Surgical staplers, including those made by Minnesota-run Medtronic, have been associated with such high numbers of deaths, injuries and malfunctions that the Food and Drug Administration is considering moving them to a higher-risk category that would give the regulator more control over the commonly used devices.
The agency will convene a May 30 meeting to consider the higher-risk classification, after revelations that surgical staples and staplers used inside the body to reclose tissues have been associated with 366 reported patient deaths, 9,000 serious injuries and more than 32,000 malfunctions since 2011, according to adverse-event reports filed with the FDA.
"As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices," Dr. Jeffrey Shuren, head of the FDA's medical device division, said in a statement Tuesday. "We believe additional actions must be taken to better ensure the safe and effective use of these devices."
Surgical staplers for internal use are deployed in a range of surgeries, including gastrointestinal, gynecologic and thoracic procedures. They can remove parts of an organ, cut through organs and tissues, and make connections between structures in the body, the FDA said. Malfunctions and misuse of the device can lead to bleeding, sepsis, tears in organs and tissues, and increased risk of recurrent cancer.
Medtronic, the Ireland-based medical device maker that is run from offices in Fridley, is the industry-leading supplier of surgical staplers, competing with other companies like Johnson & Johnson's Ethicon division. Medtronic doesn't report its stapler sales individually, but the devices are a major component of Medtronic's Surgical Innovations branch, which had $1.4 billion in sales during the three months ended Jan. 25, securities filings show.
"We believe the FDA should hold the May 30 announced public meeting, share the data, have a panel discussion and make a determination that is best for the patient," Medtronic spokesman John Jordan said via e-mail Tuesday. "We look forward to participating in the discussion. We are confident in the performance of our surgical staplers when used in accordance with their instructions for use."
Although the FDA said it published an educational alert about staplers after it identified concerning rates of injuries and malfunctions, the alert appeared less than 48 hours after a major story published by Kaiser Health News that found the FDA accepted more than 1 million adverse-event reports since 2016 using an obscure nonpublic format called "alternative summary reporting." Those reports included more than 10,000 hidden reports of malfunctions of surgical staples and staplers in 2016, at a time when the public-facing version of the data included just 84 reports.
The Star Tribune reported in 2016 that Medtronic has been one of the most prolific users of an even more obscure form of alternative summary reporting called "retrospective summary reporting," which FDA officials said is no longer in use today. "In addition, after review of the ASR program, the majority of the exemptions have been revoked," FDA spokeswoman Deborah Kotz said in a March 28 e-mail. "Only 3 exemptions are still active today with plans to fully phase out the program this year."
The previously hidden data on injuries and malfunctions associated with surgical staples and staplers will be presented to the FDA's General and Plastic Surgery Devices Panel meeting on May 30, along with data that are already public.
Reporting an adverse event to the FDA's public database, called MAUDE, does not necessarily mean the device caused the problem or the death.
Manufacturers face broad legal requirements to report device problems, including many situations where they can't prove that their device caused the problem. Medical device companies may even have legal incentives not to publicly report that a device problem caused a particular death or surgical complication.
The most commonly reported problems in the reports on surgical staples and staplers include reopening of incisions, malformation of staples, misfiring and difficulty firing, and staples that are applied to the wrong tissue or are wrongly sized for the tissue.
The FDA issued guidance recommending device makers improve their packaging to clarify contraindications like not using staples on dead tissue and warnings like avoiding use of large blood vessels. The agency also wants to move staplers and staples to the medium-risk category, up from its current status as a low-risk device. Reclassifying the devices would give the FDA the ability to require mandatory performance testing and demonstrations of the devices' usability and the clarity of its label.
"We always make patient safety our top priority," Medtronic's Jordan said. "The FDA [has] stated recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers, the most important of which is for clinicians to read and carefully follow the stapler manufacturer's instructions for use (IFUs). These IFUs provide directions on the safe use of the product, including guidance on its benefits and risks."