Surgical staples: Uses, safety, and removal

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Surgeons use surgical staples to close an incision after surgery as an alternative option to sutures. They are quick and easy to use and typically have a low risk of infection.

During most surgical procedures, a surgeon makes an incision in a person’s skin. After surgery, they must close this incision to prevent infection and allow it to heal. Surgeons often use sutures or surgical staples to close an incision after surgery.

This article outlines what surgical staples are and lists their uses. It also details how long surgical staples remain in the body and how to care for them.

What are surgical staples? 

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Surgical staples are usually metal staples that hold together tissues in the body. Surgeons often use them as an alternative to sutures to close a wound after surgery.

The metals that most commonly make up surgical staples include titanium and stainless steel. However, other materials that sometimes make up surgical staples can include:

• iron
• chromium
• nickel
• plastic

Surgical staples may be different shapes, including:

• straight
• curved
• circular

Uses of surgical staples

Surgeons use surgical staples to close wounds or incisions on a person’s skin after surgery.

Some advantages of using surgical staples over sutures include:

• being quick and easy to place
• having minimal tissue reaction
• having a low risk of infection
• providing strong wound closure

A surgeon may use surgical staples to join tissues within the body. Sometimes, these staples may be permanent and will not require removal.

How long do they stay in the body?

A medical professional usually removes surgical staples around 10–12 days after the procedure. However, this can vary.

Several factors can affect how long the staples remain in the body, including:

• the size of the incision
• the direction of the incision
• the type of surgery
• the severity of the incision or wound
• the area of the body where the staples are present
• how quickly the wound heals

In some cases, surgical staples can offer wound closure 10 times faster than sutures.

How to care for surgical staples

It is important for a person to always wash their hands before and after they touch their incision.

The initial aim is to keep the incision and surgical staples dry. Avoiding activities that could cause dirt or sweat to enter their incision is also important.

A person can check with their doctor when they can bathe again. Until then, a sponge bath is advisable to avoid getting the incision wet. If surgical staples do get wet, an individual can pat rather than rub them dry.

A bandage will usually be in place to protect a person’s incision. It is important to leave this until a medical professional advises they can remove or change it. Usually, after the first 12 hours, a person may aim to change their dressing every 24 hours, or as advised by their doctor.

Once a person is able to get their incision wet, they can aim to clean it once a day by:

1. Washing and drying their hands.
2. Removing the bandage.
3. Washing the area gently with soap and warm water.
4. Using a wet cotton swab to loosen and remove any blood or crust.
5. Dabbing the area dry and applying a thin layer of antibiotic ointment.
6. Putting on a new bandage.
7. Washing their hands.

When washing the area, it is important to avoid products that contain hydrogen peroxide, as these can slow healing. A person may wish to cover their cut with a thin layer of petroleum jelly. They can then apply a nonstick bandage. Individuals should also avoid any activity that may cause the wound to reopen during healing.

Removal of surgical staples 

A person should not remove surgical staples at home — a medical professional will remove them using a staple remover tool in a hospital or medical setting.

In some cases, they may use local anesthetic such as lidocaine to help ease the pain of staple removal. Studies show that applying a lidocaine patch around the wound before removing surgical staples can effectively reduce pain.

Surgical staple procedure

Applying surgical staples often requires two medical professionals.

The first person will use a pair of forceps to align the edges of the skin. They will then ensure the proper closure of the wound.

The second person will then use a surgical stapler to apply the staples to the wound.

Risks of surgical staples

Surgical site infections (SSIs) are a possible risk of the use of surgical staples. SSIs are infections that can occur after a surgical procedure in the part of the body where the surgery took place.

A 2019 meta-analysis compared the risk of SSIs associated with surgical staples and sutures after orthopedic surgery. It concluded that there was insufficient evidence of a difference in SSI risk when comparing surgical staples and sutures after orthopedic surgery.

Other potential risks of surgical staples include:

• the opening of the staple line
• malformation of the staples
• misfiring staples
• misapplied staples

Staple and stapler malfunctions or misuse can result in prolonged surgical procedures or additional surgical interventions. In cases with deep internal staples to realign internal tissues, these can lead to other complications, such as:

• bleeding
• sepsis
• tearing of internal tissues and organs

These complications may also be life threatening.

Some people may have concerns regarding staples and scarring. However, while scarring depends on factors such as the individual and type of wound, staples are sometimes preferable as they can remove tension from the skin edge.

Additionally, staples can apply suitable pressure to manage bleeding. While staples can result in marks on the skin, the risks are typically low if a surgeon removes them within 10–12 days.

Summary

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Surgical staples are an alternative to sutures to close incisions after surgery. A medical professional applies these staples using a surgical stapler. They usually remain in the body for up to 10–12 days, but this can vary due to several factors.

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A person should not remove their staples at home. A medical professional should always remove surgical staples using a staple remover tool in a hospital or clinical setting.

Complications associated with surgical staples include the risk of surgical site infections (SSIs). However, studies show that surgical staples present the same risk of SSIs as traditional sutures. Other risks associated with surgical staples include the opening of the staple line, malformation of the staples, and stapler malfunctions or misuse.

Surgical staplers and staples are medical devices that may be used in place of sutures. They can close large wounds or incisions more quickly and be less painful than stitches for patients. They are often used in minimally invasive surgery. They can also be used to close wounds in areas where skin is tight against bone, in operations to remove organs or to reconnect parts of internal organs.

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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.

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 2022 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 2015, 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 2016, 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 2019 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 recalled more than 92,000 Endo-Surgery Intraluminal Staplers on April 11, 2019.

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 2015, 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 2018 and 2019. 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 2018 recall, according to the company. The 2019 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 2019. 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 2019. Kaiser Health News reported that more than half of all surgical stapler malfunctions from 2011 through 2018, 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.

Timeline of FDA Actions

• Jan. 1, 2011 to March 31, 2018

  The FDA received over 41,000 individual medical device reports to its public database for surgical staplers and staples for internal use. The reports included 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions.

• March 8, 2019

  The FDA sent a letter to health care providers expressing concerns about an increasing number of adverse events associated with surgical staplers and staples for internal use.

• April 11, 2019

  Ethicon recalled circular staplers for insufficient firing and failure to completely form staples. The FDA identified the recall as Class I.

• April 23, 2019

  The FDA issued a draft guidance to help manufacturers develop labeling with information about specific risks, limitations and directions for use of the device.

• April 24, 2019

  The FDA issued a proposed order that would reclassify surgical staplers for internal use from Class I (low risk) to Class II (moderate risk) medical devices with special controls.

• May 30, 2019

  The FDA held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate. (The advisory panel reportedly recommended switching the devices to a higher-risk classification with additional safety requirements.)

• May 30, 2019

  A Kaiser Health News report revealed that the FDA acknowledged that more than 56,000 additional surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018, bringing the total to 110,000 malfunctions or injuries during that time period.

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