New reports show that the Food and Drug Administration (FDA) – who is responsible for protecting the public health of all Americans – has acknowledged that it did not disclose information regarding more than 56,000 surgical stapler malfunctions that were reported to the agency from 2011 through 2018.
While the FDA has reported some malfunctions publicly, many reports were hidden from view – providing surgery patients, healthcare watchdogs and the general public with a substantially understated view of the safety of staplers, the staples themselves and the doctors who use them.
These new reports were outlined in a report for FDA advisers in March as the agency was meeting to determine whether surgical staplers should be removed from its ‘low risk’ category of medical devices and be subjected to more testing and agency oversight.
Based on the numbers now reported, the answer seems to be ‘yes.’
From January of 2011 through March of 2018, 41,000 cases were reported as ‘adverse events’. With 56,000 previously unreported cases, that total rises to nearly 100,000 adverse events.
During the time when many cases were still not reported publicly, the FDA indicates that there were:
- More than 32,000 malfunctions
- More than 9,000 serious injuries
- 366 deaths
For victims of surgical staple complications here in Florida and around the country, these are astounding numbers.
Surgical staplers and implantable staples are now commonly used during surgical procedures to ‘sew up’ or close incisions or tears of tissue and organs after resection surgery or other procedures. Generally, these surgical staples have been shown to close wounds faster and are less likely to cause tissue reactions and post-surgery infections.
However, on March 8, 2019, the FDA issued a warning letter to healthcare providers detailing serious complications and injury risks associated with surgical staplers and staples.
In the issued letter, Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers, the agency expressed it’s concern of “the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”
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
Those are scary ramifications for patients to consider. The potential for injuries sustained by these surgical staples is real, both during the surgical procedure and afterwards.
Have you or a family member suffered from post-surgical site complications with surgical staples?
If so, you may be entitled to recover financial compensation. The attorneys at Baron and Herskowitz in Florida are reviewing patient complications. Severe and fatal injuries have been associated with malfunctioning and defective surgical staples – as well as the negligent use of these surgical instruments by doctors during the procedure.
For more information, please call our office at 305-670-0101 for your free, no-obligation medical case evaluation – or fill out the form on the right hand side of this page.
Victim of surgical stapler complications? Want to report problems to the FDA (per their website)?
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products.
If you suspect or experience a problem with surgical staplers or implantable staples, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Read more here:
Tampa Bay Times: More than half of surgical stapler malfunctions went to hidden FDA database
Becker Hospital Review: Surgical staplers linked to 41,000 injury, malfunction reports, FDA says