Recent Bariatric and Healthy Living News

New Study Finds That Gastric Banding Pays for Itself In Approximately Two Years for Patients With Diabetes and Four Years for Patients Without Diabetes
Added June 24, 2011

Analysis Demonstrates Gastric Banding is a Safe and Cost-Effective Weight-Loss Surgery Procedure

IRVINE, Calif., June 22, 2011 /PRNewswire/ -- Allergan, Inc. (NYSE: AGN) today announced a new study published in the peer-reviewed journal Surgery for Obesity and Related Diseases that found the cost of a gastric banding weight-loss surgery procedure, such as Allergan's LAP-BAND® Adjustable Gastric Banding System, was offset by reductions in obesity-related medical costs within 2.25 years for surgery eligible patients with diabetes, and within four years of the procedure for all surgery eligible patients.

The study evaluated healthcare claims data from 7,310 patients who had undergone gastric banding compared to claims from a matched control group of 7,306 surgery eligible obese individuals who did not have weight-loss surgery, for the purpose of quantifying the potential savings of gastric banding. The study found that while post-surgery medical costs for the gastric banding group declined slightly, medical costs for the control group continued to rise, thus resulting in significant savings for the banding sample. These findings underscore the critical effect gastric banding has on containing healthcare costs among the target population. 

"Although the gastric banding procedure is associated with upfront costs, our analysis shows that those costs are recovered in a relatively short period of time, particularly for obese patients with diabetes," said study lead author Eric A. Finkelstein, Ph.D., of Duke University and Duke-NUS Graduate Medical School in Singapore. "Although the potential for cost-savings should not drive coverage decisions, some insurance providers are hesitant to cover the costs of bariatric procedures for fear they will break the bank. These results may allay some of those concerns," Finkelstein said. 

Currently, one in three American adults is obese.(1) Due to increased medical expenditures, absenteeism, and presenteeism (reduced on the job productivity due to health reasons), obesity now costs U.S. businesses roughly $70 billion per year.(2) The total medical bill for the nation as a result of obesity is now projected at $147 billion per year, or nearly 10 percent of all medical expenses in the United States.(3) This figure is projected to reach 16-18 percent of all U.S. healthcare costs in the next 20 years.(4) Given its known correlation to life-threatening co-morbid 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. Furthermore, medical research has found that if left untreated those individuals who are currently obese will likely remain obese,(5) highlighting the unmet clinical need among obese patients for the availability of and reimbursement for effective treatment options.

"This study is consistent with the vast findings from the published literature that support gastric banding is an effective and safe weight-loss surgery procedure that can produce sustained weight loss, ultimately resulting in reduction of obesity-related comorbid conditions and medical costs," said Frederick Beddingfield, M.D., Allergan's Vice President of Clinical Research and Development. "Research of this kind is integral in our efforts as a company to ensure appropriate access to and affordability for the LAP-BAND® System procedure for patients across the country."


About the LAP-BAND® System
The LAP-BAND® System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In February 2011, the LAP-BAND® System became the first and only FDA-approved device for bariatric surgery for use in obese patients with a BMI of 30-35 with at least one obesity-related comorbid conditions. The LAP-BAND® System has been approved internationally since 1993, and over the past 18 years, more than 650,000 procedures have been performed, leading to more than two million patient years of exposure for the device. As such, the LAP-BAND® System has an 18-year safety and effectiveness record.

Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.

Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.

Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient's ability to tolerate a foreign object implanted in the body.

Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.

CAUTION: Rx only.

Forward-Looking Statements

This press release contains "forward-looking statements," including, but not limited to, the statements by Dr. Beddingfield and Mr. Finkelstein, and other statements regarding potential cost-savings and reimbursement coverage as well as the safety, effectiveness, adverse reactions, product availability and market potential of the LAP-BAND® System. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2010 Form 10-K and subsequent Quarterly Reports on Form 10-Q. Additional information about Allergan is available on the World Wide Web at www.Allergan.com or you can contact the Allergan Investor Relations department by calling (714) 246-4636.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 9,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
© 2011 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved.
APC78MN11
(1) CDC: National Center for Health Statistics. NCHS Data on Obesity. Available at http://obesity.procon.org/sourcefiles/NCHSDataOnObesity.pdf. Accessed 3/22/10.
(2) Finkelstein et al. The Costs of Obesity in the Workplace. Journal of Occupational & Environmental Medicine. 2010; 52(10):971-976.
(3) Finkelstein et al.Health Affairs 28, no. 5 (2009): w822—w831.
(4) Wang Y, Beydoun MA, Liang L, et al. Will all Americans become overweight or obese? Estimating the progression and cost of the US obesity. Obesity October 2008;16(10):2323-2330.
(5) Kuczmarski MD, Prevelance of Overweight and Weight Gain in the United States. Am J Clin Nutr 1992; 55:495S-502S.  
SOURCE Allergan, Inc.

