The use of surgical staplers results in 8,000 to 9,000 reported complications every year in the United States, with many resulting in injuries or death, according to the U.S. Food and Drug Administration (FDA).
Problems include staplers that fail or misfire, staples that do not form properly, separation of suture lines and stapling devices that become stuck in patients' tissue. Patients often suffer bleeding, infection and anastomosis failure, or the separation of the surgical connection between internal organs and vessels, such as the intestine.
The FDA received reports of 2,180 injuries and 112 deaths due to surgical staplers between late 1994 and July 2001. And that, one FDA epidemiologist told The Boston Globe, is only "the tip of the iceberg" since it is estimated that only a small fraction of problems with surgical staplers is reported.
The FDA estimates that of the 8,000 to 9,000 incidents reported annually involving surgical staplers, 9 percent result in injuries and less than 1 percent in fatalities. Fully 65 percent occurred in gastrointestinal surgeries such as gastric bypass surgery, also known as bariatric surgery.
It said 19 percent occurred in lung surgeries, with other incidents in appendix, cardiac and circulatory system surgeries.
One common problem was leakage of blood or other body fluids, particularly from the stomach or bowel, leading to serious infection. Some patients injured by staplers were left requiring colostomies in which they had to wear an external bag to collect body waste.
It is estimated that surgical staples are used in more than 100,000 surgeries each year.
The major U.S. maker of surgical staplers is Tyco International, though many of the problems with staplers are blamed on physician error in using the devices, rather than the staplers themselves.
Kline & Specter, PC, is a Philadelphia-based law firm with more than 40 experienced attorneys. Five of the firm's attorneys are also highly skilled doctors. Kline & Specter is one of the nation's leading law firms with the ability and experience to successfully litigate medical malpractice and medical device lawsuits including lawsuits relating to complications from surgical staples. Please call us at 800-243-1100 for a free case evaluation.