Realize vs. Inamed

[WASaBubbleButt 41]

I think WasA is right about it being like chocolate. Because the way the Realize port is placed sounds better to me. :blushing:

I also prefer that the Realize band is one-size-fits-all because I've heard too many stories about people being given a too small band and having erosion or a too large band and not getting enough restriction or, worse, having slips. Then there are the ones whose band is the right size when it's put on but now that they've lost so much weight, it's too big and then slips.

The Realize band has a much bigger balloon for saline and so can be made to fit a wider variety of people. Of course, if it's too small for you, you need a different band, because one-size-fits-all is really one-size-fits-most.

I do agree about the buckle on the Realize band -- that's the only thing I don't like about it. It's really kind of honking big and I worry that if it moves around, it could lead to erosion. Though the data doesn't really show that. But I worry anyway. I'm a worry wart. :wub:

I think this shows how important it is to have choices and why one band isn't right for everyone.

Not getting good restriction is rare but it happens. Thing is, it happens with J&J too. There are four people on OH right now that are complaining that they have 10-13cc in a 9cc band and have no restriction. I have to wonder if they think they have that much in the band. Maybe the doc missed when filling them, maybe there is a leak, maybe maybe maybe.

I don't like the buckle on the band, looks like a duck bill. My concern wasn't erosion, the duck bill doesn't touch your stomach. I kinda wondered about it rubbing against the liver. But I haven't heard of it happening yet.

But I do like the way the J&J band looks under fluoro w/contrast. I like the company better than Allergan, mostly I like that Allergan (Inamed) has competition. That will be great for patients in the end. Inamed isn't king bee of banding anymore.

[Ellisa 6]

Totally off the subject here but for those with the Realize band - How many fills or what fill level did you reach before feeling a decent amount of restriction. I am leaning more toward this band but haven't decided for sure yet. My surgeon seems happy with both.

I felt a lot of restriction post op, unfilled. Then 4 weeks later I had my 1st fill (under flouro) and had good restriction for a couple of weeks. 4 weeks later, had my second fill, and had good restriction for about one week. I go again in two weeks for my next one. My definition of "good restriction" is that when I take my first bite of food or swallow of liquid, I have the sensation that there's something in there around my stomach. Even when I don't have that sensation I still feel full at a reasonable point. I have 4 cc's of fill so far. I like that feeling that there's something down there, it's a nice little reminder. I guess that good restriction depends on your anatomy. As the swelling goes down following surgery and we lose weight, that point will constantly change. It seems that way for my DH also.

Regarding how much is in the band, I'm not sure how other facilities do things, but DH and I go to different places. He goes to Barix in Columbus (where he had his surgery). He's never had a fill under flouro and my first one was under flouro. But after that at both places, before adding any fill, they remove what is in our bands to see what's there, then add additional. I think that's so they can tell if there's leakage.

[Angie4b1g 1]

BTW Ellisa - I'm a Dr. Curry patient, too. I drive down from Cleveland!

[NukeChik 1]

Here's the information that was submitted to the FDA for the Realize band approval in the US. It states the the port is suturable.

All subjects enrolled in the US clinical study were implanted with the Model 2100-X

Band with titanium port. That device has been modified to the Model 2200-X Band

with Velocity Injection Port. The modifications made to the Model 2100-X to make

the Model 2200-X with Velocity Injection Port include:

1. Simplification of the locking mechanism by providing a buckle/tab closure on the

reinforcement band;

2. A suture pre-tied to the end of the band for surgeon convenience (helps with

placement of the device);

Summary of Safety and Effectiveness Data P070009, REALIZE, Adjustable Gastric Band

Page 5 of 35

3. Change in the manufacturing process to allow for rounding of the reinforcement

band edges;

4. Port now includes a connector sleeve integrated with the locking connector;

5. The port can be attached to the fascia using either sutures or by using fasteners

which are an integral component of the port. The method of attachment is

dependent on the surgeon's preference.

