FDA Issues Warnings About Misleading Lap-Band Ads

The FDA has issued warning letters to eight surgical centers in California and a marketing firm behind the 1-800-GET-THIN number for misleading advertising of the Lap-Band, an implanted device intended to promote weight loss in severely obese individuals.

According to the FDA, these groups posted billboards and mailed advertising inserts about Lap-Band that failed to provide “required risk information, including warnings, precautions, possible side effects and contraindications.” And in some cases where warnings were included, the FDA says the font size may be too small to be read.

“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”

If these ads are not fixed in a timely manner, the FDA says further action, including product seizure or civil money penalties, could be merited.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

FDA issues Warning Letters for misleading advertising of Lap-Band [FDA.gov]

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  1. carlathecommander says:

    What? You mean to say losing the excess weight won’t solve all my problems and make me happy?!

    • pop top says:

      That’s not what this article is about.

      • carlathecommander says:

        I’ve seen the ads and they’ve made me angry. They show women who have the lap bad talking about how great their life is. Having friends and family who’ve had the surgery, I know that isn’t so.

        So that was my point.

        • Coffee says:

          Right, but the FDA can’t really tell the company to not portray people who receive the procedure as happier…that’s a subjective thing and pretty much an advertising standard. The article is talking about withholding the disclosure of side effect information, which definitely is something the FDA can police. That was squinko’s point.

          • Loias supports harsher punishments against corporations says:

            Consumerist readers, sadly like most of the general public, lack coherent critical thinking skills that allow them to identify the subject of a paragraph.

            And everyone thought those word problems were total bullshit. No, they had a purpose!

        • Eremis77 says:

          Same with the gastric bypass. I know at least two people who had that surgery who were miserable afterward. One woman kept losing weight so fast afterward that she was near skeletal. And one of my closest friends is in constant pain and has to take huge amounts of vitamins because his digestion doesn’t work right any more.

          Bottom line – screwing up your body processes just to lose weight is NEVER the right choice.

          • ChaosOnion says:

            I thought the lap band could be removed. A friend had gastric bypass because his insurance would not cover the lap band because the surgery could be “reversed.” Can it not be reversed or do these problems remain even after reversal?

            • Nigerian prince looking for business partner says:

              It’s explicitly listed as non-covered procedure in my plan book. I don’t think insurers need any specific reason to cover anything.

          • Such an Interesting Monster says:

            This is patently untrue. For every messed up bypass or lapband there are thousands that are done successfully without issue.

            I’m sorry your friends have had issues, but they are the exception, not the rule. For some people that are crippled by excess weight, fatty liver, diabetes and/or metabolic syndrome these kinds of surgeries are life-savers.

            And all bypass patients are required to take vitamins for the rest of their lives. This *should* have been explained to them during their consultations.

          • cromartie says:

            As one of the tens of thousands of people who have been through a procedure successfully and seen every obesity sourced medical problem disappear as a result, I’ll politely disagree with this conclusion. Sorry.

        • bosozoku says:

          My wife has it – lost 120 lbs, looks great, feels great – life is good here. She was even asked to do one of the ‘testimonial’ ads.

          For those that fail at ‘lap band’ – it’s because they don’t change their lifestyle to a healthy one – it’s still possible to be obese with a lap band by drinking milkshakes, drinking beverages 1/2 hr before or after eating – eating junk food – etc… you really have to make the changes in your diet and stick with it.

          (And yes the lap band can be removed if necessary)

    • Such an Interesting Monster says:

      It depends upon why you’re unhappy. If your weight has a negative impact on your self-esteem, social life, and general sense of well-being then yes, losing a ton of weight is going to make you happy.

      If you’re just a sour-puss regardless of your weight, then yeah, it’s probably not going to help much. You’ll still be a sour-puss, just a thinner one without liver, joint, and blood sugar problems.

  2. Nigerian prince looking for business partner says:

    I wonder if they’ll go after the vasectomy industry. They have billboards all over the place, either without any kind of warnings or in a tiny, unreadable font. The ones that advertise on billboards are also incredibly cheap and between 1/3 to 1/2 the going rate.

    • Cat says:

      Generally, though, men don’t shop price on vasectomies, since most insurance will pay for it. Bypass / lap bands, a whole different story – people price shop because insurance fights it every step of the way.

