you to file a suit after either the injury occurs or you become aware of that injury. You will not be able to pursue a lawsuit once this statute of limitations expires.
Statutes of limitations vary by state. Make sure you know the statute of limitations in your location, and, if you believe you have a case, contact a surgical staple injury attorney right away to avoid missing the statute of limitations deadline.
Has a surgical stapler injured you or a loved one? You might have a surgical stapler case. At a minimum, you want to work with a lawyer experienced in personal injury and defective product lawsuits. Some attorneys have experience and good track records, specifically with surgical lawsuits as well.
With this in mind, spend some time talking with each attorney you come across. Ask them as many questions as you need to make a decision. Doing so will help you feel more confident in your ability to win your case and maximize your compensation.
Once again, remember that these suits have statutes of limitations. If you think you have a case, don’t hesitate to look for an attorney right away.
Surgical disposable staplers and staples are medical devices that can be used in place of sutures. They allow faster closure of large wounds or incisions and are less painful for the patient than sutures. They can also be used to close wounds in areas where the skin is close to the bone and for procedures that remove organs or reattach parts of internal organs.
They are useful in minimally invasive surgery because they require only a narrow opening to quickly cut and seal tissue and blood vessels. Skin sutures are used externally to close the skin under high tension, for example on the skull or body trunk.
What are surgical staples made of
Common materials used for staples in surgery include stainless steel and titanium. These are strong metals and tend to cause little or no problems for patients during surgical procedures.
However, plastic staples are often used for people who are allergic to metals or to reduce scar tissue. Staples made of plastic or metal do not dissolve like many sutures, so extra care must be taken to prevent infection.
Staples made from polypropylene and polyethyleneglycol are intended to be reabsorbed by the body. They are often used in cosmetic surgery because, like plastic staples, they reduce scarring.
How do surgical staples work
Surgical staplers work by compressing tissue, joining two pieces of tissue with interlocking B-shaped surgical staples, and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.
There are several designs for different types of surgery, most of which are classified as linear or circular. Linear staplers are used to attach tissue or remove organs during minimally invasive surgery. Disposable circular staplers are commonly used for procedures involving the digestive tract from the throat to the colon.
When using a disposable linear stapler, the surgeon uses a handle on one end to close the "jaws" of the other end of the suture on the tissue.
The circular stapler fires two interlocking rows of staples from a circular cassette. This circular layout allows the anastomosis to connect two sections or another tubular structure after a portion of the intestine has been removed. The staples allow the tissue to be sandwiched between the staples to form a ring or doughnut. The built-in blade then cuts away the overlying tissue and seals the new connection.
The surgeon observes the closed wound for approximately 30 seconds to ensure that the tissue has been properly squeezed together and to confirm that there is no bleeding.
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The surgical stapler most likely has a European history. To prevent spillage of bowel contents during abdominal surgery, the Hungarian surgeon Hümer Hültl developed the first known surgical stapler together with the engineer Victor Fischer in (Fig. 1)1,2.
The stapler consisted of U-shaped steel wire staples. After stapling, the tissue had to be cut. The staples did not completely close to prevent tissue necrosis, but were left in a B shape after stapling to allow tissue perfusion. The Fischer–Hültl stapler took 2 h to reload with individual staples and weighed about 5 kg. The first operation using this stapler was a subtotal gastrectomy for gastric cancer. In , Aladar Petz, who was trained by Hültl, developed a lighter version that used nickel–silver alloy staples and weighed 1 kg (Fig. 2)3.
The Petz stapler gained in popularity and became the most used stapler for the next 40 years. An important modification was made by the German surgeon Friedrich, who developed replaceable cartridges preloaded with staples in . Here, an exchange system comparable to that of surgical blades developed by Morgan Parker, as described earlier in this series, was introduced4.
In World War II, Vasilii Kolesov worked as a military surgeon during the siege of Leningrad5. His hospital had a high caseload owing to the numerous war injuries, and was often confronted with vascular injury. To decrease procedure time, the engineer Vasilii Gudov developed a vessel stapler to anastomose blood vessels (Fig. 3)5,6.
Kolesov eventually used this device in coronary artery surgery. In addition, it was often used in animal experiments and laboratory settings. However, the vascular stapler was not practical to use and needed more vessel length in comparison to a sutured end-to-end anastomosis.
Staplers become more popular in the Soviet Union, and several models were developed for vascular anastomoses, parenchymal resection, and gastrointestinal anastomoses1.
It was Mark Ravitch who brought surgical stapling from the Soviet Union to the USA. Ravitch was a New York-born surgeon and son of Russian immigrants. In , a group of American surgeons, including Ravitch, visited Kiev to learn about Russian blood banking principles. Here, Ravitch met Nikolai Amosov, head of a thoracic surgery department. When shown movies of pulmonary resections, Ravitch saw stapled bronchus resections and metal staples on postoperative chest X-rays. Ravitch requested the staplers used, but was refused. Eventually he bought several models of surgical stapler in a store in Leningrad and started using them to close bronchial stumps2.
In Leon Hirsch, a businessman who collaborated with Mark Ravitch, founded the United States Surgical Corporation. Based on the staplers from the Soviet Union, they added improvements such as linear cutting and circular stapling, and developed the thoracoabdominal (TA) stapler and gastrointestinal anastomosis (GIA) model under the brand name Auto Suture™ (Fig. 4).
Fig. 4
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Latest models of thoracoabdominal and gastrointestinal anastomosis staplers7
These staplers gained in popularity and the company grew. Interchangeable cartridges with different sizes and heights of staple specifically for the tissue stapled were introduced. With the rise of laparoscopic surgery, stapling technology further developed, and automated firing and powered stapling was added (Fig. 5).
Fig. 5
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Endostapler for use in tissue division and anastomoses in thoracolaparoscopic surgery.
The stapler is battery-powered and uses automated firing8.
From an environmental perspective, staplers are made from disposable materials and equipped with single-use batteries. Recently, more attention has been given to the concept of reusing materials, and reusable staplers may possibly become more popular again. Several projects have been initiated to reuse individual components of staplers.
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