Here's the link to said doc if you would like to read it. I don't think that J&J would outright lie to the FDA.

http://www.fda.gov/cdrh/pdf7/p070009b.pdf

[irideaqh 0]

WasA,

Thanks for the answer to my question. You have an excellent way of explaining things so they are easy to understand.

[WASaBubbleButt 41]

Here's the information that was submitted to the FDA for the Realize band approval in the US. It states the the port is suturable.

All subjects enrolled in the US clinical study were implanted with the Model 2100-X

Band with titanium port. That device has been modified to the Model 2200-X Band

with Velocity Injection Port. The modifications made to the Model 2100-X to make

the Model 2200-X with Velocity Injection Port include:

1. Simplification of the locking mechanism by providing a buckle/tab closure on the

reinforcement band;

2. A suture pre-tied to the end of the band for surgeon convenience (helps with

placement of the device);

Summary of Safety and Effectiveness Data P070009, REALIZE, Adjustable Gastric Band

Page 5 of 35

3. Change in the manufacturing process to allow for rounding of the reinforcement

band edges;

4. Port now includes a connector sleeve integrated with the locking connector;

5. The port can be attached to the fascia using either sutures or by using fasteners

which are an integral component of the port. The method of attachment is

dependent on the surgeon's preference.

Here's the link to said doc if you would like to read it. I don't think that J&J would outright lie to the FDA.

http://www.fda.gov/cdrh/pdf7/p070009b.pdf

I'm not sure how it would be sutured, there are no holes to run sutures through. I also have to say I don't know what the Model 2011X is. I just know them by their names.

The port is like a stack of quarters. No place to put sutures in. Maybe one of the docs who place them will chime in and explain. The way I saw the port it would be like having a stack of quarters glued together. If you were to sew the stack of glued quarters together to a piece of fabric, how would you do it?

The old port had holes for sutures, but not the new one.

ETA: I just emailed the band manufacturer for clarification. We'll see if they can clarify.

[Ellisa 6]

<table class="pt_doc_section"><tbody><tr class="pt_doc_section"><td class="pt_doc_section">Realize Band Laparoscopic Procedure - REALIZEBand.com

The REALIZE Band and REALIZE Port<sup class="pt_doc_sscript">7</sup>

The REALIZE Band is made of strong, flexible silicone and has a soft balloon that fits around the stomach. The balloon can hold up to 9 cc (1.8 teaspoons) of sterile saline which is medical grade saltwater. The amount of saline in the balloon controls the tightness around the stomach.

</td><td class="sectionImage"></td> </tr> </tbody></table> <table class="pt_doc_section"> <tbody><tr class="pt_doc_section"> <td class="pt_doc_section"> The balloon’s tightness affects how much food you are able to eat during a meal and the length of time it takes for food to leave your stomach pouch to travel through your digestive system. How does this help you achieve your weight loss goals and improve your quality of life? You’ll feel fuller sooner and stay fuller longer with the REALIZE Band.

</td> </tr> </tbody></table> The band’s tubing is connected to the REALIZE Port. The port is made from an implant-grade medical plastic and silicone. It is usually fastened (or sutured) on the left or right side, about 2 inches below the rib cage. The exact location will depend upon your body shape and your surgeon’s decision. The REALIZE Port is attached during the gastric band procedure.

[Ellisa 6]

I copied and pasted the entire post above from the web site... did I break any rules? Copyright? Oh dear.

[lsuza 0]

There is no such thing as "one size fits all" That's bs marketing by J&J because the Swedish band only comes in one size - for example, The staplers they sell used in gastic bypass are different sizes depending on anatomy. How come one size doesn't fit all for them?

As far as "needles vs staples" same thing - it's not a stitch. If it doesn't need to be sutured in, why are there holes inthe port for stitching?

What J&J is now telling doctors because a study was done is that it takes 20 minutes to place the port because you have to dig a bigger hole to seat it flat which is longer than than it takes to place the Allergan band.

