Surgical Staples Lawsuit

FDA warns of complications and death resulting from stapler malfunction.

Manufacturers have hidden more than 56,000 surgical stapler complication reports from the public in secret FDA filings.

medtronic surgical staples lawsuit

Surgical Staple Warnings & Recalls

Internal or implantable surgical staples are used in millions of patients each year who undergo gastrointestinal, gynecologic, or thoracic surgeries. 

Now, after a seven-year review, the FDA is warning doctors and patients that the malfunction or misuse of these devices can result in serious injury or death. A leading manufacturer, Ethicon, was also forced to issue a recall. 

FDA records show that more than 100,000 medical device complication reports have been filed for surgical staplers since 2011, with over 10,000 serious injuries and nearly 400 patient deaths. 

Surgical staple complications can result in tissue or organ damage, internal bleeding, infections, additional surgeries, cancer recurrence or death.

Since patients were never warned of these severe risks, they may be entitled to substantial compensation from device manufacturers.

Do You Qualify for a Lawsuit?

A recent report showed manufacturers hid more than half of the approximately 100,000 surgical stapler complications from the public in secret FDA filings. 

If you or a loved one suffered any of the following during or after a surgery, you may qualify for a lawsuit:

  • Staple opening or malformation
  • Prolonged or repeat surgery
  • Internal bleeding
  • Infection or sepsis
  • Tissue or organ damage
  • Cancer recurrence after tumor removal
  • Death

Lawyers are filing claims against several surgical stapler manufacturers including Medtronic, Covidien, Johnson & Johnson and Ethicon. 

Unfortunately, over 10,000 patients may have suffered serious injury or death in recent years without knowing the risks.

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Surgical Staple Warnings & Studies

The Timeline Leading to Surgical Stapler Lawsuits

June 3
FDA panel recommends that surgical staplers for internal use be reclassified from Class I to Class II medical devices, allowing for more regulation and scrutiny.
A Keiser Health report finds at least 56,000 additional surgical stapler complications were reported to the FDA through a private program between 2011 and 2018, but never disclosed to the public, bringing the total number of stapler malfunction cases to nearly 110,000.
April 11
FDA forces Ethicon to issue a Class I recall of 92,496 Endo-Surgery Curved Intraluminal Staplers due to risks of death, sepsis, bleeding, nutritional and digestive issues, suture leaks, and the need for additional surgeries or treatment.
March 8
The FDA warning letter advises doctors the agency has received over 41,000 reports of surgical stapler complications, including over 9,000 serious injuries and 388 deaths.
Doctors from the University of Pittsburg first warn of the dangers of internal use stapler malfunction, saying “Most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25% have had to significantly alter the planned operative procedure due to the malfunction.”
Johnson & Johnson’s Ethicon brand begins selling surgical staplers.
United States Surgical Corporation introduces the first commercially available surgical stapler device in the United States, which is later rebranded as Covidien.
Hungarian surgeon Humer Hultl pioneers the first stapler used in medical .

Risks of Surgical Stapler Malfunction

According to the FDA, patients facing the greatest risk of surgical stapler malfunction are those undergoing gastrointestinal, gynecologic, or thoracic surgeries. Specifically, these devices are often used when doctors remove part of an organ, cut through organs and tissues, or create connections between tissue. 

Currently, most of these surgical tools are classified as Class I medical devices by the FDA, which requires no pre-market testing and little safety regulation by the agency. 

The most common types of complications that occur with surgical staplers include:

  • malformed staples
  • suture line opening
  • stapler misfiring or failure
  • difficulty in firing the stapler during surgery
  • staples of the wrong size or to wrong tissue.

These complications may be caused by defective stapler devices themselves or by poor product training of medical staff by the manufacturer as to their proper use. 

Regardless, a malfunctioning surgical stapler can result in longer surgeries for the patient, internal bleeding, infections, sepsis, tissue and organ damage, digestive failure, cancer recurrence, the need for additional surgeries, or even death.

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Which surgical staple lawyer is best for your case?

If you or a family member suffered serious injury, repeat surgery or death after undergoing a surgery, it is important that you learn whether a defective medical device was the cause.  

Even if you don’t know the cause of your surgical complication, a lawyer can investigate your case, reviewing the extensive surgical reports that your doctor may not normally discuss. However, there’s only a limited amount of time to file a claim. 

Fortunately, it’s easy to get help and file a claim if you qualify, and you won’t pay anything unless you receive an award. Also, the right lawyer can handle most aspects of your case without you ever having to leave your home or attend court hearings.  

DrugNews makes it easy to speak directly with a lawyer or patient advocate today to learn more about your options. And, we work only with the top attorneys and law firms that have successfully handled thousands of defective medical device lawsuits against the largest companies.  

For more information, or to learn about your options - call, chat or email us today.

Do you have a case?

Speak with a lawyer who specializes in the surgical stapler litigation.

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