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  and October , 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, 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 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.

What are surgical staples?

Surgical staples are used to close incisions after surgery. Staples may be a better option in some cases than stitches or sutures.

Unlike stitches, surgical staples don&#;t dissolve as your incision or wound heals. For this reason, they require some special care and must be removed by your doctor once the incision has healed.

How long do they need to stay in your body?

Surgical staples need to stay in for a few days or up to 21 days (in some cases) before they can be removed.

How long your staples must stay in place depends largely on where they&#;re placed and other factors such as:

• the size and direction of the incision
• the type of surgical procedure you had
• the complexity or severity of your incision or wound
• how quickly the area heals

For example, after a C-section, staples used to close a low transverse (horizontal across the body) incision may be removed after three to four days. But staples used in a vertical incision may not be removable for 7 to 10 days or more.

Several indicators that your surgical staples may be ready to be removed include:

• The area has healed well enough that staples aren&#;t needed anymore and the wound won&#;t reopen.
• There&#;s no pus, fluid, or blood drainage from the area.
• There aren&#;t any symptoms of infection.

Can you remove surgical staples at home?

Never try to remove surgical staples yourself at home. Always have a licensed medical professional remove staples.

Your doctor will follow special procedures and use specific tools in order to safely remove surgical staples without causing complications.

How are they removed?

The exact staple removal procedures your doctor uses will depend on:

• where the staples are located on your body
• what type of surgery you had
• whether they&#;re used inside or outside your body

It&#;s usually not painful when your doctor removes your surgical staples. You may feel a tugging or pinching sensation as each staple is removed.

When removing your surgical staples, your doctor will follow these general steps:

1. Remove any wound dressing or other materials covering the area.
2. Look for any abnormal symptoms or issues with the wound&#;s appearance.
3. Clean and sterilize the entire area with medical antiseptics.
4. Slide the lower part of a staple extractor tool underneath the outermost staple on either side of the stapled area.
5. Wiggle the staple gently side to side until it comes out of the skin.
6. Put the staple on a clean sheet of gauze immediately.
7. Repeat steps 4 to 6 on every second staple along the area until the end of the incision is reached. You may not have all your staples removed at a single appointment if the area is not fully healed.
8. Remove all remaining staples.
9. Put a sterile strip on each area from which a staple was removed.

Some staples may stay inside your body permanently. This is often done to keep internal organ tissues connected and resistant to further damage.

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When are surgical staples used?

Surgical staples are used to close surgical incisions or wounds that are too big or complex to close with traditional stitches. Using staples can decrease the time needed to complete surgery and can be less painful.

Staples may be simpler, stronger, and speedier to use to close large, open wounds than traditional stitches, and may be used after major surgery.

For example, staples are often used after C-sections because they help the incision heal faster while also reducing scar appearance.

How do I care for surgical staples?

After getting staples, the following steps will help keep them clean as you heal:

• Follow all postsurgical instructions from your doctor.
• Don&#;t remove any dressings or bandages until your doctor says it&#;s safe to do so.
• Rinse the area gently with clean water twice a day.
• Use Vaseline or petroleum jelly and a sterile bandage that doesn&#;t stick to cover the area.
• Replace bandages at least once a day or every time it gets soiled or wet.

What are surgical staples made of?

Some common surgical staple materials include:

• Titanium. Known to easily adhere to both bodily tissues and bone, titanium is less likely to cause inflammation or infection.
• Plastic. This material is used if you&#;re allergic to metals found in other surgical staples.
• stainless steel. Plastic is commonly used for staples and may help reduce scar appearance.
• Polylactide-polyglycolide copolymer. This material is easily reabsorbed into the body. It&#;s popular in plastic surgery because it&#;s less likely to leave a noticeable scar following healing.

How are surgical staples placed?

Surgical staples are placed with a special stapler.

They don&#;t look quite the one on your desk. Surgical staplers look more like commercial-grade construction staplers with a handle and lever that your doctor pushes down to place the staple.

Surgeons use these specially designed staplers to safely, quickly, and precisely place surgical staples on a wound. The process is much faster than stitching or suturing because the staples are placed instantly.

What are the risks of surgical staples?

Surgical staples do carry some risks, including:

• infection from not taking care of the wound (or from bacteria getting into the area)
• improper placement of the staples causing the wound to heal poorly or not close all the way
• wound reopening after staple removal (if staples are removed too early)
• allergic reaction to staple materials

When should I call a doctor?

Seek emergency medical attention if you notice any of the following symptoms around the area that&#;s been stapled:

• severe or new pain
• bleeding from your incision
• redness or swelling of your incision and surrounding area
• increase in the size or depth of the stapled area
• dark or dry appearance around the stapled area
• thick, bad-smelling pus or discharge colored yellow, green, or brown
• low-grade fever (100°F or higher) that lasts for four hours or more

The takeaway

Staples have a number of advantages over stitches for especially large or complex surgeries, injuries, or incisions. In some cases, they may even lower your chances of complications like infection.

Talk to your doctor before getting staples. Be sure to let your doctor know about any allergies you may have and if you&#;ve had any complications from surgical staples in the past.

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