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Diabetes/Obesity
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Should the FDA Lower the Gastric Banding Bar?
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| Allergan, Manufacturer of the LAP-BAND®, Thinks So | |||||
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On December 3, 2010, an FDA advisory committee considered Allergan’s request to reduce the standard of how obese a person must be to qualify for use of its LAP-BAND® device ("Lap-Band"). The Lap-Band is an adjustable, inflatable silicone ring that a surgeon adheres to the top portion of a patient’s stomach during a procedure called gastric banding. Designed to promote long-term weight loss by reducing the amount of food a person’s stomach can contain, gastric banding provides an alternative strategy for obese people who have been unable to reduce their weight through exercise, diet and pharmacotherapy. The procedure is considered less invasive than gastric bypass surgery, which involves stomach cutting, stapling, or intestinal re-routing.
A person is considered obese if his or her BMI, or body mass index, is 30 or above. A measurement of the relationship between weight and height, BMI signifies whether a person falls into a weight category associated with compromised health. Obesity is strongly connected with the development of type II diabetes and cardiovascular disease, as well as hypertension, osteoarthritis, sleep apnea and depression. It is also linked to the development of cancers of the colon, breast, kidney and esophagus, and is also associated with increased risk of cancers, like those of the prostate, pancreas, and ovary, and Hodgkin lymphoma. The American Cancer Society cites excess body weight as a contributing cause of 14 to 20 percent of all cancers, and estimates that one of every three cancers is connected to excess weight, physical inactivity or poor nutrition.
In 2001, the FDA approved the Lap-Band for severely obese adults (those with a body mass index, or BMI, of 40+), or those who are obese (with a BMI of at least 35) and have at least one obesity-related health condition. Allergan now wants the FDA to lower the qualifications so that people with a BMI of 30 who also have a related health problem, and those with a BMI of 35 without other health complications, can undergo the gastric banding surgery. While gastric bypass surgery typically costs between $ 20,000 to $30,000, gastric banding runs between $12,000 and $20,000.
In Allergan’s report to the FDA committee, it is stated that people with BMI between 30 and 40 experience the same co-morbid conditions (hypertension, cancer, osteoarthritis, and type II diabetes) as morbidly obese people, just at slightly lower percentages, and that weight loss can improve or resolve these conditions. Allergan, which stands to double its sales of the Lap-Band if the device's use becomes less restricted, also cites that, while 15 to 20 percent of people are successful in keeping weight off through non-surgical weight loss interventions (diet, exercise, behavioral therapy, and pharmacotherapy), a large number of obese people fail do not respond to these “conservative” weight loss options.
If Allergan’s request is approved, the number of people who qualify for use of the Lap-Band could double (to almost 20 percent of the American adult population). Amidst an obesity epidemic, its expanded use might be promising. However, many experts say that more research is needed to prove safety and effectiveness of the device; while gastric banding is less risky than more invasive bariatric surgeries, it can erode into the stomach, leak, and cause negative side effects or even death. These side effects, when weighed against health risks associated with being morbidly obese (BMI 40 and above), may be lesser evils when diet and exercise efforts have not been effective weight loss strategies. Researchers are divided, though, as to whether gastric banding can help people achieve long-term weight loss with few complications. (See Anwar, Dallal, Singhal and Cunneen.)
Underage Banding
Gastric banding surgery is gaining popularity, even among people for whom the procedure is not approved. A recent study (Jen HC et al.) showed that almost 600 teens (aged 13 to 20) in California underwent the surgery between 2005 and 2007, despite lack of insurance coverage for those under 18. The researchers concluded that, while the number of adolescents who have undergone gastric banding surgery has increased dramatically, determination of the relative safety, efficacy and health care costs requires longer-term study. Allergan did not request that the FDA approve the Lap-Band device for obese people under the age of 18 in its report.
Making Weight Loss Treatment Choices
The non-profit Obesity Action Coalition (OAC) states that “there is no one weight loss treatment for obesity,” and advises people to work with their doctors on weight loss plans that are best for them. Starting with changes in lifestyle behaviors such as eating habits and level of physical activity, the OAC suggests that people also set realistic weight loss goals, become educated about bodily nourishment, engage in a support group, and/or participate in extracurricular activities. Noting that patients thinking about gastric banding should be at ease with the thought of the device being inside them for life, the OAC’s position on the procedure is that it is safe and effective, and can lead to meaningful, sustained weight loss as long as people also change lifestyle behaviors that have contributed to their obesity. In addition to information on lifestyle modification, the OAC also provides overviews of other bariatric surgeries, as well as physician-supervised programs.
For some people, gastric banding may be the best available tool with which to help jump-start necessary lifestyle modification. By restricting the amount of food ingested, the band can help acclimate one’s stomach to the receipt of smaller portions and the body / mind to related changes. Citing that some high calorie / low nutrition foods such as sodas, ice cream, cookies, and cakes can easily pass through the band, the OAC emphasizes that people with gastric bands need to also watch what they eat, in addition to how much.This is especially important if other obesity-related complications like type II diabetes or hyperlipidemia are present.
Treating gastric banding as an adjunct tool for weight loss, rather than the end-all-be-all obesity solution, may be what helps patients best engage their inner healers. Although the band may be what gets an obese person started, it’s important to remember that “calories-in” and “calories-burned” (exercise) are really the pillars of weight loss. Choosing foods wisely and exercising, as opposed to just getting surgery, sends an unconscious message to one’s children, as well. The keys to weight loss, then maintaining a healthy weight, are commitment to, passion for, a healthy lifestyle.
References:
© 2010 Heart MD Institute, PA |
Pathology (becoming ill) is really a form of dis-ease that emerges from chaotic imbalance of mind, body and spirit. Heart disease frequently results from this disturbed relationship. When considering any illness, diagnosis or treatment, it's important to focus not only on the disease and the physical dysfunction created, but also on the human operational planes - the physical, metabolic, emotional, mental, and even the spiritual.
- Heartbreak and Heart Disease
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