Ethicon Surgical Staplers

Surgical staplers can offer major benefits in surgeries. They can help close wounds quickly and with a strong closure that doesn’t reopen easily. There’s typically a low risk of infection from the sterile surgical staples used. Plus, there’s a minimal risk of the tissue reacting to the staples. However, like all surgical devices, there’s still a risk, especially when the company that manufactures them produces staplers with a defect.

Ethicon has recalled several models of surgical stapler due to misfirings that caused staples to be malformed. Malformed staples can be dangerous for patients, causing injury or even death. In the best-case scenarios, malformed staples require additional tissue to be cut or can prolong surgery or even require additional surgeries to correct the problem.

Ethicon voluntarily recalled a number of surgical stapler models after investigations and reports of injuries and even deaths due to misshapen staples coming from the surgical staplers involved. However, these surgical staplers were on the market and used in surgical procedures for months before they were recalled. Thousands of surgeries occurred in that period, meaning that thousands of injuries could have happened in that time.

If you underwent a surgical procedure in which the surgeon used one of the recalled staplers and experienced injuries or health complications as a result, you may have a case against Ethicon. The surgical staplers that were recalled include:

Endo-Surgery Curved Intraluminal Stapler (with staples of adjustable height)
Endo-Surgery Endoscopic Curved Intraluminal Stapler (with staples of adjustable height)
ECHELON Flex 60 Endopath Stapler and Articulating Endoscopic Linear Cutter
ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length
ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter with a 34cm Shaft Length

If you or a loved one experienced complications in a surgery in which one of the above surgical staplers was used, you may be eligible for compensation due to pain and suffering, medical costs, or even wrongful death. Contact Farah & Farah for a free consultation. We’ll help you seek the compensation you deserve from the company whose faulty device caused you harm or even the death of a loved one. Don’t hesitate to contact us. You won’t have to pay a dime unless your case is successful.

What Is a Surgical Stapler?

A surgical stapler is a type of medical device used in surgeries to seal both wounds and incisions. These wounds or incisions can be located either external to the body or internal. External injuries or incisions are in the skin and can be wounds caused by injury or incisions made for a medical treatment such as a surgery. Internally, surgical staplers can be used to connect tissues inside the body, such as an organ. Surgical staplers are used to close up patients after a surgery is complete. Surgical staplers are also able to cut off excess tissue around the suture site.

There are many benefits to using surgical staplers for closing wounds and surgical incisions. These include:

A low risk of infection
A strong closure of the wound or incision
Minimal risk of tissue reaction
Quick placement of the staples

What Is the Ethicon Echelon Surgical Stapler?

The Ethicon Echelon series of surgical staplers are surgical staplers that are manufactured by the company Ethicon, which is a part of Johnson & Johnson’s medical devices group of companies. The Ethicon Echelon surgical staplers come in a variety of types. Ethicon manufactures a circular surgical stapler for use on tube-shaped organs as well as linear surgical staplers.

Ethicon Echelon Linear Surgical Stapler

The Ethicon Echelon linear surgical stapler is a surgical stapler typically used for external wounds and incisions and for closing wounds internally, so long as they are in a straight line.

Ethicon Echelon Circular Stapler

The Ethicon Echelon circular stapler is a surgical stapler designed to close internal wounds on organs that are circular in nature. These organs are typically tube-shaped, such as an intestine.

Who Makes the Ethicon Surgical Staplers?

Ethicon is a subsidiary of Johnson & Johnson. It falls within the Johnson & Johnson medical device manufacturing section. Ethicon has been making medical devices for closing wounds and incisions since as early as 1915. By World War II, Ethicon’s share of the surgical closure device market was up to 70% across the world. In the United States, Ethicon’s market share is currently about 80%, making it one of the most purchased-from surgical closure device manufacturers in the country.

The company was founded in 1915 in Edinburgh, Scotland by George F. Merson. It began as a facility where the company manufactured catgut, silk, and nylon sutures, as well as packaging and sterilizing them. Ethicon was acquired by Johnson & Johnson and brought under the umbrella of Johnson & Johnson’s subsidiary companies in 1947.

How Is the Ethicon Surgical Stapler Used?

