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An alarming number of severe and life-threatening complications have been linked to problems with surgical staplers and internal staples, after devices sold by Ethicon, Covidien and other companies misfired, failed to fire, or punctured internal organs, causing severe injuries, infections and some wrongful deaths
SURGICAL STAPLER LAWSUIT STATUS: Product liability lawyers are reviewing potential surgery staples injury lawsuits for complications caused by design defects. All cases are handled under a contingency fee, which means there are no fees or expenses unless a recovery is obtained.
OVERVIEW: Surgical staples are commonly used in the operating room to close internal organ wounds during procedures. They often involve disposable staplers, which may need to be removed with another special device. However, if the stapler misfires or malfunctions, it could result in devastating internal injuries.
In March 2019, the FDA announced it had received more than 41,000 adverse event reports linked to surgery staple problems between January 2011 and March 2018. These included more than 9,000 reports of severe injuries and 366 reports of deaths.
The agency subsequently proposed a new rule reclassifying surgical staplers as moderate-risk medical devices, which requires them to undergo greater scrutiny for premarket approval.
Ethicon, Covidien and other manufacturers have also been provided new guidance, which indicates doctors and patients should be provided better warnings about the risk of surgery staples complications, which can include:
- Internal tissue and organ punctures and tearing
- The recurrence of cancer
The warnings came after a number of surgical stapler recalls due to design defects associated with certain widely used devices. Ethicon staplers have been the subject of recalls in 2012 and 2014, and a Covidien stapler recall was issued in 2012.
In May 2019, a panel of advisers endorsed the FDA’s plan to reclassify the staplers as moderate-risk medical devices.
LAWSUITS OVER SURGICAL STAPLER PROBLEMS: Through product liability lawsuits, surgery staples lawyers can help determine whether financial compensation may be available for:
- Surgical complications when a stapler failed;
- Internal injuries from a surgical stapler misfire;
- Additional surgery to remove a loose or embedded staple
- Wrongful Death
Free consultation and claim evaluations are available to help determine if an injury or complications may have been caused by a dangerous or defective product. Submit information about a potential surgical stapler case.