FDA Warns Medical Industry of Surgical Staple Danger
The US Food and Drug Association (FDA) is alerting the healthcare industry about the danger of surgical staplers used for internal operative procedures.
What Makes a Medical Stapler?
Most people are familiar with office staplers. A depressed lever inserts a staple that holds paper together. Construction staplers do a similar job on other industrial materials. In a surgical setting, staplers can lessen pain associated with stitches, close large wounds quickly, and provide a stronghold for healing wounds.
While surgical staples are used to close wounds and incisions on the outside of the body, they are also used in internal gynecological, thoracic, and gastrointestinal surgical procedures.
Surgical staples can be made of stainless steel, titanium, and composite plastics. Together, staples and the stapler are considered one medical device. In March 2019, the FDA sounded a warning to healthcare providers concerning the high number of adverse events being reported that involve surgical staplers used for internal procedures.
In April of this year, the FDA expanded its warning to healthcare providers. The FDA detailed some of its concerns about surgical staplers including:
- More than 41,000 adverse event reports involving surgical staplers were received by the FDA between January 2011 and March 2018. Adverse events are medical mistakes, medical device failures, medication and other errors that cause patient harm.
- Problems with surgical staplers include misfiring, deformed or defective staples, misapplied staples or use of the wrong size staples for a surgical procedure.
- The reports received by the FDA detailed over 32,000 device malfunctions and errors that caused 9,000 severe injuries and the death of 366 patients.
Just some of the injuries caused by staplers or mistakes made with surgical staples include:
- Severe infection including sepsis
- Bleeding and the formation of abscesses or fistula
- Damage to blood vessels by the stapler, even when no staples have been inserted
- Tearing or separation of internal tissues or organs on which staples were used
- Higher risk of recurrence of cancer
FDA Pursuing Increased Regulation
In addition to warning physicians and the healthcare industry, the FDA is pursuing increased regulation of staplers and has provided draft guidance on the use of staplers for internal use. In its March, 2019 letter, the FDA also provided recommendations on the use of staplers, including when not to use them.
If you suffer serious injury as a result of surgical staplers or other error, speak with an experienced medical malpractice attorney about your condition. Once seen as a fast and efficient means to close internal and external wounds, surgical staplers should be used with caution.
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Schochor, Federico and Staton, P.A. is a leading medical malpractice law firm with a track record of successfully representing patients and families against institutional defendants and individual physicians. If you suffer medical negligence, we can help. Contact us today or call 410-234-1000 to schedule a free consultation.