      #moneywellspent
      #onehappyneuterdcat

      • Nigerian prince looking for business partner says:

        Yes, insurance will pay for it if you have a low deductible. If you have a high deductible, you’re pretty much on your own. I had two vasectomies from a very prominent urologist with a long waiting list and had to pay for both completely out-of-pocket. Even though the second one was discounted, it was still incredibly expensive.

        The really shitty thing is that when shopping for health insurance, they want to know about all large medical claims. It doesn’t matter if you paid for it out-of-pocket or not.

        • Solkanar512 says:

          I hope I’m not being intrusive, but why would you need two? If it’s a situation where the first one failed, why would they make you pay for a second one?

          • Nigerian prince looking for business partner says:

            Even after all the follow up testing, the first one did revert. There wasn’t any kind of warranty on the procedure and I did have to pay for the follow up surgery, albeit at a discounted rate. None of the urologists in my area offered any kind of warranty. I’m not sure if this is the norm everywhere or just in West Virginia.

  3. CosmosHuman says:

    Ok, I’m going to get hell for this but…Insurance companies would rather pay for diabetes meds, MD/hospitalizations from complications, ect and plus other medical problems that are the result of obesity than for weight loss surgery; lap band or gastric by-pass. I do agreee that therapy needs to be done with this type of surgery so that the reasons for getting obese is not repeated.

    Diet and exercise don’t always for for every overweight person. I have been struggling for years to lose weight and I am a type II diabetic on Byetta and occasional metformin (makes me horribly ill). They only way I can lose weight is to eat less than 1000 calories and work-out to death. Right now I am sucking down 5 high protein shakes and one low carb meal a day.

    My friend had the gastric by-pass and her diabetes was gone the next day. She lost all of her weight and looks and feels great. She was in a clinical trial that included psychotherapy. I don’t qualify, as I am way less than 100# overweight, but still need to lose 30#.

    Insurance companies would rather have you die from diabetes and its horrible complications than pay for life-saving treatment.

    • Loias supports harsher punishments against corporations says:

      Surgery has a myriad of complications that don’t occur from medications, nor are any of those complications easy or cheap to address, whereas complications with medication generally resuolt in changing medication or stopping medication.

      Surgery, in all cases, carries high risk that is not associated with topical, medicated, or behavioral fixes.

    • Cat says:

      They would also rather pay ~$150 a year for eyeglasses / contacts, every year FOR THE REST OF YOUR LIFE, than pay for Lasik just ONCE.

      Until about ~10 years ago, they would have rather paid for unlimited children rather than birth control pills, too.

      • Nigerian prince looking for business partner says:

        Insurance companies don’t care about long term savings. It’s all about making a profit for each plan year, since participants and groups are constantly changing insurers. In the past 20 years, I’ve probably had at least a dozen different health insurance policies.

        I just dumped the crappy policy at work (Anthem) for a cheaper crappy policy from Highmark. I have no loyalty to Anthem and they most definitely have none towards me.

      • CosmosHuman says:

        I never ever had insurance that would pay for glasses or contacts, just the diabetic vision exam at the regular co-pay of a medical visit.

        I wish I could afford LASIK instead of spending lots of money on glasses and lenses. I do buy them at Sams Club or Costco to save money.

        • Nigerian prince looking for business partner says:

          Vision insurance is a lot like dental insurance, where really only makes sense when someone else is subsidizing the premiums.

        • dolemite says:

          I’ve always wanted Lasik, but 2 things about it put me off. I work at a computer like 12 hours a day, and I worry that my vision will get bad again a few years after getting it. Also, I think I would absolutely freak out at having my eyes pried open and lasers/needles and whatnot around them. Like Arnold when he goes to Total Recall. I don’t even get shots if I can help it.

      • Rachacha says:

        When my wife started working for her current employer (about 12 years ago) their insurance covered Lasik…almost everyone in the office opted for the surgery. The next year that benefit had been dropped, but it didn’t matter as everyone that wanted the surgery had already obtained it.

    • dolemite says:

      My guess: They are worried that once people are healthy, they will drop their ridiculously priced insurance, or choose the cheapest plan. “Hey, my vision is great, I’m in perfect health…what do I need you guys for?”

