Rosenfeld Injury Lawyers LLC represents clients who have been injured by surgical staplers. Thousands of 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 defective surgical staplers. If you have been injured from surgery involving staplers, you might be eligible to receive a large financial settlement in a product liability lawsuit.
The modern surgical stapler was invented and marketed in the 1960s as a time-saving alternative to manual sutures that surgeons made to close wounds after surgery. The two primary manufacturers of gastric bypass staplers in the U.S. are Ethicon and Medtronic (which purchased Covidien, formerly U.S. Surgical Corp., in 2015). Both have had serious problems reported with their products. Maquet Medical Systems Inc. makes the TigerPaw brand of staplers which are primarily used in heart surgery and which was recalled for safety defects by the Food and Drug Administration in 2015.
If you or a loved one has been injured by a surgical stapling procedure, you likely have questions about your legal rights. This web page will address the following issues:
- How are surgical staplers used in gastric bypass procedures?
- What injuries have been associated with defective surgical staplers?
- What stapler brands have been reported to malfunction most often?
- How is the TigerPaw surgical stapler used in open heart surgery?
- How have TigerPaw staplers allegedly harmed patients?
- Why was the TigerPaw stapler recalled?
How are Surgical Staplers Used in Gastric Bypass Procedures?
Over nine million Americans are classified as morbidly obese. Gastric bypass 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 surgeons 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 gastric bypass surgery can prove to be a lifesaver. But while the surgery has proven successful for the right patients, it has also had disastrous consequences when performed negligently or when a malfunction occurs with the stapling devices.
What Injuries Have Been Associated With Defective Surgical Staplers?
Since they came into widespread use, surgical staplers have been cited in numerous complaints as being unreliable and unsafe. In May 2019, the Food and Drug Administration acknowledged receiving more than 110,000 surgical stapler failure reports between 2011 and 2018, more than half of which had never been publicly disclosed. About 56,000 reports had been kept out of the FDA’s publicly available online “Manufacturer and User Facility Device Experience” (MAUDE) database. According to the agency, there have been more than 400 patient deaths related to defective surgical staplers since 2011.
Problems that have been 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.
Injuries that can result from the use of a defective 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 areas that reopen after bypass procedures
- Infection of the staple site or the incision
- Septic shock, an infection which reaches the bloodstream and travels to major organs
These and other complications often require the patient to undergo one or more corrective surgeries. In the most severe cases, complications from defective surgical staplers can result in the death of the patient.
In recent years, victims and their families have successfully filed lawsuits against medical device-maker Ethicon for product liability, which holds the manufacturer of a product responsible for any injuries the product causes when it is used as intended. Rather than responding to reports of adverse events by recalling their products or improving their designs, the surgical stapler manufacturers have chosen instead to deflect blame onto surgeons. Ethicon has repeatedly claimed the equipment malfunctions are the result of 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.
What Stapler Brands Have Been Reported to Malfunction Most Often?
According to the FDA’s MAUDE database, which lists adverse events involving surgical staplers going back to 2009, the following Ethicon products have been cited most often in malfunction reports as frequently leading to surgical complications and injury:
- Echelon Flex60
- Echelon Flex45
- Echelon 60
- Echelon Endopath
The following Medtronic/Covidien staplers have each had dozens of reported malfunctions during surgery:
- Endo Gia
If you underwent a surgical stapling procedure and suffered injuries due to staples not forming correctly or failing to close your wound, you may be entitled to receive compensation from the medical device manufacturer for the cost of medical treatment required to correct the issue, pain and suffering you experienced, and any other financial losses you incurred as a result.
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 of 2015, the TigerPaw was recalled when it was discovered the devices not only failed to perform their intended function, but could cause additional injury that can lead to serious complications or death.
Rosenfeld Injury Lawyers is actively involved with potential claims and lawsuits involving the TigerPaw surgical stapler. If you or a loved one suffered complications 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.
The function of the TigerPaw System II
Atrial fibrillation occurs when the upper chambers of the heart fail to maintain a steady rhythm, leading to the possible formation of blood clots in the heart which can cause cardiac arrest or stroke. If you suffer from this condition, you may have been placed on blood-thinning medication as a means of preventing these clots.
However, blood thinners come with risks and complications of their own, so your doctor might recommend surgery to prevent blood from clotting in the upper chambers of your heart. The left atrium is the most common area for clots to form, so your surgeon would close the left atrial appendage during the procedure using the TigerPaw System to staple the area shut.
How Have TigerPaw Staplers Allegedly Harmed Patients?
Reports began to surface that patients undergoing surgery using the TigerPaw System II experienced serious complications and injuries to their hearts. Among the adverse events were reports that the 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. Concerns with the TigerPaw System II include the following:
- Internal bleeding from tears in the atrial wall or at the site where the 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 medical device 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 stapling procedures prior to this recall may have valid claims against Maquet Medical Systems, which purchased the previous manufacturer of the device in 2013. To learn more about current litigation and how it may affect your own claim, 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 of your own.
Our Surgical Stapler Injury Lawyers can Help You Win Compensation
Rosenfeld Injury Lawyers LLC has represented thousands of clients in medical negligence and product liability claims. Our success stems from our access to a team of experts in fields that are crucial to building your case, establishing its value, and presenting it effectively in front of a jury. By enlisting the assistance of experts in fields such as medicine and economics, we are able to successfully argue your case to ensure that your present and future expenses are covered.
If you have been injured from any kind of stapling surgery, Rosenfeld Injury Lawyers has the resources needed to represent your interests and see that you receive fair compensation for your injuries. Arrange a risk-free and confidential consultation with us today to learn how we can help you secure the compensation needed to pay for your care. Our attorneys can advise you on your legal options and how best to pursue your claim. If for any reason we are unable to secure financial recovery on your behalf, you will not be charged for our legal services.
The following FDA database contains malfunction reports on staplers and other medical devices dating back to 2009: