Yourlawyer.com (Gastric Bypass Malpractice News)

Study Finds Risks of Bariatric Surgery Increase with Patient's Age

Tue, 21 Mar 2006 00:00:00 -0800

A study conducted by researchers at Oregon Health & Science University and published in the March issue of Archives of Surgery has found that the risk of complications associated with bariatric (obesity) surgery increase with the age of the patient.

The team found that every extra year of age carried an additional 6% increased risk for complications. This included the more serious complication such as leaking, dehiscence, or hemorrhage.

While no definitive age was found to mark the beginning of any dramatic increase in risk, the researchers suggest that any patient who is 60 or older should be told about the heightened risk of complications associated with age.

The study also found the biliopancreatic diversion with the duodenal switch procedure was associated with about twice the risk of complications compared with the gastric bypass procedure.

The study retrospectively reviewed the records of 452 patients. Of those, 372 were women and 80 were men. Their average age was 44. All of the subjects had their surgeries between 2000 and 2003. The average follow-up was more than 400 days.

Overall, the major complication rate was 10% and the minor complication rate 13%. Factors such as body-mass-index, gender, diabetes, laparoscopic versus open approach, and surgeon experience did not significantly affect complication risk.

Although these particular researchers have not set any specific age limit as an absolute contraindication to bariatric surgery, they do “approach older patients with caution,” and believe that their findings as well as other recent data suggest the benefits of such procedures “with respect to longevity may wane in older patients."

Experts Debate Safety of Various Weight-Loss Surgeries While Lawmaker Urges Strict Oversight of Obesity Surgery Programs

Tue, 03 Jan 2006 00:00:00 -0800

Overweight Americans now have several surgical options to help them lose weight, including gastric bypass surgery, adjustable stomach bands, and an operation which removes part of the stomach and reroutes the intestines. Doctors, however, are divided on what is the safest and most effective procedure.

Gastric bypass, in which the stomach is stapled to reduce its size, is currently the most frequently performed weight loss surgery in America. It is effective in facilitating the rapid loss of a large amount of weight and is used to treat people with heart problems and diabetes caused by obesity.

In Europe and Australia, adjustable stomach bands are preferred over gastric bypass. In this type of surgery, a ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.

This reversible procedure is safer, with a 0.1% death rate compared to about 2% for gastric bypass. Long-term it is nearly as effective at helping patients lose weight. It is also the recommended procedure for children or women who may want to get pregnant after surgery.

According to the research of Dr. Paul O'Brien, director of the Centre for Obesity Research and Education at Monash University in Melbourne, Australia, the bands are just as successful as gastric bypass for achieving weight loss over an extended period.

O’Brien considered results on 23,638 patients in 43 published studies to determine that although bypasses induced a greater weight loss in the first three years, bands were comparable after seven years, with 55% (bypass) and 51% (bands) of excess weight lost.

The third, and by far the most risky, option is a surgical procedure that removes three-quarters of the stomach to create a banana-shaped organ that is connected to the small intestine. This surgery bypasses more of the small intestine than a regular gastric bypass does. Although the mortality rate can be as high as 5%, the procedure is becoming more common and now represents 5% of U.S. obesity surgeries.

While a large U.S. government study has begun to evaluate the benefits and risks of the three procedures, studies indicate that no surgery will have a significant impact without the patient’s commitment to a healthy diet and exercise routine.

Overweight patients should not undergo any surgical procedure unless other methods of weight loss have proved unsuccessful. To qualify for the surgery they must also be at least 100 pounds overweight, or have a Body Mass Index over 35 as well as diabetes or high blood pressure.
Increasingly, many people fall into these categories and the numbers of surgeries have risen dramatically. Whereas less than ten years ago, fewer than 10,000 surgeries were done in the United States, in 2005 it is estimated there will be more than 170,000 according to the American Society for Bariatric Surgery.

In the future there will be more options for obese Americans trying to lose weight. These include vagus nerve stimulation, to curb the desire for food, and new drugs such as rimonabant that shuts off a pleasure signal in the brain that triggers people to eat.

In a related story, a investigative report by the Boston Globe has prompted Massachusetts Senator Richard T. Moore to call for an investigation of mortality and complication rates for obesity surgery at hospitals that fail to meet existing safety guidelines in that state.

A comprehensive report by the Boston Globe found that, even though they fail to meet voluntary patient-safety guidelines, at least five Massachusetts hospitals continue to perform obesity surgery.

But starting in 2007, Blue Cross and Blue Shield of Massachusetts, the state's largest health insurer, will no longer pay for the procedure at hospitals that do not meet these and other standards.

In the wake of a highly publicized patient death, the state-appointed committee of health officials urged (in August 2004) that the medical community in Massachusetts adopt strict standards for gastric bypasses and other popular obesity surgeries.

The committee offered several suggestions to hospitals, one being that they handle more than 100 cases per year, and that individual surgeons perform a minimum of 50 operations per year.

The Globe surveyed hospitals that did not meet this volume standard in 2004 and found that at least five hospitals still perform obesity surgery, even though they treat fewer patients than recommended by the committee: Caritas St. Elizabeth's Medical Center in Boston, Morton Hospital in Taunton, Beverly Hospital, Tobey Hospital in Wareham, and Winchester Hospital.

Although the hospitals did between seven and 70 of the surgeries during the fiscal year that ended Sept. 30, 2005, they defended their programs. Several said they expect to exceed 100 cases by the time the Blue Cross payment policy takes effect in 2007.

The panel had other recommendations for hospitals and doctors, including how to train surgeons, the level of hospital staff expertise, and how to select patients. The Globe did not ask hospitals whether they comply with these recommendations, however.

According to state officials, 22 Massachusetts hospitals performed 3,040 obesity surgeries in the fiscal year that ended Sept. 30, 2004. Just 402 obesity operations were performed in 1998.

On average, obesity surgery carries a 1% risk of death and a 1% to 15% risk of complications, according to the panel. A recent study found that the risk of death is elevated for the elderly: 2% within 30 days of surgery and 4.6% within a year.

Blue Cross spent $20.5 million to cover obesity surgery for 1,214 members in the year ended June 2004. Executives at Blue Cross believe that the surgery should be done only at hospitals that demonstrate high-quality care and a good performance record.

"We know there is a significant variability in care across Massachusetts," said Dr. John Fallon, Blue Cross's chief physician executive and a member of the committee that developed the surgery guidelines.

Hospitals will now receive applications from Blue Cross asking for detailed information on obesity surgery programs. The hospitals will have one year to comply with the panel’s recommendations. Blue Cross and Blue Shield of Massachusetts will stop paying for obesity surgery at hospitals that fall short of these standards starting in January 2007.

Moore wants that date moved up to October 2006, when hospitals begin their fiscal year, and he will request Blue Cross to accelerate its starting date. He also intends to request that the state's other major insurers adopt a similar policy.

According to the Globe, Moore, co-chairman of the Legislature's Joint Committee on Health Care Financing, requested the investigation in a letter to Paul Cote, Commissioner of the Massachusetts Department of Public Health, asking him ''to take strong corrective action if any of [the hospitals'] patients were harmed in any way as a result of the failure."

Moore said that if any of the low-volume hospitals also fail to meet other safety guidelines, they should be prohibited from performing the surgery. ''This surgery has had a lot of deaths in the past few years; that's why we set up this panel to recommend specific practices."

Researchers Find Bariatric Surgery Deadlier than Previously Thought

Wed, 19 Oct 2005 00:00:00 -0700

Recent studies suggest that stomach-shrinking surgery is more dangerous than had been thought especially for men, the elderly, and people with conditions such as hypertension.

A study of 16,155 Medicare patients by Dr. David Flum of the University of Washington, published in the Journal of the American Medical Association, also found less experienced surgeons are putting patients at risk.

According to Flum, while patients are told the mortality rate is approximately one in 500 (.2%) to one in 1,000 (.1%) it can be considerably higher for specific groups such as those over the age of 65 and those who are disabled by a range of problems including obesity where "the risk of death is more like one in 50" (2%).

Flum's study found 11% of patients over 65 died after stomach-shrinking surgery, a mortality rate higher even than that following open-heart surgery.

Men were found to be twice as likely to die as women, with a mortality rate of 7.5 % within a year of their surgery. (Women make up about 80% of the patients undergoing the procedure).

The death rate after 30 days was 2% for Medicare recipients. After 90 days, that rate was 2.8% and after a year, 4.6%t. This study also found the death rate was 1.6 times higher when done by a surgeon who performed a low volume of bariatric surgeries.

