Gastric Lap-Bands: What You Need to Know

Diana Zuckerman, PhD, and Jenna Carroll, Cancer Prevention & Treatment Fund

Commonly known as “Lap-Band surgery,” because of the brand name of the most popular version, gastric band surgery peaked in 2008 and has plummeted ever since. In 2008, there were about 35,000 of these procedures in the United States. By 2014, there were only about 5,000.[1] This decline is due to increased awareness of the many risks and limited benefits. Patients with a gastric band are likely to need follow-up surgeries (usually to remove them), which aren’t cheap. In addition, patients’ weight loss tends to be temporary – 6-12 months is typical. According to researchers from the University of Michigan, “There is broad consensus now that the use of gastric band device should be significantly restricted, if not eliminated.”[1]

The first gastric band devices, called Lap-Bands, were approved by the FDA in 2001. A similar device, the “REALIZE band,” was approved by the FDA in 2007 but U.S. sales were discontinued in late 2016. Today the Lap-Band is the only gastric banding device available in the US. The major manufacturer of Lap-Bands, Allergan, sold the rights to the technology in 2013, and the device is now made by Apollo Endosurgery.[2]

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 it again. But it is important to keep trying, because obesity can kill by increasing the risk of heart disease, diabetes, and even some kinds of cancer.  Gastric bands help many people lose weight rather dramatically – some lose 50-100 pounds in the first 6 months or year. Unfortunately, the bands are not usually a lasting solution to obesity. For example, an obese woman with high blood pressure will see her blood pressure go down in the first year after surgery, but it will increase if she gains weight back after that.

Even more controversial than the use of Lap-Bands to treat life-threatening obesity is the use to treat people who are not extremely overweight. The American Heart Association advises that “bariatric surgery should be reserved for patients who have severe obesity” and only when medical therapy has failed and surgery is a safe option.[3] The FDA came to a different conclusion. Ten years after approving Lap-Bands for very obese patients in 2001, the FDA approved Lap-Bands for people who are only slightly obese (with a BMI as low as 30) in 2011.  Despite FDA approval that made more patients eligible for the device, the popularity of Lap-Bands decreased.

If you’re still 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 you 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. Research reveals that other weight loss methods are much more effective in the long-term.

Q: Which Is More Effective, Lap-Band or Gastric Bypass Surgery?

A: Studies comparing Gastric Bypass surgery to gastric banding surgery consistently find that Gastric Bypass is more effective and should be the recommended weight loss surgery instead.[4][5][6][7] 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.[7] In contrast, patients with the gastric band device were more likely to require later procedures to fix complications.

Other studies have come to similar conclusions – short-term results for gastric band surgery are often positive, but as time goes on, patients have more trouble staying healthy. Lap-Band patients regain more weight than patients who have Gastric Bypass. They also need more follow-up operations because of problems with the banding devices.[6][8]

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

A:  There are fattening foods that people can eat in large quantities 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 that you may not lose much weight or any at all. In fact, 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 gastric band surgery. Almost all patients will survive the surgery, but the risks increase after surgery. We know that patients have died as a result of gastric bands, including some patients who were not so overweight that their obesity would have killed them. We don’t know exactly 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 gastric band surgery is that weight loss after surgery can increase the risk of sudden death from cardiac arrhythmias. Research also 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. 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.

Q:  What Happens When Lap-Bands Deteriorate? Will Aging Lap-Bands Cause Even More Serious Health Problems?

A: Gastric bands do not last forever. A gastric band that deteriorates can kill or seriously harm a patient if it is not removed. Researchers at the European School of Laparoscopic Surgery studied patients with gastric banding devices for 12 years. They found that more than one-fourth of patients had their bands wear out, and half of the patients had their bands removed.[8] Each additional surgery, whether to take a band out or replace it, is an added risk. Even patients with good experiences will eventually need it removed (and replaced, if the patient wants it to be).

Q:  Why Do People Have Their Lap-Bands or Other Gastric Bands Removed?

A:  Some people never lose weight from a gastric band, so they get the 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 gastric band slips off or starts to deteriorate, requiring surgery, and the patient decides to remove the band and not take that risk again.

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:  How Much Does Lap-Band Surgery Cost? How Much Does It Cost to Remove a Lap-Band?

A:  The average cost of Lap-Band surgery in the United States is about $15,000, but it can cost as much as $30,000. If there are complications, removal will cost at least that much and possibly much more. If you are considering a Lap-Band, be sure to find out if your health insurance will pay for the surgery and if it will pay to have the Lap-Band removed. Some insurance companies will only pay for one Lap-Band surgery, so they will pay to put it in, but not to take it out. Some insurance plans will not pay for any type of bariatric surgery, including Lap-Bands. For plans that cover bariatric surgery, many companies will only pay for a Lap-Band for extremely obese patients and when other weight loss surgeries have not worked for them.

