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May 17, 2019 - A Class 1 recall of surgical staplers, the strongest the FDA can issue, was initiated in early April. The devices, more than 92,000, were recalled for faults which can potentially cause serious injury or death. The devices do not require premarket submission to the FDA and are used by surgeons during gastrointestinal procedures.
Surgical staplers are used in a number of routine surgeries, but what happens when a routine surgery becomes a matter of life and death? That is exactly what has happened for thousands of patients, but the adverse events went unreported, at least that’s how it would appear as the reported injuries and deaths were housed in an FDA secret database, referred to as “alternative summary reporting.”
In a damaging report released by Kaiser Health News on Friday, the FDA supposedly has created and expanded a “vast and hidden repository of reports on device-related injuries and malfunctions.” Included in that hidden database are reports of injuries or deaths caused by surgical staplers.
Used in “gastrointestinal, gynecologic, thoracic, and many other surgeries”, surgical staplers are used both externally and internally. Removable skin staples, for external use, “close wounds under high tension, including wounds on the scalp or the trunk of the body.” Internally, surgical staples “deliver compatible staples to internal tissues during surgery.”
But, thousands of reports of surgical staplers malfunctioning during surgery have been recorded. In one such instance, a surgical stapler misfired during a man’s liver surgery, severing a vein. CPR was performed for 22 minutes. The individual was in a coma for two weeks, and when he woke, he was unable to walk. His surgical stapler injury story is one of many – men and women injured or killed by surgical stapler malfunctions.
If you were to look up reports of injuries in the public database in 2016, 84 adverse events were reported. The FDA secret database paints a different story. Nearly 10,000 malfunctions were reported to the hidden database – an alarming difference.
In 2012, a Pennsylvania family alleged the death of their loved one was caused by a defective stomach stapler during gastric bypass surgery. The Ethicon stapler, according to the lawsuit, failed to properly seal the surgical area which then allowed the stomach contents to spill into the intestines. A jury awarded the family $5 million in damages. In May 2013, the surgical staplers, like the one used in the botched gastric bypass surgery, Ethicon Echelon 60 mm and Echelon Flex were recalled due to the high adverse events reported.
In another surgical stapler incident on January 2012, Florence Kuhlmann alleged that an Ethicon proximate surgical stapler misfired and sealed her anal cavity-causing two weeks of hospital care and the permanent use of a colostomy bag. A California jury awarded her $80 million, including nearly $70 million in punitive damages. In October 2012, Ethicon recalled over 157,000 of the hemorrhoid staplers.
While the issue of how injuries are reported is recent, complications as a result of surgical staplers are not and have been occurring for years. Most commonly, injuries and death are caused by:
Many lawsuits claim error by the surgeon caused injuries or death of patients, but there have many, many reports of defective surgical staplers that misfired provoking questions of fault.
The report released by Kaiser Health News prompted the FDA to release a response to the public on March 8, 2019. The letter announced a plan to review the safety of surgical staplers. As part of the review, the FDA could reclassify the staplers, putting them under tighter control. Also, recommendations to surgical stapler manufacturers could be issued.
Surgical staplers are primarily manufactured by two companies – Medtronic, and its subsidiary Covidien, and Ethicon. The former acknowledged they had an exemption that allowed them to report adverse events to the FDA privately. Ethicon, on the other hand, has never used the reporting exemption. Yet, Medtronic has been labeled the market leader in surgical staplers. The exemption has led many to believe this provides manufacturers, Medtronic specifically, an advantage. By privately reporting adverse events, manufacturers can promote their product as a “safer” alternative.
FDA spokesperson, Deborah Kotz, confirmed that any device manufacturer can request an exemption.
The bigger concern is the realization that a hidden database established by the FDA years ago exists. The database essentially allowed adverse events, including deaths, to go unnoticed by doctors and patients alike for years. Since 2016, 1.1 million adverse events, either injuries, deaths, or malfunctions, have been reported to the hidden, internal database instead of being publicly acknowledged. Even former FDA deputy commissioner, Dr. Robert Califf, was unaware of the existence of such a database.
If only evaluating adverse events reported to the public Manufacturer and User Facility Device Experience (MAUDE), surgical staplers would appear safe to use, even efficient, for external and internal usage. But, the hidden database depicts otherwise. Along with hidden adverse reports related to the surgical stapler, the hidden database includes “about 100” other medical devices with similar reporting exemptions.
According to Larry Kessler, a former FDA official, the database was created to avoid under-reporting and alleviate the time it took to review reports of similar context. Device manufacturers would apply for “exemption” status to avoid reporting certain events to MAUDE. As part of that exemption status, the manufacturers would keep track of any injuries or deaths and on a regular basis, either each quarter, half-year or year, report the events to the FDA via spreadsheet.
The program, launched in 2000, originally only included a few devices and was made public, but it has since grown in both size and secrecy.
As part of Kaiser Health News report, Freedom of Information Act requests were filed in September 2018, but none have been fulfilled yet. The FDA cited the lack of urgency for delaying the response. Requests can take up to two years to fulfill.
Since the damaging report was released, the FDA has announced it is ending the program that hid reports of medical device malfunctions and injuries from the public. In addition to the ending of the program, the FDA will be releasing past reports to the public within weeks.
Manufacturers that have exemption status is largely unknown, but the FDA did confirm exemptions have been used for mechanical breathing machines, balloon pumps, pacemaker electrodes, pelvic mesh, MitraCLip, and implantable defibrillators.
The lack of transparency has likely put many individuals at risk. Without a clear picture of the number of injuries and deaths a device has caused, doctors unwittingly conclude that a particular device is safe for consumer use. Unbeknownst to the doctor and patient, the risk is much, much higher than predicted.
In terms of the surgical stapler, the FDA will evaluate its safety, but for the millions of people affected by the internal, hidden database, justice will not be achieved until all of the devices are evaluated for safety.
Dr. Michael Carome, director of the Public Citizen Health Research Group said, “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”
If you have any questions about a surgical stapler lawsuit or the FDA secret database, contact TorHoerman Law at 1-888-508-6752.
July 12, 2019 - A lawsuit was filed by a California man alleging a surgical stapler severely injured him during surgery, requiring extensive pain and additional surgeries. The suit says the manufacturer, Johnson & Johnson and one of its subsidiaries said the device was safe, yet the FDA issued a Class 1 recall.
Jewett, Christina, and Heidi de Marco. "Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices." Kaiser Health News, Kaiser Health News, 7 Mar. 2019, khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
Jewett, Christina. "FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers." Kaiser Health News, Kaiser Health News, 8 Mar. 2019, khn.org/news/fda-announces-sweeping-plan-to-review-safety-of-surgical-staplers/
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"Products and Medical Procedures - Surgical Staplers and Staples." U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm110739.htm
"U.S. FDA Labels J&J Surgical Staplers' Recall as Severest." Reuters, Thomson Reuters, 17 May 2019, www.reuters.com/article/us-johnson-johnson-recall/u-s-fda-labels-jj-surgical-staplers-recall-as-severest-idUSKCN1SN1T4.
Last Modified: November 7th, 2019 @ 04:21 pm
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