Weighing the risks of gastric bypass surgery: bariatric surgery is an increasingly popular way for the morbidly obese to lose weight, but the risk for complications and the failure of surgeons and facilities to meet standards of care can lead to injury or death.

One can barely read a newspaper or magazine or watch television without being constantly reminded that many Americans are grossly overweight and getting more so every year. Almost two-thirds of the adults in the United States are overweight, and 30 percent are considered obese. (1)

Morbidly obese people are more than 100 pounds over their ideal body weight, putting them at a greatly increased risk of heart disease, hypertension, diabetes, and other chronic diseases. Obesity also increases the risks of complications related to surgery. Nevertheless, seriously overweight people for whom diet and exercise alone have not worked are increasingly turning to a surgical approach to weight loss.

The highly publicized, successful gastric bypass surgeries of singer Carnie Wilson and NBC's Al Roker have also influenced the dramatic increase in the number of gastric bypass surgeries--from 16,800 in 1993 to more than 103,000 in 2003. Over 140,000 surgeries were predicted for 2004. (2)

Bariatric surgery is the general term for the invasive procedures used to treat morbid obesity, with Roux-en-Y gastric bypass (RGB) being the one surgeons use most often. (3) It can be performed as an open-abdominal procedure, which is considered major surgery with a high risk of complications even for healthy people. It also can be safely and effectively performed using laparoscopic techniques. (4)

Given the underlying medical conditions associated with morbid obesity--such as hypertension, cardiac disease, diabetes, respiratory disorders, and gallbladder disease--laparoscopy, a far less invasive procedure with an easier post-surgery recovery, is preferable for most bariatric surgery candidates. However, laparoscopic surgery requires an advanced level of skill, which some surgeons may not possess, and the procedure still carries a risk that postoperative complications will occur.

And it isn't all smooth sailing even for patients who don't have underlying problems. After gastric bypass surgery, many patients lose an enormous amount of weight in a short time, and often their skin is not elastic enough to shrink back down. For comfort, aesthetic, and personal hygiene reasons, these patients seek more surgery to remove the hanging folds of skin, which poses additional risks involving anesthesia and postoperative recovery. (5)

The risks of gastric bypass surgery have made even some insurers jittery. In the past, most private insurance companies paid for the procedure, but recently some insurance plans announced they would stop covering it, saying they "can't afford to keep paying for what they see as risky surgery, with a reported death rate of three out of 1,000 procedures, that is increasingly being done by less-qualified doctors." (6)

The surgery

The anatomy of the gastrointestinal tract is simple: Food and fluids pass through the esophagus and into the stomach. The average adult stomach can hold up to 3,000 cubic centimeters (cc) (about 12 1/2 cups) of food and fluid. The stomach's contents pass into the duodenum, the first part of the small intestine, where bile from the gallbladder and digestive juices from the pancreas mix in. Then the contents continue into the small intestine, where digestion and absorption occur. The next stop is the large intestine, which reabsorbs fluids produced during digestion, a function largely unaffected by gastric bypass surgery.

Gastric bypass surgery works to restrict both the amount of food a person consumes and its absorption by reducing the functional size of the stomach by more than 90 percent.

In the RGB procedure, the surgeon closes off a large part of the stomach with staples, forming a small pouch. The small intestine is cut below the duodenum, and one open end is brought up and connected to the pouch. (See diagram at right.) Food and fluids pass from the esophagus into the pouch, which holds less than 70 cc (about 1/3 cup), then bypass the rest of the stomach and duodenum to flow directly into the small intestine.

Since the larger portion of the stomach remains intact, it continues to secrete digestive fluids, which drain into the duodenum. Below the duodenum, where the small intestine has been cut to attach one loop to the pouch, the cut end is surgically reconnected to the small intestine farther down. This creates a surgical Y, with one top branch being the esophagus-pouch-intestine loop and the other being the large stomach-duodenum-intestine connection. These two parts of the intestine join to form the bottom of the Y, allowing drainage to continue through the rest of the small intestine and into the large intestine.

