Surgical Staplers and Staples

Surgical staplers for internal use are used to deliver staples to tissues inside the body during surgery for:

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• Removing part of an organ (resection)
• Cutting through and sealing organs and tissues (transection)
• Creating connections between structures (anastomoses)

Surgical staplers and staples for external use are used outside the body to close large wounds or surgical cuts on a patient's skin or scalp.

Advantages of surgical staplers and staples include:

• Quick placement
• Minimal tissue reaction
• Low risk of infection
• Strong wound closure

Are there problems associated with surgical staplers?

Yes, the FDA describes problems that have been reported in letters to healthcare providers, issued in March 2019 and October 2021, in which the FDA also provides several recommendations and new FDA actions regarding the safe use of surgical staplers and staples for internal use. Due to the increased number of adverse events reported to the FDA, the agency held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on May 30, 2019 to discuss reclassification of surgical stapler devices for internal use from Class I to Class II.

To help protect patient safety and reduce the number of malfunctions, injuries, and deaths associated with the use of surgical staplers for internal use, in October 2021 the FDA issued:

• A final order to reclassify surgical staplers for internal use from Class I to Class II medical devices. Classification of surgical staplers from a Class I to a Class II device subjects these devices to the requirement to submit a premarket notification (510(k)) and to mandatory special controls.
• A final guidance, "Surgical Staplers and Staples for Internal Use - Labeling Recommendations," to help manufacturers develop labeling with information about specific risks, limitations, and directions for safe use of the devices.

The FDA continues to monitor the safety profile for surgical staplers and staples. In addition, the FDA continues work with hospitals and professional societies to encourage training and education to support the safe use of these devices.

How can I report a problem with a surgical stapler or staples?

Consumers can report serious adverse events or other problems related to surgical staplers and other medical devices through the FDA's MedWatch Program.

Manufacturers, hospitals, and other user facilities must report deaths, serious illness, and injuries associated with the use of medical devices.

 

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.

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Assistive Equipment

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

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.

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.

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