One Month Weight Loss Results

The average weight loss is now 31% with one patient at 50%!

Updated Results from Mexico

All patients are doing great, happy and losing weight.

The average excess body weight loss has increased to 22.1% – up from 16% at week one.  The weight loss ranged from a low of 10% to a high of nearly 43%.  The first followup endoscopy has been performed on all patients with good results.

There was a migration of the device in one patient – with the device successfully removed from the stomach using an endoscope.  This was likely due to insufficient knot tying in the esophagus during implant (the older knot pusher used in the first cases did not function as well as the newer version used in the last half of the cases).  The device migrated at day 16 – the weight loss was 34% at the time of the migration.  The patient has since regained 4 1/2 lb and his hunger has returned.  We will continue to monitor this patient  over the next several weeks.  Dr. Trevino reports that he is very sad that he no longer has a Full Sense Device and is ready for another one ASAP!

The patient who had gall bladder surgery is doing well and losing weight.

There are two diabetic patients in the study – one is completely off their diabetic medications and the other has reduced their dosage by 50%.

We are only a few weeks away from exceeding the longest implant times (the first study lasted 6 1/2 weeks).

Weight Loss One Week after Implantation of Full Sense Device

Week #1 results are in and all patients are losing weight.  At their one week followup patients lost an average of 16% of their excess body weight.  This ranged from a low of 6% to a high of 37%.  There are 4 males and 9 females with an average BMI of 37.  One patient had pain and nausea several days after the procedure and was found to have acute cholecytitis requiring removal of her gallbladder.  Gall bladder symptoms can be seen with significant weight loss.

This week all patients return for their first endoscopy (examination of the device with a camera positioned on the end of a flexible tube).  This will permit an evaluation of the positioning of the device, the esophageal and stomach tissue in contact with the device and the security of the fixation sutures.

The patient with the greatest weight loss has been reported to be “excercising like crazy”.  Another patient is “playing a lot of basketball” again which he has not done in a while.  His diabetes is also improving requiring less medications.

To put this in perspective, most medical programs hope to have patients lose 5-6% of excess body weight by the conclusion of the program.  The weight loss we are seeing is better than most bariatric surgical patients experience at this point.

Note:  Excess body weight was calculated as the patient’s weight at a BMI of 25 subtracted from their actual weight.

Full Sense Device Distending the Stomach at Implantation

The view inside the abdomen from the laparoscope showing the distension of the stomach caused by the Full Sense Device.  This distension puts pressure on the upper portion of the stomach causing satiety.

Surgeons Implanting the Full Sense Device

From left to right:  Dr. Foote, Dr. Kemmeter, Dr. Baker and Dr. Trevino.

Dr. Foote and Dr. Trevino are assisting laparoscopically, while Dr. Kemmeter and Dr. Baker are operating the endoscope.

13 Patients Received Full Sense Device

Thirteen patients were implanted with the Full Sense Device at Galenia Hospital in Cancun.  All procedures went well and the patients were discharged from the hospital.

Full Sense™ Device to Undergo Additional Evaluations at Mexican Bariatric Center

Additional studies are planned for the Full Sense Device at Galenia Hospital located in Cancun, Mexico.  Patients who will have the device implanted for up to one year.  The first phase of the study is scheduled for March 22 – 26, 2010 in which patients with a BMI between 30 and 40 will receive the Full Sense Device.  Additional implants groups will include patients with diabetes, previous gastric bypass surgery and other comorbidities.