      • Nigerian prince looking for business partner says:

        That’s exactly what I did last week. We just dumped our crazy expensive policy because it would cost $15,000/year for a high deductible and replaced it with an even crappier policy but with an easier to stomach $6,000/year price tag.

        My wife and I are both fixed, so there’s no reason to have maternity coverage. We don’t take any prescriptions, so there’s no reason to pay for Rx coverage either. Those kind of things really jack up premiums.

      • Dallas_shopper says:

        I think part of it also is that many adults (like me) get their insurance through their employer and the insurance company, after paying $30k for the surgery and associated costs, doesn’t see the cost benefit of the surgery because you’ve moved on to another job. So, at Job A you have Cigna. Cigna pays for your surgery. 1 year later you accept Job B, whose provider is Blue Cross Blue Shield. BCBS realizes the saved costs of your healthcare because of what Cigna paid for.

        Also, the people responsible for choosing a plan at your job will often leave off things like that because it makes the plan cheaper for everyone else. I don’t want to pay higher premiums out of pocket because someone else needs obesity surgery. We all pay the same, there’s no premium on being obese or a smoker or having other unhealthy habits. (Yes, obesity is almost always a choice.) If the obese or smokers had to pay a surcharge, then we’d be having a different conversation.

        I say this as a current smoker and someone who was once obese but lost the weight through diet and exercise, so I do have some skin in the game here.

    • carlathecommander says:

      I’ve wondered the same thing. An Aunt has horrid diabetes that she has a hard time controlling. If she had GBPS it would be gone in an instant. Instead she has toes amputated, is losing her eye sight, etc. I wonder if they’ve studied reattaching the intestine as a cure for diabetes and not just for weight loss.

    • Greg Ohio says:

      Any chance you’re near Cleveland? The Cleveland Clinic has been conducting a trial to demonstrate that some people who don’t presently qualify should indeed be eligible for the surgery.

      I have no idea if the trial is still going on.

      http://my.clevelandclinic.org/staff_directory/staff_display.aspx?doctorid=6010

    • cromartie says:

      I’d switch providers if it’s possible. If you really sit down and do the math, and most insurance companies have, it’s cheaper to pay for the surgery than it is to subsidize a progressive series of more expensive illnesses.

      Figure that a gastric bypass is $40-$60k depending on the provider, now add up the cost of the cumulative impact of morbid obesity over the years and it makes no sense for an insurer not to cover the procedure. I’m mystified why you’re having this problem, actually.

    • Such an Interesting Monster says:

      Well that’s not really the issue here. The purpose of bariatric surgery is not to treat diabetes, tho that can be a positive side IF, and only IF, the diabetes is obesity-related. If your diabetes is NOT obesity-related then having bariatric surgery isn’t going to help much on that front.

      The government only allows the surgery to be performed if one meets a certain criteria, the #1 being a body mass index (BMI) of over 40. It can also be done on those with a BMI of 35-40 if they also have obesity-related illness such as high blood pressure, fatty liver, diabetes, or metabolic syndrome (but again, “obesity-related” is the key). Most insurance companies will pay for the surgery if you meet the previous criteria, but will most likely require a number of prerequisites such as being on a doctor-supervised diet and exercise plan and/or counseling for at least 6 months. Many insurers will also only pay for the surgery when it’s done by larger medical centers or groups that have a very comprehensive program that not only includes the surgery but extensive pre and post surgery counseling and consultations.

      The reason insurance companies pay for these surgeries is because it saves them money in the long run. There is no advantage for them in continuing to pay for one’s obesity-related illnesses for the rest of their lives.

  4. axhandler1 says:

    Ow! My duodenum!

  5. CubeRat says:

    timely manner, LOL.

    These ads have been on for several years.

  6. HalOfBorg says:

    Ow! My lasagna!

    I’ll never understand an insurance company that won’t pay a bit extra now knowing full well that it will save them a ton over the next decade. My wife needed surgery, but insurance made her go through all these exercises and shit that her doctor said would never help. THEN they paid for the surgery about a year of pain later – and it HAD to cost more.

    • Nigerian prince looking for business partner says:

      It’s because there’s no guarantee that anyone will keep the same insurer from year-to-year. The goal is to pay out as little as possible because any claims are a liability for the current plan year. Long term liabilities aren’t factored in because they are a major unknown.

