By Diana Zuckerman, Ph.D.
National Center for Health Research
When the governor of New Jersey, Chris Christie, admitted in May 2013 that he got gastric Lap-Band surgery, many pundits assumed it was because he plans to run for president. But the choice raised questions about the governor’s judgment. Why would he chose a weight loss strategy that has become so unpopular that the major manufacturer of lap bands, Allergan, no longer wants to make them?1
Most weight loss strategies don’t work for most people – usually they lose weight and then gain it back, and that can make it harder to lose again. But it is important to keep trying, because obesity can kill people by increasing the risk of heart disease, diabetes, and even some kinds of cancer. Lap-Bands help many people lose weight rather dramatically – some lose 50-100 pounds in the first 6 months or year. Unfortunately, Lap-Bands are often not a lasting solution to obesity. For example, an obese woman with high blood pressure will see her blood pressure go down in the first years after surgery, but will increase if she gains weight back after that.
Even more controversial than the use of Lap-Bands to treat life-threatening obesity if the use for people who are not extremely overweight. The American Heart Association advises “bariatric surgery should be reserved for patients who have severe obesity” and only when medical therapy has failed and surgery is a safe option.2 The FDA came to a different conclusion, and they approved lap-bands for people who are only slightly obese (with a BMI as low as 30) if the person has a serious health problem caused by their weight.
If you’re thinking about getting a Lap-Band, here’s the information that can help you decide.
Q: What is a Lap-Band?
A: A Lap-Band is a silicone band around your stomach that reduces the room for food so that you feel full after eating very small amounts. If you eat too much, especially too much of certain kinds of food, you will feel nauseous or will vomit. That will discourage your from overeating and help you lose weight. It is a less complicated surgery than gastric bypass surgery, but most people with Lap-Bands don’t lose as much weight as patients undergoing gastric bypass. Also, Lap-Bands are reversible, and gastric bypass is not.
Q: Whatever diet I use, I can’t keep my weight off. Will a Lap-Band help me lose weight and keep it off?
A: Most people with Lap-Bands lose weight during the first year. Surprisingly few people continue to lose weight after that, despite the small amounts of food they can comfortably eat. After a year, people who have Lap-Bands usually stabilize at their new weight, or start gaining weight again. Some gain and lose weight just like they did when they were on different diets. Despite how difficult it is to eat solid food, many people don’t lose weight with a Lap-Band. Approximately one-third of the people with Lap-Bands have them removed and not replaced within 1-5 years.
Q: If a Lap-Band makes it impossible to eat a large amount of food, how is it possible that some people don’t lose weight with a Lap-Band?
A: There are fattening foods that people can eat large quantities of even with a Lap-Band, such as ice cream and liquids. If you enjoy ice cream, drink many high-calorie beverages, or eat small meals all day long, it is possible to not lose weight or not lose much weight. In fact, a company that makes Lap-Bands, Allergan, found in their research that some patients actually gained weight!
Q: Can a Lap-Band be dangerous? Can it kill you?
A: All surgery has risks, including Lap-Band surgery. Almost all patients will survive Lap-Band surgery, but the risks increase after surgery. We know that patients have died as a result of Lap-Bands, including some patients who were not so overweight that their obesity would have killed them. We don’t know how often that happens, but it is important for patients and their families to understand that there are serious risks that may be greater than the likely benefits for patients who are not dangerously obese.
One of the risks of Lap-Bands is that weight loss after surgery can increase the risk of sudden death from cardiac arrhythmias.
Research shows that the Lap-Band can deteriorate or causes a perforation in the gastro-intestinal tract, where acids and fecal matter can leak into the abdomen. Researchers at the European School of Laparoscopic Surgery found that more than one-fourth of Lap-Band patients had experienced band deterioration within 12 years.3 It can take less than 30 minutes of surgery to get a Lap-Band, but patients can end up undergoing emergency surgery and staying in the hospital for days when something goes wrong.
Lap-Bands do not last forever, so even if the patient has a good experience with a Lap-Band, eventually it will wear out and need to be removed (and replaced, if the patient wants it to be). The European School of Laparoscopic Surgery study followed Lap-Band patients for 12 years and found that half had their bands removed within that period of time.3 Each additional surgery, whether to take a band out or replace it, is an added risk.
Q: Why do people have their Lap-Bands removed?
A: Some people never lose weight from a Lap-Band, so they get the Lap-Band removed a few months after it’s put in. Some have terrible side effects, such as nausea, vomiting, or perforation of the gastro-intestinal tract, mentioned above. In some cases the Lap-Band slips off or starts to deteriorate, requiring surgery, and the patient decides to remove the Lap-Band and not take that risk again. Lap-Bands can deteriorate after just a year or two, or possibly a few years later. These are some of the other reasons why people have their Lap-Bands removed.