Ethicon surgical staplers and staples are used in a wide variety of surgical procedures, from gastrointestinal and gynecologic surgeries to thoracic and many more. They can be used to:

Connect tissues together
Remove tissue or part of an organ
Cut through tissues or organs

How Does the Ethicon Surgical Stapler Work?

All types of surgical stapler work similarly. They have a cutting mechanism that can slice away excess tissue or cut through an organ or other tissue. They also have the stapling feature that can close a wound or incision. They do this by compressing the tissue on either side of the wound or incision together and then inserting staggered rows of staples, typically shaped like the letter B. Once the staples are in place, the surgical stapler can help keep the wound clean by cutting away any superfluous tissue around the sealed wound.

What Are the Risks Associated with the Ethicon Surgical Stapler?

There are certain risks associated with any usage of surgical staplers and surgical staples. These risks include:

An allergic reaction to the surgical staples
The wound or incision reopening after the stables have been removed
Poor healing of the wound due to improper placement of the staples
Wound not closing all the way due to improper placement of the staples
Infection from bacteria that gets into the wound (especially if it’s not taken care of properly)

However, on top of these normal complications, there are additional complications that have arisen for many patients on whom the certain Ethicon surgical staplers were used during surgery. Ethicon has recalled several types of surgical stapler, of both linear and circular types, due to complications.

Ethicon Surgical Stapler Complications

Ethicon recalled several models of its surgical staplers due to complications. Several different models of surgical stapler produced by Ethicon have been found to be defective and have been recalled by the company. What all of these recalled surgical stapler models have had in common was a tendency to misfire, which would then cause the staples to be misshapen. This in turn can cause serious injuries or even death in the patients on whom a misfiring stapler was used.

Ethicon Surgical Stapler Recalls

In 2019, Ethicon issued recalls of several types of surgical stapler for misfiring. The staplers recalled include:

Endo-Surgery Curved Intraluminal Stapler (with staples of adjustable height)
Endo-Surgery Endoscopic Curved Intraluminal Stapler (with staples of adjustable height)
ECHELON Flex 60 Endopath Stapler and Articulating Endoscopic Linear Cutter
ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length
ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter with a 34cm Shaft Length

The two Endo-Surgery curved (circular) surgical staplers were recalled in April of 2019, while the ECHELON Flex linear staplers were recalled in October of that same year.

Ethicon Endo-Surgery Intraluminal Surgical Staplers

The Ethicon Endo-Surgery Intraluminal surgical staplers that were recalled in 2019 were used in gastrointestinal surgeries. They were meant to connect two sections of tissue together. After many complaints about the Intraluminal surgical staplers, Ethicon conducted an investigation and found that the staplers weren’t firing sufficiently, which didn’t properly cut washers within the stapler and for the integrity of the line of staples in the patient’s tissue to be compromised. Surgeons could hear an audible crunch when the staplers misfired. If the washer is uncut when the stapler is fired, it means that the stapler failed to complete the full 360-degree circular line of staples.

Effects of Ethicon Intraluminal Surgical Stapler Misfiring

Patients undergoing surgery in the gastrointestinal tract are at risk of experiencing health complications, injuries, or even death from a surgical stapler misfiring. The possible risks include:

Bleeding
Sepsis
Permanent need for an ostomy bag
Permanent digestive issues
Permanent nutritional issues
Leaks in the closure of the incision
Need for additional surgeries
Need for additional closures
Need for antibiotics
Need for imaging studies
Death

Confirmed Injuries from Ethicon Intraluminal Surgical Staplers

Ethicon has confirmed that two patients were seriously injured by the Ethicon Intraluminal surgical stapler. Both patients had to have an additional resection on top of the resection already planned for during their surgeries. There may, however, be more injuries or health complications caused by these staplers that haven’t been confirmed by Ethicon.

Ethicon ECHELON Flex 60 Surgical Staplers

Ethicon’s ECHELON Flex surgical staplers were designed to be used to cut and to staple internal tissue on a single patient. They were typically used in surgeries that were either open or minimally invasive. The surgical procedures these staplers were used for included procedures in the following categories:

Gynecological
Thoracic
Pediatric
Urologic
General surgeries

The ECHELON Flex staplers affected by Ethicon’s recall were included in the recall because the company found that a component within the jaw of the device didn’t meet specifications. This component could therefore cause staples to be malformed when the stapler was used on a patient.

