What are Surgical Staplers and Staples?

Surgical staplers, which are sometimes preferred to sutures for minimally invasive surgeries, can cause serious injuries by firing malformed staples into organs or other tissue in the body. Defective staplers may not fire all staples necessary to bind an incision, causing bleeding or leaving an incision unsealed. Used in “gastrointestinal, gynecologic, thoracic, and many other surgeries”, surgical staplers are used both externally and internally. Removable skin staples, for external use, “close wounds under high tension, including wounds on the scalp or the trunk of the body.” Internally, surgical staples “deliver compatible staples to internal tissues during surgery.”

What Causes Surgical Stapler Injury?

While the issue of how injuries are reported is recent, complications as a result of surgical staplers are not and have been occurring for years. Most commonly, injuries and death are caused by:

  • Device malfunction, including misfiring
  • Design defect, which is when the design of the stapler is at fault for an injury
  • Manufacturing defect, which is when the device was assembled incorrectly
  • Complications with surgical staples
  • A failure to warn, which is when the manufacturer failed to warn consumers of risks associated with the stapler

Many lawsuits claim error by the surgeon caused injuries or death of patients, but there are many reports of defective surgical staplers that misfired provoking questions of fault. Thousands of reports of surgical staplers malfunctioning during surgery have been recorded.

INJURIES CAUSED BY SURGICAL STAPLES

Used to close wounds quickly, the staplers misfire, fail to fire, punch holes in the body without injecting a staple, and insert malformed staples. Staples are more popular with doctors than suturing or stitching incisions. Injuries are severe, including:

  1. Opening of the staple line
  2. Infections
  3. Organ damage
  4. Sepsis
  5. Fistula formation
  6. Death

Nearly 80 percent of surgical staplers and sutures used in American hospitals are manufactured by Johnson & Johnson with its subsidiary Ethicon, and by Medtronic with its subsidiary Covidien.   Other manufacturers include 3M; B. Braun; Cardica; Care Fusion; CONMED; Frankenman; Meril Life Science; Purple Surgical; Smith & Nephew; Stryker; U.S. Surgical; Welfare Medical; Reach Surgical; and Zimmer Biomet. 

Manufacturers were able to hide pertinent data for years.

The FDA's MAUDE database (Manufacturer and User Facility Device Experience) has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers. These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that an additional 56,000 reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public. The FDA had created an exception for stapler makers to report adverse events in its Alternative Summary Reports database, where it was top secret and not even available to doctors. The program was in effect from 1997 through June 2019, when it was closed. “ The FDA finally warned doctors in a letter issued March, 2019.

If you or a loved one has been injured by surgical staples or a surgical staple gun contact the attorneys at Ennis & Ennis, P.A. for a free consultation at 1-800-856-6405 or visit us online at www.Ennislaw.com.