Surgical Staples Lawyer
Surgical Staples Lawsuit
Surgical staplers and staples have risks of adverse events causing the FDA to issue a warning letter to healthcare professionals on March 8, 2019. The FDA revealed that from January 1, 2011 to March 31, 2018, they received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.
The FDA believes that many of the problems can be attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler. Some of the most commonly reported problems in these adverse event reports include:
- opening of the staple line or malformation of staples,
- difficulty in firing,
- failure of the stapler to fire the staple, and
- misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as:
- fistula formation,
- tearing of internal tissues and organs,
- increased risk of cancer recurrence, and
On May 16, 2019, an FDA Class I recall was issued for Ethicon’s Circular surgical staplers for failure to fire and correctly form staples when surgeons are repairing certain gastrointestinal surgeries,including, colorectal cancer and bariatric (weight loss) surgeries. The FDA states this is the highest recall level and signifies that the defects found could cause serious personal injury or death.
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.
Cut washers are significant to the surgeon. When the device is working properly, the surgeon will hear a crunch and feel the device cut the washer, thereby signifying the staple line is intact. Misfired staples, on the other hand, can cause a tremendous amount of collateral health issues.. Additional surgeries can lead to additional health complications for the patient.
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