Effects of Ethicon ECHELON Flex 60 Surgical Stapler Misfiring

If staples aren’t formed correctly when the surgical stapler is fired to close a wound or incision, there is a risk to the patient. The possible effects on a patient from malformed staples can include:

Prolonged surgery
Need for additional surgeries
Leaks at the closure
Hemorrhaging
Hemorrhaging shock
Death

Confirmed Injuries from Ethicon ECHELON Flex 60 Surgical Staplers

As of October 2019, it had been reported to Ethicon that at least 7 people had experienced serious injuries from the Ethicon ECHELON Flex 60 surgical stapler that had been used in their surgeries. In that same time period, Ethicon also received a report of a death due to the same product class of Ethicon surgical staplers. There may have been many more injuries and deaths that hadn’t definitely been reported to Ethicon or to the FDA.

FDA Classification of Ethicon Recall

The FDA classified Ethicon’s recall of the affected surgical staplers as a Class 1 recall. Class 1 is the FDA’s highest classification of a recall event and is reserved for only the most serious recalls. Typically, Class 1 recalls are for those devices or other products that have a high risk of causing severe injuries or even death. The FDA’s classification of the Ethicon surgical stapler recall as a Class 1 recall event indicates that there was a high risk of the recalled surgical staplers causing severe complications in patients. There were 8.256 linear surgical staplers affected by the recall that could have caused severe injury to patients or even caused their deaths. There have been seven major injuries reported to the FDA and to Ethicon as well as a death. This recall in October of 2019 followed Ethicon’s earlier recall of 92,000 circular surgical staplers for similar reasons.

While Ethicon’s surgical stapler recall is among the most recent, occurring in 2019, the FDA has been closely monitoring the safety of surgical staplers. Between 2011 and 2018, the agency received thousands of reports of malfunctioning surgical staplers and hundreds of reports of deaths linked to complications from those malfunctions.

Ethicon Lawsuits

Companies have an obligation to the consumers of their products. In the case of a medical device such as a surgical stapler, Ethicon has an obligation to the patients receiving surgery to produce staplers that will work as intended and won’t cause injury or death. Patients who have experienced health complications or injury during surgery because of a misfiring surgical stapler may have a case against the manufacturer, Ethicon, whose product caused them harm. Loved ones of patients who died because of those health complications or injuries as a result of misfiring surgical staplers may also have a case in a wrongful death lawsuit.

The recall of the Ethicon surgical staplers occurred just last year, with the affected models of stapler in use for only a few months before serious injuries and a death forced the company to recall the devices. As of yet, lawsuits have not yet been announced against Ethicon for the company’s role in the malfunctioning of their surgical staplers. Although Ethicon has not yet settled any lawsuits regarding their malfunctioning surgical staplers, other companies manufacturing surgical staplers have settled for amounts ranging from $5 million to $80 million.

Should I Consider an Ethicon Surgical Stapler Lawsuit?

If you or a loved one has undergone surgery and has experienced injury or health complications as a result of misshapen or malformed staples caused by a misfiring surgical stapler, you may have a case against the manufacturer. The first step is to determine that the model of surgical stapler that caused the problem is one of the ones affected by the recall. After you’re certain that it was a recalled Ethicon surgical stapler product that caused the injury or death, the next step is to contact Farah & Farah for a free consultation. We’ll help determine whether or not you have a case against Ethicon.

If you have a case against Ethicon for failing to produce surgical staplers that didn’t misfire, causing malformed staples to injure or cause the death of patients, we’ll help you seek the compensation that you deserve. You may be eligible for compensation for the following:

Medical costs
Pain and suffering
Lost wages
Disabilities
Permanent injuries
Hospitalization costs
Emotional distress
Wrongful death

Don’t hesitate to contact us. Don’t wait to seek the compensation you deserve. Get in touch with Farah & Farah and schedule an appointment for a free consultation regarding your case with one of our talented and experienced attorneys.