Pregnancy in Obese Women                                                        Added December 17, 2008 

The following is a summary of the article “Pregnancy in obese women: What you need to know” from Contemporary OB/Gyn, November 2008:

  • It is estimated that approximately one third of pregnant women are obese in the United States.  Both overweight and obesity are linked with a number of maternal and fetal complications.
  • The complications can include gestational diabetes and hypertensive disorders in the mother, and congenital malformations such as heart and neural tube defects in the baby.  The risk of an infant who is stillborn also increases.  In fact, the risk of fetal death is more than twice the rate in obese women.
  • Prepregnancy management can make a big difference to decreasing the above risks as well as additional risks to the infant later in life.  Research shows that infants born to mothers with a higher weight during pregnancy are more likely to become obese as adults.
  • If you are overweight or obese and are planning to become pregnant, please discuss your plans with your physician.  Weight loss can prevent complications and also increase your fertility.  Management of obesity during pregnancy usually involves the avoidance of excessive weight gain.  Significant weight loss during pregnancy is generally discouraged.
  • Weight loss surgery is one tool that can be used to help morbidly obese patients.  There is evidence showing that obese women undergoing bariatric surgery to revert to a lower weight prior to pregnancy can prevent the complications described above.  It’s important to note that pregnancy is not recommended until at least 12 months after bariatric surgery.  At LifeWeigh we recommend waiting 18-24 months.
  • If you are overweight or obese and are currently pregnant, discuss a balanced diet with a dietitian to ensure you can meet all your nutritional needs without gaining excessive weight.  Supplemental folic acid up to 5 mg may also be recommended as obesity is associated with lower blood values and an increased risk of neural tube defects.  However, do not take any supplements without first discussing your needs with your physician.
  • It is important to get back to a healthy weight after your pregnancy as well.  A nutritionally balanced diet and exercise are just as essential during the post-partum period.                

                                                                                   -Summary compiled by Sherrill Johnson, RD, LDN

Download a PDF summary:

 

Healthy Eating News

Hair Loss in the Bariatric Patient

Hair loss is a concern for many people, including bariatric patients.  Hair loss has many causes.  Those causes specific to the bariatric patient include: major surgery, rapid weight loss, low protein intake, iron or zinc deficiency and certain medications such as beta blockers, anticoagulants or retinoids.  Hair loss rarely lasts more than six months unless there is a dietary cause.  Iron deficiency is often linked to hair loss and research indicates that a ferritin level less than 40 ug/L is highly associated with hair loss in women.  Low protein intake is also associated with hair loss.  Bariatric surgeries that reduce the size of the stomach, which in turn reduces hydrochloric acid, pepsinogen and normal stomach churning, may contribute to maldigestion of protein which could result in hair loss.  Hair loss can also be caused by thyroid disease and polycystic ovarian syndrome.  Genetics also plays a role.  If you are a recent bariatric patient and are experiencing hair loss, know that time and patience and good nutrition will help hair grow back.  If you had bariatric surgery more than six months ago, speak with your Physician. 


Healthy Activity News 

HEART RATE MONITORS
It is significantly important to monitor your heart rate during exercise if you truly want to maximize your potential weight loss benefits...Studies have shown that by monitoring your heart rate during physical activity, one can expect to improve your resting metabolic rate or resting metabolism...Your resting metabolism is your body's ability to be able to burn calories while you're at rest...Why is this significant? We're at rest most of the time and not exercising...Often times, we can get so concerned with how many calories we're burning while we're on the treadmill, but you should be more concerned with how many calories you're burning when you step off of it...Most of the time we're not exercising, so if you can improve your body's ability to burn more calories while at rest, it will make your job much easier not only getting to your goal weight but more importantly, being able to keep it there...Now you might ask what does resting metabolisms have to do with heart rate monitors? Good question but here's an even better answer...Long term studies show that the longer you exercise at your target heart rate, the more you improve your resting metabolism...The best way to figure out what your target heart rate, is to make an appointment with Life Weigh for and exercise assessment...The best way to monitor your heart rate, is by simply using a heart rate monitor...