Some people just get tired of their Lap-Bands because they don’t like to have such draconian limits on what they can eat. They long to have a sandwich or a small bowl of pasta, or to eat a regular meal with their family or friends. As long as you’re losing weight, the restrictions may be tolerable for many people, but may not seem worth it if you haven’t lost any weight in months or even years.
Q: What are the health benefits of a Lap-Band?
A: If a person who is overweight has the willpower to eat only the small amounts of food needed to feel full, a Lap-Band can help him or her lose weight and keep it off. How often does that happen? Most people who are obese don’t eat only when they are hungry, they eat for other reasons.
There are no studies to tell us how long the average obese person will keep a Lap-Band, but we know that many patients have their Lap-Bands removed. The latest research shows that two-thirds of very obese people with Lap-Bands needed additional surgery over the next decade and almost half had their Lap-Bands removed because of complications. That doesn’t include people who had their Lap-Bands removed because they were ineffective or because the patients didn’t like them. Would less obese people do any better? On the contrary, it seems logical that a very obese person will be more motivated to keep their Lap-Band because they are more thrilled about losing 60-100 pounds than a slightly obese person will be about losing 30 pounds.
We need better research to find out what the real benefits are. Here’s a good research study that someone should do: find 200 average height women who are 30 pounds overweight at the age of 25 and who want Lap-Bands. Then find 200 of the same height and weight who choose other types of dieting instead. Ten years later, how healthy are the women who had Lap-Bands compared to those that didn’t – and how much do the women weigh in each group?
Q: Which is more effective, Lap Band or Gastric Bypass surgery?
A review of research studies comparing Gastric Bypass to Lap band surgery found that the Gastric Bypass was more effective, and should be the recommended weight loss surgery in the United States.4 For example, a study comparing the two after 3 years of follow-up found that Bypass patients lost more weight and saw more improvements in blood pressure and diabetes. In contrast, the Lap Band patients were more likely to require later procedures to fix complications.5 The study was well-designed: before their surgery, the patients had the same BMI and whenever possible were the same age, sex, and had the same health problems. The patients were also given the same diet advice and counseling before surgery.
Q: How much does Lap-Band surgery cost? How much does it cost to remove a Lap-Band?
A: It usually costs between $15,000-$30,000 to put in a Lap-Band. If there are complications, removal will cost at least that much and possibly much more. If you are considering a Lap-Band, find out if your health insurance will pay for the surgery and be sure to find out if it will pay to have the Lap-Band removed. Many insurance companies will only pay for one Lap-Band surgery, so they will pay to put it in, but not to take it out.
Remember that Lap-Bands do not last forever, and we don’t know exactly how long they usually last. Some last just a year or two, and we estimate that most will not last more than 10 years even in the most ideal circumstances.
Q: I’ve seen ads that say a Lap-Band can save your life. Can they say that if it isn’t true?
A: It is possible that a Lap-Band could save a person’s life. That doesn’t mean it can save your life, and it doesn’t mean it will save the lives of most people who get them. It may not even improve the health of most people who get them. Ads by doctors are usually not regulated to ensure “truth in advertising.”
Q: Lap-Bands have been sold in the U.S. for almost 10 years and in other countries for 15 years. Why are there no studies of people who have had Lap-Bands for 10 years?
A: Some people think the companies that make Lap-Bands haven’t done the studies because they are concerned that the results won’t be good for sales. All we can say is that the companies haven’t published any studies, and the companies say that they have not done the studies.
Q: What happens when Lap-Bands deteriorate? Will aging Lap-Bands cause even more serious health problems?
A: A Lap-Band that deteriorates can kill or seriously harm a patient if it is not removed. We don’t know how long most Lap-Bands will last in the human body before they deteriorate and that is why the FDA is requiring Allergan to do studies to answer those questions. However, the FDA says Allergan can sell Lap-Bands to people who are only slightly obese even before those studies are started.
Q: What is the scientific evidence that Lap-Bands are safe and effective?
Allergan, one of the companies that makes Lap-Bands, provided two studies to the FDA. One is a 3-year study of about 178 patients from the ages of 18 to 55, with the original BMI criteria of 35 or higher. Those people were dangerously obese.
The second study has only 149 patients from the new target weight group, who were slightly obese (BMI of at least 30) with weight-related health problems. All the patients were 18 to 55 years old and none had diabetes. They were all studied for only one or two years.
Q: Isn’t 149 people a rather small study? Did the studies include men and women and different racial and ethnic groups?
A. Yes, 149 people is a small study, and the study included only 14 men, 14 African Americans, and 16 Hispanics. There were even fewer Asians and Native Americans. The men had less success with the Lap-Band than women. We need better research to determine whether men don’t do as well when researchers control for confounding variables such as weight and illnesses. We need to study more African Americans and Hispanics to know if it is safe and effective for them.
Q: Why was the new study only one year long?
