Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of the bowels or lungs. The use of staples over sutures reduces the local inflammatory response, the width of the wound, and the time it takes to close.
Surgical Staplers Recalled
The FDA said it was a class I recall, the most serious category declared only when there is a risk of serious harm or death.
The recall applies to more than 8,000 of J&J’s Echelon Flex Endopath staplers, distributed in the U.S. during in August and September. See the FDA recall link here – Surgical Stapler Recall
The device, made by J&J’s Ethicon unit, is used to simultaneously cut and staple tissue back together during surgery. But problems with a part caused misformed staples that failed to properly close incisions, the FDA said in a statement, leading to potential leakage, bleeding or more surgery.
The recalled staplers caused serious damage instead of having the intended effect of repairing areas warranting such surgical services.
The serious defect in the staplers produces among other concerns “malformed” staples, which have caused serious injuries in patients, such as:
- Bleeding (internal)
- The need for permanent ostomy “bag”
- Life-long digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries
- Need for antibiotics
- Need for additional imaging studies
- And even death…
Risk of Serious Injury and Death
The FDA classified this as a Class I recall – see FDA – the most serious category declared only when there is a risk of serious injury or death. The staplers have been linked to one death and seven injuries before Ethicon began recalling them. The agency’s notice states that if a problem with the staple line is not recognized or not properly addressed, there is a potential risk of prolonged surgery, postoperative connection leak, hemorrhage, hemorrhagic shock, additional surgical intervention or death.
The FDA also sent a letter to health care providers after finding more than 40,000 medical device reports that describe adverse results and deaths associated with the use of surgical staplers and staples for internal use during the 2011 and 2018 period.
Medical device manufacturers have a duty and an obligation to make devices that are safe for consumer use. When they make defective devices, consumers who receive those devices are not only put in extreme danger but may also need to surgically extract the device from their bodies. This leads to additional pain and suffering, and costs associated with surgery, hospitalization and so on.
Injured victims of defective medical devices such as this can seek compensation by filing a product liability lawsuit against the manufacturer and our proven experienced product defect legal team stands ready to advise you regarding your legal rights and options.
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