On October 7th, 2021 the U.S. Food and Drug Administration (FDA) released a statement providing additional recommendations for health care providers in order to protect their patients and reduce the adverse risk associated with surgical staplers. This follows litigation and settlements against various medical device companies.
Surgical staplers are devices used to cut and staple internal tissue throughout a wide variety of surgeries. Unfortunately, FDA reported that out of 41,000 staples used between 2011 and 2018, 32,000 staples malfunctioned resulting in over 9,000 injuries and 366 deaths.
The over 9,000 injured patients suffered through serious medical complications including:
- · Bleeding
- · Sepsis
- · Fistula formation
- · Tearing of internal tissues and organs
- · Sealing of untargeted tissues
- · Increasing risk of cancer recurrence
- · The need for a permanent ostomy “bag”
- · The need for additional closures (anastomoses)
- · Leaks in the closure (anastomotic leak)
- · Life-long nutritional and digestive issues
- · Death
In order to combat these complications, the FDA recommended that healthcare providers have a range of various staple sizes available in order to select the correct size cartridge for different tissue types and thicknesses. They advised that “if you have difficulty squeezing the handle of the stapler, you may need to select a different size staple”. Using an incorrectly sized staple can result in staple malformation.
In addition, the FDA advised that physicians should consider other options other than staples if the patient’s tissue is edematous (swollen with fluid), friable (tissue that readily tears, fragments, or bleeds when gently palpated or manipulated), or necrotic (death of tissue). In cases such as these, the staples are less likely to securely approximate tissue which can lead to various complications.
Physicians should also be familiar with the structures around the intended staple site. This includes checking that unintended structures such as a urinary bladder or foreign objects are not in the staple line.
Physicians should also avoid clamping the staple or delicate tissue, as clamping can cause injuries even when no staples are fired.
The FDA continued by stating that checks must be performed in order to ensure that the staples are compatible with the stapler, and physicians should be aware that there is a risk of increased leak rates when staple lines are crossed.
Lastly, physicians need to have appropriate methods of blood vessel control in place in the event of the stapler failing although practical, proximal control of blood vessels is always recommended prior to stapling.
The FDA finalized their statement by advising that “all unique clinical scenarios cannot be captured through general stapler recommendations. These recommendations are intended to supplement, and not replace, good clinical judgment”.
If you or a loved one has experienced any complications due to defective surgical staplers, please contact our New York attorneys. Rheingold, Giuffra, Ruffo & Plotkin LLP has over 50 years of experience specializing in defective medical devices. We will do a detailed investigation to determine the manufacturer of the stapler as well as investigate if healthcare providers did not diagnose the complications quickly enough. We are here to guide you through this difficult time and get you the justice you deserve. Please contact us today for a free consultation.