In the past 20 years, laparoscopy has revolutionized abdominal surgery by allowing previously open-abdominal operations--such as removal of the gallbladder or appendix--to be performed using small incisions to insert tiny instruments and a camera through the skin and into the abdominal cavity.

Laparoscopy is more difficult when the patient is obese. In patients of normal weight, the distance between the skin and the abdominal cavity is a few inches, and one small stab with a scalpel can traverse all tissue layers. However, in morbidly obese patients the distance between the skin and the abdominal cavity is much greater. A long, pointed trocar--similar to a barbecue skewer--must be used to cut through the layers of fat and other tissue. The surgeon makes a small incision in the skin directly above the abdominal cavity and pushes the trocar into a patient's abdomen, through a layer of tissue called the peritoneum, until it reaches the cavity.

To begin any laparoscopic surgery, the surgeon first creates an operative field by lifting the abdominal wall up and away from the organs--stomach, intestines, and so forth--located in the abdominal cavity. The peritoneum has two layers: One lines the wall of the abdominal cavity and the other encases the organs within it. Pumping carbon dioxide--a gas that the body rapidly absorbs after surgery--between the peritoneal layers separates them, creating a large space in which to perform surgery.

Using another trocar, the surgeon inserts a camera into the space, so that the surgical team can see the abdominal cavity on a large TV monitor. Additional trocars are used to insert small instruments for cutting, cauterizing, and stapling. In a typical bypass surgery, the surgeon makes six 1-centimeter stab incisions into the abdomen, three on each side. Once the instruments and camera are inserted, the surgeon identifies and isolates the parts of the stomach and intestines to be bypassed and then performs the procedure, which usually takes several hours.

Candidacy and informed consent

Generally, a surgeon recommends surgery to a patient to treat a specific medical problem. The opposite is often true of gastric bypass surgery: Patients seek surgeons out and request the procedure. Also, many bariatric surgeons promote their services directly to the public with advertisements and fancy brochures touting advantages and successes. Some surgeons use testimonials from former patients for marketing.

But not all patients who request gastric bypass surgery are appropriate candidates. The accepted medical indications required for the surgery include a weight of at least 100 pounds over ideal body weight, or a body mass index (BMI) greater than 40, or a BMI of 35 to 40 with significant obesity-related medical problems.

Other patients may suffer from a condition like hypertension or heart disease that may be so severe that the risk of not surviving surgery are unacceptably high. Although drastic weight loss may be necessary for these patients to improve their health, and gastric bypass surgery may be their last resort, surgeons should refuse to operate if the risks of surgery outweigh the benefits.

Surgeons must discuss with all patients the surgery's risks, alternatives, and potential outcomes, including that the patient may fail to dramatically reduce weight afterward. These should also be given to the patient in writing. If this has not been done, the patient cannot be deemed to have given informed consent.

One special aspect of gastric bypass surgery is psychological screening, which some surgeons require to determine if the patient is likely to be able to cope with the dietary and other lifestyle changes necessary to achieve the needed weight loss. Preoperative psychological testing can preselect patients for whom the surgery is likely to be a success and weed out those with significant psychopathology for whom surgery might be contraindicated. However, according to the American Society for Bariatric Surgery (ASBS), psychological evaluation has proven of limited value in both situations. (7)

Skill and experience

Since neither gastric bypass surgery nor laparoscopic techniques existed when many surgeons trained as residents, many of those who perform these procedures have learned the techniques at seminars that are taught over three to five days---or less. Therefore, one critical aspect of any case is the skill level and experience of the surgeon and any assistant surgeon.

Even highly skilled and experienced surgeons can be negligent, but unfortunately, the surgeons are the only knowledgeable witnesses to the procedures. While others in the operating room, such as nurses or the anesthesiologist, can see the TV monitor, they may not understand what they are observing. Although the surgery is performed using a camera and monitor, it is rarely videotaped, leaving only the testimony and records of the defendant surgeons as evidence.

