Kim Gale  |  November 25, 2020

Category: Legal News

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Doctor writes notes while nurses tend to patient in the background

FDA approved surgical staplers have been linked with some serious complications, and have resulted in surgical stapler lawsuits, but the U.S. Food and Drug Administration has proposed new rules that it says would increase safety.

The federal agency has three categories of FDA approved devices, based on what level of regulatory controls it determines are necessary for both the safety and efficacy of a medical device. These three categories are Class I (general controls), Class II (special controls), and Class III (premarket approval).

FDA Certified: What Has Improved?

Surgical staplers are devices used to cut and staple internal tissue during a variety of surgeries, including both open and minimally-invasive procedures. These devices have been linked with some serious potential complications, but the FDA recently proposed changes to help better regulate the devices.

The FDA has proposed that surgical stapler devices be reclassified from Class I to Class II, requiring special controls and subject to premarket review. The FDA notes that the available evidence indicates that injuries associated with these devices were commonly caused by mechanical issues or defects that further control would be better able to regulate.

The FDA’s announcement of the proposed rule for FDA approved surgical staplers notes that the agency believes that certain special controls are “necessary and sufficient to mitigate” the health risks associated with surgical staplers, as well as “provide a reasonable assurance of safety and effectiveness for surgical staplers for internal use.”

The new rules would require mitigation measures including performance testing, usability testing, labeling comprehension study, labeling, biocompatibility evaluation, sterility testing, and shelf-life testing.

Surgical Stapler Complications

The proposed reclassification came after a slew of injury and death reports associated with surgical stapler use, including 412 reports of death as of mid-2019.

Surgical staplers have been linked with a device malfunction that causes malformed staples, which in turn can lead to complications like prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or even death.

Other malfunctions associated with these devices included staple lines not forming or staples missing; sticking, locking, or jamming of devices; tissue damage or leaks; staplers misfiring, breaking, or not cutting; and cartridges failing to load properly.

These complications led the FDA to issue a recall of Ethicon surgical staplers. FDA recalls are divided into Class I, II, and III recalls, where products with Class III FDA recalls are unlikely to cause adverse health consequences and products with Class I FDA recalls have a “reasonable probability” of causing “serious adverse health consequences or death.”

Demonstration of surgical stapler on silicone sampleThe recalled devices were manufactured and distributed for about a year, between March 2018 and March 2019, with the recall initiated on April 11, 2019. The recall announcement specifically notes that “the use of affected product may cause serious patient harm or death.” As of Oct. 3, 2019, Ethicon noted that seven serious injuries and one death had been reported linked with the product codes affected by the recall.

The FDA acknowledged upon announcement of the recall that “many more device malfunction reports” had actually been reported over these devices than the agency had previously disclosed to the public. Indeed, more than 56,000 reports of surgical stapler malfunctions were reported through non-traditional channels between 2011 and 2018. Combined with the reports made through regular channels, this brought the total number of these reports over surgical stapler malfunctions or injuries to nearly 110,000 during this period of time.

A list of Ethicon staplers that have been affected by the recall can be found on the FDA’s website—approximately 100,000 devices in all.

How Do Surgical Staplers Work?

These devices are used in a number of settings, according to the FDA, from thoracic to gastrointestinal surgeries. In addition to creating connections, they can be used to cut through tissues or organs as necessary.

They have both internal and external applications, according to the oversight agency, and are beneficial because of the ease of placing the staples for the surgeon. Additionally, studies have shown that tissues do not react as much to a staple as other devices, leading to a lower risk of infection and improved wound closure.

However, the use of surgical staplers can be risky, according to experts. The ECRI Institution deemed the devices one of the most dangerous used in hospitals in 2020. The Institution says they based their review on the number adverse events and device malfunctions reported.

The health of a surgery patient depends on the safety and reliability of these devices; however, Ethicon allegedly manufactured surgical staplers that failed perform appropriately, reportedly resulting in patient injury and even one death. Despite reports of problems with Ethicon surgical staplers, the company did not issue a recall until 2019.

Ethicon surgical staplers were used in procedures for years and, according to legal action against the manufacturer, the company knew about issues with its device. Indeed, a number of lawsuits have been filed against Ethicon and its parent company, Johnson & Johnson over injuries caused by surgical staplers.

Staplers must be FDA approvedNew Specialized Surgical Stapler Tested

The University at Buffalo says an FDA approved clinical trial found a new surgical stapler designed for operations for sleeve gastrectomy was successful in August.

A sleeve gastrectomy, also called gastric sleeve surgery, is an operation that involves the removal of a portion of the stomach to assist in weight loss. The remaining portions of the stomach form a small sleeve, or sack, which is about a tenth of the size of the patient’s original stomach. The reduction in stomach space helps the person feel full faster, prevents the person from physically being able to overeat, and as a result, helps the patient lose weight.

Eight patients enrolled in an Investigational Device Exemption study that allowed surgeons to use Standard Bariatric’s Titan SGS stapling technology. The longitudinal gastric stapler is unique because it can create the longest continuous stapler cutline yet possible at 23 centimeters and was engineered with gastric tissue in mind.

The eight patients reportedly have not had any leaks in their stapled gastric lines, according to Aaron B. Hoffman, MD, principal investigator, clinical associate professor and chief, Division of General Surgery in the Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences at UB, Buffalo General Medical Center, where he led the team that conducted the surgeries.

“The unique length of this gastric stapler appears to allow a more consistent and reproducible sleeve formation, and eliminates any possibility of crossing of staple lines seen with current cartridge-based stapling technology,” said Hoffman in a press release. “Unlike cartridge-based, multi-fire general-use surgical staplers, the Titan SGS creates one continuous staple line during sleeve gastrectomy, which appears to result in more consistent sleeve morphology, fewer malformed staples and less bleeding by eliminating the crossed staple lines of traditional staplers.”

Are You Still At Risk?

Any medical device, medication, or surgical procedure still comes with a certain amount of risk, but this proposed FDA reclassification of Ethicon devices would introduce safety measures that are meant to help prevent issues like these from occurring.

Filing a Surgical Stapler Lawsuit

A growing number of people are coming forward with allegations of malformed surgical staples, leading to serious complications.

If you or someone you love has suffered from these or other complications after internal staples were used during surgery, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by serious medical complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with health complications, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Join a Free Ethicon Surgical Stapler Lawsuit Investigation

If you or a loved one suffered from surgery complications caused by internal staples, you may qualify to joing in a Ethicon surgical stapler lawsuit investigation.

See if you qualify by filling out the free form on this page. 

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