"Among Medicare beneficiaries, the risk of early death after bariatric surgery is considerably higher than previously suggested and associated with advancing age, male sex, and lower surgeon volume of bariatric procedures," wrote the study authors.

In a related study, re-hospitalization rates within a year following the surgery were found to be as high as 19%, while another said bariatric surgery has increased substantially since 1998 when only 13,365 procedures were performed.

The latter estimated 130,000 procedures would be performed in the United States in 2005. The number is expected to rise to 218,000 by 2010. A large number of these patients are women, and nearly two-thirds live in neighborhoods with the highest household incomes.

The increase in procedures corresponds with the quadrupling of the obesity rate between 1986 and 2000. According to Heena Santry of the, University of Chicago, about 5% of U.S. adults are “morbidly obese” having a body mass index of 40 or higher.

The most commonly performed bariatric surgery is Roux-en-Y gastric-bypass where the stomach is made smaller and a part of the small intestine is bypassed so that fewer calories and nutrients are absorbed. Among the risks from this procedure are infection, hernia, and long-term nutritional deficiencies.

Dr. Edward Livingston, chairman of gastrointestinal and endocrine surgery at the University of Texas Southwestern School of Medicine and chairman of the bariatric surgery work group for the Department of Veteran's Affairs national health care system said, "I was not surprised by these findings. These studies are really a very small piece of the overall picture for bariatric surgery."

According to Livingston; "Bariatric surgeries result in weight loss, but they can result in complications and death. They can improve the complications of obesity and quality of life, and they may increase longevity." He reminded patients, however, that the decision about whether to have the surgery is a complicated one, and needs to be made on a fully informed, case-by-case basis.

Clearly, the elevated risks of death and other serious complications of bariatric surgery in particular classes of people is a factor that should be explored and explained to prospective patients especially when they belong to one or more of those higher-risk groups.

Stomach Surgery's Risks Higher Than Were Believed

Wed, 19 Oct 2005 00:00:00 -0700

Stomach surgery to treat obesity is much riskier than had been thought, with patients facing a far greater chance of being hospitalized and dying following the increasingly popular operations, according to two large new studies.

One analysis of more than 60,000 California patients found they were twice as likely to require hospitalization after the operations than before, while the second study of federal data from more than 16,000 patients nationwide found the chance of dying after being released from the hospital was significantly higher than earlier studies indicated.

The studies are the largest to examine the risk of hospitalization and death after the surgery, which helps obese people lose weight by reducing the size of their stomachs.

"This is a reality check for people thinking of having obesity surgery," said David R. Flum of the University of Washington at Seattle, who led the nationwide study. "Patients really need to go into this with their eyes open. This can be a high-risk operation."

Proponents of the operations said the benefits still surpass the risks for many patients, and efforts are underway to make the procedures safer by more carefully selecting appropriate patients and ensuring the procedures are done by the most experienced surgeons.

"We're talking about patients for whom nothing else works," said Harvey J. Sugerman of the Virginia Commonwealth University in Richmond, speaking on behalf of the American Society for Bariatric Surgery. "They can't walk. They can't work. They are miserable. They have diabetes and hypertension, and they die at a much higher rate. This operation is the only thing that helps these people."

The new studies come as the federal Medicare program is considering whether to pay for the procedures nationwide, a move that proponents of more aggressive medical treatment for obesity see as crucial for encouraging insurance companies to cover more weight-loss therapies in response to the nation's obesity epidemic.

Critics say the new research should dissuade the government from covering the procedures.

"Expansion of Medicare to cover weight-loss surgery will result in numerous malnourished and frail elderly, many of whom will die prematurely as a result of this treatment," said Paul Ernsberger of Case Western Reserve School of Medicine in Cleveland.

Steve Phurrough of the Centers for Medicare and Medicaid Services said officials would consider the new data in making the decision, which is expected by the end of November.

"The question that you really want to answer is, 'Does it work better than not having the surgery?' This research makes me -- and should make anyone who wants to have the surgery -- concerned about doing the surgery until we see data that says not having the surgery makes you more likely to die," said Phurrough, who heads the office that is evaluating whether to cover the procedures.

The number of people undergoing stomach surgery has been rising quickly, jumping from more than 13,000 in 1998 to nearly 103,000 in 2003, according to a third study published in today's issue of the Journal of the American Medical Association. If current trends continue, the number will surpass 130,000 this year and could hit 218,000 by 2010, the researchers projected.

Proponents saythe operations not only help obese patients lose significant amounts of weight, but also reverse many of the most serious obesity-related health problems. The safety of the procedures, however, has been the focus of intense concern, with reports of deaths and complications sparking investigations in several states and some insurers balking at paying for the operations.

To gather more accurate safety information, Flum and his colleagues analyzed data collected by Medicare on 16,155 patients who underwent the surgery from 1997 to 2002. The average age of the patients was 48.

Overall, 2 percent of patients died in the first month after surgery, nearly 3 percent died within the first three months and nearly 5 percent died within the first year, the researchers found. Previous reports have generally put the risk well below 1 percent. The risk was higher among men, and much higher among those 65 and older, putting those patients at nearly double the risk they would face from heart bypass and hip surgery, Flum said.

Most deaths result from infections or the stress of surgery, Flum said.

The procedure's supporters said the findings could be explained at least in part by the fact that Medicare patients tend to be older and sicker than the general population.

In the second study, David S. Zingmond of the University of California at Los Angeles and his colleagues analyzed data from 60,077 people who underwent surgery in California from 1995 to 2004. They found that about 8 percent were hospitalized in the year before the surgery, but nearly 20 percent were hospitalized in the year afterward.

Most of the hospitalizations were for complications from the surgery, such as nausea and dehydration, gallbladder problems or plastic surgery to remove excess flab.

The American Society of Bariatric Surgery has launched a program designed to minimize the risks by standardizing the procedures and certifying centers that have the most experienced surgeons, who tend to have better outcomes.

"This is the best way to get at the problems that these papers raise," said Walter Pories of East Carolina University in Greenville, N.C. "There's no question that the mortality in some cases is higher than we would like, but it's still less for many of these patients than if they didn't have the surgery."

California Surgeon Accused of Gross Negligence and Incompetence in the Treatment and Death of Several Gastric-Bypass Patients

Thu, 28 Jul 2005 00:00:00 -0700

Dr. Terry L. Sanderfer has a lucrative practice specializing in weight-reduction surgery. Unfortunately, he has also been sued more than 20 times for gastric-bypass surgeries gone wrong.

In fact, according to public records and the doctor’s own accounting, 13 of his gastric-bypass patients have died from complications stemming from surgeries he performed.

Now, the Medical Board of California is seeking to revoke Sanderfer’s medical license for a host of reasons including delayed treatment or failing to act promptly after problems arose, failure to adequately evaluate patients before and after surgery, keeping incomplete or illegible records, and abandoning the care of his patients.

These charges are in connection with the treatment if 11 gastric-bypass patients, including six who died following surgery.

Dr. Sanderfer performs surgeries at Corona Regional Medical Center, Riverside Community Hospital, and Parkview Community Hospital. Over $1.2 million has been paid to settle three medical malpractice claims against Sanderfer.

Gastric-Bypass Surgery Offers Rapid Weight Loss, Risks

Wed, 09 Feb 2005 00:00:00 -0800

The obesity epidemic, media hype and aggressive hospital marketing have fueled demand for the most drastic weight-loss solution: bariatric surgery.

The number of surgeries performed in 2004 surged to 141,000, according to the American Society for Bariatric Surgery, in Gainesville, Fla.

And, while 170,000 surgeries are expected to take place this year, they represent a fraction of the medical need. An estimated 8 million Americans are morbidly obese more than 100 pounds overweight and could qualify for the surgery.

For many patients, bariatric surgery is a lifeline. It reduces the size of the stomach, and patients shed 1 pound a day until they've lost an average of 100 pounds.

Weight-loss surgery has become a lucrative business for hospitals and surgeons. It carries a price tag of $25,000. The surgery is not typically covered by health plans, meaning patients usually pay for it out of their own pockets.

As the number of surgeries continues to rise, so do deaths and complications. Gastric-bypass surgery, the most common stomach-reducing procedure, kills as many as one in 50 patients, experts say.

Lawyers say they've seen a flood of cases, and medical-malpractice insurers are scrutinizing bariatric surgery, in some cases refusing to write new policies until they can better quantify the surgery's risks.

New York's Medical Liability Mutual Insurance Co., which covers half of New York's doctors, in November imposed a moratorium on the operation. It's the third and final New York carrier to halt coverage for new bariatric surgeons, effectively limiting the market.

Increased risk management doesn't mean patients won't have access to the surgery. Rather, it's a wake-up call to doctors and hospitals: Improve your program or leave the business.

