FDA Moves On Surgical Stapler Malfunctions
Surgical staplers and implantable staples are used in a variety of surgical procedures, including gynecological surgery, gastrointestinal surgery, appendectomies, lung surgery, heart surgery, and thoracic surgery. Compared to manual suturing, surgical staplers and staples drastically reduce the overall time it takes to complete a procedure. The staples can be placed relatively quickly, cause negligible tissue reaction, and carry a low risk of infection. However, this does not imply they are not without serious problems.
A recent U.S. Food and Drug Administration (FDA) internal analysis reveals that between January 1, 2011 to March 31, 2018, the agency received more than 41,000 MDRs regarding surgical staplers and staples. Incidents listed in the reports consisted of over 32,000 malfunctions, 9,000 serious injuries, and 366 deaths. Unfortunately, this information was not made available to the public until very recently.
According to FDA data, common problems included opened staple lines, malformed staples, and misfiring staplers. Another recurring issue was misapplied staples, which can occur in two ways: when a staple is applied to the wrong area, or when a staple of the wrong size is used. Complications from surgical stapler and internal staple malfunctions can be severe and can result in an extended surgical procedure, additional surgeries, and further complications such as bleeding, tearing of the organs and surrounding tissue, and death.
This Previous Ruling Could Be Indicative Of Future Trends
In 2015, a California jury awarded approximately $80 million in damages ($10 million in compensatory and $70 million in punitive) against Ethicon, a Johnson & Johnson subsidiary. The plaintiff, a former police officer, was injured when doctors accidentally stapled her anus shut during a hemorrhoid operation. The accident resulted in scars and a deformed bowel, which necessitated the use of a colostomy bag.
The plaintiff’s complaint alleged that the surgeon could not fire the stapler properly due to a severe defect, and that this defect could be detected in almost one third of Ethicon’s hemorrhoid staplers. The jury agreed, concluding that the device lacked essential lubrication as the result of a manufacturing defect. However, the jury did not assign blame to the surgeon, who the plaintiff also listed as a defendant. The doctor could not have been responsible, they concluded, because they received no warning of the device’s defectiveness. The jury assigned the blame to Ethicon, who they alleged was aware of the device’s issues but instead opted to blame the doctors rather than work to improve the manufacturing processes.
During the trial, evidence was presented that showed Ethicon may have been aware of the hemorrhoid stapler’s problems for over a decade but failed to take action until a Class 1 recall in 2011. Class 1 recalls are reserved for devices or drugs that can cause severe health problems, up to and including death.
Reporting-Exemptions and Litigation Complaint Summary Reporting
Dr. Douglass Kwazneski was assisting a Pittsburgh surgeon with the removal of an appendix when the surgical stapler they were using locked up. After the event, Kwazneski scoured the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA’s public database for tracking medical device failures, and could not find anything related to his inquiry. Shocked, Kwazneski consulted several prominent surgeons and discovered that approximately two-thirds had either experienced similar problems or were aware of someone who did.
Following Kwazneski’s inquiry, Kaiser Health News (KHN) launched an investigation that subsequently discovered that the FDA had granted an exemption to makers of surgical staplers that allowed them to sidestep MAUDE and file reports pertaining to device malfunctions in a secret repository. According to an article in the Miami Herald, since 2016 over 1.1 million incidents were diverted from the publicly available MAUDE and stored in this repository.
The FDA eventually confirmed the existence of a reporting-exemption program, as well as acknowledged thousands of instances of injury or device malfunctions that had never been made public. In 2018, the exemption program was nearly eliminated (they still remain in place for implantable defibrillators and pacemaker electrodes), resulting in an alarming slew of surgical stapler-related reports. For example, Medtronic analyzed reports of Covidien’s surgical staples and found 1,000 malfunctions in 2015 compared to 11,000 in 2018.
Another tool the FDA has handed device manufacturers is litigation complaint summary reporting, which allows manufacturers to file a single “summary” report with up to 1,175 individual patient injury reports attached. If one were counting the number of injuries related to a particular product, that summary report would emerge as a single injury. To put this in perspective, FDA records provided to KHN show that the program kept over 480,000 injuries or malfunctions from public view.
The FDA’s Solution: Reclassification
Hours after KHN’s investigative findings were published, the FDA sent a letter to healthcare providers that signaled their awareness of the rising number of medical device reports (MDRs) involving surgical staplers and surgical staples. The letter also outlined two safety precautions the agency is planning in the coming months: a public advisory hearing and a draft guidance with labeling instructions for manufacturers. According to the agency, the goal of each of these steps is to improve the safety of surgical staplers and implantable staples.
As of this writing, surgical staplers are regulated as Class I medical devices, meaning premarket submission to the FDA is not mandatory. Conversely, implantable surgical staples are Class II and require premarket review. The FDA is essentially considering reclassifying surgical staplers to Class II, which would enable the use of several key tools, such as strict performance testing, usability demonstrations, and labeling comprehension.
Looking to the Future
The Global Surgical Staplers market is expected to exceed $4 billion by 2024. This is largely due to the growing number of surgical procedures performed per diem, the rising popularity of medical tourism, various technological advancements, and the development of minimally invasive procedures. Given the severity of potential injuries, the lack of publicly available information, and current litigation trends, it is very likely that we will witness a slew of device-related mass-tort trials in the near future.