Some problems may be obvious at the time of surgery. For example, I currently have two death cases involving trocar use at the start of surgery. In one, the trocar hit the heart and caused an immediate cardiac arrest on the operating table. In the other, the trocar hit the abdominal aorta, and although the procedure was rapidly converted to an open procedure, the patient later died from shock-induced sepsis.

Postoperative complications

The incidence of major postoperative complications reported by the ASBS is less than 1 percent; the most common complications are gastric leak or bleeding and pulmonary embolus.

A gastric leak or bleeding occurs when there is a breakdown of tissue at any of the areas that have been stapled. A leak of gastric contents from the stomach can cause acute inflammation of the peritoneum (peritonitis) that can be difficult to treat and generally requires surgery. This is usually an open procedure, although laparoscopic surgery may be sufficient in some cases to repair the leak or stop the bleeding.

A pulmonary embolus is a blood clot that usually forms in the legs or deep pelvic veins, then breaks off and travels to lodge in the lung. A large pulmonary embolus can cause immediate cardio-respiratory arrest. Treating this condition generally involves administering a clot buster called tissue plasminogen activator (TPA) and heparin, an anticoagulant that decreases the chance of more clots forming. Both of these medications increase the risk of postoperative bleeding.

The incidence of pulmonary embolus is slightly less than gastric leak or postoperative bleeding, but the chance of death is greater, in part because there is time to treat a gastric leak or bleeding with further surgery, whereas a massive pulmonary embolus can cause sudden death. All morbidly obese patients have an increased risk of developing a deep-vein thrombosis (a blood clot in a deep vein that accompanies an artery), which can break off and cause a pulmonary embolus.

Pulmonary embolus and gastric leaking have similar clinical symptoms, including chest pain, shortness of breath, and a rapid heart rate. Because of this similarity, it is important that doctors establish a correct diagnosis as quickly as possible, especially since treatments for the conditions differ significantly. In most hospitals, a pulmonary angiogram or pulmonary CT scan can show an embolus. However, these tests require that the patient be moved in and out of a scanning machine on a table that slides. Many of these tables have a weight limit of 350 pounds. Since gastric bypass patients often weigh more than this, hospitals where the surgery is performed may not have the equipment they need to diagnose this complication.

There are X-ray tables for patients up to 450 pounds, but many hospitals have not yet invested in such equipment. Those hospitals must use a ventilation-perfusion (VQ) scan to diagnose a pulmonary embolus, because this test uses a standard, nonsliding X-ray table that can accommodate heavier patients. A VQ scan is subject to greater variation of interpretation than a pulmonary-angiogram or CT scan, making it an inferior test, although it can still provide useful "probabilities" about a pulmonary embolus.

In one case, a 375-pound woman developed symptoms of chest pain, shortness of breath, and a rapid heart rate about 30 hours after gastric bypass surgery. The hospital could provide only a VQ scan to assist in diagnosis, and the radiologist made an error in interpretation, leading to a diagnosis of pulmonary embolus and treatment with TPA and heparin. When another radiologist reviewed the scan 12 hours later, the diagnosis was revised, and the surgeon took the patient back to the operating room, where a gastric leak and bleeding were discovered. However, because of the delay in correct diagnosis and treatment, the patient developed shock and sepsis, and ultimately died.

In that case, the pulmonologist, hospital, and surgeon settled during the course of the trial; the jury found the radiologist negligent. He has appealed the verdict, claiming that his incorrect diagnosis was not the cause of the patient's death. (8)

Taking the case

When lack of indication for surgery or lack of informed consent, surgical error, or postoperative complications indicate a potential negligence claim, a plaintiff attorney should take the following steps and consider several issues.

