Did You Suffer a Surgical Injury From Internal Staples?

Internal staples may be used to close wounds following surgery, though some of these products can be associated with life threatening complications and have resulted in surgical staples lawsuits.

What Are Internal Staples?

After a surgery, surgical wounds need to be closed. In some cases, stitches or sutures are used to close wounds. However, in other cases surgical staplers are considered to be a better option for wound closure. Some advantages of surgical staples include quick placement, minimal risks for tissue reactions, low infection risks, and strong wound closures, according to Healthline.

There are both external and internal staples available for different uses. External staples may be used for large or complex wounds which couldn’t be closed with traditional methods such as sutures.

Internally, staples may be used for resection (removing tissue), transection (cutting through tissues), or anastomoses (adding connections between structures). Internal staples are most commonly used in gastrointestinal, gynecologic, and thoracic surgeries, though other surgeries may use these devices.

After external staples are used, these closures will have to stay in for anywhere from three to 21 days. The removal time frame for each patient will vary depending on their situation and treatment. The size and direction of the incision, the type of surgery done, the complexity of the wound, and the rate of healing all impact how long staples need to stay in.

Once it is time for these closures to be removed, patients cannot remove them at home. Removal must be done by a medical professional who has access to the required tools to remove the staples without complications.

In contrast to removable external staples, internal staples are not removed. Depending on the material used in the staples, these closures may be left in permanently to hold internal tissues together or may dissolve after a certain period of time.

Although patients can easily tell if their surgery involved external staples by simply examining their surgical wound, it can be more difficult to identify when internal surgical staples were used. If your doctor did not tell you whether they used surgical staples in your surgery, you can ask your surgeon or hospital for this information. Even if your surgeon no longer works for the same hospital, your records should include documentation of if surgical staplers were used and, if so, which brand.

Can Stapler Complications Occur?

Internal staplers may be associated with complications which can be life threatening. Some of these complications include malformed staples, misfiring, difficulty firing, failure to fire, and misapplied staples. These complications may lead to serious issues such as bleeding, sepsis, fistula formation, tearing of internal tissues, increased risk of cancer recurrence, and even death.

These risks prompted the U.S. Food and Drug Administration (FDA) to take action. In April 2019, the agency issued a draft guidance on safe surgical stapler practices. The agency has also considered reclassifying these devices as Class II medical devices – requiring more strict approval requirements.

In addition to taking these actions, the FDA released recommendations for healthcare providers using internal staples. The agency’s recommendations include:

• Read manufacturer’s instructions before use.
• Select the appropriate staple size based on the stapled tissue’s type and thickness. Failure to chose the right staple size can lead to staple malformation.
• Consider other closure options if working with swollen, friable, or necrotic tissue as these tissues may not be secured with staples.
• Be familiar with structures around stapled tissue and check that these structures are not clipped in the staple line.
• Avoid large blood vessels such as the aorta.

Have Surgical Staplers Been Recalled?

Even when healthcare providers do their best to use internal staples safely, these devices may lead to complications if they are defective. Some of these defects have lead to surgical stapler recalls, including an Ethicon recall.

In April 2019, Ethicon recalled their Ethicon Endo-Surgery Intraluminal Staplers for use in gastrointestinal surgery after these devices were linked to injuries and deaths. According to the recall announcement, the staple systems could cause insufficient firing and compromised staple line integrity.

This failure can reportedly cause serious complications such as sepsis, bleeding, closure leaks, the need for further surgery, and even death. The FDA recall announcement notes that two patients suffered “serious injuries” in connection with the recalled staplers.

Patients who were injured by surgical staplers may be able to take legal action. Consumers have already filed lawsuits against Ethicon and other manufacturer, arguing that the companies’ now recalled products were defective and dangerous. Taking legal action could help patients and their families recover compensation for medical expenses, permanent disability, wrongful death, and more.