By the way the little pic of the band on the other post is bs too..the band is straight and they are showing it to look pre curved - more BS marketing by J&J.

[Ellisa 6]

As you've mentioned before, we can all be very successful and healthy with either band as long as we follow the rules. Even the old LapBands aren't necessarily dangerous. I think we all agree that marketing is highly influential today and everything isn't always exactly what it seems. And all companies have their share of BS when it comes to marketing. Thankfully there are laws that can cause companies to have huge lawsuits/fines if their advertising is proven to be false or misleading.

So get the best surgeon you can and trust his judgment.

[lsuza 0]

agreed - i feel J&J showing their band in a pre curved position when it's straight and creases is misleading. If they have nothing to hide show a real pic of the product

[Ellisa 6]

Isuza,

It's really not unusual for photographers to show products looking their best. The thing does bend, it goes around a stomach. So if it's straight or curved for the photo isn't "hiding" anything, just showing that it can curve. I have a Realize band and saw it "in person" before my surgery, I don't feel deceived by the photos.

How many boxes of frozen dinners have you ever bought that don't look like the picture on the box. The same stuff is in there, but the veggies look all bright when in fact when I heat them they are covered with brown sauce. Then the pictures of fresh fruits and vegetables, they look so shinny and colorful. they are coated with oil and PhotoShopped for the picture. Photographers do that to make things look appealing. We won't EVEN go into human models. Posing and positioning is something that photographers do. So what? I've asked women to stand slightly sideways with one foot and their face toward the camera, it's more flattering, I'm not trying to pass them off as something else.

Some years ago a car dealer in Columbus Ohio was accused of false advertising because he said he had a "used car factory." Somebody thought he was trying to mislead people. Well the powers-that-be realized we are all smarter than that and he can still use his cute advertisement.

But again, Isuza, it'll be great when you get your band, maybe you won't be so stressed out by this stuff and you can get on to enjoying your success with your AP band. I know how stressful waiting can be. You mentioned you might wait for the next generation band, (on the Realize thread) I hope if you do, it's not too long.

I've lost 5 lbs. this week (went a few without weight loss, but losing inches) so I can tell you that success like this doesn't make me one bit concerned about my band's photo shoot.

[lsuza 0]

see that's where you're wrong, it CAN"T curve - it creases which can lead to crease fold failure and erosion, which is why they are not showing it the way it really is. J&J is planning the launch of a second generation band later this year called the VC band, the current realize band does not curve, it creases.

I can throw out a frozen dinner, I can't throw out a medical implant without another operation.

I never said no one will lose weight on the Realize Band - you just won't lose as much as the Allergan AP band, based on available clinical data. Individual results obviously vary.

[WASaBubbleButt 41]

see that's where you're wrong, it CAN"T curve - it creases which can lead to crease fold failure and erosion, which is why they are not showing it the way it really is. J&J is planning the launch of a second generation band later this year called the VC band, the current realize band does not curve, it creases.

I can throw out a frozen dinner, I can't throw out a medical implant without another operation.

I never said no one will lose weight on the Realize Band - you just won't lose as much as the Allergan AP band, based on available clinical data. Individual results obviously vary.

Are you aware that there is no proof of what causes erosion? There are only theories. They used to think caffeine caused erosion, now they know better. They used to think smoking caused it. Now they know better. Then for some time they thought NSAIDs caused it, now they know better.

The Inamed band has creases between each little bubble and that has not demonstrated to cause erosion, how would creases in a different band cause the problem?

Where is the proof that the Realize band causes erosion? Where is the proof that one won't lose as much weight unless they have a non-Realize band?

[Ellisa 6]

Isuza,

The proof will be in the pudding. I'll let you know year after year how my weight loss compares. And if I happen to be as or more successful than folks in my age group (and that's an important factor) than people with LapBand will you come back and say that I watched my diet better or exercised more or had better surgical technique?

Again, Isuza, once you have your band this band-brand thing won't be nearly so important to you. You'll have so many more exciting things to think about.