Staples failed to close around the patient’s tissue, the apparent problem in the Brigham case. A review by the Food and Drug Administration has linked 112 deaths and 2,180 injuries to surgical staplers, the same device implicated in the death of a Lawrence woman after gastric bypass surgery last month at Brigham and Women’s Hospital.
In many cases, the staples failed to close around the patient’s tissue, the apparent problem in the Brigham case, or the stapler failed to release the staples. Among the patients who died, the stapled tissue typically had begun leaking fluid or blood, leading to infection, an FDA official said.
The FDA plans to launch a website early next year to alert surgeons to the problems and ask for more complete reporting. An FDA committee formed in September 2001 has reviewed nearly 20,000 reports of problems with the devices from 1992 to mid-2001, and another thousand a year since. FDA epidemiologist Lori Brown said the agency believes the reports are “the tip of the iceberg.”
If you have a very low rate of problems, it would affect a lot of patients
“Because these [devices] are used so often, even if you have a very low rate of problems, it would affect a lot of patients,” said Brown.
Staples are used in place of hand-stitches in at least 100,000 operations a year, ranging from gastric bypass to lung surgery to appendectomies. A surgeon uses the device to fire double lines of titanium staples and then to cut the tissue between the staples.
Tyco International, whose U.S. Surgical subsidiary made the device used in the Brigham surgery and dominates the stapler market, says that more than 500,000 surgeries have been performed since 1998 with its latest line of staplers. The FDA reports include more than 3,800 problems, including several deaths, linked to that Endo Gia brand.
Tyco spokesman Gary Holmes said the reports “do not necessarily signify that the product failed to perform as intended.”
“When used in accordance with its instructions for use, every U.S. Surgical product is safe and efficacious,” he said in a statement. “The company goes to great lengths to ensure our equipment is used in accordance with proper standards and regulations. We provide surgeons with technical training and support on the use of our products.”
An autopsy showed another part of the stapled tissue had separated, allowing the contents of the stomach to leak
In the Brigham case, surgeon David Lautz initially used a laparoscopic technique, operating through small incisions. He said he noticed that staples in one row had popped out, so he switched to open surgery and hand-sewed a portion of the patient’s stomach. Two days later, the patient, Ann Marie Simonelli, 37, died in her hospital bed without warning.
An autopsy showed another part of the stapled tissue had separated, allowing the contents of the stomach to leak, Brigham officials said. They are still investigating what caused her death and declined to comment on the FDA findings.
The reports to the FDA on earlier problems showed that some patients required colostomies, in which the intestine is connected to an artificial opening where wastes drain from the body into a bag. Brown, of the FDA, said the reports were not detailed enough to prove that the staplers caused the deaths or injuries. The problems may have resulted from design or manufacturing problems, mistakes by surgeons, or the condition of the patient, she said.
One of the most common problems reported was that the staple gun became stuck in the patients’ tissue when it was fired, requiring surgeons to cut away tissue to remove the gun. The problems often prolonged surgery or forced doctors to switch from minimally invasive laparoscopic surgery to open surgery. Typically, open surgery entails more risk and a longer recovery.
Device manufacturers and hospitals are required to report problems to the FDA
Device manufacturers and hospitals are required to report problems to the FDA, but officials estimate that no more than one out of every 10 problems is reported. The FDA said it began its study because of the significant number of reported problems.
Balancing the problems against the benefits of the devices, FDA officials said they decided on an educational campaign, rather than on more drastic action, such as pulling the devices off the market.
The FDA will not be the first to issue cautions. Emergency Care Research Institute, a nonprofit that investigates safety issues, printed cautions in its Health Devices newsletter in 2001 about deaths, tearing of tissue, and dangerous leakage of bowel contents. But the institute suggests many of the problems are caused by surgeons’ misuse of the staplers.
“Certainly, devices fail,” said Mark E. Bruley, vice president at the institute. “But at least 70 percent of medical device-related accidents are caused by the technique used. If you use the wrong size staples, it’s going to come undone.”
Many surgeons remain unaware of the extent of the problems
Many surgeons remain unaware of the extent of the problems. “I haven’t heard of serious problems,” said Dr. Paul Wetter, chairman of the Society of Laparoendoscopic Surgeons. “I believe the vast majority of experience [with the devices] has been very good and very safe.”
Wetter said the staplers are generally better for patients than hand-suturing and that a careful surgeon can spot most problems with the device while using it. “The row of staples can be applied in a matter of seconds, versus a half-hour or 45 minutes of suturing. It’s much more precise than a human being can do by hand-sewing.”
But Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said he was concerned that the FDA was taking so long to act.
“If they were worried enough to launch an investigation two years ago, why haven’t we heard anything?” he said. “They seem to be good at protecting industry, and not the public.”