Remember that Lap-Bands do not last forever. Because the post-market studies submitted by the makers of Lap-Band ended after only five years, we don’t know exactly how long Lap-Bands last. Many patients do not keep their Lap-Bands for 10 years, either because they stopped losing weight or had complications, such as the band slipping or deteriorating.

Many people who get a gastric band have a follow-up surgery, and the cost of those operations is substantial. From 2006 to 2014, $820 million of the $2.1 billion spent on gastric banding devices was for reoperations. As time goes by, more and more of the money spent on gastric bands is for removal, adjustment, and replacement rather than the initial operation. This suggests that fewer people are spending money to implant a gastric band, and more people are spending money to fix the complications that it caused. In recent years, about 90% of total spending on gastric banding devices was for reoperations.[1]

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:  What Is the Scientific Evidence That Lap-Bands Are Safe and Effective?

A: Allergan, formerly the largest manufacturer of Lap-Bands, provided two studies to the FDA. One was 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 had 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?

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. But at this point, many experts question whether Lap-Bands may not be safe or effective enough to justify use for any patient group.

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. We are left 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 to determine long-term safety. Implanted devices often work well for a few years, and then problems arise.

In fact, we now know that Allergan’s small, short study underestimated how often patients had surgeries to adjust, replace, or remove their Lap-Bands. The study found that as few as 4% of patients required reoperation. However, in the entire population during that same year, more than 50% of total spending on Lap-Bands was for reoperations. This suggests that many more patients require additional surgeries than the study found.[1]

Q:  Are Lap-Bands Especially Risky for Some People?

A:  People with a personal history or family history of autoimmune diseases should not get a Lap-Band. The implant was not studied on people with a history of autoimmune problems because of concerns that it would make problems worse. Lap-Bands also should not be implanted in people with any problems with the GI tract, liver, or pancreas.[10] Lap-Bands already have a high risk of complications. When you already have problems with your digestive tract, the risk of something going wrong increases even more.

In the studies submitted to the FDA by the makers of Lap-Band, the participants were not representative of the types of people who get Lap-Bands. For example, one study to see how effective Lap-Bands were for less obese people. Less than 10% of the participants were men and over 75% of the participants were white.[11] This and other studies have not determined if sex or race affects how Lap-Band works.

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 even more 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.

Do you have autoimmune symptoms or family members with an autoimmune disease such as rheumatoid arthritis, lupus, MS, or scleroderma? If so, the risks of a Lap-Band are higher for you.

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, including other types of bariatric surgery.

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 weight loss surgery risks might be worth it, but this should not be a quick decision.

Bottom line: Recent research shows that gastric band surgery may help only a small set of patients. There are likely more effective and less risky alternatives for you to lose weight.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Ibrahim AM, Dimick JB. Monitoring Medical Devices: Missed Warning Signs Within Existing Data. JAMA. Published online June 24, 2017. doi:10.1001/jama.2017.6584
  2. The Wall Street Journal. “Apollo Endosurgery Buys Lap-Band from Allergan.” October 29, 2013. https://www.wsj.com/articles/DJFVW00020131029e9atf0dzi
  3. Bariatric Surgery and Cardiovascular Risk Factors: A Scientific Statement from the American Heart Association, Circulation, 2011, 123, available online on March 15, 2011.
  4. Courcoulas AP, Yanovski SZ, Bonds D, et al. Long-term outcomes of bariatric surgery: a National Institutes of Health symposium. JAMA Surg. 2014;149(12):1323–9.
  5. Gloy VL, Briel M, Bhatt DL, et al. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013; 347:f5934.
  6. Chang S, Stoll CRT, Song J, Varela JE, Eagon CJ, Colditz GA. The Effectiveness and Risks of Bariatric SurgeryAn Updated Systematic Review and Meta-analysis, 2003-2012. JAMA Surg. 2014; 149(3):275-287. doi:10.1001/jamasurg.2013.3654
  7. 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
  8. 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.
  9. 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
  10. LAP-BAND AP® Adjustable Gastric Banding System with OMNIFORM® Design, http://www.lapband.com/resource/1394661427000/Lapband/Lapband/pdf/lapband_AP_dfu.pdf
  11. Dixon, J B, Eaton, L L, Vincent V, Michaelson R. LAP-BAND for BMI 30–40: 5-year health outcomes from the multicenter pivotal study. International Journal of Obesity, 2016 Feb;40(2):291-8. doi: 10.1038/ijo.2015.156. Epub 2015 Aug 18.