Death points to risk of obesity surgery
Ann Marie Simonelli, 37, was so disgusted about gaining weight after a skiing accident, a friend said, that on Oct. 21 she took a drastic step: gastric bypass surgery. But her death two days later at Brigham and Women's Hospital highlights the risks of a surgery that is growing rapidly in popularity across the country.
Simonelli died in her hospital bed, minutes after she asked a nurse to help her up from a chair so she could lie down. The hospital has not yet determined a cause of death, Brigham's top physicians said. But surgery chief Dr. Michael Zinner said doctors believe a staple gun used to reduce the size of Simonelli's stomach misfired, some staples came undone, her stomach contents leaked out, all possibly contributing to her death.
"It didn't hold. It didn't work," Zinner said. "It appears to be a misfiring of the staple gun. We're still considering whether anything else played into it."
Brigham suspended the kind of gastric bypass surgery that Simonelli received until it completes an investigation into her death, doctors said. Her surgeon, Dr. David Lautz, has performed hundreds of gastric bypass surgeries, so Zinner does not believe lack of training was to blame.
The staple gun is called an Endo Gia Universal Auto Suture. It is about twice the diameter of a pencil, thin enough to slide through a half-inch abdominal incision during laparoscopic surgery, a minimally invasive form of the gastric bypass operation. The staple gun is made by US Surgical, a division of Tyco International, which is based in Bermuda and has its US headquarters in Princeton, N.J. Company executives said yesterday they are investigating Simonelli's death.
"More than 500,000 surgeries have been performed with this device since 1998, and incidents like this are extremely rare," the company said in a written statement.
Driven by the growing number of overweight Americans who fail diets, obesity surgery has become highly popular. Between 2000 and 2002, the number of operations nearly doubled in Massachusetts, to 1,950. Nationwide, the number of obesity surgeries is expected to rise dramatically this year from last, to 103,200 operations.
Hundreds of surgeons and hospitals are opening new surgery programs, waiting lists at some Boston hospitals extend out a year, and companies that make gastric bypass surgical equipment are seeing business boom.
In the surgery, doctors shrink a patient's stomach, restricting the amount of food one can eat. Laparoscopic surgery, which has fueled part of the boom, enables patients to feel better in days and is less painful than traditional surgery, which requires a long incision and a four- to six-week recovery. Brigham still performs traditional gastric bypass surgery.
But patients face serious risks, sometimes death. In gastric bypass programs at most academic medical centers, like Brigham, about one in every 200 or 300 patients die of complications from surgery, said physicians at one-half dozen hospitals. Three patients, including Simonelli, out of 750 operations have died since the mid-1990s, at Brigham, Zinner said.
In comparison, Zinner said, fewer than one of 1,000 patients die from gall bladder surgery, while two or three patients of 100 die from coronary bypass surgery, one of the riskier procedures.
Complete statistics on the numbers of patients who have died during or soon after obesity surgery are hard to come by.
The Massachusetts Board of Registration in Medicine, which licenses doctors, sent hospitals an advisory in June, saying it was concerned about six patients who had died within 30 days of surgery during an 18-month period. In some cases, they died from blood clots in their lungs or from severe infection after stomach juices had leaked into their bodies, common gastric bypass complications.
Board executives would not say whether they are investigating Lautz's conduct during Simonelli's surgery. Lautz declined to comment, a hospital spokesman said.
Another of Lautz's patients complained to the board late last year about his handling of her obesity surgery. She developed complications after surgery and complained she could not reach Lautz despite repeated phone calls, according to board documents. The board sent him a letter saying "communication is a key to any successful patient-physician relationship." In that case, Lautz said a staple gun misfired on him, and the patient also developed a stomach leak.
Hospitals have reported four deaths to the Department of Public Health since 1997, including Simonelli's, but one at the Brigham occurred nearly two years after gastric bypass surgery. The health department reviewed the hospital's records about Simonelli's death but has not decided whether to conduct a full investigation.
"We're waiting to review the results of the autopsy," said assistant commissioner Nancy Ridley. "So far, we don't have a problem with the way the hospital acted."
Simonelli lived in Lawrence, as do her parents. They declined to speak about their daughter yesterday. But Simonelli's father, Arthur, told WBZ-TV he thought the hospital was partly to blame for his daughter's death. "I think it was negligent," he said.
A close friend, Renee Carter, said she was with Simonelli at the hospital. Simonelli began experiencing weight problems "years ago," Carter said, after a skiing accident left her with chronic knee pain. Before then, she wore size 10 dresses. Unable to exercise at the gym after the accident, Simonelli dieted, attempting the low-carbohydrate Atkins diet and sought counseling from Weight Watchers, Carter said.
"It's not like she didn't try," Carter said. "But she got diabetes, and she started to feel bad. That's when she got interested in the surgery."
Brigham's Zinner did not know Simonelli's weight, but said she would have had to been at least 100 pounds overweight to qualify for surgery. Lautz operated on Simonelli Oct. 21, intending to conduct the surgery laparoscopically by threading instruments and a tiny camera through several half-inch incisions in her stomach. The stapler also is threaded through a small incision, and the surgeon pulls a trigger to fire the staples.
Lautz, as is routine, began firing staples, said Dr. Andy Whittemore, Brigham's chief medical officer. The gun fires six rows of parallel staples. An attached knife automatically cuts the tissue down the middle, separating the stomach into a large pouch and a tiny pouch. The large pouch will no longer function. After the surgery, patients can eat enough food to fill only the small pouch.
During Simonelli's surgery, Lautz noticed that staples in one row had popped out, so he converted the operation to a traditional open surgery, Whittemore said. Lautz closed that portion of her stomach with traditional hand sutures, Whittemore said.
Afterward, Simonelli did well her first day. On the second day, she sat in a chair in her room and asked a nurse for help getting into bed. The nurse left the room to fetch wound dressing, Whittemore said, and when she returned, Simonelli had no pulse and was not breathing.
"The nurse was gone less than a couple of minutes," he said. "We called a full code, but we were unable to resuscitate her."
During an autopsy, doctors discovered another part of a staple row had come undone and that some of her stomach contents had leaked out, Whittemore said. Major leaks are a common complication of gastric bypass surgery, and occur in about 1 in every 300 cases, according to the American Society for Bariatric Surgery. But when major leaks cause death, it's usually because the leaking digestive juices created a major bacterial infection inside the body.
Doctors conducting Simonelli's autopsy, Whittemore said, did not find immediate evidence of a major infection. Final results will take several weeks.
