J&J's Realize Band Gets US Approval

[fabfatgrl 10]

I"m glad they're finally in the US market... but I really wonder how much this will affect Allergan's market share. I'd love to know how they improved the old Obtech Band.

J&J's Obesity Device Gets FDA Approval - Forbes.com

The Realize Band, which is marketed under the name Swedish Adjustable Gastric Band outside the United States, has been commercially available outside the U.S. since 1996. The company said Friday the device will be available in the U.S., once doctors are trained to use it.

[KarenG. 0]

I don't understand the difference between this band and the ones already being used? Sounds very similar to me.

[WASaBubbleButt 41]

I hope J&J takes over the market. While both products are quality products, J&J is a much better company, a more stable company, they have a rep of standing behind their products, and they are more customer friendly.

Allergan/Inamed has the morality of a stray alley cat.

[tarheelladybug 0]

I was banded with the J and J on Sept. 19 and have not had any problems except a little nausea in the beginning. The J and J was offered to me as $800 cheaper and a much better band (I was a self-payer). Something was said about it being made of silicone and the problem of erosion was greatly reduced. I had my banding done in Mexico, so the J n J was not available in the US. If anyone hears of a doctor who will fill a JnJ, please let me know. It's free to fill at the clinic in Mexico, but my airfair is costly. Anyone else get the JnJ out there?

[anonemouse 1]

Something was said about it being made of silicone and the problem of erosion was greatly reduced.

The Inamen/Allergan band is also made of silicone.

[Daisalana 33]

I was gonna say someone lied to me then.. my inamed band is silicone

[fabfatgrl 10]

I hope J&J takes over the market. While both products are quality products, J&J is a much better company, a more stable company, they have a rep of standing behind their products, and they are more customer friendly.

Allergan/Inamed has the morality of a stray alley cat.

I actuallyworked for one of JNJ's medical device divisions. I wouldn't necessarily say they are better or more stable. Allergan is a billion dollar company on its own. Just because they make botox doesn't make them evil.

JNJ's advantage comes through Ethicon-Endo making a lot of the lap equipment in use as well as the harmonic scalpel... Ethicon making the sutures... etc. They also have a big training center for docs in Cincinnati. So they can offer a total package deal. Still, it will probably take some time before a significant number of docs are trained in it... although I'm sure the learning curve is a small one for docs already used to the Lap-Band.

I'm really curious as to what has changed... as Dr. Curry posted some results from a poster at the recent ASBS conference...and I seem to remember the Swedish Band having much greater erosion rates.

Trace W. Curry, M.D. :: View topic - ASBS update - comparing band results

Comparitive Results of three adjustable gastric bands for the treatment of morbid obesity. Stefanidis et al

Complication type/Swedish Band/Lap Band/AMI

% excess weight loss at 2 yrs / 77% / ??? / 65%

Complications / 21% / 15% / 18%

Erosions / 12% / 0% / 0%

Slippages / 1% / 7% / 2%

Device failures / 1.5% / 1.8% / 12%

Other / 5% / 5% / 4%

Also see Prospective Evaluation and 7-Year Follow-up of Swe...[J Gastrointest Surg. 2007] - PubMed Result

J Gastrointest Surg. 2007 Sep 1; [Epub ahead of print]Click here to read Links

Prospective Evaluation and 7-Year Follow-up of Swedish Adjustable Gastric Banding in Adults with Extreme Obesity.

Balsiger BM, Ernst D, Giachino D, Bachmann R, Glaettli A.

Division of Visceral Surgery, Hirslanden Salem-Spital, Bern, Switzerland.

BACKGROUND: Swedish adjustable gastric banding (SAGB) is a widespread laparoscopic procedure in bariatric surgery. Few long-term data is available. AIM: To determine long-term outcome after SAGB in 196 patients studied prospectively. PATIENTS AND METHODS: 196 patients, 40 men, and 156 women have been operated from 1996 to 2005. Age was 38 +/- 1 (mean +/- sem) years. Mean follow-up was 63 +/- 2 months. RESULTS: Hospital morbidity was 3% (0.5% early reoperation); mortality was 0. Late complications were band migration (1%), leakage (5%), slipping (4%), or pouch dilatation (8%). Minor reoperations (tube replacement, port-related, and hernias) were needed in 7.5%. Cumulative major reoperation rate reached 32%. Eighteen percent had a band replacement; 14% had removal of band anatomy. Late mortality was 0.5%. Exactly 7 years after SAGB, BMI decreased from 45 +/- 1 kg/m(2) to 33 +/- 1 kg/m(2), and excess weight loss (EWL) was 61 +/- 4%. Sixty-eight percent of the patients reached >/=50% EWL. CONCLUSION: In 14% of the patients, the band anatomy had to be removed. Seven years of intact band anatomy leads to a successful EWL of 61 +/- 4% and to EWL of >/=50% in 68%. However, cumulative major reoperation rate of 32% in 7 years makes it mandatory to offer and discuss other bariatric procedures to the respective patients.

PMID: 17763916 [PubMed - as supplied by publisher]

[WASaBubbleButt 41]

Aren't those studies from the old Swedish band vs. the new and improved version?

[Fish 0]

Hello all!

I just found some info about the new JNJ band. Here you go.......

www.ethiconendo.com

[fabfatgrl 10]

Aren't those studies from the old Swedish band vs. the new and improved version?

Not sure on the first one. That's what I'm trying to figure out... what did JNJ do to the old Band to improve it? The press-release announcing the approval says that the Band has been in use in Europe since 1996. So... I think that if this was an improved version or whatever, they'd say that. KWIM?

[fabfatgrl 10]

From Fish's link:

"In the multi-center U.S. clinical trial of 276 patients with the REALIZE Band, patients who completed the three-year U.S. clinical trial (n=228) lost an average of 42.8 percent of their excess body weight. Thirty-five percent of patients who completed the three-year trial lost 50 percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The most commonly reported adverse events after surgery during the U.S. clinical trial were nausea, vomiting, Constipation and gastroesophageal reflux (GERD). Only nine (3.3 percent) patients experienced a serious adverse event that was considered unanticipated and related to the REALIZE Band."

Three years and, on average, 42.8% of EWL. I think Lap-Band shows better stats, but I don't have time to look it up. Still.. I'm glad there's another option on the market.

[faithmd 14]

I hear ya fab, even the link provided above your post (from ethiconendo themselves) says it has been marketed since 1996 under the SAGB name. I didn't see anything about it being improved before release in the US. But one would think it has been, wouldn't you?

[TracyinKS 7]

The more the better! Plus I am part of JNJ's DRIP plan.. so the more the better!!!!!!!!!!!

[faithmd 14]

The more the better! Plus I am part of JNJ's DRIP plan.. so the more the better!!!!!!!!!!!

??? What's the DRIP plan?

[fabfatgrl 10]

??? What's the DRIP plan?

Dividend Reinvestment... instead of receiving a dividend check, the money goes to buy new shares of stock. (Definitely the way to go with any stock you have if it pays a dividend.)

I still have a lot of JNJ stock too... so, of course, I hope they are successful.

I did notice that the Band is now filled with saline. The old obtech band was filled with a contrast solution. I don't remember if it was omnipaq or not, but I remember back when I was first looking at banding, that was an issue... because most US docs who did Band fills would not do Swedish bands.