A heart rate monitor is a device that allows a user to measure their heart rate in real time. It usually consists of two elements: a chest strap transmitter and a wrist receiver (which usually doubles as a watch). Strapless heart rate monitors are available as well, but lack some of the functionality of the original design. Advanced models additionally measure heart rate variability to assess a user's fitness.
The chest strap has in contact with the skin to monitor the electrical voltages in the heart. When a heart beat is detected a radio signal is transmitted, which the receiver uses to determine the current heart rate. This signal can be a simple radio pulse or a unique coded signal from the chest strap; the latter prevents one user's receiver from using signals from other nearby transmitters.
There are a wide number of receiver designs, with all sorts of advanced features. These include average heart rate over exercise period, time in a specific heart rate zone, calories burned, and detailed logging that can be downloaded to a computer.
Heart rate training are not only used by world class athletes for improved performance, but also everyday people as well...From runners, joggers, bicyclers, and swimmers, to walkers, and people performing either water or chair aerobics...The brand name "Polar", were the first to come up with heart rate monitors and are the best ones on the market...You can purchase your Polar Heart Rate Monitor at Life Weigh by calling our Downers Grove office at 630-261-9393...


Bariatric News from Dr. Rosen

Surgery for Obesity and Related Diseases 3 (2007)

Participation in 150 min/wk of moderate or higher intensity physical activity yields greater weight loss after gastric bypass surgery.

This is a study from Virginia Commonwealth University and The Miriam Hospital in Rhode Island. This study compared the weight loss outcomes at 12 months from gastric bypass surgery in relation to a patient’s participation in 150 minutes or more per week of moderate to higher intensity exercise compared to those not meeting this requirement.

They followed several hundred patients at 3, 6 and 12 months after gastric bypass surgery. They found the patients that followed their recommendations of 150 minutes or more per week did significantly better in weight loss, %excess weight loss, total %weight loss and BMI reduction than other patients who did not comply with the exercise recommendations.

The reason for the better outcomes can be related to several reasons but some of the theories include improvement in Basal Metabolic Rate (BMR) and maintaining muscle mass. BMR is your ability to burn calories while you are at rest. When one decreases their caloric intake then the BMR decreases as well. We discuss this with each patient whether a patient has weight loss surgery or non-surgical weight loss. The study addresses gastric bypass patients but can be applied to Gastric Banding patients as well.

We encourage you to find an efficient way to get your exercise accomplished for the week. Call our exercise physiologist to set up an exercise assessment to help establish your 150 minutes of exercise per week. The exercise time is important but during that time you must be efficient that is being in the right range of intensity of the work out

Bariatric News from Barb MacTaggart

Obesity in Young Children  Summary of article by Deborah Krepcio, RN, MSN, CPNP, Kathleen Foell, RD, MS, Sara C. Folta, PhD and Jeanne P. Goldberg, RD, PhD

Childhood obesity is a rapidly growing health problem which extends across populations, races, ethnicity, income, or education.  Children in the U.S., ages 2 to 5, approximately 26% are overweight (greater than the 85th percentile on BMI charts).  Weight problems lead to other health problems.  Obesity is the most common cause of abnormal acceleration of growth in childhood.  It leads to early puberty in girls and abnormalities in sexual development in boys. Diabetes mellitus is becoming more prevalent also.  Obese children are more likely to become obese adults, and obese adults have a greater risk of developing health problems such as hypertension, dyslipidemia, coronary heart disease, diabetes mellitus, gallbladder disease, respiratory disease, certain cancers, gout, and arthritis.  Childhood obesity has psychosocial consequences also.  Studies have shown that even young children are sensitized to obesity, and older children rank overweight children as low potential friends.

Causes of childhood obesity:  Hormonal imbalances are rare, and account for less than 1% of children.  Inactivity contributes to obesity and has been documented even in babies less than a year old.  The percentage of body fat is inversely related to their activity level.  Dietary trends also contribute to obesity.  Compared to 25 years ago, children have doubled their intake of soda (almost all is regular, not diet).  Children are also consuming foods higher in calories, such as pizza and snack foods.  Consumption of vegetables has decreased, except for fried potatoes, which has increased.  Families eat more meals away from home, and these meals typically have more fat and saturated fat, less dietary fiber, and less nutrients, and large portions.  Television viewing also contributes to obesity, not only because it displaces physical activity, but also food intake increases.  Children view advertising which affects food preferences.  Typically, these foods are nutrition poor.

Interventions:  Limit children’s television and video game time.  Keep a food diary and review with a health professional.  Avoid using food as a reward for good behavior or to keep the child occupied.  Schedule meal and snack times.  Caloric restriction is ineffective for managing children’s weight.  Encourage children to eat slowly.  Eating should not be in front of the TV.  Decrease the amount of calorie dense foods offered to the child.  Encourage physical activity the entire family can participate together.  Make realistic goals with one or two changes at a time with positive reinforcement  

Dr. Rosen Note:  This is the same calories in – calories out equation we all talk about.  We are learning that our bodies and minds can influence this equation to a great extent and there are multiple influences including genetics that can make calories in worse and our society can make the calories out less.  Let’s all work on these for all of our families to become healthier.

General Health (Outside source)

Science Topics (Outside source)