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In March 2019, the U.S. Food and Drug Administration (FDA) issued a letter to health care providers warning them of the increasing number of adverse events associated with surgical staplers and staples for internal use. The FDA analyzed the medical reports concerning these devices and found that from January 1, 2011, to March 31, 2018, there were over 41,000 individual medical device reports for these devices, including 366 deaths and over 9,000 serious injuries.

In May 2019, the FDA announced a recall of Ethicon Endo-Surgery Intraluminal Staplers, identifying it as a Class 1 recall, which is the most serious type. In October 2019, Ethicon also recalled the Echelon Flex Powered Plus Endopath 60mm Stapler, both of these due to the potential for malfunction. Surgical stapler manufacturer Medtronic also issued recalls for its staplers, including the Endo GIA surgical stapler.

Now, Medtronic is facing litigation over its allegedly faulty surgical staplers. Most recently, three people filed new Medtronic stapler lawsuits in Minnesota and Texas courts, stating that they were seriously injured by Medtronic devices used in their surgeries.

Three Plaintiffs Blame Medtronic for Complications After Surgery

According to a report in the Star Tribune, the three plaintiffs all went through gastrointestinal surgeries that required staples to be precisely placed to reconnect the tissues after the surgery was completed. The plaintiffs claim that the Medtronic surgical staplers malfunctioned, causing complications.

The staplers allegedly created holes in the tissues without leaving staples behind, for example, or failed to close the implanted staples. Complications included severe infections, cardiac problems, and the need for corrective surgeries. One of the plaintiffs, an Iowa man, required several additional surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his bowel.

One of the other plaintiffs, a Texas woman, endured the puncturing of her intestines when the Medtronic EEA surgical stapler allegedly misfired during her surgery. All three plaintiffs blame the manufacturers for these incidences, stating that the staplers were defectively designed and manufactured and that Medtronic failed to warn doctors and patients of the potential dangers.

Problems with Surgical Staplers Hidden for Years

Another important issue in these and other surgical stapler lawsuits is the fact that for years, the FDA’s ASR (alternative summary reports) program allowed manufacturers to, in essence, hide the seriousness of the adverse effects associated with their devices.

The FDA established the program to manage high numbers of adverse events that were deemed to be well-known and well-established risks associated with a particular device—in this case, with surgical staplers. It wasn’t until a recent reporting series by Kaiser Health News that the extent of the issues associated with surgical staplers came to light.

The FDA eliminated the program in 2019 following a stream of critical reports, and now recommends new clinical studies on the devices to reduce their risks.

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