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Gastric Band Approved by the FDA
September 28, 2007
The Realize™ Adjustable Gastric Band has been approved by the FDA for the treatment of severe and morbid obesity. Ethicon news release
Dr. Ponce has used this band during the U.S. FDA trial study since 2003. He was one of twelve Investigator surgeons that participated in the study. Also, for a couple of years in Mexico between 1997-1999, he placed more than 400 of them, making him one of the most experienced in the country with this band. Dr. Ponce’s thoughts are that both bands (LAP-BAND® and REALIZE™ ) will be similar in effectiveness. The minor details between the two are outlined below. If you prefer one band over the other, please tell me before the day of your surgery. I personally don’t think one band is significantly better than the other one.
BAND NAME |
Allergan Medical
LAP-BAND® System |
Ethicon Endo-Surgery
Realize™ Adjustable Gastric Band |
Worldwide usage (Laparoscopic surgery) |
Since 1993 |
Since 1996 |
U.S. approved usage |
Approved by FDA in 2001 |
Approved by FDA in 2007 |
Dr. Ponce's usage |
Began using 1998 in Mexico/ U.S. FDA trial use since 2000 |
Began using 1997 in Mexico/ U.S. FDA trial use since 2003 |
Made of |
Silicone |
Silicone |
Sizes |
Two: AP Standard and AP Large |
One universal size |
Adjustable |
Yes |
Yes |
Circumferential balloons |
Yes |
Yes |
Band Balloon |
Low pressure |
Low pressure |
Weight Loss at 2-3 years |
50% |
50% |
Slippage |
Low rate <3-5% |
Low rate <2-3% |
Erosion |
< 1% |
< 1% |
Adjustment by port |
Yes |
Yes |
Band balloon capacity |
10cc AP Standard / 14cc AP Large |
9 cc |
Adjustment port |
Anchored by sutures |
Anchored by special clasps |
Approximate adjustments first 2 years |
8 |
8 |
Here is a brief description of the support offered by the manufacturers:
- LAP-BAND® AP™ System: manufactured by Allergan. The LAP-BAND® original version has been available worldwide since 1993 and approved by the FDA for use in the United States since June 2001. The AP™ is the newer version and comes in two sizes. We have extensive experience since 1998 and Dr. Ponce was one of 20 surgeons that participated in the FDA clinical trial before approval. Allergan offers:
- Financing of your insurance deductible or total cash payment
- A web site called Emmi™with comprehensive patient education for the procedure, adjustments and follow-up. For more information please visit: www.lap-band.com and www.lapbandemmi.com
- REALIZE™ Adjustable Gastric Band: manufactured by Ethicon Endo-Surgery, a division of Johnson & Johnson. This band has been available worldwide since 1996, and approved by the FDA for use in the United States since September 2007. Dr. Ponce was one of 12 surgeons that participated in the FDA clinical trial before approval and placed the first band in the United States (June 4, 2003 in Dalton GA). We have extensive experience. Only for the patients choosing this band, Ethicon Endo-Surgery is offering:
- Financing of your insurance deductible or total cash payment thru an agreement with National City bank with an extra discount (0.25% additional interest reduction) for choosing a REALIZE™ band (call 1-866-REALIZE for more information).
- Insurance coverage verification: support service to assist with verifying that your insurance carrier covers gastric band surgery, determining the amount of coverage available and claims denial support (call 1-866-REALIZE and have your insurance card available).
- Easy-to-use interactive web portal called “REALIZE mySUCCESS” which will allow you to have access to hundreds of band friendly cooking recipes, food journal, exercise activities, weight loss tracking, news and reminders, and many other features. Please review the brochure and visit: www.realizeband.com
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