Birmingham Surgical Stapler Lawyer
Ethicon Surgical Stapler Attorney Serving Alabama
Surgical Staplers & Staplers Have Been Found to Be Unsafe!
The FDA has conducted observations to make an analysis of the safety of the use of Ethicon surgical staplers, and also implantable staples. The FDA created 41,000 reports on surgical staplers medical devices, between the dates of January 1, 2011, and March 31, 2018. During this period of time, there were over 32,000 cases of malfunctions with the device, from those, over 9,000 were considered serious, and a staggering 366 events of patients' death. The FDA believes that the main reason is the malfunction of these medical devices, and the most often reported issues were:
- Stapler Misfire
- Difficulty Firing the Stapler
- Surgical Stapler Fail to Fire
According to the FDA announcement, Ethicon’s surgical staplers are used by surgeons to create a connection between structures in the gastrointestinal tract after surgery. The FDA said that Ethicon performed a thorough investigation into consumer complaints the company received from surgeons as well as products returned to the company as defective. Ethicon learned through its examination that uncut washers found in the stapler and improperly formed staples signify that the device was not firing correctly.
Ethicon became aware of the defect after two patients sustained severe injuries during surgery. The misfiring stapler forced the resection of the lower rectum in one patient and the middle rectum in another patient even though both patients had upper rectum rescission surgery.
Patients who have recently had gastrointestinal surgery, including patients who had bariatric surgery or surgery to treat colon cancer is at risk for having difficulties and should consult their surgeon.
What is the Risk?
The recalled Ethicon surgical staplers have been linked to life-threatening injuries and death. Malformed staples that are not fixed can lead to:
- Prolonged surgery
- Leaking from the surgical incision site
- Bleeding
- Major catastrophic internal hemorrhage
- Sepsis (blood infection)
- Intestinal perforation or leakage
- Fistula formation
- Tearing of internal tissues and organs
- Needing another surgery
- Death
Defective Ethicon Staplers in Stomach Surgery
When surgical staplers malfunction during a gastrointestinal surgery, patients may also develop these complications:
- Need for permanent ostomy “bag”
- Life-long nutritional and digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries or closures (anastomoses)
- Need for antibiotics
- Additional imaging studies
Get a Free Consultation
If you think that you have been victimized by the use of surgical staplers you may be entitled to fair compensation. Contact DeGaris Law today for a free consultation regarding your legal rights.
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