Surgical staplers are medical devices used inside and outside of the body during surgery. For more information, please see the FDA website. Skin staples are medical devices used externally to close wounds during surgery using high tension. Staples are often used for wounds on the scalp or torso of the body.
How are surgical staplers used ?
Surgical staplers are used in many different types of surgeries including gastric, gynecologic, thoracic, and other procedures. Staplers can be used externally, for closing wounds as well as internally to secure tissue during an operation. Potential benefits of using staplers include: fast placement, very minor infection risk, strong and durable wound closure. Some examples of surgical stapler use include:
removing part of an organ during surgery (resection)
Cutting through organs and tissues (transection)
Establishing connections between body structures and systems (anastomoses)
What are stapler lawsuits about ?
Thousands of patients have suffered severe lifelong injuries as a result of surgical stapler defects and malfunctions. Shockingly many of the injuries were hidden in a secret FDA database. The public records show less than one hundred surgical stapler injuries in 2016 compared to more than ten thousand adverse malfunctions in the secret database.
In March 2019, the FDA issued a warning letter describing some of the problems with staplers and issuing recommendations to doctors to protect patient safety and reduce injuries. The FDA announced that it received over 41,000 reports from 2011 to 2018 concerning surgical staplers for internal use. Among these reports there were over three hundred and fifty deaths, over nine thousand serious injuries, and more than 32,000 malfunctions.
Did the FDA learn what was the problem with surgical staplers ?
Yes. The FDA reported that in the past seven years, the adverse events associated with surgical staplers included:
Misfiring the staple
Difficulty in firing the staple
Failure or inability to fire the staple
Use of the wrong size staple
Applying staples to the wrong tissue
Opening up of the staple line after use
What are the legal reasons to file a lawsuit ?
Design defect: when the stapler’s design is at fault for an injury
Failure to warn patients of the full harms and risks of using the staplers
Manufacturing defect which means the device was assembled or made improperly and is unsafe to use
What are the most common injuries people suffer from surgical staplers ?
Surgical stapler or staple malfunctions can result in a variety of injuries including:
The need for additional surgeries
Extending, prolonging, or complicating existing surgery
Formation of fistulas
Tearing of internal tissues or organs
Increased risk of cancer recurrence
Did the FDA create any safety rules with regard to surgical staplers ?
Yes. One of the measures created by the FDA was a mandatory adverse event reporting requirement for manufacturers. Serious injuries and deaths must be reported on a special form known as 3500A.
Have there been lawsuits against the makers of surgical staplers ? What was the outcome ?
Yes. There have been a number of reported lawsuits:
2012 – a family in Pennsylvania filed a lawsuit against the manufacturer of the Ethicon stapler. They alleged the stapler did not properly seal the internal surgical site during a gastric bypass operation because the patient’s stomach contents spilled out into the intestines. A jury agreed by allowing a Five million ($5,000,000.00) damages verdict.
2012 – A California woman filed a lawsuit claiming that an Ethicon stapler misfired sealing her anal cavity which resulted in prolonged hospitalization for weeks and a colostomy bag for life. The jury allowed for a total of eighty million dollars ($80,000,000.00) including 70 million in punitive or exemplary damages meant to punish the stapler maker. Following the trial in October 2012, Ethicon recalled more than 150,000 hemorrhoid staplers.
2013 – Surgical Staplers including Ethicon Echelon 60 mm and Echelon Flex were recalled by its manufacturer, Johnson & Johnson, because of very high adverse events
Since 2014 more than two million (2,000,000) staplers have been recalled across all U.S. manufacturers.
If I was injured after surgery and think a stapler may be involved, what can I do ?
If you or a loved one has been seriously injured by a surgical stapler, contact the F&A Injury Law Firm for a free confidential consultation at (212) 222-1111 or (866) ATTY LAW. There is never any legal fee. Our goal is to investigate your case fully to determine if you are entitled to compensation. If we accept your case, the only legal fee will be a small percentage of the winning recovery we obtain for you. Injured patients and their families do not have to be left alone facing an uphill battle in a tough fight against billion dollar corporations. The F&A Injury Lawyers have been helping patients and their families for more than twenty years. Contact us today.