      In addition, premiums will just be adjusted upwards based on the risk of the individual or group.

      • Rachacha says:

        “In addition, premiums will just be adjusted upwards based on the risk of the individual or group.”

        Exactly. I used to work at a company that had about 75 employees. We had health coverage, but it was not anything super special. Unfortunately, one of our coworkers was diagnosed with Cancer and hada bunch of chemo as well as surgery before passing away. The next year, our insurance premiums jumped because we were a higher risk. Thankfully, our employer absorbed most of the cost increase, and they searched for a new provider the next year.

        • Nigerian prince looking for business partner says:

          We had exactly the same thing happen here, though our pool is even smaller.

          Two years ago, a coworker developed cancer and her 6-figure bills were absorbed by a group of less than 20. When rates went up 20%, many people jumped ship and bought their own policies, went on their spouse’s insurance, or just went without. She had to quit over the summer because of being so sick. But her bills were so high, Anthem wanted a 20% increase in premiums to renew our group.

          That meant our rates went up to about $1,500/month ($1,200/month employee and $300/month employer). We dumped our insurance last week, as did everyone else who had other options.

          • Dallas_shopper says:

            My father’s business had to cancel its employee health coverage because the wife of one of his employees had a super-preemie who racked up over $1 million in bills in a single year. His payroll was small enough so he wasn’t legally required to offer any kind of insurance as a benefit, he just did it because he thought it was the right thing to do…but he couldn’t make a profit and pay for the increased costs after that super-preemie was born.

    • Awesome McAwesomeness says:

      I had to self-pay for mine. I lost 70 lbs (still have 50 to lose, but I have lost and kept the 70 off over 5 years.) I have gone from stage 4 morbid obesity to just obese. I’m not too far from just being overweight. My sleep apnea is gone, my heart arrhythmia is gone, my bone and joint pain is gone. I can get up and exercise, and I feel so much better. I have lupus and hypothyroidism, so I have to go to the doctor 4 times a year, but I went from taking 6 meds at a cost to the insurance company of about $700 a month to 3 that cost $12 to me b/c they are $4 generics. I also am off my cpap so they no longer have to pay for my supplies or new machines, or monitoring, or retesting. The surgery saved them thousands upon thousands of dollars.

      The sad thing is that they keep having a nurse call me to talk to me about my weight issues and how to take off the weight (even though it should be apparent that my weight is going down.) I have told her that I eat 1200 calories a day, eat a very balanced diet, and exercise regularly and she still keeps bugging me. I have a thyroid issue and weight loss is super hard for me. It took me 5 years to take off that 70 and keep it off. It’s going to be a lifelong struggle for me. The lap band helps so much though. Having to stick to an extreme diet plan for years and years with no break is almost impossible for most people. Consuming only 1200 or so calories a day is a piece of cake with the band. I still have to be very mindful, but it helps. I do think I will be down to a normal weight within 3 years or so.

  7. Earl Butz says:

    Long past overdue. In Southern California, these people have been on the radio pimping their ridiculous claims (as well as a fair bit of alarmist rhetoric over how ‘health care reform’ would take away your ability to get weight loss surgery) for more than four years. I’m glad that the FDA has finally gotten a clue and hopefully they’ll pull the fangs of these snake-oil pushers.

  8. NumberSix says:

    Let your new life begin! Call 1-800-GET-LAZY!

  9. Maltboy wanders aimlessly through the Uncanny Valley says:

    And here I thought a lap band was the guys who play music at strip clubs.

  10. Greg Ohio says:

    Bottom line: surgery is a valuable tool for the right people, i.e. people whose obesity is literally killing them. It is not an alternative to Jenny Craig. These billboards make it sound like Jenny Craig, so the FDA is right to reign them in.

    As for all those chiming in about self-control and exercise, consider this: a person who is overweight enough to qualify for surgery has a 1/2000 chance of obtaining normal weight without it.

    • SilverBlade2k says:

      If they *did* have any form of self-control and exercised, they wouldn’t need surgery in the first place.