That should benefit patients in the long run. There's also a movement afoot to designate a special class of top-notch bariatric programs and physicians. Those hospitals would receive a seal of approval from the Raleigh, N.C.-based Surgical Review Corp., much like credentialed trauma and transplant programs, for implementing extensive safety measures and employing only experienced surgeons.

From 1999 to 2000, an estimated 64 percent of U.S. adults were overweight or obese, which is more than 20 percent overweight, according to the Centers for Disease Control and Prevention.

Obesity goes beyond health.

Worse, after a person becomes more than 100 pounds overweight, diets often don't work, said expert bariatric surgeon Dr. Henry Buchwald of the University of Minnesota.

That fuels the popularity of bariatric surgery, which appears to be one of the few remaining solutions to a drastic problem.

Although the surgery's most visible effect is weight loss, the effects are more profound. Morbid obesity can lead to diabetes, heart disease, sleep apnea, high cholesterol, hypertension and joint pain. Weight loss cures the diseases.

"You have a patient who walks into your office with a problem," said Dr. Jonathan Schoen, a bariatric surgeon at the University of Colorado, "and their problem isn't going to kill them today, or tomorrow or necessarily next year, but it is going to kill them."

Julie Svoboda, who gained weight in her teens, due to polycystic ovary syndrome, was desperate for the surgery, which she had last November.

She likened the risks to a shoulder surgery she had.

"It's the same risks. You're going under," she said. "There's blood clots for both; if it was my time, it was my time."

Eighty-five percent of surgeries are gastric bypasses. The surgeon creates a 2-inch-long pouch at the top of the stomach and then attaches a portion of small intestine. After surgery, patients can eat only a small amount of food, and it passes quickly through the stomach and digestive tract meaning fewer calories are absorbed.

The most common complication occurs when a staple fails, causing the stomach's contents to leak. The resulting infection can quickly turn fatal.

Studies show that in the two months after surgery, one in 20 patients will suffer significant complications, and one in 10 will suffer a minor complication.

Deaths are more difficult to quantify. Experts' estimates of deaths from the surgery range from one in 200 to one in 50.

Dr. David Flum, an assistant professor at the University of Washington in Seattle, followed the long-term survival of 3,000 morbidly obese patients who underwent gastric-bypass surgery.

He found that 1.9 percent died within 30 days of the surgery. And patients who went to surgeons who had performed 20 or fewer surgeries were five times more likely to die.

Buchwald takes a different tack. His research found mortality rates of one in 200 for gastric-bypass surgery.

"The risk of obesity surgery is no higher, and probably lower, than the risk of any other major surgery," he said. "We don't have these questions being asked about breast cancer, or heart attacks, or colon cancer."

The Physician Insurers Association of America notes a slight increase in the number of bariatric-surgery malpractice claims, up to 21 in 2003 from 10 in 2000.

But lawyers say that doesn't reflect the recent surge in lawsuits because of the lag between surgery, claim and a court date or settlement.

If the surgery for bariatric patients is complex, so are their pre- and postoperative needs. Morbidly obese patients require expensive equipment and special staff training.

In response to an alarming rise in complications, a movement is gaining steam to designate "Centers of Excellence" in bariatric surgery. To date, 200 institutions have applied.

"It points out that these are very difficult and vulnerable patients, and the surgery is technically demanding, and the care is demanding," said Dr. Walter Pories, president of Surgical Review Corp., the nonprofit credentialing organization.

Man Sues Gastric Bypass Doctors

Wed, 15 Sep 2004 00:00:00 -0700

Jeremy Martinez of Espaola struggled with obesity his entire adult life, so when the 27-year-old saw television commercials about a low-risk, weight-loss surgery from a California medical group last year, he seized the opportunity.

But despite its billing as a "low-risk" surgery, Martinez suffered serious complications from the gastric bypass procedure he had last year, according to a lawsuit filed Friday in state district court in Santa Fe. He developed an intestinal blockage that left him unable to keep food and most liquids down and that eventually required a second surgery to fix, the suit states.

Martinez is seeking unspecified monetary and punitive damages from the California doctors involved in the surgery and their practice, Laparoscopic Bariatric Specialists at Bellflower Medical Center in the Los Angeles area. The suit contends that they engaged in unfair or deceptive trade practices, that they were negligent and intentionally misrepresented the risks of the procedure and that they committed medical malpractice.

Also named in the lawsuit is Murray Ryan, an Espaola medical doctor who provided follow-up care to Martinez. The suit accuses Ryan of medical malpractice.

Contacted by telephone on Tuesday, Ryan declined to comment on the lawsuit. Messages left at Laparoscopic Bariatric Specialists Tuesday afternoon were not returned.

"Jeremy was extremely distraught about the effects of the surgery after it happened," said his attorney, who is representing Martinez and his family in the suit. "He was told that a lot of people have buyer's remorse."

Martinez, now 28, weighed about 330 pounds in September of 2003 when he underwent the surgery, which involved stapling most of his stomach pouch shut, his lawyer said. She said he felt betrayed that he had not been told that intestinal obstruction was a risk associated with the procedure.

Her client decided to pursue litigation because of the medical bills and lost income he and his family incurred during the ordeal and to let others know about his experience with the procedure.

According to the complaint, the California medical practice marketed its services to New Mexico consumers through television advertisements, seminars, mailings and through the Internet.

Martinez and his wife, Tammy, flew to California for the procedure on Sept. 8, 2003. He underwent the surgery on Sept. 10 and was discharged Sept. 13. Martinez was scheduled to return to the California medical facility days later for a follow-up visit and to have the staples removed, but returned to New Mexico before going back for his follow-up visit after being told that two of his children were sick, the suit states. Martinez followed up with his own physician.

According to the suit, the plaintiffs told Martinez that the surgery had gone great and that his symptoms were normal.

But in the ensuing days, the suit states, Martinez became more and more ill and frequently went to the Espaola emergency room and to Ryan.

It wasn't until he went to the emergency room in Santa Fe after passing out and having a seizure that he was diagnosed with an intestinal obstruction, the suit states. He then went to University of New Mexico Hospital in Albuquerque for treatment.

His lawyer said Martinez had to be hospitalized twice. She said he underwent a second surgery to reverse the gastric bypass in November of last year. But according to the suit, he continues to suffer from seizures and anxiety.

Doctors Issue Pregnancy Warnings About Gastric Bypass Surgery Following Death of Obese Pregnant Woman

Sun, 15 Aug 2004 00:00:00 -0700

A 440-pound woman who was eight months pregnant died of complications related to gastric bypass surgery 18 months after undergoing the weight-loss procedure, according to a letter published in the Aug. 12 issue of the New England Journal of Medicine, the AP/Detroit News reports (Johnson, AP/Detroit News, 8/12).

The 41-year-old woman went to her local hospital at 31 weeks gestation with sudden stomach pain, nausea and vomiting, according to a letter written by doctors at Brigham and Women's Hospital in Boston. After 48 hours, the patient was transferred to Brigham and Women's obstetrical department with a presumed diagnosis of pancreatitis.

At that time, doctors discovered that the fetus was no longer viable. The woman then underwent emergency surgery, during which doctors discovered that most of the woman's small intestine had herniated through a tear in an adjacent membrane, a defect that sometimes results when the intestines are rearranged during gastric bypass surgery.

The hole had cut off the blood supply to the woman's intestines and had caused them to become gangrenous. Surgeons removed 61 cm of her small intestine and the nonviable fetus, but the woman died three hours after the procedure (Moore et al., NEJM, 8/12). The woman's death is believed to be the first fatality of a pregnant woman as a result of gastric bypass, according to the AP/News.

Ramifications

Doctors at Brigham and Women's Hospital who treated the woman said that her death raises concerns because the majority of the 110,000 people who undergo gastric bypass surgery each year in the United States are women of childbearing age, the AP/News reports (Johnson, AP/Detroit News, 8/12).

In addition, weight loss among morbidly obese women often results in increased sexual activity and improved fertility. As a result, doctors expect the number of women who undergo gastric bypass and become pregnant to increase (NEJM, 8/12).

Dr. Harvey Sugerman, president of the American Society for Bariatric Surgery, said that the woman's death "is a tragic case, but you need to look at the overall risk-benefit of the surgery," according to the AP/News.

