Surgical stapler use can help surgeons perform surgery more quickly, but it isn’t without its side effects, there is a risk of defective staplers, the side effects from surgical wound staplers might be the result of malpractice and you may need an attorney to help you with the side effects which may result from the use of various surgical stapler types. A 2013 study came to the conclusion that orthopedic surgery patients whose wounds were closed with surgical stapler instruments had a higher risk of wound infection than patients whose wounds were closed with sutures.
On March 8th, 2019, the U.S. Food and Drug Administration (FDA) sent a letter (hyperlink “letter” to health care providers about their concerns and recommendations regarding the safe use of surgical staplers and staples. The letter states that 366 deaths and over 9,000 serious injuries as a result of the use of surgical staplers and staples were reported between January 1, 2011 and. March 31, 2018.
Surgical Stapler Malfunction
Injuries occurred from causes including defective staplers, failure to fire staples, the staple line opening, staples becoming malformed, surgical stapler misfire and misapplication of staples. Ways in which staples were misapplied included staples being applied to the wrong tissue and staples of the wrong size being applied to tissue.
Stapler Surgery Side Effects
Injuries which occurred from the use of surgical staplers and staples included sepsis, bleeding, formation of fistulas, internal tissue tears, organ tears, the risk of cancer recurrence increasing and death.
A lawsuit jury awarded $5 million in 2007 in the wrongful death of a Pennsylvania woman caused by the use of surgical staples in a gastric bypass surgery. A Houston woman filed a lawsuit after, she said, the use of a surgical stapler eventually caused gangrene and caused her to lose both of her legs in 2014. An Illinois woman died in 2013 when, as a surgeon testified, a surgical stapler malfunction caused the woman to bleed to death.
FDA Recommendations For Surgical Stapler Use
The FDA’s letter provided recommendations to health care providers on how to avoid problems with the use of surgical staplers and staples, and announced a series of actions the FDA will take in response to this issue. The FDA says they will issue a draft guidance, open to public comment, in 2019. It will be regarding the FDA’s recommendations to surgical stapler and staple manufacturers about their product labeling.
The FDA says they will hold a public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in 2019 to discuss the surgical stapler FDA classification, possibly reclassifying surgical staplers for internal use as class II devices. This reclassification would subject surgical staplers to pre-market notification and allow the FDA to mitigate the device’s risks by establishing mandatory special controls. The FDA continues to analyze previous and new adverse reports about the use of surgical staplers and surgical staples and will publicly publish the analysis in the future.
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f you or a loved one has suffered an injury or death from medical malpractice and/or the use of surgical staplers and staples, you need tough, battle-tested, aggressive lawyers like you’ll find at Nadrich & Cohen, LLP to fight for you every step of the way and obtain for you the largest recovery possible. We are contingency lawyers, meaning we only get paid a portion of your recovery and we only get paid if we obtain you said recovery. You will never owe us a single penny out of pocket. Call our attorneys today at 1-800-718-4658 for a free and confidential consultation or complete the free and confidential “Do I Have A Case?” form on the right.