Discovery should focus on obtaining information about the training and experience of all those involved in the surgery. Request a copy of any videotape made during the gastric bypass procedure even though the defendant may say none was made. Identify the equipment and capabilities of the facility where the surgery occurred. Then compare the capabilities of the defendant facility with recommendations for facilities performing gastric bypass surgery published by the American College of Surgeons. (9)

Identify and obtain experts with sufficient experience to evaluate the standard of care and causation issues in the case--preferably surgeons who are ASBS members and who teach courses on laparoscopic techniques and gastric bypass surgery.

Issues at trial include dealing with the societal prejudice against people who are morbidly obese. Identify and exclude prospective jurors who believe that people are overweight because they cannot control how much food they eat. People may be reluctant to admit to this bias, but it is essential to identify such prospective jurors. Otherwise, the plaintiff's case may be doomed once the jury is selected.

Because gastric bypass can involve several medical complications and more than one defendant, the legal causation instruction to the jury is an important one. It recognizes that the negligence of several defendants may interact with each other or the patient's underlying condition to produce the injury or death. This jury instruction also recognizes that it is usually impossible for any medical expert to determine the extent to which a factor contributed to causation. So to find for the plaintiff, the jury need determine only that there was a relationship among different factors, including the patient's underlying condition, sufficient to cause the injury or death.

Whenever a new and risky surgery is introduced and its use expands almost tenfold in as many years, the potential for predictable and preventable adverse outcomes increases as the procedure's popularity grows and more surgeons enter the field. Pursuing a medical negligence case involving gastric bypass surgery can be both medically and legally challenging, but a prepared plaintiff attorney can work through the complex medical issues to expose the underlying error.

Notes

(1.) AM. SOC'Y FOR BARIATRIC SURGERY, GUIDELINES FOR GRANTING PRIVILEGES IN BARIATRIC SURGERY (Jan. 2003), available at www.asbs.org/html/guidelines.html (last visited Mar. 29, 2005).

(2.) Robert Kazel, Insurers Trim Bariatric Surgery Coverage, AM. MED. NEWS, Apr. 5, 2004, available at www.ama-assn.org/amednews/ 2004/04/05/bi120405.htm (last visited Mar. 29, 2005); see also American Society for Bariatric Surgery Web site at www.asbs.org.

(3.) Gastrointestinal Surgery for Severe Obesity, National Institutes of Health Consensus Development Conference Statement, at 7 (Mar. 25-27,1991), available at consensus.nih.gov/cons/084/084_statement.pdf (last visited Mar. 29, 2005).

(4.) Philip R. Schauer et al., Outcomes After Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity, 232 ANNALS SURGERY 515 (2000);Alan C. Wittagrove & G. Wesley Clark, Laparoscopic Gastric Bypass Roux-en-Y-500 Patients: Technique and Results with 3-60 Month Follow-Up, 10 OBESITY SURGERY 233 (2000).

(5.) Between 2002 and 2003, the number of these body-contouring procedures used to treat weight-loss patients increased significantly: abdominoplasty (increased by 42 percent to 117,693 procedures), lower body lift (increased by 127 percent to 10,964 procedures), thigh lift (increased by 109 percent to 8,806 procedures), and upper arm lift (increased by 68 percent to 10,595 procedures). See Am. Soc'y for Aesthetic Plastic Surgery, Body Contouring: Shaping Curves to Shedding Pounds (Apr. 16, 2004), available at www. surgery.org/press/news-release.php?iid=344 (last visited Mar. 29, 2005).

(6.) See Kazel, supra note 2.

(7.) AM. SOC'Y FOR BARIATRIC SURGERY, supra note 1.

(8.) Mayes v. Powell, No. GC-027757 (Cal., Los Angeles County Super. Ct. Dec. 23, 2003).

(9.) American College of Surgeons, Statement of the College, Recommendations for Facilities Performing-Bariatric Surgery (ST-34), 85 BULL. AM. C. SURGEONS 20 (2000).

BRUCE G. FAGEL is a licensed physician and trial lawyer who practices in Beverly Hills, California.