Our attorneys are investigating claims that surgical staplers are causing serious injuries, life-changing complications, and even death. Contact us today to get your case evaluated for free.
Surgical staplers are used in many different kinds of surgeries, and their use has been increasing. Most of the surgical staplers used in American hospitals are manufactured by either Ethicon, which is a subsidiary of Johnson & Johnson, or Covidien, which is a subsidiary of Medtronic.
These devices – which operate much like the home, office, or construction staplers most of us are familiar with – use to close wounds and surgical openings. They are used as an alternative to hand-stitching, or suturing, surgical incisions and openings.
However, like the staplers you use in your home and office, surgical staplers can jam, misfire, or fail to close the staples. When this happens near sensitive tissues and organs, such as the gastrointestinal tract, heart, lungs, or kidneys, the consequences can be devastating. Complications from a surgical stapler failure can include death, sepsis, internal bleeding, the need for permanent ostomy bag, damage to internal organs, additional surgeries, and life-long nutritional and digestive issues.
Surgical Staplers: What’s the Risk?
Unfortunately, surgical staplers fail all too often. The FDA recently reported that between 2011-2018, there were 109,997 reports of surgical stapler malfunctions, including 11,181 serious injuries and 412 deaths. To put those numbers in context, that is more than 4 serious injuries a day caused by surgical stapler malfunctions, and approximately one death per week.
The manufacturers of surgical staplers have known about these problems for years, and there have been numerous recalls of these devices. In May 2019, Ethicon issued a Class I recall of 92,496 units. This is just the latest of numerous surgical staples recalls in recent years. Since 2014, over 2 million units have been subject to a recall across all manufacturers.
While surgical stapler manufacturers have known of the problems with their devices, and the amount of malfunctions that were occurring, the doctors and hospitals that use these devices have been kept in the dark. A recent investigative report by Kaiser Health News discovered that the malfunction reports received by surgical stapler manufacturers were being kept in an obscure non-public database. As a result, when a doctor or a hospital would go to look up information about the safety of these devices, they would only see a handful of malfunction reports, as opposed to the 109,997 that were actually sent in. In 2016 for instance, only 84 stapler injuries or malfunctions were openly submitted, while nearly 10,000 malfunction reports were included in the hidden database.
Surgical Stapler Malfunctions: What Are the Consequences?
Surgical staplers have a unique ability to harm patients. Misfired staples can embed in tissues or organs that were not intended to be stapled. If a staple fails to close or completely seal a wound, bacteria and other foreign matter can invade the wound and cause sepsis or infection. Internal organs and organ systems can hemorrhage, bleed internally and sustain organ damage. Stapler failures can take days to identify and some of the complications can be irreversible. In many cases, additional surgeries are required to fix the problems caused by a stapler failure. Fistulas can be formed by such failures, and anastomoses can remain open.
The FDA recently notified the medical establishment of these risks in a letter dated March 8, 2019. The FDA also announced that they are now considering upgrading surgical staplers from a Class I medical device to a Class II medical device, and considering forcing manufacturers to prove the safety and effectiveness of surgical staplers through performance testing and usability testing.
Morgan & Morgan Lawyers May Be Able to Help You Get Compensation
If you or a loved has been seriously injured by the use of a surgical stapler, our surgical stapler lawyers want to hear from you. Contact us today for a free, no-obligation consultation to learn how may be eligible for compensation.
Victims of malfunctions and errors involving surgical staplers are already filing lawsuits. A jury in California awarded one victim $80 Million, including $70 Million in punitive damages, for a surgical stapler injury suffered during surgery that inflicted significant internal injuries.
If you’ve been seriously injured by a surgical stapler, know that you don’t have to fight for justice and compensation alone. Our attorneys at Morgan & Morgan have decades of experience helping injured clients get the financial rewards they deserve.