Surgical staplers and implantable staples are used in a variety of surgical procedures, including gynecological surgery, gastrointestinal surgery, appendectomies, lung surgery, heart surgery, and thoracic surgery. Compared to manual suturing, surgical staplers and staples drastically reduce the overall time it takes to complete a procedure. The staples can be placed relatively quickly, cause negligible tissue reaction, and carry a low risk of infection. However, they can also cause major problems if the stapler malfunctions or misfires.
A recent U.S. Food and Drug Administration (FDA) internal analysis reveals that between January 1, 2011 to March 31, 2018, the agency received more than 41,000 MDRs regarding surgical staplers and staples. Incidents listed in the reports consisted of over 32,000 malfunctions, 9,000 serious injuries, and 366 deaths. Unfortunately, this information was not made available to the public until very recently.
According to FDA data, common problems included opened staple lines, malformed staples, and misfiring staplers. Another recurring issue was misapplied staples, which can occur in two ways: when a staple is applied to the wrong area, or when a staple of the wrong size is used. Complications from surgical stapler and internal staple malfunctions can be severe and can result in an extended surgical procedure, additional surgeries, and further complications such as bleeding, tearing of the organs and surrounding tissue, and death.
If you have been harmed by a surgical stapler, please call us at 877.LAW.3707 for a free case evaluation. We are trial lawyers that specialize in medical device and pharmaceutical litigation and bring a unique perspective to every case.