Weight Loss Surgery News Blog

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Bariatric Surgery (especially the Gastric Bypass Surgery) are surging in popularity. With massive weight loss in a short time, skin often does not shrink well. Body contouring plastic (or cosmetic) surgery can help deal with this extra skin and give such individuals a new image after losing massive weight.

Whether a person loses weight through diet and exercise or through bariatric surgery, there are a few problems that arise as a result of the weight loss. One that will be most noticeable is the loose skin that remains after the weight is gone. When someone is overweight, the skin stretches to accommodate the increased volume of weight. After weight loss, the skin often fails to tighten, and so it sags. In many cases, it hangs (especially in the arms, stomach, thighs, breasts, and buttocks). It acts as a constant reminder of the weight you once carried around. Exercise WILL NOT tighten skin (exercise never tightens skin - only muscles). The only way to tighten loose skin is through plastic or cosmetic surgery.

Though tummy tucks, lower body lifts, and liposuction are not new to the cosmetic surgery world, performing these (and other) procedures on post-bariatric patients often requires a different approach. What makes body contouring, or body reshaping, more difficult after bariatric surgery is that the skin has usually been permanently damaged by being so extremely stretched. The result is that the patient's skin will loosen with age faster than a normal patient's. Bariatric patients desiring such reshaping after surgery should use a specialist with experience dealing with this type of situation.

A variety of surgical procedures are often necessary and performed at different times. Depending on which area bothers you the most, the surgery can be tailored to fit your needs, starting with the area of greatest concern.

Often an abdominoplasty (Tommy Tuck) is done first, though a circumferential lower body lift may be needed instead. Breast lifting surgery, arm lifts, face lifts and neck lifts are all additional procedures that can be done at separate times. A body lift is the combination of tummy tuck and a lower body lift (inner thigh lift, and outer thigh/buttock lift).

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GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced initial, positive results from a clinical trial evaluating 12 months of treatment with the EndoBarrier™ Gastrointestinal Liner. The first group of patients from this trial have successfully completed 12 months, or 52 weeks, of treatment with the EndoBarrier Gastrointestinal Liner, an important milestone in the clinical development of this non-surgical therapeutic. The clinical trial was led by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, Brazil.

“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity”

“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity,” commented Keith Gersin, M.D., FACS, chief of bariatric surgery at Carolinas Medical Center and chief medical director of GI Dynamics. “The data we have seen previously in patients treated for up to six months is very compelling, and these data from 52 weeks of treatment further extend the potential impact and efficacy of this approach. I look forward to the full data set from this trial as the rest of the patients complete the 12-month mark.”

The 52-week trial was designed to evaluate the EndoBarrier Gastrointestinal Liner in 22 obese patients with type 2 diabetes. The primary endpoints in the trial include improvement in type 2 diabetes and excess weight loss. To date, the first six of the 22 subjects implanted with the EndoBarrier have successfully reached the 52-week endpoint.

The average baseline weight for the subjects was 270.5 lbs (± 22.2 1bs), average baseline HbA1c was 9.3% (± 0.8%) and subjects were taking oral anti-diabetes medications. Top-line results for the first six subjects show that on average patients achieved the following results:

HbA1c decrease of 2.5% (± 0.6%) with 5 of the 6 getting below 7.0%
25.9 % excess body weight loss (± 4.6%)
35.5 lbs weight loss (± 9 lbs)
“This is a landmark achievement for the EndoBarrier and GI Dynamics,” said Stuart A. Randle, chief executive officer of GI Dynamics. “I want to congratulate and thank our technical, clinical and scientific teams for their efforts which have led us to a successful 12-month device design and the meaningful results we have observed clinically to-date. We believe that EndoBarrier is well positioned to provide a transformative alternative to pharmaceutical and surgical methods for treating type 2 diabetes and obesity. This milestone further enhances the potential clinical value of the EndoBarrier offering.”

Addressing Unmet Need for Treating Type 2 Diabetes and Obesity

The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval for the treatment of type 2 diabetes and obesity in December 2009. Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy.

GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

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With more than 23 million Americans already diagnosed with diabetes, the number of individuals affected by the condition in the U.S. is expected to double over the next 25 years, according to new research.

A study published in the December issue of Diabetes Care claimed that the aging population and the persistence of high obesity rates will produce a populace at a greater risk for type 2 diabetes than in the past, HealthDay News reports.

Researchers expect that the obesity rate will remain stable throughout the study's timeframe, ranging from about 27 percent to 30 percent.

The study predicted the price tag on treating those with diabetes in 2034 will be about $336 billion, about three times the estimated cost for 2009.

According to the Centers for Disease Control and Prevention, about 23 percent of Americans over 60 have diabetes.

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A consensus statement on diabetes surgery is published online today in the Annals of Surgery. This appears the first statement towards a concenus of surgery for diabetes type 2.

At present, bariatric surgery is only available as a treatment for severe obesity, defined as having a body mass index (BMI) of 35 kg/m2 or more, according to National Institutes of Health (NIH) guidelines established in 1991. The DSS consensus statement acknowledges that the cutoff is arbitrary and not supported by scientific evidence, and recognizes the need to use more appropriate criteria for surgery in patients with diabetes.

The report illustrates the findings of the first international consensus conference -- Diabetes Surgery Summit (DSS) -- where an international group of more than 50 scientific and medical experts agreed on a set of evidence-based guidelines and definitions that are meant to guide the use and study of gastrointestinal surgery to treat type 2 diabetes. The document is considered to be the foundation of diabetes surgery as a medical discipline of its own.

In its position statement, the Diabetes Surgery Summit states: "Surgery should be considered for the treatment of type 2 diabetes" in patients with a BMI of 35 or more "who are inadequately controlled by lifestyle and medical therapy." The statement goes on to state that diabetes surgery may also be appropriate for treatment of people with type 2 diabetes and merely mild-to-moderate obesity (BMI 30-35). This goes beyond parameters established by the NIH for bariatric surgery in 1991, which reserved bariatric surgery for people with a BMI of 35 or more with an obesity-related condition, or a BMI of 40 or more with or without any obesity-related condition. These parameters are still adhered to by most insurance companies in determining coverage of the surgery.

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Obese patients with uncontrolled type 2 diabetes who were treated with an investigational endoscopic duodenal-jejunal bypass liner achieved near normalization of glycemic control in one week, as compared with a sham group. Implantation of the liner was also associated with reductions in fasting blood glucose levels and weight loss.

The EndoBarrier (GI Dynamics) is a non-surgical therapeutic device that is implanted in the gastrointestinal tract through an endoscopic outpatient procedure. It creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system.

In clinical studies conducted to date with the EndoBarrier, patients have experienced immediate resolution of type 2 diabetes while the EndoBarrier is implanted, and continued resolution of their diabetes after the device is removed, as well as the important benefit of weight loss.

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