Johnson & Johnson Subsidiary Ethicon Recalls Proximate® Reloadable Surgical Stapler

Searcy Denney Scarola Barnhart & Shipley
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Searcy Denney Scarola Barnhart & ShipleyIn 2019, Johnson & Johnson subsidiary Ethicon issued a recall for its Proximate® reloadable surgical staplers due to a flaw with the device that may have resulted in staple lines being compromised during gastrointestinal surgeries. The U.S. Food and Drug Administration has classified the recall as a Class I recall, which means that, “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

According to the FDA, Ethicon recalled the devices, also known as endo-surgery endoscopic curved intraluminal staplers and endo-surgery endoscopic curved intraluminal staplers, on April 11, 2019. Just over a month later, more than 92,000 Proximate® reloadable surgical staplers had been recalled. Ethicon distributed the staplers to health care providers between March 15, 2018 and March 8, 2019.

PROXIMATE® RELOADABLE SURGICAL STAPLERS RECALLED DUE TO A CRITICAL FLAW

In describing the reason for the recall, the FDA writes that Ethicon has confirmed, “uncut washers in the stapler and malformed staples occur . . . due to insufficient firing, which can compromise staple line integrity. . . . Failure to cut the washer suggests complete 360-degree staple line failure.” The FDA’s recall notice from May 2019 states that Ethicon has confirmed “serious injuries to two patients,” and also notes that the recall was triggered by the investigation of multiple complaints and returned products.

The FDA states that potential risks to patients who underwent gastrointestinal surgeries performed with Ethicon’s Proximate® reloadable staplers include:

  • The need for additional imaging studies
  • The need for antibiotics
  • The need for additional surgeries
  • The need for a permanent ostomy “bag”
  • The need for additional closures (anastomoses)
  • Leak in the closure (anastomotic leak)
  • Life-long nutritional and digestive issues
  • Bleeding
  • Sepsis
  • Death

Shortly before Ethicon issued the recall, the FDA sent a letter to health care providers warning of an increase in the number of adverse events associated with surgical staplers in general. In the letter, the FDA states that it received more than 41,000 reports related to surgical staplers between January 1, 2011 and March 31, 2018, including reports of more than 9,000 serious injuries and 366 deaths.

WHAT SHOULD YOU DO IF YOU OR A LOVED ONE WAS HARMED BY A DEFECTIVE SURGICAL STAPLER?

If you or a loved one has been or may have been harmed, by a defective Proximate® reloadable surgical stapler, we would encourage you to speak with a lawyer about your legal rights. Unfortunately, issues with defective medical devices are common, and individuals and families are often forced to take legal action in order to hold manufacturers such as Ethicon and Johnson & Johnson accountable.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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