Surgical Stapler Lawsuit
Surgical staplers are commonly used to close surgical incisions and join tissue. However, these devices have been linked to serious injuries and patient deaths.
Surgical stapler malfunctions can result in severe internal bleeding, punctured organs, and infection. In some cases, revision procedures or additional surgeries are required to repair the damage caused by a malfunctioning stapler.
Did you suffer a surgical stapler injury after undergoing a procedure? The personal injury attorneys at Rosenfeld Injury Lawyers, LLC are legal advocates for injured victims harmed by faulty surgical staplers or medical malpractice.
Contact our defective medical device lawyers at (888) 424-5757 (toll-free phone number) or use the contact form to schedule a free consultation.
All confidential or sensitive information you share concerning your surgical stapler lawsuit remains private through an attorney-client relationship.
Defective Surgical Staples
Reports from the Food and Drug Administration (FDA) indicate over 49,000 adverse events were reported related to surgical staplers from January 2011 to April 2021. These incidents resulted in over 12,000 serious injuries and deaths.
In addition to surgical stapler malfunctions, there has also been incorrect medical device use that leads to the need for additional surgeries due to damage to internal organs.
Problems include healthcare providers using the wrong size or type of stapler during surgical procedures, resulting in torn or detached internal tissues and bleeding.
The FDA has issued warnings and guidelines for the proper use of surgical staplers, and several lawsuits have been filed against manufacturers for a botched surgery. Despite legal actions and healthcare providers warning of serious problems, patients continue to suffer severe injuries from using these medical devices.
Device malfunctions using surgical staplers have led to significant surgical stapler injuries. Thousands of defective stapler lawsuits have been brought against medical device manufacturers by patients who have suffered internal bleeding, organ damage, and other life-threatening injuries after undergoing gastric bypass, heart surgery, and other medical procedures involving faulty surgical staplers.
FDA Recalls Faulty Surgical Staplers
Modern surgical staplers were invented and marketed in the 1960s as a time-saving alternative to manual sutures that surgeons made to close wounds after a surgical procedure.
According to adverse event reports, the two primary manufacturers of gastric bypass staplers in the US are Ethicon and Medtronic (which purchased Covidien, formerly US Surgical Corp., in 2015).
The FDA's hidden database, inaccessible to the general population, identified serious concerns over injuries associated with surgical staplers.
The public databases show that both have reported serious problems with their products. Maquet Medical Systems Inc. makes the TigerPaw brand of staplers primarily used in heart surgery, and it was recalled for safety defects by the Food and Drug Administration (FDA) in 2015.
Many injured patients filed their surgical stapler lawsuit before the first recall. These plaintiffs claim they experienced health issues due to the risks associated with surgical staplers, including:
- Health complications including cardiac arrest
- Allergic reaction
- Organ damage
- Fistula formation
- Excessive bleeding (life-threatening blood loss)
Surgical Stapler Lawsuit FAQs
Our personal injury law firm understands that many families have unanswered questions about dealing directly with insurance companies after being hurt by a defective product or medical negligence. An attorney from our legal team has answered some of those questions below.
Contact us today at (888) 424-5757 for additional information or to schedule a free consultation on receiving financial compensation for your damages.
How are Surgical Staplers Used in Gastric Bypass Procedures?
Over nine million Americans are classified as morbidly obese. Gastric bypass (bariatric) surgery involving stapling has become commonly used as a last resort when diet and other weight-reduction measures fail to control a patient's obesity.
Gastric bypass divides the stomach into two separate parts, one of which is a very small upper pouch and the other which is the remainder of the stomach.
The surgical stapler allows medical professionals to close the incisions made during the procedure, which are too large for stitches. After the surgery, patients eat less because the upper portion of the stomach becomes full more quickly, controlling the appetite.
In the case of morbid obesity, which seriously threatens a person's health and life expectancy, successful gastrointestinal surgeries (gastric bypass surgery) can prove to be a lifesaver.
What Serious Injuries Have Been Associated with Defective Surgical Staplers?
Ethicon surgical staplers are cited in numerous complaints as unreliable and unsafe. In May 2019, the Food and Drug Administration acknowledged receiving more than 110,000 surgical stapler malfunction reports in the previous decade, more than half of which had never been publicly disclosed.
Approximately 56,000 reports were kept out of the hidden database of the FDA's publicly available online “Manufacturer and User Facility Device Experience” (MAUDE). According to the agency, there have been more than 400 patient deaths related to faulty staplers since 2011.
Problems reported with these devices include their failure to form correct staples, inability to properly “fire,” and staples that later come loose or fail to keep the incision closed.
