An investigation has found that Ethicon voluntarily recalled their surgical staplers after malformed staples were discovered during surgery. The device’s failure to produce the correct staple size can result in tissue damage, injury, and even death. Additional surgeries may be required due to the additional tissue cutting and lengthened surgery time. Thousands of surgeries could have occurred during this time. However, the company has yet to release any further information about this issue.
Hundreds of thousands of Ethicon surgical staplers have been recalled due to problems with malformed staples. In addition to causing severe pain, malformed staples can lead to additional surgeries, bleeding, or even hemorrhage. In extreme cases, these complications can be life-threatening, including wrongful death. Malformed staples can also damage the integrity of the staple line, and may even result in a patient’s death.
Exempt from FDA scrutiny
While the FDA has never published individual Ethicon Surgical Staples Lawsuit injury reports involving a particular medical device, it is secretively tracking more than a million such events in an internal database. Of those, about half were related to Ethicon surgical staplers. As a result, the company is able to avoid the scrutiny that comes with FDA-required safety reports. And what’s more, doctors and researchers can’t use this data without permission.
Exempt from inspection by Medtronic
A recent article in the New York Times reveals that the FDA is ignoring reports about the safety of Ethicon surgical staplers and that it may be using a secret database to suppress adverse events. According to the article, the FDA has recorded over 1.1 million adverse events regarding the surgical staplers and has not made any public disclosures about these reports. The FDA claims to only recognize a small fraction of these incidents. Despite this, however, the report indicates that the number of adverse events involving Ethicon surgical staplers is much higher than average.
Class 1 recall
A recall has been issued for the Ethicon(r) Endo-Surgery Curved Intraluminal Stapler and Echelon Flex(tm) Endopath Stapler due to a defect in the devices. The staplers can fail to enter the body properly and can misfire. This has led to seven reported cases of major injury and seven deaths. Affected patients may have experienced complications including exploratory surgery.
Links to injuries and death
Since the FDA began investigating the safety of surgical staplers, the company has recalled the Ethicon Surgical Stapler, and it is not alone. There are over 32,000 reports of malfunctions and over 366 deaths attributed to this brand of stapler. In fact, the company has been contacted by hundreds of hospitals across the nation about injuries and deaths associated with the stapler.