A: As stated above, one has to wonder if the company was concerned that a longer study would not have favorable results. That still leaves us wondering why the FDA did not require a study that lasted at least 3 years. Obviously, a one- or two-year study is too short-term to determine long-term safety. Implanted devices often work well for a few years, and then problems arise. Since Lap-Bands have been sold in the U.S. for almost 10 years, the company should have studied them for at least 5-8 years.
Q: Are Lap-Bands especially risky for some people?
A: In the study conducted by Allergan, none of the patients had a personal history or family history of autoimmune. That’s because of concerns that the implant could exacerbate autoimmune problems. For that reason, Lap-Bands should not be approved by the FDA for patients with a personal history or family history of autoimmune disease.
Allergan proposed a “caution“-not a warning-for patients with autoimmune diseases or symptoms, and did NOT mention a family history of those conditions. That is risky, since the company intentionally did not study patients with either a family history or personal history of autoimmune disease because of concerns about the dangers.
We don’t know if the FDA will require a warning for autoimmune patients and those who have family members with autoimmune diseases, but they should. We know that some doctors don’t know that Lap-Bands were not studied in patients with autoimmune disease, and don’t know that the company has cautioned against their use for those patients. As a result, some patients get very ill.
Jessica Resas is one such patient, living in Texas. Jessica had an autoimmune disease and her sister had lupus when Jessica got her Lap-Band. She lost more than 100 pounds, but says she has never felt so sick as she does now. In a letter, she asked, “Please advise me of what I need to do to verify if my issues are due to a reaction to the Lap-Band, and if I remove it will the symptoms disappear? …I don’t want to become debilitated to the point that I can’t work or function. I have a 70-year old mother to look after.”
Jessica’s autoimmune symptoms might be caused by her Lap-Band, or might not be, but we need research to find out for sure. If studying Lap-Bands on people with Jessica’s autoimmune history is too risky, then it is also too risky for doctors to put Lap-Bands in people with that autoimmune history.
Q: Is there any reason to think Lap-Bands are less safe for African American or Hispanic women?
A: African American women and Hispanic women are especially vulnerable to lupus and several other autoimmune diseases. There are also other racial and ethnic differences that could influence safety. Is the Lap-Band safe for them? We can’t answer that question because so few were studied. However, we think the risks are likely to be greater than the benefits for African American and Hispanic women because they are more likely to have autoimmune symptoms or diseases.
Q: Should I get a Lap-Band?
A: Are you addicted to eating? If so, a Lap-Band is probably not going to help you lose weight.
Do you love ice cream or fattening drinks? If so, a Lap-Band is probably not going to be effective in helping you lose weight.
Does your insurance cover additional surgery if the Lap-Band doesn’t work out? If it does, are you sure your insurance will be as generous a few years from now, when you are most likely to need additional surgery? If insurance or tight finances might be a problem for you, you should probably not undergo Lap-Band surgery at this time.
Think about all the eating restrictions with a Lap-Band: no more regular size meals. (We don’t mean no more Thanksgiving dinners, we mean no more dinners that are one-third the size of a Thanksgiving dinner). No more pasta dinners – maybe four noodles will be ok, but not more. Before choosing a life of those types of restrictions, make at least one more serious effort to improve your diet and exercise habits, and see if you can lose weight without surgery. After you have made that effort, if you are still obese, check out what the latest research shows about Lap-Bands and talk to your doctor about your options.
After you read this article, think about how you feel about your life. What risks are you willing to take to lose weight for what might be only a year or two? If you are dangerously obese or extremely unhappy with your weight, the risks might be worth it, but this should not be a quick decision. You might want to wait a year or more until better research has been done, to figure out how effective Lap-Bands are and if some types of gastric bands are safer than others.
- Reuters. “Gastric Banding: Pros and Cons of Christie’s Surprising Choice.” May 7, 2013. href=”http://www.reuters.com/article/2013/05/07/us-usa-newjersey-christie-lapband-idUSBRE94617T20130507″>http://www.reuters.com/article/2013/05/07/us-usa-newjersey-christie-lapband-idUSBRE94617T20130507 ▲
- Bariatric Surgery and Cardiovascular Risk Factors: A Scientific Statement from the American Heart Association, Circulation, 2011, 123, available online on March 15, 2011. ▲
- Himpens, J., Cadière, G., Bazi, M., Vouche, M., Cadière, B., & Dapri, G. (2011). Long-term outcomes of laparoscopic adjustable gastric banding. Archives of Surgery, 146(7), 802-807. doi: 10.1001/archsurg.2011.45 ▲
- Tice, JA. et al. Gastric Banding or Bypass? A Systematic Review Comparing the Two Most Popular Bariatric Procedures. The American Journal of Medicine. 2008. 121, 10 , 885 – 893. ▲
- Cottam, DR. et al. A Case-Controlled Matched-Pair Cohort Study of Laparoscopic Roux-en-Y Gastric Bypass and Lap-Band® Patients in a Single US Center with Three-Year Follow-up. Obesity Surgery. 2006. 16, 534-540 ▲