Surgical Staplers Put Patients at Risk for Bleeding, Sepsis, and Death

On March 8, 2019, the FDA sent a letter to health care providers because of concerns regarding an increasing number of adverse events associated with surgical staplers.  From January 1, 2011, to March 31, 2018, the FDA received over 41,000 individual medical device reports for these devices, including:

• 366 deaths,
• over 9,000 serious injuries,
• and over 32,000 malfunctions.

In April 2019, the FDA issued guidance for labeling updates meant to help guide physicians in their use of the devices.  More recently, the administration convened a meeting of experts to determine whether surgical staplers should be reclassified into a different category of medical devices that require more testing and oversight.

What are Surgical Staplers?

Surgical staplers are similar to regular office staplers, in that they “staple” objects together.  Instead of papers, however, the devices staple tissues together to help close wounds and connect tissues in the body.  Some are used for external wounds, but the ones that that FDA has raised concerns about are used to staple internal tissues during surgery.

Internal surgical staplers may be used during gastrointestinal, gynecologic, and thoracic surgeries, and in other procedures where it’s necessary to cut through organs and tissues.  They are believed to shorten surgical procedure time when compared to manual suturing.

Currently, surgical staplers are considered Class I devices, which have a low to moderate risk to the patient and/or user.  Because of the problems, however, the FDA has recommended changing that classification to Class II, which includes devices that have a moderate to high risk to the patient and/or user.  This would place the staplers under more stringent regulatory controls and may subject the devices to mandatory testing and assessments.

Surgical Stapler Malfunction Side Effects

Some of the most commonly reported problems with surgical staplers include:

• Misfiring or difficulty in firing
• Failure of the stapler to file
• Malformation of staples
• Misapplied staples

Kaiser Health News reported on a case of a Pittsburgh surgeon who was removing a patient’s appendix when the surgical stapler meant to seal the tissue around the appendix locked up.  When the surgeon later surveyed his peers about the issue, he discovered that more than two-thirds had experienced similar surgical stapler malfunctions, or knew of another surgeon who did.

Potential injuries caused by a malfunctioning stapler include:

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

Awareness of these issues may have occurred earlier than this, but for years the FDA granted the makers of the devices a special exemption that allowed them to file adverse event reports to a database hidden from public view.  The FDA recently decided to abandon this hidden database and is making all of the reports visible.

In a 2004 article published in the Journal of the American College of Surgeons, former FDA official Dr. S. Lori Brown reported that in the first 28 months of filing adverse event reports to the hidden database, surgical stapler manufacturers filed more than 5,100 reports of malfunctions or injuries. There were also 121 publicly reported deaths during that time.