Lap Band Clinic Gets FDA Warning Letter Over Marketing Claims
Allegedly misleading advertising statements about the risks and benefits of Lap-Band weight loss surgery has led the FDA to send a warning letter to a Los Angeles clinic, as the agency continues to ratchet down on what are often seen as fly-by-night surgical centers that promote the procedure as a quick fix, without disclosing the potential health risks.
The FDA warning letter was sent to Lap-Band VIP on June 25 and released to the public this week, referring to the clinic’s commercials and billboards as false and misleading.
The text of two commercials and two billboards are highlighted in the letter, none of which provide any information about the potential health risks. There is no mention that there could be surgical complications and the advertisements do not tell the consumers that the Lap-Band requires a drastic change in eating habits, according to the federal regulatory agency.
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The FDA has requested that the clinic immediately stop marketing the Lap-Band in advertisements that violate federal regulations and indicated that the clinic could be subject to potential regulatory action if it does not comply. The FDA warned that it could seize the company’s assets, get an injunction against its operation or pursue monetary fines if it failed to comply.
The Lap-Band, also known as the laparoscopic adjustable gastric banding, is a loop of material placed around the upper part of the stomach, creating a small pouch which quickly fills with food. People with the band feel full after eating small amounts, which promotes weight loss.
Although the Lap Band can be effective, there are a number of potential complications associated with the weight loss surgery, including erosion of the band through the stomach wall, the band moving out of position, nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD), abdominal pain, and leaking of the gastric band.
The Lap-Band forces recipients to change their eating habits, as they are unable to eat large meals and must eat a series of smaller meals throughout the day for the rest of their lives or until they have the band removed.
Recent studies have suggested that 40% of patients implanted with the weight loss device may suffer serious complications and problems following Lap-Band procedures.
In December, the FDA raised concerns about many clinics that were not fully disclosing the risks associated with Lap-Band procedures in direct-to-consumer advertisements. The agency has focused on several Lap-Band clinics in recent months, particularly in the L.A. area.
ShahnilaApril 4, 2013 at 10:44 pm
I had a lap band surgery done in July of 2010. since then I was sick. Sometimes the band felt too tight and sometimes everything could go in. I could feel the port and the burning from it. At the time of my periods it was worst pain and it felt something is cutting inside. Doctor said to m very time it is normal. Finally on march 28 2013 I saw a wound around m port site, went to the doctor, he gav[Show More]I had a lap band surgery done in July of 2010. since then I was sick. Sometimes the band felt too tight and sometimes everything could go in. I could feel the port and the burning from it. At the time of my periods it was worst pain and it felt something is cutting inside. Doctor said to m very time it is normal. Finally on march 28 2013 I saw a wound around m port site, went to the doctor, he gave antibiotics but it did work and I rushed into emergency on April 2 2013 because the drainage from the food was getting worst. Doctor said the lap band has to come out and he operated me on April 3 2013 and the whole system came out due to an infection. How and what made the infection to occur nobody knows. I am happy I rushed to the ER otherwise who knows what worst then his would have happened.
AmandaAugust 13, 2012 at 11:26 pm
I had the lap band surgery in 9/2009. I spent 11 days in the hospital, it was suppose to be 24 hours. I was told that my lung collapsed. Since then I have spent about 3-4 days a week in doctor's offices. Having fluid added and withdrawn. My port is rooked, which causes pain everytime they add or remove fluid. The doctors have bent and even broke needles on me. I've been on the stage 1 and 2 diet r[Show More]I had the lap band surgery in 9/2009. I spent 11 days in the hospital, it was suppose to be 24 hours. I was told that my lung collapsed. Since then I have spent about 3-4 days a week in doctor's offices. Having fluid added and withdrawn. My port is rooked, which causes pain everytime they add or remove fluid. The doctors have bent and even broke needles on me. I've been on the stage 1 and 2 diet restrictions most of this time. I throw up daily and always suffer from constipation, despite taking in 3 liters of water nd then other liquids. And then on top of taking all the water in, I feel like I'm choking constantly! My diabetes has gotten worse. My high cholestrol and blood pressure have not changed. I've lost a grand total of 32 lbs. I also have pain in my stomach where incisions were made. My husband and I went to every seminar givn by every doctor performing the surgery within a 30 mile radius of our home, and everyone said the same thing.... We were told that this would be the best procedure for me. Well, it was the worse thing I could have done! Now, I find out that noone around us even does lap band surgeries. And trying to have this thing removed is next to impossible! I rarely leave my house, exept for my many doctor appointments that I now have because of this. I'm not the only one affected by this....my husband and our four boys have pretty much lost me. I spend so much time being sick and at the doctor that I have no energy for anything else. I have become very depressed over this and have almost given up hope on ever feeling like a normal person again. Today, I am just p*ssed and hurt! I feel like a test subject, and the test didn't work, so forget about me... I'm going to have to deal with the sickness and the pain for the rest of my life...and who wants that?
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