Today’s surgeons rely more on surgical staplers as an alternative to stitches and sutures due to the increased speed and ease of use provided by the devices. However, sometimes the stapler can misfire during a procedure leading to serious injuries and medical complications. Due to the frequency of these misfires, the U.S. Food and Drug Administration (FDA) recently issued a Class 1 recall (the most serious level) for certain types of defective surgical staplers.
The recalled staplers received mounting reports for “misfiring staples” which cause serious damage and potentially life-threatening injuries. The defects also cause the stapler to jam and produce “malformed staples” which can lead to the following patient complications:
- Internal bleeding
- Tearing and tissue damage
- Life-long nutritional deficiencies
- The need for a permanent ostomy “bag”
- Fistula formation
- Life-long digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries
- Need for antibiotics
- Need for additional imaging studies
- Wrongful death
Thousands of patients have reported serious injuries resulting from defective surgical staplers. The FDA recently reported that they had received more than 50,000 claims of stapler malfunctions over the past seven years.
Numerous lawsuits have been filed on behalf of victims hurt by a malfunctioning surgical stapler. Some of the lawsuits have gone to trial and led to sizable verdicts against the defendants. Most prominent among them was a recent California case that ended with a victim being awarded $80 million including $70 million in punitive damages against surgical stapler manufacturer Ethicon.
The Issue Analyzed
ORIGINALLY INTENDED FOR EXTERNAL USE ONLY
Staplers were originally created to close external wounds and cuts on the surface of the skin replacing more traditional sutures. Surgical staplers were not originally intended for internal use on soft tissue. Currently, stapler litigation involves cases where surgical staples were used internally, most commonly for surgical procedures involving the gastrointestinal tract.
FUNDAMENTAL FLAWS WITH SURGICAL STAPLERS
A fundamental issue with surgical staplers is that they are typically made from inexpensive, flimsy materials in offshore factories employing unskilled, cheap laborers. While this may be good for the manufacturer’s bottom line, it’s far from the ideal way to craft a precision surgical instrument.
A second fundamental problem is that most devices currently on the market were approved through the quick and easy 510K process which requires no clinical trials and very little oversight. Many of the staplers designed for INTERNAL use were based on claims by the manufacturer that the device is “substantially equivalent” to a stapler that was approved for EXTERNAL use.
STATISTICS ON INJURIES FROM SURGICAL STAPLERS
Based or our most recent review of the FDA’s MAUDE database, there were more than 143,000 adverse events reports for surgical staplers and staples. Of those, more than 30,000 were cases where the patient suffered injury. Additionally, more than 1,000 deaths have been reported as a result of a defective stapler misfiring.
WHAT HAPPENS WHEN STAPLE FAILS TO DEPLOY
When a surgeon fires the device, it first performs a cut to the tissue then almost immediately fires a staple to close the tissue. Sealing of the tissue is known as surgical anastomosis. One common malfunction is when the cut is made but the staple does not fire to close the tissue. The tissue is left open, creating a wound in the gastrointestinal tract. If the staples fail to fire it can be life threatening due to the massive amount of blood that is lost quickly from the wound which remains open.
If this type of misfire occurs during a laparoscopic or “key-hole” procedure, the surgeon may be forced to convert to an open surgery to repair the damage and save the patient’s life. These situations are almost always life threatening as the patient may bleed out and die within a few minutes.
COMPLICATIONS ARISING AFTER SURGERY
For some patients, complications arise after the initial surgical procedure is over. Oftentimes, patients are forced to return to the operating room almost immediately for an unplanned, emergency repair surgery. Others may be released from the hospital only to return a few days later once symptoms arise. Most complications are cause by the staples failing to adequately close the incision due to a misfire or a staple that does not fully close resulting in one or more of the following injuries.
- Gastrointestinal surgery patients will experience leakage of digestive fluid, bowel fluid, or bowel material causing serious internal infection or sepsis.
- Patients may also experience severe bleeding.
- Misfiring of the device leading to incomplete staple lines and malformed staples.
In each of the above situations, emergency surgery is typically required to repair the staple line, close the leak, and treat infection. The operative report from the second surgery should note that there was a leak caused malformed staple due to a misfire.
WHO ARE THE TOP MANUFACTURERS OF SURGICAL STAPLERS?
Covidien and Ethicon are the two market leaders for surgical staplers controlling 95 percent of the endoscopic surgical stapler market in the United States. Covidien is a subsidiary of Medtronic (NYSE: MDT) which has a market cap of $152 billion as of December 31, 2019. Global giant Johnson & Johnson (NYSE: JNJ) is parent company of Ethicon boasting a market cap of $384 billion as of December 31, 2019.
Covidien was originally an Irish-headquartered global health care products company and manufacturer of medical devices. Covidien became an independent publicly traded company after being spun off from Tyco International in 2007. The company was later purchased by Medtronic in a transaction that closed in 2015. Covidien now operates as Medtronics Minimally Invasive Therapies.
Ethicon, Inc. is a subsidiary of Johnson & Johnson. It was incorporated as a separate company under the Johnson & Johnson umbrella in 1949 to expand and diversify the Johnson & Johnson product line. Ethicon has manufactured surgical sutures and wound closure devices since 1887 according to Wikipedia. After World War II, Ethicon’s worldwide market share in surgical sutures rose from 15 percent to 70 percent.
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