Sugerman said that three studies have shown that extremely obese people who have bariatric surgery have death rates four to five times lower than obese individuals who do not have the surgery. According to the AP/News, about 20% of all patients who undergo gastric bypass will experience complications and 0.5% to 2% will die. Dr. Sattar Hadi, who runs a high-risk obesity clinic at Vanderbilt University's Center for Human Nutrition, said that most physicians recommend that women who undergo the surgery use contraceptives to avoid pregnancy for two years after the operation, according to the AP/News. Dr. Mark Tucker, director of bariatric surgery at the University of Medicine and Dentistry of New Jersey, said that hernias similar to the one experienced by the woman who died are common up to five years following gastric bypass (AP/Detroit News, 8/12).

Deaths Raise Fears Over Stomach Stapling

Wed, 11 Aug 2004 00:00:00 -0700

An obese Massachusetts woman and her 8-month-old fetus died of complications 18 months after stomach-stapling surgery, an apparent first that is leading to warnings about the risks of pregancy soon after the surgery.

The deaths raise concerns because most of the 110,000 people who have gastric, or stomach, bypass surgery each year in this country are women in their child-bearing years, say doctors at Brigham and Women's Hospital in Boston who tried to save the mother and baby. They reported on the case in a letter in Thursday's New England Journal of Medicine.

Brigham surgeon Dr. Edward E. Whang cared for the 41-year-old woman nearly two years ago, when she was brought to their emergency department after two days at another hospital, where the cause of sudden pain in her upper stomach was misdiagnosed.

"She was nearly dead," said Whang, who noted the woman had the gastric bypass and prenatal care at other hospitals.

After tests and symptoms indicated a massive infection, Whang did emergency surgery. He found most of the woman's small intestine had slid through a hernia, or tear, in an adjacent membrane, a defect sometimes left after the intestines are rearranged in the bypass operation. The hole choked off blood to the stretch of intestines, and the tissue turned gangrenous.

By then the fetus had died. Whang repaired the intestine, but the woman died within a few hours. She still weighed 440 pounds; her original weight was not available.

"This is a tragic case, but you need to look at the overall risk-benefit of the surgery," said Dr. Harvey Sugerman, president of the American Society for Bariatric Surgery, an educational group for obesity surgeons.

Sugerman said three studies show extremely obese patients have death rates as much as four or five times lower if they undergo gastric bypass surgery, compared with those who don't, and other research shows lower rates of pregnancy complications after the weight-loss surgery.

Sugerman estimated more than 110,000 gastric bypasses will be done in the United States this year. Complications strike as many as 1 in 5 patients, and it is believed that for every 200 patients, 1 to 4 will die.

Sugerman and other doctors said they know of no other mother-baby deaths after the operation.

But Whang said about 85 percent gastric bypasses are performed on women, most of childbearing age. He advised any pregnant patients with sudden pain to see a bypass expert quickly.

"Most doctors recommend contraceptives for two years after the surgery" to avoid pregnancy until the woman's weight stabilizes, said Dr. Sattar Hadi, who runs the high-risk obesity clinic at Vanderbilt University's Center for Human Nutrition.

Hadi said it's unclear whether the Massachusetts woman's hernia was due solely to the surgery "or the fetus pushing onto the intestines."

Dr. Mark Tucker, director of bariatric surgery at the University of Medicine and Dentistry of New Jersey in Stratford, said such hernias are not uncommon and can happen up to five years after the surgery. Because fertility increases with major weight loss, he said, reports of pregnancies within a year of surgery are becoming more common.

In the standard type of gastric bypass surgery performed on this woman, a small pouch at the stomach's top is separated from the rest using staples. Moving down the small intestine a few feet, the surgeon then cuts it in two, pulls the bottom segment up and attaches it to the new pouch. The dangling upper segment, which carries digestive juices, is then reattached to the lower segment.

Patients then lose weight because the new pouch holds a few ounces of food at a time, and some calories and nutrients are not absorbed because the food bypasses much of the stomach and small intestine. Patients must take protein and vitamin supplements to avoid malnutrition.

Since the start of 2003, three other Massachusetts patients have died after gastric bypass, and the state is developing guidelines to increase safety.

The federal Medicare program has paid for stomach bypass surgeries for a few years, but only in people with related medical conditions such as diabetes. It covered 7,801 operations in 2003, about double the number in 2001.

Dr. Steve Phurrough of the Centers for Medicare and Medicaid Services said the agency recently ruled obesity can be considered an illness on its own, so an advisory panel this fall is to recommend whether Medicare should cover the surgery in people without related conditions. He expects the panel will urge waiting until there's more research on the surgery on the elderly.

"We have significant concerns about the risks," Phurrough said. "People die from this procedure."

Two Deaths Lead to Malpractice Suit

Mon, 26 Apr 2004 00:00:00 -0700

Stephanie Wildes and Edward Quintana will never have a chance to advertise their dramatic weight loss from gastric bypass surgery.

They died at UNM Hospital with machines helping them breathe. Their dreams of new, thinner lives extinguished by infections.

Whether they died because of medical error or by chance may ultimately be decided by juries if their cases against the hospital go to trial. Their cases are among three wrongful death cases and one malpractice case pending against the hospital.

According to attorneys and depositions in the case, everyone seems to agree that gastric bypass surgery is serious and performed on people who are high surgical risks.

"Gastric bypass is a very dramatic and complex procedure," said Jerry Walz, an attorney for the hospital. "There are a slew of problems that give rise to medical complications. The first being is that these are not your average type of patients."

The attorney, who is representing the patients' families, said the surgery has dangers but the hospital "seems to be unprepared to handle diagnose and evaluate these patients once they have the surgery."

Wildes and Quintana's deaths are the darker side of a growing industry in which obese people go under the knife in a desperate attempt to lose weight.

More than 100,000 people will undergo some version of the procedure this year, up from 63,000 just two years ago. And based on recent studies, between 300 and 2,000 of them are likely to die of complications.

Wildes, a 51-year-old nurse with rheumatoid arthritis, weighed 429 pounds when she sought out the surgery in November 2001.

Quintana, 25, was a 500-pound former football player known as "Big Dawg" when he was operated on in April 2002.

In each case, staples used in the surgery didn't hold, allowing contents of the digestive system to flow into the abdomen.

Donald Fry, who operated on Wildes and Quintana, testified that he visually inspects the staple lines. He said using air or dyes to detect leaks creates more problems than a visual inspection.

Fry, who at the time had done about 550 of the procedures, testified that a dozen patients had experienced leakage from the surgical sites, a rate that appears to be in line with other public and academic hospitals.

Gastric Bypass Riskier Than Many Patients Know

Thu, 01 Apr 2004 00:00:00 -0800

In 1991 Diana Nejbauer hit 261 pounds and was thrilled to undergo surgery to reduce the size of her stomach. But the procedure didn't work. I was sick from the very beginning, says Nejbauer.

Not only did she vomit constantly, but her weight, which fell initially, started climbing back up to where it had been. It was devastating. I couldnt believe it, she adds.

Eventually Nejbauer found her way to Dr. Thomas Stellato, a weight surgery specialist at University Hospitals of Cleveland, who often repairs complications from other doctors operations.

How much of his practice could be re-dos or fixes from previous operations, if he let it be that? If I let it be that, Id be quite busy, says Stellato.

Catherine Basts husband Dave died from complications of his weight-loss surgery. We would have never went through it knowing all the risks, she says.

No one knows the complication rate from obesity surgery because there is no national registry to track it. Estimates of the death rate alone are as high as 2 percent.

The number of Americans getting weight loss surgery has skyrocketed tenfold in the past decade to 103,000 last year, and surgeons say there is no end in sight for the demand.

There is such an incredible demand, says malpractice lawyer Herman Praskier, that some surgeons are not adequately prepared. Their training is basically limited to sometimes going to a three-or-four day seminar where they learn how to do it or they watch another physician doing it and then they start doing it.

A recent article in the New England Journal of Medicine warned the surge in demand for these operations and the potential financial opportunities for physicians and hospitals that perform them are placing some patients at risk.

Internet pop-up ads even advertise the surgery at a discount from the usual cost of $20,000 to $50,000.

Stellato says a good program must include an experienced surgeon and extensive counseling of patients that includes warning them about the risks. Stellato routinely gives patients a questionnaire to fill out before surgery. If patients check that the risk of the operation is low, thats a red flag for us," he adds.

After a second operation, Nejbauer is back to a healthier weight. Its a wonderful procedure, she now says.

But its a procedure that carries far more danger than many desperate patients know.

Big Chance: Widow Makes Gastric Bypass Plea

Thu, 15 Jan 2004 00:00:00 -0800

Mark Gratta looked the picture of health when he played on the Hingham High School football team 28 years ago.

I remember thinking, He's so handsome and in such good shape,''' said Louise Gratta, who is now his widow.

Few people knew the truth. He was dieting even then,'' she said. Weight was always an issue.''

