Surgical Stapler Manufacturers Support Reclassification, with Caveats

The FDA has recommended changing the classification of surgical staplers—medical devices used to close wounds during surgery—because of the safety risks associated with them. The proposed change would move the devices out of the Class I category and place them into the Class II category, which describes devices considered to have a moderate to high risk to the patient.

So far, two surgical stapler manufacturers—Medtronic Inc. and Johnson & Johnson—have expressed approval for the reclassification, though both companies expressed concern over possible increased special controls on devices already in clinical use.

FDA Reports Thousands of Incidences with Surgical Staplers

The FDA issued a draft on the proposed reclassification in April 2019, after issuing a warning about safety concerns associated with surgical staplers. In that warning, the FDA advised that it was concerned about the increasing number of adverse medical device reports associated with the use of these devices for internal use.

Surgical staplers and staples are frequently used to close wounds and join high-tension tissues in gastrointestinal, gynecologic, and thoracic surgeries. They can shorten surgical time and help hold larger wounds together more effectively than traditional sutures. They can also result in less scarring.

Currently, these devices are regulated as Class I devices, which are considered to have low to moderate risk to patients, and do not require a premarket submission to the FDA. Class II devices, since they carry greater risk, are required to go through a premarket review before manufacturers can sell them and are subject to more stringent controls than Class I devices.

Between January 2011 and March 2018, the FDA received more than 41,000 individual adverse event reports for surgical staplers and staplers for internal use, including 366 deaths, more than 9,000 injuries, and more than 32,000 malfunctions.

Among the issues reported were staplers that misfired, failed to fire, or misapplied staples.

Surgical Stapler Manufacturers Concerned Over Retroactive Approval Requirements

After discovering the growing number of reported problems associated with surgical staplers for internal use, the FDA decided to take additional action to better ensure public safety. First, the FDA is seeking to reclassify the devices into a higher-risk category, which requires the devices to undergo review and clearance prior to reaching the market.

A Class II designation also allows the FDA to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension, and specific labeling elements supporting the safe use of the device.

The Regulatory Affairs Professionals Society (RAPS) reported in July 2019 that Medtronic and Johnson & Johnson support the reclassification, but are concerned about these new special controls, particularly as they may apply retroactively to devices already on the market.

Both companies want their current products approved by the FDA immediately, or at least to be granted an expedited process toward approval. If the FDA requires retroactive review on products already in clinical use, the companies claim, it could affect the supply of staplers available for patient use. They also claim that additional testing of the devices that are already in use is also unlikely to provide clinically meaningful data.

On May 30, 2019, an FDA advisory panel met to discuss the reclassification, and unanimously recommended that surgical staplers be categorized as Class II devices.