Surgical staplers are medical devices commonly used by surgeons to close wounds and incisions and to help repair internal organs. These devices were developed with the intention that they would help to save time and reduce the risk of inflammation at the site of the wound or incision.
Unfortunately, this has not always been the case and serious health complications have been linked to the surgical staplers manufactured by Medtronics, Ethicon and several other manufacturers.
Recently a review of the U.S. Food and Drug Administration (FDA) – Manufacturer and User Facility Device Experience (MAUDE) database found more than 41,000 adverse event reports filed for surgical staplers and staples between January 1, 2011, and March 31, 2018. The statistics revealed that the devices malfunctioned approximately 32,000 times, resulting in 9,000 patient injuries and over 350 deaths. Sadly these numbers don’t accurately represent the actual number of incidents that have occurred which has been proven to be much higher.As seen in an investigation by Kaiser Health News that examined seven years’ worth of hidden FDA reports, nearly 10,000 reports of surgical stapler malfunctions in 2016 alone were found in the FDA’s internal database. A number that is much higher than the 100 surgical stapler injuries reported in the MAUDE/FDA review.
In addition, the Kaiser Health News report showed that the FDA has built a hidden repository of reports on medical device-related injuries. This internal alternative summary reporting program recorded at least 1.1 million incidents of device malfunctions and injuries since 2016. Because these reports are not included in MAUDE/FDA, doctors are unable to use them to identify problems that could put patients at risk.
According to the FDA, common surgical stapler malfunctions include:
- Difficulty in firing
- Failure of the stapler to fire staple
- Misapplied staples (for example, using the incorrect staple for a particular surgery)
- Staple malformation
Leaks in the staple line (the incision or wound closure)Do you believe you have suffered an injury or complication caused by a defective surgical stapler? It is important that you talk with an experienced Connecticut surgical stapler lawyer at Wocl Leydon as soon as possible. The time to file your claim is limited by the statute of limitations so call us today to schedule a free and confidential consultation.
What Causes Surgical Stapler Complications?
Frequently complications are a result of defective surgical staplers. Most surgical stapler injuries occur because the stapler did not fire properly. When the staples misfire, they do not seal properly, causing leakage in or separation of the areas that were stapled.
Additionally, it can be very difficult to determine the thickness of the tissue being stapled and the surgeon may choose the wrong staple. If the staple is too small, the area won’t totally close, causing bodily fluid leakage. If the staple is too large, it can cause internal damage. It is obvious from all of this information that the risks of complications caused by using surgical staplers is high regardless of whether those are caused by stapler defects or user error.
Liability for Surgical Stapler Complications in Connecticut
Defective surgical staplers are determined to be defective if there is clearly a design, manufacturing or marketing flaw. The surgical stapler may contain serious design issues. In addition, flaws can also arise when the device functioned well for a while, then deteriorated causing injury. If the surgical stapler was not manufactured properly, it may have a manufacturing flaw. False marketing or failure to warn about its risks, can cause marketing flaws.
Once a surgical stapler has been determined to be defective, it is essential to determine who is liable. Liability is proved when the manufacturer (or someone else) had a duty of care, breached that duty of care, and an injury resulted because of that breach. Our experienced product liability attorneys in Connecticut can help you prove not only that the surgical stapler in your case was defective, but also who is ultimately liable for the defects, your injuries and for paying you the compensation you deserve.
Surgical stapler lawsuits usually involve one of the following claims:
- The surgical staplers are defectively designed in a way that causes an injury.
- There was a manufacturing defect that caused the stapler to misfire.
- The manufacturer was negligent in designing the surgical stapler.
- The stapler is otherwise defective, and its manufacturer should be liable.
Victims of defective surgical staplers should promptly seek experienced legal representation. The attorneys at Wocl Leydon are experienced in defective surgical stapler cases and will work to prove through medical evidence that the stapler used in your procedure was defective and how it caused your injuries.
Surgical Stapler Complications in Connecticut
Surgical staplers that are defective can cause surgical staples to be misfired which can in turn lead to the separation of suture lines or can cause the staples to become lodged in bodily tissues.These injuries result in many serious complications including:
- Internal bleeding
- Severe pain
- Sepsis, a serious condition caused by the body’s response to infection
- Formation of a fistula, an abnormal connection between body parts
- Leaking fluids
- Diarrhea and constipation
- Increased risk of cancer
- Tearing or puncturing of tissue and organs
- Organ damage or failure
Of these, the most common is the leakage of blood or bodily fluid which can lead to severe infection, life-long medical complications, and even death.
If you have been the victim of surgical stapler complications, you may be entitled to “compensatory damages”. Compensatory damages are meant to compensate you for the costs associated with your injuries. These damages may include:
- Past and future medical expenses
- Lost wages
- Lost earning capacity
- Disability-related expenses
- Pain and suffering
- Mental anguish
- Loss of enjoyment of life
- Funeral and burial costs in cases of wrongful death
In addition, defective medical device lawsuits can result in “punitive damages”. Punitive damages are meant to punish defendants for wrongful and/or negligent conduct, such as refusing to recall a surgical stapler that has been found to put people at risk or harm, for example.
Wocl Leydon Will Be on My Side
The experienced Wocl Leydon attorneys have represented patients who received defective staples and/or those who were injured by defective staplers and suffered complications as a result. The key in these cases is determining if your injuries were a result of a defective stapler, and this is very hard to do without an experienced team of attorneys on your side. This is why the experienced attorneys at Wocl Leydon are here to help you. We will thoroughly investigate your case and the vast amounts of medical information involved and will determine if your injuries were due to a defective device.
Our team of Connecticut product liability lawyers work on a contingency fee basis. This means you don’t pay anything unless you receive an award. We have the resources, experience and knowledge necessary to hold negligent surgical stapler manufacturers accountable. Contact us now for a free, no-obligation, confidential consultation. We will help you and explain your legal options.