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Surgical Stapler

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A surgical stapler offer certain advantages over traditional sutures. However, recent reports suggest these devices frequently malfunction, resulting in serious injury and even death.

Surgical Staplers for Internal Use

Ethicon, Inc., Medtronic, Inc., and Stryker Corp. are just a few of the medical device companies currently marketing surgical staplers and implantable staples to seal internal tissue and blood vessels.

By some estimates, these devices are used in approximately 100,000 procedures every year, including:

• Gynecological surgery
• Bariatric (weight loss) surgery
• Thoracic surgery
• Gastrointestinal surgery
• Tissue & wound management procedures
• Laparoscopic surgery

Internal surgical staplers are now more popular than traditional sutures due to several perceived advantages:

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

However,  a growing number surgical stapler lawsuits allege these devices have malfunctioned during surgery, causing patients to suffer serious injuries or even die.

How the FDA Regulates Internal Surgical Staplers

The U.S. Food & Drug Administration (FDA) currently regulates surgical staplers for internal use as Class I medical devices.

This designation apparently encompasses 47% of all medical devices sold in the United States, including elastic bandages, dental floss, and enemas. Because they are considered low to moderate risk, these products receive the lowest level of regulatory scrutiny and are not subject to the agency’s stringent premarket approval process.

The FDA considers implantable surgical staples Class II medical devices.

Examples of Class II devices include condoms, at-home pregnancy tests, and powered wheelchairs. These products pose a slightly higher risk than Class I medical devices and must be approved by the FDA before coming to market.

Surgical Stapler Injury and Malfunction Reports

Until recently, internal surgical staplers were exempt from the FDA’s normal reporting requirements for medical devices.

That’s because the agency created a so-called “alternative summary program” in 2000, without any public notice or regulations. Once the agency granted an exemption under this program, a medical device manufacturer could report malfunctions and injuries to a special database hidden from doctors and the public.

According to Kaiser Health News, internal surgical stapler manufacturers submitted over 5,000 malfunction and injury reports to the secret database within 28 months of its launch.

Surgical stapler malfunctions and injuries are an unacknowledged problem, largely because the alternative summary program concealed the vast majority of adverse events from both the medical community and the public.  The FDA’s publicly-available MAUDE database received  just 18 adverse event reports involving internal surgical staplers in 2011, 84 reports in 2016, and 79 last year. By contrast, the secret database received over 10,000 surgical stapler injury and malfunction reports in 2016 alone.

The FDA did revoke most reporting exemptions in 2017, following the institution of a new program that requires device manufacturers to publicly file summary adverse event reports. However, millions of injury reports involving scores of medical devices remain in a database accessible only to the agency.

FDA Reviewing Surgical Staplers for Internal Use

The FDA finally acted to curb surgical stapler injuries in May 2019, when it announced a sweeping safety review that could ultimately result in their reclassification.

According to letter to health care providers, internal stapler systems were implicated in more than 41,000 adverse event reports from January 1, 2011 to March 31, 2018, including:

• 366 deaths
• Over 9,000 serious injuries
• Over 32,000 malfunctions

Some of the most commonly reported malfunctions included:

• Opening of the staple line or malformation of staples
• Misfiring
• Difficulty in firing
• Failure of the stapler to fire the staple
• Misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

In many cases, stapler malfunctions resulted in prolonged procedures, the need for additional surgery or medical interventions, and additional serious health consequences, including:

• Bleeding
• Sepsis
• Fistula formation
• Tearing of internal tissues and organs
• Increased risk of cancer recurrence
• Death