Allergan Gastric Band: Europe Questions Long Term Benefits

Editor's Choice
Main Category: Obesity / Weight Loss / Fitness
Also Included In: Medical Devices / Diagnostics
Article Date: 22 Mar 2011 - 11:00 PST

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Pharma giant Allergan is under attack in Europe concerning a new weight loss device to hit the market full force, the Lap-Band System. This system was recently U.S. FDA approved for those with a lower body mass index (BMI) than ever before, but is catching some flack in European studies.

A new study has questioned the long-term effectiveness of the popular Lap-Band weight-loss device, finding that many patients suffered major complications and half of them eventually had the device removed.

This information focused on 82 surgeries performed between 1994 and 1997. Even though patients reported losing significant weight, complications such as band erosion and infections led researchers to conclude the surgery had relatively poor long-term outcomes.

Back in February of 2011, Frederick Beddingfield, M.D., Allergen's Vice President of Clinical Research and Development stated:

"Given the proven and significant health ramifications of obesity, we are pleased with the FDA's decision to expand the use of the LAP-BAND System. Although this label expansion represents a significant advancement in obesity treatment, the LAP-BAND System is not intended for everyone. The LAP-BAND System does represent a potential treatment option for those patients with obesity and a related health condition, which have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option."

The Lap-Band, manufactured by Irvine-based Allergan Inc., is a silicone ring that's surgically fitted over part of the stomach to discourage overeating. Allergan officials have criticized the new European study, saying it was flawed and contradicts other studies that have found the device safe and effective. A 2004 study, for instance, found that just 17% of patients had opted to have their bands surgically removed, said Caroline Van Hove, an Allergan spokeswoman.

Over the past 18 years, more than 650,000 procedures have been performed, leading to over two million patient years of exposure for the device.

Four patients have died within the last two years following Lap-Band surgeries performed in Southern California, prompting medical malpractice lawsuits and investigations by the Medical Board of California.

None of the patients involved in the European study died as a result of the surgeries. But 32 of 82 reported major complications, and 49 of them had additional surgeries, either to correct problems or because of a lack of weight loss.

Smoking is America's number one killer, but obesity is the second-leading cause of preventable death in the United States. Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese.

Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator adds:

"As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success. These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. The LAP-BAND System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss."

This week's report states that many surgeons in Europe are opting for a more invasive gastric bypass surgery. The trend is the opposite in the United States, where gastric banding is more common than bypass surgery.

Sources: Archives of Surgery and Allergan Incorporated

Written by Sy Kraft, B.A.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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