A year ago yesterday, the 43-year-old contractor from Hingham tried to solve his lifelong weight problem by having most of his stomach stapled shut, an increasingly popular operation.

He was 5 feet 6 inches tall and weighed 366 pounds, giving him a body-mass index of 58. An index of 40 or more is considered obese.

He died of a massive infection eight days after the surgery. His surgeon at Boston Medical Center, Dr. R. Armour Forse, left five surgical sponges inside Gratta's abdomen. But Forse denies that is what caused the infection.

His widow, who has filed a wrongful death suit, wants his death to serve as a cautionary tale for tens of thousands of Americans considering gastric bypass surgery.

People need to be warned,'' she said. Ask yourself: Would you rather be dead than live the way you are?' Mark didn't feel that way.''

At least six million Americans are morbidly obese, generally at least 100 pounds overweight. Many lose weight by dieting, but most gain it back within five years, studies show.

Extremely obese people face serious health problems, including diabetes, heart disease and high blood pressure. They also contend with societal disapproval and contempt.

The most effective and permanent solution doctors can offer is bariatric surgery, a group of procedures that limit food intake by shrinking the stomach or bypassing other parts of the digestive system.

Doctors began performing the most popular bariatric procedure, gastric bypass, about 40 years ago, said Georgeann Mallory, executive director of the American Society for Bariatric Surgery.

In that procedure, a surgeon staples off most of a patient's stomach, creating a small pouch that at first holds only a few ounces and eventually can hold about one cup. The stomach normally can hold about three pints of food.

Patients usually lose two-thirds of their excess weight within two years, but it's not foolproof,'' Mallory said. They must eat sensibly, get checkups and change other habits to stay healthy, she said.

Risks range from death to nutritional deficiencies. Up to 5 percent of patients die within 30 days, studies show. Other potential short-term complications include damage to the intestine, bleeding, clots and wound infections.

Long-term problems can include breaks in the staple line, dehydration, iron and vitamin deficiencies, and gallbladder disease, according to a review of research by the Blue Cross and Blue Shield Association.

Six years ago, surgeons developed a way to perform the procedure by laparoscopy. This less invasive method allows a doctor to insert surgical instruments through tubes, staple the stomach and create a link to the intestine without opening the abdomen.

Laparoscopic gastric bypass now accounts for 55 percent of gastric bypass operations, Mallory said.

Mark Gratta turned to surgery after trying diet after diet and failing, said Louise Gratta, 44. He didn't yet have heart disease, diabetes or other serious health problems, but he didn't want to die young from the complications of obesity, she said. He wanted to see his children, Anna, 14, and Mark, 15, grow up. He just loved his family and wanted to be around for them,'' she said.

His surgery began as a laparoscopic procedure. But he developed bleeding during the operation and Forse decided to open his abdomen for a conventional procedure.

Any open'' operation can increase the risk of leaving sponges or instruments in a patient, according to a study by Brigham and Women's Hospital researchers.

Gratta developed a fever after the surgery, and he could not breathe on his own. All antibiotics failed, and his body temperature rose to 108 degrees state Department of Public Health found.

Forse reopened Gratta's abdomen and discovered five sponges behind his spleen. Gratta died the next day. Afterward, doctors re-examined X-rays taken two days after the surgery and found evidence of the sponges.

The radiologist who looked at the X-rays told the state investigator that he had been looking for evidence of leaks and had misinterpreted the sponges as surgical drains.

Nurses and technicians in the operating room had certified that no sponges were missing, records showed.

Louise Gratta names Boston Medical Center, Forse, the radiologist and three other doctors in the wrongful death suit.

All except two doctors who were recently added to the suit have filed answers to the suit denying wrongdoing.

At a hearing last month in Suffolk Superior Court, a lawyer for Forse said it was up to operating room nurses, not the surgeon, to keep track of sponges.

Besides, the surgical pads are very difficult to see because of the enormous amount of abdominal fat'' in gastric bypass patients, the attorney said.

Forse couldn't look for sponges in some parts of Gratta's abdomen because the probing might have caused bleeding that would pose a danger to the patient,'' the lawyer said.

The Grattas researched the surgery before Mark made his decision and found nothing to dissuade him, Louise Gratta said.

We want to stop this surgery until more work is done,'' said Mark's sister, Maria Pagnani of Hanson. People are getting hurt and maimed. This has to stop.''

Gastric Bypass Risk Is Linked To Inexperience

Sun, 04 Jan 2004 00:00:00 -0800

With thousands of obese Americans opting for gastric bypass surgery, a growing collection of research suggests that this increasingly popular operation can have a hidden risk: inexperienced surgeons.

Over the past several years, dozens of hospitals and physicians have rushed to open weight-loss surgery programs. Most surgeons have begun performing the surgery laparoscopically, guiding pencil-thin tools and video cameras through tiny incisions, a gentler procedure that lessens pain, recovery time, and scarring.

"Gastric bypass is the hottest thing in surgery right now, unfortunately some of that is economically driven," said Dr. Steven Rothenberg, a surgeon at Presbyterian/St. Luke's Medical Center in Denver. "The thing that made it take off is that now it can be done laparoscopically."

Surgeons promote laparoscopic surgery to patients as safer than traditional more invasive surgery. And it is in the hands of experienced doctors.

But the gastric bypass is so difficult, according to physicians who have tracked the results of their cases, that patients of surgeons who have done fewer than 70 to 100 operations have complications more often and a greater chance of death from those complications than patients of more experienced doctors. These results are exacerbating worries that surgeons are rushing into the field without adequate training. Some hospitals allow surgeons to operate after one weekend seminar, during which they do a handful of cases under the guidance of a more experienced surgeon.

"Laparoscopic surgery has opened up this whole new problem," said Dr. Philip Schauer, director of bariatric surgery at the University of Pittsburgh Medical Center and who has performed more than 2,000 laparoscopic bypasses. "Most surgeons didn't get this training. It's a fundamentally different skill."

Surgeons at Tufts-New England Medical Center, for example, have kept a detailed database of their cases, which total more than 700. During their first 100 cases, one patient died a mortality rate of 1 percent and 22 patients, or 22 percent, had infections, bleeding, hernias, or other complications. Over 700 cases, mortality dropped to 0.28 percent, meaning two patients died, and 9.4 percent experienced complications.

Their experience is typical. Dr. Daniel Jones, a surgeon at Beth Israel Deaconess Medical Center, tracked the first 140 cases at the University of Texas Southwestern Medical Center in Dallas, finding all major complications dropped after 70 patients. One of the most serious complications of gastric bypass surgery is when the staples come lose and abdominal fluid leaks and infects the patient's other organs. Surgeons use staples to reduce the stomach to the size of an egg, restricting the amount of food patients can eat. During the surgeons' first 70 operations at the University of Texas, four patients, or 5.7 percent, experienced leaks, compared with one patient, or 1.4 percent, in the second group.

The results of these studies have powerful implications for overweight Americans, who are driving the popularity of gastric bypass surgery. The number of bypass operations grew from 23,100 in 1997 to 63,100 last year, according to estimates from the American Society for Bariatric Surgery. Surgeons say few patients ask how many operations their doctor has performed.

When surgeons began removing gallbladders laparoscopically in the early 1990s, hundreds of patients who had suffered complications from an operation long considered routine filed malpractice claims against their surgeons. Many of these doctors had not undergone much training. The surge in claims occurred three years after the first laparoscopic gallbladder removal, and malpractice specialists expect a similar spike in claims from bariatric surgery patients and their families.

General surgeons are more skilled in the delicate hand-eye coordination of laparoscopic surgery now than when they began removing gallbladders through inch-long incisions in 1989. But gastric bypass is far more challenging, as surgeons must maneuver instruments through layers of fat, patients with diabetes and other medical complications make surgery risky, and intense follow-ups to ensure adjustments to their restrictive new diets are required.

"All these factors will magnify what we saw with gallbladders," said Dr. Sayeed Ikramuddin, co-director of minimally invasive surgery at Fairview University Medical Center, a teaching hospital of the University of Minnesota. "We're at the tip of the iceberg, but some of the red flags are coming up. Surgeons are starting new laparoscopic programs and having to shut them down because of a death or complication."

Last fall, patients died after gastric bypass surgery in Boston, Providence, and Iowa. In at least the Boston and Providence cases, surgeons performed the operations laparoscopically. The chiefs of surgery at both hospitals involved Brigham and Women's Hospital in Boston and Roger Williams Medical Center in Providence said the surgeons were experienced. Even the busiest and longest-running programs in the country see one patient die every 200 to 300 surgeries, and a 10 percent complication rate.

