Parker Waichman LLP

03/13/2019 | News release | Distributed by Public on 03/13/2019 10:30

Surgical Stapling Risks Hidden from Public View

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Hidden surgical stapling risks

A report from Kaiser Health News reveals that a large number of complications from surgical stapling devices have been filed in a database that is hidden from public view. By using a loophole in reporting to the U.S. Food and Drug Administration, the manufacturers of surgical staplers have been able to keep risk information away from patients and their doctors.

Kaiser Health News reports that numerous surgeons have experienced issues with surgical staplers and staples during medical procedures, but their experiences look quite uncommon from a review of the FDA's public adverse event reporting database for medical devices (called MAUDE). Medical device manufacturers have for years been taking advantage of an exemption allowed by the FDA that enables malfunction reports to be filed in a private database.

The private database, known as the Alternative Summary Reporting program, has received at least 1.1 million reports regarding device malfunction and patient injuries since 2016, according to Kaiser Health News. This information is only viewable by the FDA, meaning patients and doctors never see it. About 100 devices are described in Alternative Summary reports, according to Kaiser Health News, including surgical staplers.

The FDA says that the Alternative Summary Reporting program is intended for issues that are already widely known and documented to the FDA. It is supposed to eliminate redundancy, the agency says. Yet, the program itself seems unknown to the medical community, and at least with regard to surgical staplers, it seems manufacturers use it for reporting issues that are not well-known to patients or doctors.

In the first 28 months of the Alternative Summary Reporting program, surgical stapler manufacturers filed more than 5,100 reports regarding patient injury and device malfunction. In all of 2011, only 18 reports were publicly filed regarding patient injury and device malfunction.

Medtronic subsidiary Covidien, which makes surgical staplers, informed Kaiser Health News that it used the Alternative Summary Reporting program through July 2017. Medtronic is one of the leaders in stapler manufacturing. Another manufacturing leader, Ethicon, told Kaiser Health News that it does not use the Alternative Summary Reporting program.

On March 8, 2019 the FDA published a release regarding the risks of surgical staplers and implantable staples. This was the same day as publication of the Kaiser Health News article. Also on the same day the Kaiser Health News article came out, the FDA sent a letter to medical providers regarding an increased incidence of reported complications from surgical staplers and staples.

The FDA noted in both the release and the health care provider letter that it had identified 41,000 adverse event reports related to the devices. Those reports included 9,000 instances of serious injury to patients and more than 350 patient deaths.

The FDA said that the staplers could misfire or fail to fire, and the staples could become malformed. When these events occur, patients will potentially require longer operations or additional operations. The FDA identified some of the risks of stapler and staple malfunction (and additional required procedures) as fistula formation, bleeding events, organ and tissue tearing, increased possibility for cancer recurrence, sepsis, and death.

Due to what the FDA described as an increasing number of reported adverse events associated with surgical staplers, the agency said it was planning to call a panel to discuss whether the regulatory requirements for the devices should be changed. Currently, surgical staplers are Class I medical devices, so manufacturers have no premarket obligations from the FDA. The FDA also said it intended to draft new labeling recommendations for the devices.