Ethylene Oxide/Sterigenics Updates

Surgical Staplers: FDA Warns about Deaths / Injuries

The FDA announced recently that they plan to surgery-1822458_1920-300x200review and address the safety of surgical staplers.

Surgical staplers are specialized devices used in surgery to close wounds or connect tissue, instead of using traditional sutures.

The FDA‘s decision comes after a recent Kaiser News Health Report revealed that thousands of malfunctions and injuries related to staplers were hidden from the public in private internal FDA databases. In fact, in 2016 alone, while the FDA’s public database received less than 100 stapler malfunction reports, their hidden database received about 10,000 reports.

How was this possible? Kaiser News discovered that in 2000, in an effort to reduce paperwork, the FDA created a deceptive and irresponsible alternative reporting program (without any public notice or regulation) where device manufacturers could request an exemption for their products. If the exemption was granted, manufacturers could stop sending in injury and malfunction reports to the FDA’s public database, and instead send in a spreadsheet of injuries or complications directly to the FDA, thereby allowing them to keep problems hidden from the public. The manufacturers of surgical staplers and staples received this exemption.

So, instead of reporting problems to the FDA’s public database called Manufacturer and User Facility Device Experience (MAUDE), stapler manufacturers were able to report thousands of adverse effects to a hidden FDA database. As a result, doctors and researchers who rely on MAUDE to gauge medical device safety were left in the dark.

And this put surgical patients at risk. In fact, from Jan. 1, 2011 to March 31, 2018, the FDA received more than 41,000 reports of problems with surgical staples and implantable staples, including 9,000 serious injuries and 366 deaths. According to the FDA, most of these reports came from internal stapling.

Surgical staplers seal blood vessels and tissue in thousands of operations each year. When staplers malfunction during surgery, patients can bleed profusely while surgeons struggle to suture an open artery or vein. Patients have been left with serious injuries; some have even bled to death. Stapler malfunction can also lead to sepsis and tearing of internal organs or tissue.

The FDA is finally realizing that there is reason to be concerned about the safety of surgical staplers and staples. They plan on convening an advisory meeting to discuss the safety of surgical staples and consider reclassifying them to put them under tighter control. Informing doctors and hospitals of the risks involved with these devices might be a good start. To do this, the FDA needs to dismantle a warped reporting system that hides serious problems from doctors and puts patients in danger.

If you’ve had a surgery involving surgical staples and have been injured because of a stapler malfunction or defective staple, you may be entitled to compensation for your injuries. Please call our surgical stapler attorneys for a free and confidential case evaluation at 630-527-1595. Our legal team of personal injury and defective product lawyers can help you win your case.

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