The U.S. Food and Drug Administration recently issued a significant letter to health care providers about the safe use of surgical staplers and staples for internal use. The agency has received more than 41,000 medical device reports outlining a number of serious issues related to surgical staplers and internal implantable staples. When these staplers fail or are not used correctly, patients are susceptible to complications ranging from internal bleeding and life-threating cases of sepsis to dangerous tears to vital organs and even death.
What is a Surgical Stapler?
Surgical staplers are used in millions of surgeries every year and can be found in almost every operating room in the U.S. Developed as an alternative to traditional suturing, the staplers are made of either metal or medical grade plastic and the internal staples are made from titanium and bio-absorbable materials. The device and staples are utilized during thoracic, gastrointestinal, gynecological and other procedures including appendectomies and gastric bypass surgeries.
Surgical staplers and internal staples were developed to quickly close wounds and can also be used to remove organs, cut through organs or tissue and connect internal structures. For surgeons, internal, implantable staples are easier to place and typically allow procedures to be completed faster when compared to traditional suturing techniques. Surgical staplers and staples can also be used externally to close skin lacerations and cuts in place of stitches or adhesives.
Are Surgical Staplers and Staples safe?
The FDA letter outlines a current, ongoing study by the FDA. The agency’s analysis of more than 41,000 individual medical device reports found there have been 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions related to surgical staplers and staples from 2011 to March of 21, 2018.
The most common issues reported include:
- Difficulty in firing the stapler or failure to fire the staple
- Misfiring of the stapling device
- Opening of the staple line or malformation of staples
- Misapplied staples where the staples are applied to the wrong tissue or the wrong sized staples are used
Complications resulting from Surgical Staplers
When a surgical stapler malfunctions or misfires during a surgical procedure, patients are at risk of needing unplanned additional surgical interventions. For this patient this could mean being subjected to prolonged procedures and could lead to developing serious infections. Other issues may include:
- Formation of fistulas
- Increased risk of cancer recurrence
- Tears to internal tissue and organs
Warnings from Kaiser Health News
The FDA letter to health care providers came days after an investigative article by Kaiser Health News revealed the FDA has quietly granted device manufactures exemptions allowing them to log instances of injuries by medical devices into a database hidden from doctors and the public. The online publication spent months asking the FDA about this database which contains reports on about 100 medical devices including surgical staplers and internal staples. Finally, the government agency confirmed the existence of the reporting-exemption program and thousands of never-before-acknowledged instances of device malfunctions and failures.
The article outlines patient stories and doctor’s accounts of medical emergencies caused by stapler devices that led to serious life-altering injuries and death. According to the article, “surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.”
How can Meyers & Flowers help?
Meyers & Flowers has been helping patients who have been injured or harmed by defective devices for close to two decades. Our lawyers understand how each legal, medical and scientific issue impact a case, and, more importantly, how each of these issues affect our clients. Protecting our clients’ rights starts as we exhaustively develop a case, begin trial preparations and meticulously determine full and just compensation for clients and their families.
If you or a family member have experienced a surgical stapler injury, Meyers & Flowers is ready to help. Contact the Meyers & Flowers team to explore your legal options. We can be reached at email@example.com or at 877-221-2511.