Serious injuries that can result from the use of a surgical stapler on a patient include:
- Internal bleeding caused by failure to close the wound or from the staple site itself
- The leakage of stomach acid from internal organs that reopen after bypass procedures
- Infection of the staple site or the incision
- Hernia due to stapler malfunction
- Septic shock-an infection that reaches the bloodstream and travels to major organs
These and other surgical complications often require the patient to undergo one or more corrective procedures. In the most severe cases, complications from defective staplers can result in the patient's death.
Are There Surgical Stapler Lawsuits Filed Against the Manufacturer?
In recent years, victims and their families have successfully filed surgical stapler lawsuits against medical device-maker Ethicon for product liability, which holds the manufacturer of a product responsible for any serious injuries the product causes when it is used as intended.
Rather than responding to reports of adverse effects by recalling their products or improving their designs, the surgical stapler manufacturers have chosen to deflect blame onto surgeons alleging their medical malpractice is the source of patient injury.
Ethicon has repeatedly claimed surgical stapler malfunctions result from physician error, but it is becoming increasingly difficult to substantiate this claim when the devices, not the surgeons, have become the common denominator in tens of thousands of incidents.
While there is currently no class action suit, many victims are filing a surgical stapler lawsuit to recover compensation through compensatory and punitive damages.
What Stapler Brands Have Been Reported to Malfunction Most Often?
The FDA's MAUDE database lists adverse effects involving surgical staplers. Beginning in 2009, the following Ethicon surgical stapler recall products have been cited most often in public database reports as frequently leading to surgical stapler complications and injury:
- Echelon Flex60
- Echelon Flex45
- Echelon 60
- Echelon Endopath
There have been dozens of reported malfunctions during prolonged surgery involving Medtronic/Covidien staplers, including:
- Endo Gia
How is the TigerPaw Surgical Stapler Used in Open Heart Surgery?
A device commonly used in open-heart surgery is a surgical stapler called the TigerPaw II, which is used to close the tissue in the heart that was opened during surgery to correct atrial fibrillation.
In March 2015, the TigerPaw was recalled when it was discovered the devices failed to perform their intended function and could cause additional injury that could lead to serious complications or death.
The surgical stapler lawyers at Rosenfeld Injury Lawyers, LLC are actively involved with potential claims and lawsuits involving the Tiger Paw surgical stapler.
If you or a loved one suffered surgical stapler injuries such as internal bleeding, blood clots, infection, heart failure, heart attack, stroke, or death following heart surgery, let our office investigate the matter for you with no up-front cost on your part.
How Have TigerPaw Staplers Allegedly Harmed Patients?
Reports began to surface that patients undergoing the TigerPaw System II surgery experienced serious complications and heart injuries. Among the adverse effects reported: surgical staples tore the atrial wall and caused significant internal bleeding.
In other cases, the device failed to seal the left atrial appendage, which allowed blood clots to form, rendering the procedure ineffective.
Reported injuries caused by the TigerPaw System II surgical staplers include:
- Bleeding from tears in the atrial wall or at the site where the surgical staples were placed
- Infections resulting from bleeding or injuries experienced during the procedure
- Heart failure due to bleeding or infection
- Death from any of the aforementioned complications
Why was the TigerPaw Stapler Recalled?
The Class I designation given to a recall by the FDA indicates the product is capable of causing serious harm. Most surgical stapler recalls receiving this classification can cause debilitating or fatal injuries.
As a result of the FDA's order, Maquet Medical Systems has recalled over 4,100 of its TigerPaw System II stapling devices and instructed surgeons to discontinue using or remove the devices from patients.
It is anticipated that patients who underwent procedures before this recent surgical stapler recall may have valid claims against Maquet Medical Systems, which purchased the previous device manufacturer in 2013.
Our Surgical Stapler Injuries Lawyers Can Help You Win Compensation
If an Ethicon surgical stapler has injured you during surgery, Rosenfeld Injury Lawyers has the resources needed to represent your interests and see that you receive fair compensation for your injuries.
Schedule a free case evaluation with our legal team to learn how we can help you secure the compensation needed for your care. Our surgical stapler attorneys can advise you on your legal options and how best to pursue your claim.
If for any reason, we are unable to secure a financial recovery on your behalf, you will not be charged for our legal services.
Surgical Stapler Lawsuits
To learn more about current litigation and how it may affect your surgical stapler lawsuit, contact Rosenfeld Injury Lawyers. We can advise you of your legal options and help you determine whether it is in your best interests to file a lawsuit against surgical stapler manufacturers.
Contact us at (888) 424-5757 to schedule your free case review.
The following FDA database contains malfunction reports on staplers and other medical devices dating back to 2009: