Complications stemming from surgical staplers are not a new phenomenon. With more than 110,000 incidents from 2011-2018, injuries resulting from malfunctioning staplers have become widespread. In October of 2019, the Food and Drug Administration (FDA) announced a Class I recall of the Flex Endopath surgical staplers manufactured by Ethicon.
The Ethicon surgical stapler recall came after 7 severe injuries and one death were attributed to the Flex Endopath. A Class I is the most serious type of recall, signifying the severe risk associated with using the product.
While a recall can prevent new patients from suffering from medical injuries, they provide little relief for patients that had these staplers used in a procedure. A surgical stapler lawyer at Showard Law Firm can advise you of your legal rights if a stapler was used during your surgery.
History of the Ethicon Surgical Stapler Recall
The recall covers staplers that were distributed by Ethicon from August 1 through September 26, 2019. While sold under the Ethicon brand, the company is a part of the Johnson & Johnson family of companies. In total, the FDA recalled 8,256 devices distributed during this time period. There were four models covered in the surgical stapler recall:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)
According to the FDA, the recall was necessary due to the risk of severe injury or death. This was not the first recall of Ethicon surgical staplers, however. In April 2019, the FDA issued an endo-surgery stapler recall for nearly 90,000 Ethicon devices. This recall covered devices distributed from March 15, 2018, through March 8, 2019. Like with the most recent recall, the April 2019 recall also involved staple misfires.
Allegations Against the Ethicon Stapler
The staplers manufactured by Ethicon were designed to cut and staple tissue within the body. They are intended to close up sutures in minor or major surgical procedures. When staples become malformed, however, the outcome can be devastating.
The FDA investigation into the Ethicon staplers found that some devices contained a component that could cause the staples to become malformed. The defective component, located in the jaw of the device, can cause the staples to improperly seal the cut tissue following an operation.
Surgical Staple Complications
One of the most common complications from malformed staples is the prolonging of surgical procedures. In this situation, the good news is that the malformed staple was identified during the procedure. Unfortunately, prolonged surgery can involve more than just an inconvenient delay. Some patients can face serious or even fatal side effects from a prolonged surgery.
The potential complications are even more severe if the malformed staples go undetected during surgery. These staples can cause a host of health issues that can only be corrected through additional surgery. Common consequences that come with these defective staples include:
- Internal bleeding
- Increased risk of cancer
- Increased risked of infection
- Soft tissue tearing
When staples are not fired accurately, these complications become far more likely to occur. The most recent Ethicon recall resulted from staples that became malformed during the firing process.
There are signs of complications related to defective surgical staples. These signs should be taken seriously and addressed immediately. The failure to address these signs could have permanent – or even fatal – consequences. Examples include:
- Reopened incision
- Redness or swelling
- Red streaks on the skin
- Yellow or green discharge
- Unexpected, severe pain
- High fever
- Darkened, dry skin at the incision site
What to Do If Your Procedure Involved Surgical Staples
If you have had a recent procedure that involved surgical staples, it is understandable if you are concerned about complications. Often, these complications do not become immediately clear. If you are unsure if the staples used in your procedure fall under the recent Ethicon surgical stapler recall, experienced legal counsel might be able to help.
Showard Law Firm has investigated malformed surgical staples and the impact they can have. If these defective devices were used during your procedure, you could have a viable claim for financial compensation. Contact our office as soon as possible to discuss your options.
- KHN News, More Than Half of Surgical Stapler Malfunctions Went To Hidden FDA Database, https://khn.org/news/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/
- Bloomberg, J&J Recalls Surgical Tool After Patient Death, Serious Injuries, https://www.bloomberg.com/news/articles/2019-10-31/j-j-recalls-surgical-tool-after-patient-death-serious-injuries