When built and used correctly, surgical staplers have the power to save lives, by allowing surgeons to quickly seal wounds on the surgical table. However, the FDA has now issued a major Class I recall for Ethicon Endo-Surgery Intraluminal Staplers, which contain a key defect that may lead to patient injury and death. There are also many other varieties of surgical staplers and staple devices that have proved defective, with over 366 deaths recorded between 2011 and 2018.
At Wagner Reese, our defective medical device team can help you seek adequate compensation if you or a loved one have suffered injuries because of an Ethicon surgical stapler or a similar product. With more than nine decades of legal experience, our highly-recognized Indianapolis attorneys have the means and the knowledge to help you pursue a surgical stapler lawsuit.
Contact us today at (888) 204-8440 for a free consultation.
Surgical Staplers: A History of Negligence
The recent Ethicon recall is hardly the first incident to involve defective surgical staplers. Surgeons and nurses had suspected for decades that some surgical stapler brands contained defects, and it was widely rumored that these instruments were prone to misfire or fail in the middle of surgery. Until 2018, however, it was difficult for doctors and injury victims to know if these rumors were true, as there were only a handful of cases reported on MAUDE, the public FDA database.
In 2019, a Kaiser Health News report uncovered that the FDA had hidden over 1.1 million adverse events in a private database, including half of all events involving defective surgical staplers. On top of hiding this information from the public, the FDA also granted “exemption” status to certain device manufacturers, thus ensuring that giants like Ethicon could avoid scrutiny for their 56,000 recorded stapler malfunctions.
Common Injuries from Defective Surgical Staplers
Because surgical staplers are used during the most critical moments of surgery, there is a strong chance that the patient will die when they do malfunction. In the case of the Ethicon Endo-Surgery Intraluminal Stapler, that chance is even greater, due to the presence of uncut washers in some batches of this device. If the washer is not cut, the integrity of the entire staple line is compromised, and can lead to misfires or malformations.
Here are some of the most common injuries that have been reported:
- Sepsis and infection
- Cancer recurrence
- Fistula formation
- Internal bleeding
- Organ collapse
- Tissue and organ tearing
Committed to Securing Full Compensation
When medical device manufacturers are negligent, the results can be catastrophic. No matter what injuries and losses you’ve experienced because of an Ethicon surgical stapler, our Indianapolis defective device lawyers will stand by your side and fight for the fair compensation you deserve. In the wake of the FDA recall and a long history of negligence at Ethicon, it’s crucial to hold this surgical device company accountable for their actions, and secure funding to cover your mounting medical expenses.
Need to schedule a free consultation with our skilled lawyers? Call Wagner Reese at (888) 204-8440 today.