Battle of the Bands - New Products in Adjustable Gastric Banding

by Jesse Jayne Rutherford

Until recently, having an adjustable gastric band implanted in the United States meant having a Lap-band. Today, however, there are two primary bands on the market, the Lap-band Advanced Platform (AP) system and the Realize Personalized Banding Solution. This new competition has manufacturers, surgeons and patients curious as to which band is really the better band. What are the differences between the two bands, and how will these differences affect you as a WLS patient?

The Bands

Both adjustable gastric bands work by creating two stomach pouches, a small upper one and a large lower one. The patient feels full more quickly because the upper pouch doesn?t leave as much room for food. In laparoscopic or ?closed? surgery, the band is wrapped around the stomach like a belt, and a tiny tube leads from the band to a port that is implanted on the abdominal wall. After surgery, the doctor can adjust the tightness of the band by injecting saline into the port through the tube and into the band, thereby inflating the band so that it constricts a tiny amount.

Lap-band AP is the new-and-improved version of the Lap-band most WLS patients have heard of. Developed by Allergan, the Lap-band AP is wider than its predecessor and features something Allergan calls ?360° Omniform technology,? which allows inflation around the entire inside of the band through seven soft pre-curved pillows. Allergan says that the 360° technology was originally suggested by physicians: ?The AP was developed on surgeon feedback over many years. We evolved our expertise and our device to be what they wanted it to be.? The Lap-band AP also has a new unlocking mechanism allowing the surgeon to reposition the band during surgery, or even after, should the band slip.

Enter the Realize band. Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, recently purchased the Swedish Adjustable Gastric Band, which has been used outside of the U.S. for more than 20 years. They branded it as the Realize band for the U.S. market. The Realize band received FDA approval in September 2007 and is very similar to the Swedish band introduced in 1996. It features one continuous pillow that creates a cushion all the way around the stomach, and although the band is not designed to be unlocked, it is possible to unlock it for revisions, according to Dr. Jon Schram, a proctor for the Realize band who has placed hundreds of adjustable gastric bands and uses both Lap-band and Realize bands in his Michigan practice.

Comparing Technicalities

Studies comparing the two newest bands side by side have yet to be published, and without head-to-head comparisons of the Lap-band AP and the Realize band, it is too early to draw conclusions about differences between their long-term success rates. Comparing separate studies has shown equivalent results with the Realize band and older Lap-bands.

Dr. Sunil Bhoyrul, an attending surgeon at Scripps Memorial Hospital in La Jolla and Alvarado Hospital in San Diego, California, has used both Lap-bands and Realize bands for a long time. Dr. Bhoyrul says that, in his opinion, the best early results appear to be with the AP band: ?The 360° technology and wider profile have given us the best short-term weight loss results we?ve ever seen.? The design differences in the saline cushions?the seven separate pillows in the Lap-band AP as opposed to the single continuous pillow of the Realize band?could prove to be important. Currently, Allergan suggests that the individual sections in the AP band minimize the potential for leaks due to unwanted creases or folds. The Realize band, on the other hand, has been marketed as a softer, lower-pressure band. Dr. Schram says that the Realize band seems to show improved food tolerance in his patients. Questions about long-term results, food tolerance and other aspects of band performance mean that long-term and comparative study results will be eagerly awaited.

What Else Matters?

Dr. Bhoyrul was one of the original clinical investigators for the Realize band in 2004, so he has been using it longer than most surgeons. He also has a long history of experience with Lap-bands. He believes there are two factors that are equally important to patient outcomes: the quality of the product and the quality of the follow-up care. The bottom line is that even if one band ekes out a few more percentage points than the other in an analysis a few years from now, doctors agree that patient education and high-quality follow-up care are crucial.

Having an adjustable gastric band will mean radical changes in your diet for the rest of your life and a commitment to eating responsibly and learning how to take good care of yourself. How much support you receive will depend in part on your surgeon, but both band manufacturers have recognized the importance of aftercare by developing online tools for patients. Realize mySuccess is an online tool that allows patient-physician communication and tracking of weight loss progress, and My Lap-band helps patients keep track of reminders, progress, and organize checklists. Patients are not limited, however, to the band-specific sites; ObesityHelp.com offers weight-tracking and social-networking tools for people having weight loss surgery of any type.

Another factor influencing band choice for some patients is the availability of financing options. In order to assist patients who would not otherwise be able to have Lap-band surgery, Allergan has launched its CareCredit program, a financing program for patients with a low fixed rate and up to an 84-month payment cycle. Ethicon also offers a financing option for the Realize band through National City Corporation, with operations statewide in several states and in select additional markets across the nation. According to the Realize band website, this group offers ?mortgage secured and unsecured lines of credit, as well as a mortgage secured installment loan? to cover some or all of the costs of gastric banding surgery.

The Best Band

We can?t say yet definitively which of the current bands will produce superior results. We also don?t know whether one band will dominate the marketplace, which is another question altogether. Time and further study will tell whether one band or the other provides proven better long-term results or superior safety, and a variety of factors?including the success of the marketing campaigns of each company?may ultimately make one band more prominent and popular. In the meantime, what will likely drive sales of the two brands is some combination of surgeon and patient preference. Dr. Schram says that he thinks most surgeons will be willing to use both products. Each band is considered safe and effective on its own merits.

For now, most patients will find that the best band is the one the patient and his or her surgeon agree is the best fit. Either way, the future is likely to be encouraging. Competition often forces both sides to strive for better outcomes, which will help improve the quality of life for patients over time. As Dr. Bhoyrul observed, ?Every generation seems to get better results.?

 

FEATURE

LAP-BAND

REALIZE-BAND

Silicon band implanted laparoscopically to create small upper stomach pouch

X

X

Unlocking mechanism for repositioning

X

X*

Port secured with little discomfort to patient

X

X

Port secured with metal clips

-

X

Port secured with sutures

X

-

Adjusted by inflation with saline

X

X

Inflation through 360° Omniform technology (seven pre-curved pillows)

X

-

Inflation through one continuous pillow

-

X

Accompanying online support

X

X

Success contingent in part on follow-up care

X

X

Based on the Swedish Adjustable Gastric Band (SAGB)

-

X

Based on earlier Lap-band designs

X

-

Financing provided by manufacturer?s financial partner

X

X

FDA approved

X

X

Conclusive studies have compared it with its top competitor

-

-

*The Realize band is not designed to unlock, but it can be unlocked for a revision. The Lap-band AP has an unlocking mechanism designed to make the repositioning process easier.

Highlights in the History of GASTRIC BANDING

1985: Dr. Dag Hallberg of Sweden applies for the first patent for the Swedish Adjustable Gastric Band, or SAGB. It is implanted in open surgery.
1992: Hallberg?s assistant, Dr. Peter Forsell, shares the newly patented band with other European surgeons, who begin implanting it laparoscopically.
1994: Forsell presents the SAGB at an international workshop for bariatric surgery.
1996: Obtech begins manufacturing the SAGB for use in Europe.
2001: Inamed?s Lap-band becomes the first adjustable gastric band approved by the FDA.
2006: Inamed is acquired by Allergan in March. Allergan?s Lap-band AP receives FDA approval in April.
2007: Lap-band AP is launched in the US. Realize band receives FDA approval in September. Realize band is launched in the US.

For more information about your Lap-band and Realize band options, and to chat with other members on OH?s band-specific message boards, please visit www.obesityhelp.com/forums/lapband and www.obesityhelp.com/forums/realize-band.

August 2008

 

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