Have you or a loved one been hurt by the misuse of a surgical stapler? Have you considered filing a surgical stapler lawsuit?
FDA TO REVIEW SURGICAL STAPLERS AFTER THOUSANDS OF REPORTS OF MALFUNCTIONS
The Food and Drug Administration recently announced a sweeping plan to address the safety of stapler devices used during surgery. Surgical staples are used to connect blood vessels and tissues during surgery, and have been considered to be faster and easier to use than nylon sutures, but at what cost to the patient?
Surgical staplers cut and seal blood vessels and tissue. When the staples misfire, or fail to fire, patients can bleed profusely and suffer catastrophic consequences, even death. The FDA has said that stapler malfunction or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”
What types of surgeries are staplers used in?
The use of surgical staples is wide ranging due to their ease of use. Some of the more common surgeries where surgical staplers may be used include gastrointestinal, gynecologic, colorectal, vascular, and thoracic. In other words, body parts that are either hard to reach, or where speed of closure is important.
Types of surgeries where the use of a stapler is regularly include:
- Removing part of an organ (resection)
- Cutting through organs and tissues (transection)
- Creating connections between structures (anastomoses)
If you have had a surgery like any of these described above there is a good chance that surgical staples were used.
What are the most common types of injuries?
Many surgical patients have had surgeries where a stapler was used without issue. An alarming number have not. Based on the research now available the types of injuries that may arise include:
- Intestinal dysfunction – uncontrolled diarrhea, constipation
- Occlusion of gastrointestinal tract – block
- Organ damage
- Severe pain
- Bleeding and extensive blood loss
If you have suffered any of the injuries listed above you may have a surgical stapler lawsuit case. In most cases, a patient that has suffered from one of the above injuries and has had to undergo repeat surgical procedures is more likely to be a surgical stapler lawsuit victim.
If you believe that this has happened to your or a loved one, please give us a call to discuss the specifics of your case.
What the FDA and Other Investigations have Found
The FDA’s review included an examination of 7 years of hidden reports that were not added to the public database known as MAUDE (the Manufacturer and User Facility Device Experience). Public reports show that “from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.”
On March 2019, the FDA sent a letter to health care providers advising that it is reevaluating the safety of the devices and may reclassify them to place them under tighter control.
A Kaiser Health Network investigation found that in 2016 alone nearly 10,000 surgical stapler malfunction reports flowed into the internal FDA database due to reporting exemptions. That same year, the public database disclosed fewer than 100 injuries or malfunctions.
For example, Stapler maker Medtronic confirmed that its reporting exemption ended in 2017. FDA records show that its public reports of injuries or malfunctions increased from about 1,000 in 2015 to 11,000 in 2018.
The FDA is continuing to review and investigate the safety of surgical staplers. The FDA is also said to be looking for possible changes to the classification of the medical devices allowing the FDA to require greater testing of various mechanical features.
How We Can Help
Our attorneys are currently evaluating and investigating claims on behalf of patients who have been injured during surgery due to surgical stapler misuse or malfunction. If you have been injured during surgery, and believe that you qualify for a surgical stapler lawsuit please contact us immediately.
In many cases, filing a lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, and for some – funeral costs. Others file lawsuits because they want to make a difference and prevent others from suffering through the same horrors as they have. Van Wey Law Can Help, No Matter Where You Live. To discuss the specifics of your potential lawsuit in a free and confidential consultation, contact us today. You may call us at 1(888)-694-8093.
You can contact Van Wey Law for a free case evaluation to determine if you may be entitled to receive compensation from these irresponsible medical device companies who place profits over public safety.