Ann Marie Simonelli, 37, died in October in her hospital bed at the Brigham, minutes after she asked a nurse to help her up from her chair so she could lie down. Surgery chief Dr. Michael Zinner said that Simonelli's surgeon, Dr. David Lautz, had done 40 laparoscopic gastric bypass operations, in addition to other types of complicated laparoscopic surgery, and attended two intensive training programs. The Brigham, which blames a faulty staple gun that did not fully close off Simonelli's stomach, has temporarily suspended laparoscopic gastric bypass surgery while it completes an investigation.

"I don't think lack of volume makes the kind of difference that would have altered the outcome in this case," Zinner said. "She had complications, but generally patients don't die from the type of complication she had."

Dr. Paul Liu, surgery chief at Roger Williams, said the surgeon who performed the operation in which Robert Messa, 27, died was trained in laparoscopic surgery. The hospital also has suspended its weight-loss surgery program while it conducts an investigation.

"The laparoscopic nature of the case is one of the first things we would look at, given the relatively recent development of that technique in our field," Liu said. "But it's unlikely that training or experience was an issue here; he's an excellent laparoscopic surgeon."

At Iowa Methodist Medical Center in Des Moines, seven patients died after gastric bypass surgery in the past two years, six of them in 2003, including several in October. One surgeon involved in the cases, Dr. Akella Chendrasekhar, voluntarily stopped performing the surgery. Hospital spokesman Jon Ferchen, who said physicians do some surgeries laparoscopically, said the hospital is "confident that our numbers are within the range of deaths that other places experience." Ikramuddin disagreed, saying those numbers are "extraordinary."

Amid cases like these, the profession is struggling with how much training surgeons need before performing gastric bypass surgery. Surgeons always have trained on the job, improving as they perform more operations. And the most experienced surgeons in the field, including Jones and Schauer, had worse results when they began. But given that gastric bypass operations are elective, not emergency, surgery and that patients are at greater risk for complications, some surgeons are calling for hospitals to institute stricter training requirements.

"Ideally, every surgeon should be proctored for 40 to 50 cases," said Dr. Jeffrey Peters, a laparoscopic surgeon at the University of Southern California University Hospital. "Most of us feel a weekend course is not enough."

Dangers of Gastric Bypass Surgery

Sat, 03 Jan 2004 00:00:00 -0800

When Debbie Jones decided to have gastric bypass surgery, the last thing she thought was that it might kill her. But it almost did.

Jones said, "I was in ICU for 45 days. During those 45 days I was on a ventilator for 33 days."

Duane Jones, Debbie's husband said, "There were times when I walked into that room and she was just gasping for breath. And there were times when I walked into the room and she was under an ice blanket because her fever had gone to 104. When I walked in, she had huge chest tubes in her side."

With gastric bypass surgery, the stomach is stapled to make it smaller so you can't eat as much. When Debbie's stomach was stapled, the contents of her stomach leaked, so she needed two more surgeries. And then she developed a chest infection, pneumonia, a blood infection, and a heart arrhythmia.

Doctors often tell patients that the death rate from gastric bypass surgery is just 1 out of 500 patients. But a new study from the University of Washington says more recent data shows actually 1 out of 50 patients will die in the month following surgery from complications.

As consumer demand for gastric bypass has skyrocketed, more and more inexperienced surgeons are performing it.

If the surgeon is less experienced, the likelihood of the patient dying within the first 30 days of the surgery is somewhere on the order of four and a half times the risk compared to a surgeon who is more experienced.

Debbie Jones said she had the surgery because she feared she would die soon anyway. At 360 pounds she diabetes, high blood pressure, and had trouble walking.

She said, "I remember going to the grocery store and would start in the produce section and before I could get to the other side, to frozen foods, I was exhausted."

Now, at 215 pounds, she can march alongside her daughter in her band, and she's off her diabetes medication and her blood pressure is under control. So, she said despite nearly dying, she's glad she had the surgery.

"It's the worst because of the complications that I had, and the fact that my family suffered through those complications. And it's the best because I have my health. And I am here with my family. I have a terrific family, and I almost lost them," she said.

Debbie knows this procedure can be a life saver but that it can also take your life. She simply hopes nobody goes into this surgery with their eyes shut.

Judge Sets Trial Date For Gastric Bypass Suit

Wed, 24 Dec 2003 00:00:00 -0800

The civil trial date for a $5 million medical malpractice lawsuit involving a surgical weight loss procedure has been set for Sept. 8, 2004, in Winchester Circuit Court.

The suit names four Winchester physicians and two area clinics as being responsible for a mans death after a surgery meant to help him lose weight allegedly went awry.

Shayne Biser died Oct. 30, 2001, one week after having gastric bypass surgery at Winchester Medical Center.

The surgery seals off a portion of the stomach to reduce food intake, and is designed to aid in weight loss.

The lawsuit alleges Shayne Bisers surgeon, Troy M. Glembot, had difficulty during the operation.

That difficulty might have caused an internal leak that required additional surgery to remedy, the lawsuit states.

During the second operation, Shayne Biser went into cardiac arrest and died, according to the lawsuit.

The suit alleges Glembot and the other physicians who saw Shayne Biser following his surgery were negligent in their treatment.

The lawsuit requests $5 million in damages for his estate.

Before finding in Bisers favor, the Winchester civil jury will have to decide three things, court records state.

Primarily, the jury must determine if the physicians named in the suit were negligent in Bisers treatment.

If the jury finds the physicians were negligent, the jury must then decide if that negligence caused Bisers death.

If the jury decides Bisers estate is entitled to damages, they then must recommend how much those damages should be, and how the money should be divided among members of Bisers estate.

Glembot works at the Winchester Surgical Clinic, and is one of four physicians named as defendants in the suit. Gerald L. Bechamps and Anita Minghini, who also work at the clinic, are named, as is the clinic itself.

The suit also names Benjamin Franklin Lewis, a doctor at Winchester Pulmonary and Internal Medicine Associates. Winchester Pulmonary is named as a defendant in the suit as well.

As of Oct. 29, the Winchester Surgical Clinic no longer performs gastric bypass surgery, said Daniel Rodgers, clinic administrator. Bisers lawsuit did not factor into their decision, Rodgers said.

We couldnt afford to buy malpractice insurance to cover that procedure, he said. We would love to be able to continue to do it. The (Winchester) Surgical Clinic would welcome the opportunity to continue doing the surgery in a climate where we could obtain reasonable malpractice insurance.

State law mandates the most damages a plaintiff can receive in a lawsuit of this type is $1.6 million.

The jury could still decide Shayne Bisers family is owed more than that, said Malcolm P. McConnell III, attorney for Shayne Bisers family.

In that case, McConnell said, the judge likely would award the family the maximum damages allowed by law.

Although Safe, Gastric Bypass Surgery Still Carries Risks

Mon, 22 Dec 2003 00:00:00 -0800

At 27, Jeremy Martinez of Espanole, N.M., weighed 334 pounds. He was suffering from some of the complications of obesity, including sleep apnea, a potentially fatal sleep disorder.

Unable to lose the weight on his own, Martinez joined the nearly 103,000 Americans each year who choose to undergo the weight loss surgery known as a gastric bypass.

But, unlike the majority of bypass patients, Martinez, who had traveled to Los Angeles in September for the surgery, encountered problems that wouldnt go away. Since the surgery, the father of three has been bedridden, unable to keep any food down. Martinez spent four weeks in the intensive care unit of his local hospital after he began having problems, including seizures.

He was sent home with a tube running through his nose and a PICC line, short for peripherally inserted cardiac catheter, going into the blood vessels near his heart.

On Nov. 24, Martinez had emergency surgery to reverse the bypass, after he began having seizures again.

Although doctors say the surgery is safe, there are some risks.

And, although the incidence of major problems is small, the list of potential complications is long. The risks during surgery include leaks in the intestine, life-threatening pulmonary embolisms and too-small openings called stomach stenosis. Estimates for the risk of death from gastric bypass surgery range from one in 350 to one in 200, depending on the source. Even when the surgery goes right, long-term risks may include gall bladder problems, hair loss, osteoporosis and other conditions associated with malnutrition.

A degree of risk
As soon as I got home, Martinez said, I knew something was wrong.

He suffered from severe nausea and vomiting from the outset.

Nausea is to be expected after the surgery, the experts say, but this and other minor problems resolve themselves within weeks, as the body gets used to the smaller stomach.

About three weeks after that, I started having fainting spells and seizures, said the vocational school teacher. I would go to my regular doctor and he would correspond with the doctors who did the bypass and they would say there was nothing wrong.

