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Surgical Stapler Injuries

The FDA has warned that surgical staplers used in gastric bypass and other procedures have been linked to thousands of serious injuries including more than 366 deaths.

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The U.S. Food and Drug Administration (FDA) has issued a “Dear Healthcare Provider” letter warning of serious safety issues posed by the use of surgical staplers. The March 2019 letter indicates that over 41,000 medical device reports of issues with surgical staplers and staples have been received by the Agency.

These reports include:

  • Over 32,000 malfunctions
  • Over 9.000 serious injuries
  • At least 366 deaths

The letter addressed to doctors and other providers indicates that the FDA has been concerned about the problems for some time and will be issuing draft guidance later in 2019. FDA guidance letters or information are not binding regulations but educational and instructional information that is intended to reduce the risk of medical procedures or devices

FDA Surgical Stapler Reports

The FDA reports that between January 2011 and March 2108, the Agency received over 41,000 adverse event reports regarding injuries or malfunctions resulting from the use of surgical staplers and the staples themselves. More than 9,000 of these reports included serious injuries and over 366 resulted in death of the patient.

Commonly reported problems associated with surgical stapler use involved:

  • Opening of staple line
  • Misfiring of staplers
  • Staplers which failed to fire
  • Difficulty in firing
  • Staples that were misapplied (wrong size, wrong area)
  • Malformation of staples

The FDA further warned that staples or staplers which malfunctioned could result in surgical procedures taking longer than expected, or required additional surgical interventions, some of which may be emergency procedures. Increased surgical time or additional surgeries may pose additional risk to patients and may increase the chance for bleeding, infection, cancer recurrence, organ damage and death.

FDA Surgical Stapler Recommendations

In addition to stating that the Agency would be issuing draft guidance on  the  use of surgical staplers and staples, the FDA made a number of immediate recommendations. Recommendations included:

  • Reading and following stapler manufacturer’s instructions
  • Preparing for procedures by having a range of staples and supplies available
  • Considering other options if staples are not likely to secure the wound
  • Avoiding surgical stapler use on blood vessels or delicate tissue
  • Taking immediate action to protect the patient if a stapler malfunctions during a procedure

Surgical Stapler FDA Draft Guidance

The first issuance of Draft Guidance occurred in April 2019 and is open for public comment and held an advisory committee meeting on May 30, 2019 though no actions were taken. Once comments are collected and reviewed, the Agency will issue further recommendations. The FDA has indicated that it may be considering whether to increase the status of surgical staplers into the Class II device category which would require additional approval before new models of similar devices could enter the market.

Draft Guidance documents are not intended as “binding” but are recommendations or guidelines intended to improve safety in procedures and use of equipment. In many cases, draft guidance documents will be used as part of certification for health authorities who grant licensure or approval for healthcare facilities but are not considered as “laws”.

The FDA has also recommended that doctors, patients and healthcare facility workers continue to report issues that occur with the use of surgical staplers or staple placement by submitting information through the MedWatch Adverse Reporting Program.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

Sources:

Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers, U.S. Food and Drug Administration (03/08/2019)

Surgical Staplers and Staples for Internal Use – Labeling Recommendations, U.S. Food and Drug Administration (04/2019)

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