Surgical Stapler Injuries
Surgical Staples are used as an alternative to stitches.
DEFECTIVE Surgical Staplers can cause DEVASTATING Injuries.
A review by the FDA has linked 112 deaths and thousands of injuries to surgical staplers. In many cases, the staples failed to close around the patient's tissue or the stapler failed to release the staples, resulting in leakage. Among patients who died, the stapled tissue typically had begun leaking fluid or blood, leading to infection.
Another common problem reported was that the staple gun became stuck in the patients' tissue when it fired, requiring surgeons to cut away tissue to remove the gun. The problems often prolong surgery or forced doctors to switch from minimally invasive laparoscopic surgery to open surgery.
Surgical staplers are used in gastrointestinal, gynecological, thoracic, and many other surgeries to remove part of an organ (resection), to cut through organs and tissues (transection) and create connections between structures (anastomoses).
In 2001, the Emergency Care Research Institute (ECRI) printed cautions in its Health Devices newsletter about deaths, tearing of tissue, and dangerous leaking of bowel contents.
FDA epidemiologist Lori Brown believes that the reports are "the tip of the iceberg."
"Because these devices are used so often, even if you have a very low rate of problems, it would affect a lot of patients," says Brown.
Tyco International, whose U.S. surgical subsidiary dominates the stapler market, has been implicated in recent deaths. More than 500,000 surgeries have been performed since 1998 with its latest line of staplers. FDA reports have linked more than 3,800 problems, including several deaths, to Tyco's Endo Gia brand stapler.
If you or someone you love experienced fluid leakage, bleeding, infections, bowel leakage, tissue damage, painful repairs, disability or death due to the use of a surgical stapler from surgery, contact Summers & Johnson, P.C. for a free consultation to discuss your legal rights.