      • Awesome McAwesomeness says:

        I exercise (I’m a runner and am very fit in a cardio sense and have great muscles on top of my fat) and have been on a 1200 calorie or less a day a diet for 5 years. I have only lost 70 lbs WITH the lap band. I still have 50 to go. Without it, I don’t know that I could have lost any weight at all. I was gaining hand over fist on 2000 calories a day, and just barely lose on 1200 (and I do not lose weekly.) I am on thyroid meds for my thyroid issues (I lost 1/2 of my hair and almost fell into a coma when it was at its worst. I had dementia symptoms and would get lost driving home from the grocery store.)

        People like you who think they have the answers never actually do. There are plenty of things that can cause weight issues, and plenty of people who diet and exercise to an extreme cannot lose weight or do so very slowly.

      • cromartie says:

        A comment that is, at best, ill informed. Once one reaches a weight where their BMI exceeds 35 they lose their ability to properly digest food which in term causes a myriad of other problems that prevents them from losing weight.

        This idea that morbidly obese people can just diet and exercise their way back to a normal weight runs counter to contemporary research on the subject. As one poster stated above, even those people who do manage some degree of success in losing excess of 70 pounds have an 85% recidivism rate over the subsequent two years from their bottoming out point.

        For a lot of people, their body actively conspires against them in the shedding of weight. For millions of years we were not conditioned to be skinny people some people, apparently you, are better at it than others. Congratulations. But don’t be an idiot and assume that what works for you will work for everyone.

    • tinyninja says:

      I used to work for Jenny Craig. It works beautifully for anybody whose weight problem is due to too many calories/not enough exercise, which is most large people. (A few really do need low carb.) For a 300 lb woman for instance I’d typically see a 7-10lb loss the first week, and 3-5 lbs a week thereafter. Unfortunately, my best losers would freak out and stop coming after 6-8 weeks. I’m not totally sure of the reason why, but every single super obese person I signed up (and I was Program Director, so I signed up just about everybody) would swear up and down that they eat normally so they don’t know why they’re so fat. So I think when they start losing like gangbusters they are embarrassed and have to face the fact that they did it to themselves. I wasn’t able to get any of my really large clients back in after the freak outs, no matter how gentle I was. It made me very sad, as they were typically very sweet ladies.

  11. SilverBlade2k says:

    I see the lap-band as a device that is obviously pandering to people who are extremely lazy and want an easy-way out.

    • amgriffin says:

      Famous last words.

    • cromartie says:

      Then you’d better look again. There is nothing easy about having someone put a band inside your body around your stomach. It’s lifelong food intake management used to help people stabilize and normalize their nutritional intake. Some people can go through life without it. Some people can’t. I don’t begrudge the former, you shouldn’t begrudge the latter, though you seem strangely compelled to for some reason.

    • khooray says:

      Try it yourself and come tell me how easy it is.

  12. cromartie says:

    Here’s a free tip: If you are going to have any sort of invasive elective surgery, it probably shouldn’t come from an 800 number.

  13. mydailydrunk says:

    A few hours ago, my wife just got out of her 3rd surgery in a month to “correct” complications stemming from a Roux-en-Y gastric bypass.

    These are not procedures to be taken lightly, without serious contemplation or a full understanding of the possible risks involved. I don’t think that we were fully cognizant of the potential hazards and the pain and suffering associated with complications, despite our research and discussions prior to the initial surgery.

    She started looking into this over 2 years ago, during which time, did everything within her means to lose weight in a more conventional manner.

    She personally feels that this was not worth the excruciating pain or the 24 days out of the past 30 being in the hospital, 6 of which were spent in the surgical ICU, 4 of those being intubated.

    And as with any surgery, I cannot stress enough the importance of having a family member or loved one or concerned party being an informed, on-site, patient advocate to ensure the best possible care.

    • Cordtx says:

      I’m very sorry for your wife-hopefully it will start to get better now. One of my friends was so nauseated for the 1st year and threw up about 25% of her meals but now is 100# less and all the side effects have worked themselves out. I think the risl of major side effects with the lap band is much less.

  14. Cordtx says:

    My daughter just got approved for this. Our insurance did not make her jump through any hoops at all! But my husband works at a big company and the insurance is great- I haven’t seen insurace like it since the 1980’s. They even paid for him to have the snoore (laser) surgery.