About a month ago, after repeated trips to the emergency room, Martinezs wife, Tammy, took him to a Santa Fe, N.M., hospital, where a CT scan and upper GI series revealed the problem.

His stomach was almost completely closed off.

In about two months, Martinez has lost 50 pounds.

The problem is not uncommon, said Lafayette surgeon Dr. Uyen Chu.

Weve had some complications with stomach stenosis, where the opening from the stomach to the intestine becomes narrowed so food cant pass through to the pouch and you throw up all the time. We go in with a balloon and stretch it out.

In Martinezs case, however, the opening was too small even for a balloon to pass through, he said.

Martinezs doctors estimated that he would not be strong enough for corrective surgery until January, but the schedule had to be accelerated because of the seizures.

Defining the complications
While most of the news about gastric bypass surgery extols its almost miraculous results, there is little emphasis on the small percentage of bad outcomes.

The early complication rate is about 15 to 20 percent, Chu said. The late complication rate is about 5 percent and the re-operation rate is about 2 or 3 percent.

Complications sometimes depend on the surgeon performing the operation, said Dr. Thomas Borland, who has been doing weight-loss surgery since the 1980s. The more experienced the surgeon, the smaller risk of complications.

The main complication that kills patients is pulmonary embolism, Borland said.

The embolisms are blood clots in the extremities that break free and lodge in the lungs.

Even when the surgery goes right, Borland and Chu emphasize that the patient and doctor must be committed to lifelong follow-up care.

Vitamin deficiencies are a natural outcome, which allows only a very small amount of food into the tiny stomach pouch, and, in the case of the Roux-en-Y procedure, eliminates about 18 inches of the small intestine, and causes malabsorption of the food that does get through.

Gastric bypass patients also are cautioned to avoid becoming pregnant for at least 16 months after the surgery, Borland said.

Some will suffer some malnutrition, Borland said, but the majority will have normal babies.

Reversing the surgery
While most problems associated with the surgery can be overcome with time and care, there are still cases such as that of Martinez.

I think it doesnt happen often, only in about 1 percent of patients, said Houston surgeon Dr. Adam Naaman, one of only a few physicians in the United States qualified to revise or reverse the surgery.

Naaman has done more than 250 operations to repair or reverse the procedure since 1985.

Naaman said some people simply cannot tolerate the surgery.

As a matter of fact, I saw a lady who came from California. She had the surgery a year ago and lost 100 pounds, but cant eat anything, because it hurts.

While the public doesnt often hear such negative reports, Dani Hart, author of I Want to Live: Gastric Bypass Reversal, hears it all the time.

Her own surgery in 2000 left her with symptoms including chronic vomiting, shaking, malnutrition, heart palpitations, muscle weakness, hypoglycemia, lactose intolerance, hair loss and eventually, osteoporosis.

By the time I had the (reversal) I was in the beginning stages of organ failure, Hart said.

Her doctors were unsympathetic, Hart said. They said I was overeating, but when I had the reversal, they found the ring inverted itself when the food went down, so the food would come out.

Hart added that she had lived on broth and pured soup for a year and a half, until Dr. James B. Swain of the Scottsdale, Ariz., branch of the Mayo Clinic reversed the surgery in March 2002.

Her experience has prompted Hart to become a resource for others.

People are so desperate for help, Hart said. The problem is trying to find someone who will take them.

Finding a surgeon
Reversing the surgery is a concept new to the medical community, Naaman said.

I think it takes years of doing (the surgery) to develop the expertise and confidence to do a revision or reversal. And some surgeons dont know some of these can be revised or reversed.

Naaman made a presentation to a meeting of the American College of Surgeons in September on how to revise some of the procedures.

Naaman, whose patients come from around the country, has no official statistics on how many surgeons do reversals.

Its very hard to say, he said. I hear many times of people who are quite well known, but yet, their patients come and tell me their surgeon wont do a reversal.

Even those who do reverse the surgery often have certain requirements, including patients who want the reversal done for the wrong reasons.

Naaman doesnt see it that way.

We offer psychological help and dietary help, but a very small number of them feel they would rather be the way they were, so we reverse the surgery. Its their stomach.

Its not an issue of fault; its an issue of its not the surgery for them. There are very few things in life that are perfect.

Finding a surgeon to reverse the procedure is only one of the hurdles, Hart said. Paying for it is the other. The cost for the reversal can be as much as the $20,000-to-$45,000 price tag for the original surgery more if the complications are severe. And insurance companies are often reluctant to cover reversals.

The insurance companies need a medical necessity, Hart said. Youd better be pretty sick.

Some Pay The Price In Pain; Others Pay With Their Lives

Tue, 16 Dec 2003 00:00:00 -0800

While most people make it through gastric-bypass surgery safely, some suffer painful complications and a small percentage never make it out of the hospital. Here are the stories of three such patients.

A close call

Donna Sherrouse says the surgery cost her nearly everything.

At slightly more than 200 pounds, the school administrator living in Barrow, Alaska, decided to undergo gastric-bypass surgery after meeting Tacoma surgeon Dr. S. Ross Fox at an obesity seminar there.

"He took hold of my little finger and looked at me and whispered 'size 6,' " she says. "And I was like a size 12 when I was born, so he was offering a golden opportunity."

She flew to Tacoma for the surgery in June 2000 and planned to stay a couple of weeks to recover and perhaps do some shopping in Seattle. But a severe infection caused by an internal leak after the surgery left Sherrouse in a coma for three months.

Her husband, Al Sherrouse, still chokes up when he recounts the day his wife, whom he calls "Shorty," woke up. It was his birthday, Aug. 27.

"I walked through the door, and she was propped in bed and her blue eyes opened. It was the best birthday present I've ever had," he says.

She remained in intensive care for an additional three months with her intestines so swollen and infected that doctors kept her splayed open, her gaping incision covered only with gauze. A thin skin graft and bandage were all that encased her insides when she left the hospital Dec. 1.

Fourteen operations and almost one year after her gastric bypass, doctors were finally able to sew her back up.

By that time, the couple had lost their jobs, home and retirement savings. "We've now got about another 22 years before we can retire," says Al Sherrouse, who's approaching 60 and starting a new career in New Hampshire, "but at least I've got Shorty with me."

Donna Sherrouse is slimmer at 150 pounds, but her voice catches when she thinks about the price: She is bankrupt and still too weak to pick up her grandchildren.

Her malpractice lawsuit against Fox is scheduled for trial in October. Fox refuses to comment on the lawsuit but says Donna Sherrouse suffered from a complication seen in a little more than 1 percent of patients.

Half the size

One grueling year after surgery, Mary Miller of North Bend says she has no regrets.

Last February, the now svelte 28-year-old's scale read exactly twice her current weight of 148 pounds. Though her story has a happy ending complete with a wedding she says it's far from a fairy tale.

"I had a rough three months. I regretted it every day," she says. In tremendous pain and hardly able to move, she spent a month unable to eat a bite without heaving it back up.

Then, four weeks after her initial surgery, she had to be cut open again for emergency gallbladder surgery; the rapid weight loss had destroyed the organ. She suffered from severe dehydration and developed a lung infection.

Her planned two-week recovery stretched for nearly three months, causing her to lose her customer-service job.

And like 30 percent of people who get the surgery, Miller suffers from fatigue caused by severe anemia that she must treat with vitamin B-12 shots and iron pills.

"The scary thing about that misery is you don't know where you will end up," she says.

But the rapid weight loss kept her spirits up. Last September, when she was able to wear a size large wedding dress instead of a triple X, she says the months of pain became worth it.

"This is the best decision aside from marrying my husband I have ever made in my life," she says.

Deadly consequences

Steven Steen opted for gastric-bypass surgery for a chance at a healthier, longer life, but he died before he left the hospital.

At 365 pounds, Steen suffered from serious health problems, including high blood pressure, diabetes and an enlarged liver.

At 41, it was looking as if Steen would meet the fate of several of his relatives, including his mother and siblings, who died from heart problems in their 40s. But he met his death another way.

The Boeing data technician underwent the surgery Sept. 10, 1998, also with Fox, who performs more stomach-reduction surgeries than any other doctor in Western Washington. But a leak where the small intestine was joined to the newly created stomach pouch caused a massive internal infection that took his life three weeks later.

Steen's wife, Susan Steen, settled a wrongful-death lawsuit against Fox last summer. Again, Fox declined to comment on the case.

Obesity Risks Add to Complications of Gastric Bypass

Mon, 01 Dec 2003 00:00:00 -0800

The same health risks that make morbidly obese patients eligible for gastric bypass surgery also leave them susceptible to complications during and after the procedure, according to a five-year imaging study led by a Duke University Medical Center radiologist.

