Key Takeaways

  • Surgical staplers are used to close wounds or connect tissues as an alternative to stitches.
  • FDA issued a Class I recall for an Ethicon stapler on May 17, 2019, due to severe injury or death risk.
  • Since 2011, surgical staples have been linked to 41,000 adverse reports, including 366 deaths and over 9,000 serious injuries.
  • Complications from defective staples may include bleeding, sepsis, fistula formation, and tearing of organs or tissues.
  • The FDA is reviewing surgical staple safety and plans to issue guidance on internal use and labeling.

Surgical staplers are medical devices used to close up wounds or connect tissues. They are used as a substitute for stitches. Surgical staples are considered quicker, easier, and uniform, and may be used internally for organs. However, as use of surgical staples have grown, so have the number of surgical complications.

On Friday May 17, 2019, the FDA issued a Class I recall for a stapler made by Ethicon. A Class I recall is the highest-level recall because of risk of severe injury or death.

This latest recall is one of many red flags involving surgical staples. The FDA is currently reviewing the safety of surgical staples. The FDA plans to issue draft guidance for internal surgical use of staples and labeling information in the coming months. However, in the course of reviewing the safety of surgical staples, the number of possible complications the FDA identified with the use of surgical staples is staggering. Since 2011 there have been 41,000 adverse medical device reports including 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.

A review of the massive amounts of adverse event reports make it clear that defective staples might be linked to many health-related issues including:

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

If you or a loved one had a medical procedure between Jan. 1, 2011 – March 31, 2018 and experienced complications due to surgical staples, please call the law firm of Wagner Reese.

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