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FDA recall of Ethicon surgical stapler

Ethicon issued a Class 1 FDA recall of its surgical stapler devices due to a dangerous defect, prompting patients who experienced complications from these devices to consider filing a surgical staples lawsuit.

A Class 1 FDA recall is defined as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” It is considered the most serious recall the FDA can issue.

The U.S. Food and Drug Administration (FDA) issued this classification just a few weeks after Ethicon’s original recall letter was sent. The FDA notice specified that, as of Oct. 3, 2019, when Ethicon sent its recall letter, there had been seven serious injuries and one death reported to Ethicon that were linked with the staplers included in the Class 1 recall.

Many patients who experience surgical stapler malfunctions during surgery suffer from bleeding complications or require additional surgeries to repair the damage.

Patients who have survived surgical staple injuries have reported serious complications, including coma, damage to internal organs, cognitive difficulties, mood changes, loss of enjoyment in life, inability to recognize family members or letters of the alphabet, and loss of mobility.

In many cases, damage caused by a malfunctioning surgical stapler may be permanent. People who have been harmed by the recalled surgical staplers may be able to pursue compensation for their injuries.

Surgical Stapler: Overview & Risks

Surgical staplers are used to staple internal tissue during a variety of surgeries, including both open and minimally-invasive procedures. Often, when stitches or sutures are deemed to be less effective, surgical staples are used instead. Surgical staplers from a variety of manufacturers, such as Ethicon and Medtronic, have been in use for decades

According to the FDA, surgical staplers have many benefits such as quick placement, minimal tissue reactions, strong wound closures, and a low risk of infection when compared to other surgical closure methods.

Despite these benefits, surgical staplers have been associated with serious issues. According to a March 2019 FDA letter to healthcare providers, the agency received over 41,000 medical device reports about surgical staplers between Jan. 1, 2011, and March 31, 2018. These reports included 366 deaths, more than 9,000 serious injuries, and in excess of 32,000 malfunctions.

Surgical stapler malfunctions include the opening of the staple line, device misfiring, difficulty firing, failure to fire, misapplied staples, and more.

Ethicon, a major subsidiary of pharmaceutical giant Johnson & Johnson, has found that certain surgical staplers have issues the staples emerging malformed. Malformed, or misfired, staples, in turn, can lead to a number of significant complications.

Side effects linked with malformed or misfired surgical staples include:

  • Prolonged surgery
  • Postoperative connection (anastomotic) leak
  • Hemorrhage
  • Hemorrhagic shock
  • Additional surgical intervention
  • Death

In light of the risks for complications and recalls of surgical stapler products, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee’s May 2019 meeting proposed reclassifying surgical stapler devices from Class I to Class II.

As Class I devices, surgical staplers do not require premarket submission to the FDA for approval. Reclassification would allow the FDA to establish “special controls” in the approval and premarket requirements for surgical staplers.

Which Ethicon Staplers Have Been Recalled?

The October 2019 Ethicon stapler recall has affected a number of Ethicon surgical staplers manufactured and distributed between March 2018 and March 2019. According to the FDA’s website, these include:

  • 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)

Approximately 100,000 devices are affected by the Ethicon stapler recall.

This was not the first recall for Ethicon initiated in 2019. Earlier in the year in April 2019, the company recalled one of their endoscopic surgery devices which creates connections during gastrointestinal procedures. Unfortunately, these surgical stapler devices could shoot malformed staplers which unexpectedly remove tissue and cause complications.

The April 2019 Class I recall affected over 92,000 of the following products:

  • Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
  • Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples

Since the FDA surgical stapler recall, Ethicon has reportedly come out with a new device aimed to strengthen staple lines with their stapler products. The Echelon Endopath Staple Line Reinforcement (SLR) reportedly will “improve patient outcomes” and reduce the risks for air leaks and bleeding complications after bariatric, thoracic, and other surgical procedures.

Will Advances in Technology Make Surgical Staplers Safe?

In February, experts held a webinar on surgical stapler misuse. In response, the FDA penned a letter stating that internal staplers have become more common as the surgery itself advances. New stapler technology includes software and LED messaging, as well as motors that drive stapler action and replace human variability.

“All these design advances increase the need for the user to find the time to learn and understand the new technologies and to seamlessly be able to initiate countermeasures to error messages,” the FDA letter reads.

In the letter, two agency representatives also note that the FDA has proposed additional surgical stapler regulation “in order to provide a reasonable assurance of safety and effectiveness.”

They indicate that internal surgical staplers would be given a Class II device designation with special controls. Further, the FDA reps say that surgical training should be enhanced to ensure surgeons understand new and developing stapler technology.

Indeed, the FDA’s letter notes that surgical staplers are consistently one of the top 10 medical devices that harm or even kill patients. According to the agency’s representatives, these medical errors are usually linked to failed user judgment or a poor understanding of how the device works. However, 10 percent of patients’ adverse events are linked to a device malfunction, the letter states.

“The majority of surgeons in the United States have either experienced or know another surgeon who has experienced a stapler malfunction,” reads the letter, concluding that additional training should go hand-in-hand with advancing technology.

FDA recall of Ethicon surgical stapler

Hidden Device Malfunction Reports

Unfortunately, malfunctions associated with surgical staplers may be underreported. The FDA notes that between 2011 and 2018, “many more device malfunction reports” had been reported about surgical staplers through non-traditional channels, meaning that instances of side effects or even deaths may be significantly higher than long believed because of “hidden reports.”

A doctor who experienced a surgical stapler locking up during surgery said that he was unable to find any other reports of similar malfunctions in the FDA’s public medical device failure database.

However, after speaking to several prominent surgeons about the issue, the doctor reportedly learned that numerous other physicians had experienced problems with surgical staplers or knew of cases occurring, according to an interview with the Tampa Bay Times.

According to the doctor, the FDA has allowed surgical stapler manufacturers to file reports of problems with the devices in a private database. Unlike the FDA’s public reports database, the surgical stapler malfunction reports are allegedly stored in a database hidden from patients and doctors.

A Kaiser Health News investigation confirmed that at least 1.1 million cases of failing medical devices have been reported to the private database. In addition to surgical stapler malfunctions, the secret reports also include details on problems with balloon pumps and mechanical breathing machines.

What To Do If You Are Affected

If you have been injured or a loved one has died due to a surgical stapler malfunction, you may have legal recourse. A growing number of patients are filing surgical staples lawsuits, alleging they have suffered serious complications due to malformed surgical staples.

Of course, filing a lawsuit cannot take away the pain and suffering caused by these kinds of serious medical complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a surgical stapler lawsuit can be a daunting prospect, especially while dealing with medical side effects, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Join a Free Ethicon Surgical Stapler Lawsuit Investigation

If you or a loved one suffered from surgery complications caused by internal staples, you may qualify to joing in a Ethicon surgical stapler lawsuit investigation.

See if you qualify by filling out the free form on this page. 

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