The study followed patients at the University Hospitals of Cleveland after Roux-en-Y gastric bypass surgery, the most popular surgical procedure to aid weight loss in severely obese patients. The surgery involves stapling the upper stomach to create a small pouch that is then attached to the small intestine, thereby reducing stomach capacity and the intestine's ability to absorb nutrients.

Among the 335 patients that participated in the study, radiological imaging revealed 57 complications from the surgeries many of them multiple problems in the same patients including suture tears and leaks, pulmonary embolism, pneumonia and infection.

"Severely obese patients are at high risk for any type of surgery because of other conditions related to their weight," said Duke radiologist Elmar Merkle, M.D., formerly of the University Hospitals of Cleveland where the study was conducted. "In addition, there is a wide spectrum of procedure-specific complications following Roux-en-Y gastric bypass."

Merkle presented the findings today (Dec. 1, 2003) at the 89th Scientific Assembly and Annual Meeting of the Radiological Society of North America.

The results emphasize that the procedure should be a last resort after all other interventions, such as diet and exercise, have been attempted, said Merkle. The findings also highlight the importance of radiological imaging in diagnosing surgical complications in severely obese patients following gastric bypass, he added.

The researchers reported eight cases of leaks from the stomach into the surrounding abdominal cavity and five instances of staple line disruption in the stomach, complications specific to Roux-en-Y. They also observed three incidents of pulmonary embolism, two cases of pneumonia, and single cases of severe infection and open abdominal wound disruption all complications that are prevalent among severely overweight patients undergoing any surgical procedure. Within 30 days of the surgery, 17 patients were readmitted to the hospital.

"This operation should not be considered a cosmetic procedure," Merkle said. "People need to be aware of the potential complications of gastric bypass surgery and treat it as a last option after other less invasive interventions have been tried."

In addition to its complications, the procedure also requires patients to undergo major lifestyle changes, he said. Following the surgery, patients must restrict their eating habits and rely on vitamin supplements for adequate nutrition.

According to the American Society for Bariatric Surgery, 63,000 people had gastric bypass surgery in the U.S. in 2002. That number is expected to increase to 100,000 this year. The National Institutes of Health guidelines state that patients who are at least 100 pounds overweight are eligible for the surgery. Patients who are less than 100 pounds overweight may also be considered based on other life-threatening conditions related to obesity, such as type 2 diabetes or cardiopulmonary problems.

Co-authors of the study were Thomas Stellato, M.D., Cathleen Crouse, Peter Hallowell, M.D., and Dean Akira Nakamoto, M.D., all of the University Hospitals of Cleveland.

Hospital Stops Gastric Bypass Surgery

Thu, 20 Nov 2003 00:00:00 -0800

A nursing assistant died while undergoing stomach reduction surgery, and the hospital said Thursday it is suspending such operations while it investigates. Brett Davey, spokesman for Roger Williams Medical Center, would not say went wrong during the surgery or whether any doctors would be disciplined.

Robert Mesa Jr., 27, who worked at the hospital, died Tuesday about a half-hour into the laparoscopic gastric bypass operation, Davey said.

It was the third death among the 340 gastric bypass procedures performed at the hospital over the past three years, chairman of surgery Paul Liu said.

Liu said the hospital will stop performing both open and laparoscopic procedures. The newer laparoscopic technique uses smaller incisions and leads to less scarring and quicker recovery.

He said the doctor who performed the surgery has not been suspended. He would not identify the doctor, but said hes very experienced.

Last month, Bostons Brigham and Womens Hospital stopped performing the laparoscopic procedure after a 38-year-old woman there died after the staple gun apparently misfired during the procedure.

I think whats happening is the fact that its become so visible with celebrities and others who have had it done the numbers who are having it done are going up dramatically, and I think the true risk of this procedure is becoming more known, said Dr. Vincent Pera, director of the weight management program at Miriam Hospital in Providence.

Pera said the death rate for gastric bypass surgery is one in 200.

Gastric bypass surgery aids weight loss in a morbidly obese patient by shrinking the stomach from the size of a football to the size of an egg.

The smaller stomach pouch is created by stitching or stapling part of the stomach closed. A part of the small intestine is bypassed to reduce nutrient absorption, causing the patient to lose weight. Typically, patients lose 70 percent to 80 percent of their excess body weight in about a year.

But the surgery comes with risks, including postoperative complications that can include blood clots floating to the lungs or stomach juices leaking into the blood and causing infections.

Though the procedure is commonly known as stomach stapling, the hospital would not confirm whether staples were used during Messas procedure.

Davey said Messa underwent about three months of preparation for the surgery, including consulting with a cardiologist, psychiatrist and dietitian and attending a three-hour seminar on the risks and benefits of the procedure.

Study Explores Complications Associated With Weight-Loss Surgery

Tue, 13 May 2003 00:00:00 -0700

As the number of Americans considered morbidly obese continues to rise, so does the prevalence of gastric bypass surgery. The procedure aids in weight loss by surgically reducing the size of the stomach, thereby limiting the amount of food a person consumes at one time.

In a new study of the procedure, researchers and surgeons at the University of Massachusetts Medical School and the UMass Memorial Medical Center have identified three factors associated with complications from the weight-loss surgery. Namely, the experience of the surgeon, sleep apnea, and hypertension. The results of the study are reported in the May issue of The Archives of Surgery, a publication of the Journal of the American Medical Association.

The study was conducted by Assistant Professor of Surgery Richard A. Perugini, MD, and his colleagues at UMMS, who reviewed cases of 188 patients with severe obesity who met the National Institutes of Health guidelines for undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. The researchers recorded all complications that required intervention, and the amount of weight lost in the year following surgery.

The researchers found that of the 188 patients, 50 (26.6 percent) developed complications that required an invasive intervention. The most common complication requiring intervention, occurring in 27 patients (14.4 percent) was stricture of the gastrojejunal anastomosis, a closing of the passageway in the newly restricted stomach that requires additional surgery to reopen. The researchers identified surgeon experience, and the patients history of sleep apnea and/or hypertension as predictors of complications.

Laparoscopic RYGB is a challenging procedure, demanding a long learning curve, the authors wrote. To our knowledge, this is the first series that has implicated (these) factors associated with complications after laparoscopic RYGB.

Weight loss data were available for 93 of the 115 patients whose surgery had occurred one year prior. For those patients, their Body Mass Index (BMI) dropped from an average of 53 before surgery to 35 at one year after surgery. The average percentage of body weight lost after one year was 61 percent. The researchers also found that diabetes mellitus was negatively correlated with percentage of excess body weight lost after one year.

Obesity is a major health problem in the United States, and is estimated

Gastric Bypass Surgery Side Effects Lawsuit Medical Malpractice Lawyer

Tue, 13 May 2003 00:00:00 -0700

Gastric Bypass Malpractice

With thousands of obese Americans opting for gastric bypass surgery, a growing collection of research suggests that this increasingly popular operation can have a hidden risk: inexperienced surgeons. Surgeons promote laparoscopic surgery to patients as safer than traditional more invasive surgery.

But the gastric bypass is so difficult, according to physicians who have tracked the results of their cases, that patients of surgeons who have done fewer than 70 to 100 operations have complications more often and a greater chance of death from those complications than patients of more experienced doctors. These results are exacerbating worries that surgeons are rushing into the field without adequate training. Some hospitals allow surgeons to operate after one weekend seminar, during which they do a handful of cases under the guidance of a more experienced surgeon.

When surgeons began removing gallbladders laparoscopically in the early 1990s, hundreds of patients who had suffered complications from an operation long considered routine filed malpractice claims against their surgeons. Many of these doctors had not undergone much training. The surge in claims occurred three years after the first laparoscopic gallbladder removal, and malpractice specialists expect a similar spike in claims from bariatric surgery patients and their families.

Last fall, patients died after gastric bypass surgery in Boston, Providence, and Iowa. In at least the Boston and Providence cases, surgeons performed the operations laparoscopically. The chiefs of surgery at both hospitals involved Brigham and Women's Hospital in Boston and Roger Williams Medical Center in Providence said the surgeons were experienced. Even the busiest and longest-running programs in the country see one patient die every 200 to 300 surgeries, and a 10 percent complication rate.

At Iowa Methodist Medical Center in Des Moines, seven patients died after gastric bypass surgery in the past two years, six of them in 2003, including several in October. One surgeon involved in the cases, Dr. Akella Chendrasekhar, voluntarily stopped performing the surgery.

If you or a loved were injured during gastric bypass surgery, please fill out the form at the right for a free case evaluation by a qualified malpractice attorney.