Surgical Staplers and Staples – Surgery and Removal

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.

• They can be inserted quickly.
• They’re strong.
• They are easily removed with a surgical staple remover.
• They reduce the amount of time a patient is in surgery and under anesthesia.

When Are Surgical Staplers Used?

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.

Caring for Surgical Staples

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

• Bleeding enough to soak through the bandage
• Brown, green or yellow foul-smelling pus around the incision
• Change in color of the skin around the incision
• Difficulty moving in the area around the incision
• Dryness, darkened skin or other changes around the site
• Fever of 100 degrees or higher for more than 4 hours
• New, severe pain
• Cold, pale or tingling skin near the incision site
• Swelling or redness around the incision

Removing Surgical Staples

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.

How Surgical Staplers Work

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.

What Are Surgical Staples Made Of?

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.

Surgical Stapler Manufacturers

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 Brands

Ethicon

Echelon series, Contour Curved Cutter, Endo-Surgery series, Proximate series

Medtronic

Signia Stapling System, Endo GIA series of staplers, iDrive Ultra Powered Stapling System, DST series, Premium Plus CEEA Staplers, Appose Single Use Skin Stapler, DFS Single Use Fascia Stapler, Roticulator series, DST Single Use series, ILA series, GIA Single Use and Reusable series

Surgical Stapler Recalls and Injuries

Johnson & 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.

FDA Actions on Surgical Staplers

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.

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Clinical Exercise: Scalp Laceration (stapling)

Scenario:

Following a bus collision several dozen injured patients are transported to shock trauma and the emergency department. Many of the injuries consist of lacerations from sharp edges of metal and glass during the collision including several with deep scalp lacerations bleeding profusely. 

Diagnosis/Considerations:

You recognize that for most minor wounds suturing provides for the two primary goals, hemostasis and achievement of a functional scar that is cosmetically acceptable.

Staples are an acceptable alternative for linear lacerations through the dermis that have straight, sharp edges and are particularly well suited for scalp lacerations. The closure of scalp wounds with staples is faster than sutures with similar outcomes when compared to sutures (indistinguishable infection, healing time, and cosmetic outcomes compared to sutures). However, since meticulous skin positioning is not readily achievable with staples, injuries involving the face should be closed with sutures. Additionally, due to patient discomfort injuries to hands and feet are also typically not closed with staples.

Because staples may be placed more rapidly than sutures and eliminate the risk of needle stick injury which is elevated in the busy environment of a multiple casualty event, you decide that the patient's scalp wound is best addressed using a skin stapler.

Mechanism:

The goal is to bring the edges of the cut tissues close together to promote healing and provide sufficient security across the opening to achieve hemostasis.

Modern surgical staplers consist of disposable plastic dispensers that can deliver single staples either with a low profile head (usually for skin) or a long endoscopic head that can be articulated (to allow reaching deep structures through a small opening). For a scalp laceration a low profile head provides suitable access.

The use of a skin stapler involves light compression of the skin on each side of the laceration with forceps in order to bring the edges into continuity. Pressure slightly elevates the skin edges of the laceration for the staple to penetrate.

Treatment (perform these steps on the donor in a mock-procedure):

PREPARATION: Send a member of your team to the instrument supply tables to fetch one 35-staple skin-type disposable dispenser and one staple remover, which looks like a small white handle scissor-like instrument (please take only the supply numbers indicated to ensure sufficient supplies are available for all tables).

In a living patient, the skin on each side of the laceration would be anesthetized using topical (e.g. lidocaine-epinephrine-tetracaine [LET] gel) or an infiltrate analgesic (e.g. isotonic buffered lidocaine). In our donor we will skip this step.

1) Open the sterile stapler packet, observing the staple delivery and trigger ends of the device.

CAUTION: exercise care when handling staplers to prevent stapling parts of your hand or body. 

Note, it is difficult for one person to staple an incision. Typically, one person will use forceps to control the edges of the laceration to bring them into contact (i.e. reapproximate the edges) while the second person utilizes the stapler.

In a living patient, the skin is controlled using mouse-tooth forceps (i.e. the 'toothed' end forceps style), but with the higher density of tissue in an embalmed donor you may need to use a hemostat (hemostats may damage living tissue).

2) The first person should use forceps, or a hemostat if needed, to position the edges of your prior scalp incision into continuity (i.e. pressing the edges together) applying light pressure so that the skin bulges slightly on each side of the incision.

3) The second person should then position the stapler across the incision site close to the forceps tips, such that the cut edges of the tissue are positioned against the 'gap' in the dispenser from which the staple will be delivered.

4) Squeeze smoothly and firmly on the dispenser trigger and then release.

A staple should have been expelled with one arm of the staple penetrating the tissue on each side of the incision and holding the edges together.

5) Repeat the process approximately 3-5mm along the incision.

Each person should use only 3-4 staples evenly spaced. Each stapler holds only 35 staples and everyone in the team should have the opportunity to use the instrument and be the skin control person. If the stapler runs out, there are several additional at the supply table

Scenario (addendum):

As you place the staples you realize that one of them has been incorrectly positioned and is gripping only one side of the incision. Leaving the incorrectly placed staple in place would interfere with another staple in that location and could cause a weak point that may continue to bleed. Thus, you need to remove the incorrectly placed staple and re-staple securely in that location.  

Treatment (continued):

7) Identify the two sides of the staple remover teeth.

One side will be a flat ring-like structure, with the other side a vertical arm that will pass between/inside the ring. The device operates by bending the center bar of the staple which pulls the ends smoothly out of the skin.

8) Insert the flat ring-like side of the instrument deep to the staple.

9) Close the scissor arms of the instrument which will reform the staple such that it can be lifted out.

Note, the reforming bends the staple into an 'M' so the penetrating arms of the staple are now straightened and slide easily out.

NOTE: when finished suturing ensure that any removed staples are collected into one of your trays and transported to the sharps containers for safe disposal.

Return the staple remover and stapler (if any remain inside it) to the supply table.

Outcome:

The staples are neatly performed and the bleeding is controlled in this patient. You apply light antibiotic ointments to the laceration area and left open to the air (scalp stapling is typically left open, while staples to torso/limbs are covered with sterile dressing). After 7-10 days for skin healing, the patient returns to their regular physician to have the staples removed.

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