FDA Approval of LAP-BAND® and Future Plans

September 21, 2006

OBGYN.net CoverageFrom the Bandster's Bash 2001 in Tijuana, Mexico

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Roberta Speyer: "This is Roberta Speyer, and I'm reporting from Tijuana, Mexico. I'm here at the Bandster's Bash with Don Mills who is Sales and Marketing Communications Manager for BioEnterics. BioEnterics is the company in California that makes the lap-banded piece - you say it, Don."

Don Mills: "The LAP-BAND® Adjustable Gastric Banding System."

Roberta Speyer: "I dare you to say that three times fast, Don." 

Don Mills: "I can't."

Roberta Speyer: "Now this is the system that I actually have inserted inside myself that helped me lose ninety pounds, and I really believe in this product and I believe in this company and the quality. I had the pleasure of touring your facility last year and the quality control and the whole team there at BioEnterics are really dedicated to bringing a quality product to the market. You've had something very exciting that's happened to you this year and that is you got FDA approval to produce and distribute this product in the United States. Why don't you tell us a little bit about that and what's going on over at BioEnterics world headquarters since you got the FDA approval."

Don Mills: "Sure, I'm glad you mentioned quality because at BioEnterics quality is more than just an exercise or inspecting our product; quality means satisfaction of the patient. We're not happy with quality unless the patient is getting quality results in losing the weight and getting the expectation that they have going into surgery so our mission statement and our goal is to have patients who achieve the results that they want. A lot of quality goes into the product with many inspection steps from raw materials right on through final packaging. The FDA did approve this product for distribution in the U.S. in June of this year; with that approval we've had a lot of interest in the product, it's been publicized in many publications and on TV. We have some difficulty now just keeping up with the demand."

Roberta Speyer: "This represents a new challenge for you because up until this time you did not have to deal with how you're going to train the U.S. surgeons to meet the pent up demand for people like myself that say this sounds like a good solution to me. What is the process that's going on, and how are you getting those surgeons trained?"

Don Mills: "Again, the quality starts with our product and goes through the surgery, the quality also extends to the surgery and the quality of the surgical procedure by the surgeon. To that extent each of the surgeons are preselected based on their previous skills in laparoscopic surgery along with their previous experience in bariatric surgery. Once they qualify in those areas then they attend a BioEnterics workshop, which lasts two days with animals and then with patients."

Roberta Speyer: "What is a bariatric surgeon? I know that the physicians that might be watching this on OBGYN.net would know but maybe some of the women watching and are interested wouldn't. I know I wasn't familiar with that term when I started my little odyssey."

Don Mills: "Bariatrics is the branch of medicine that deals with morbid obesity or with obesity. A bariatric surgeon is a general surgeon whose practice includes surgery to correct obesity or weight loss surgery as it's called."

Roberta Speyer: "So this is a procedure that is new in their arsenal of things that they can do surgically and a lot of people are familiar with vertical banded gastroplasty and gastric bypass, and these are quite invasive procedures. We had a very good interview that will be accompanied with this one on the website with one of the doctors and he explained the differences between the procedures so I won't make you go into that but what I would like you to show us and you have one of the devices in your hand and just explain a little bit about how that actually works."

Don Mills: "Sure, I'd be happy to. With weight loss surgery there's several approaches, as Dr. Kuri explained. This particular product is a gastric band, which goes high around the stomach in a procedure called a gastroplasty. The band is connected to an access port."

Roberta Speyer: "Mine is right underneath my skin, you can kind of feel a little bump in there."

Don Mills: "The access port is attached to the band for purposes of adjusting the band at any time after surgery."

Roberta Speyer: "I think the neat part is the adjustability of it."

Don Mills: "The band is inflatable, as you can see as I inflate it with this syringe."

Roberta Speyer: "He's putting air into it now but normally they'd be putting fluid. Isn't it a saline solution or something like that?"

Don Mills: "That's correct."

Roberta Speyer: "Yes, or taking it out to make an adjustment."

Don Mills: "The band is high on the stomach, high enough to where this band will go around the stomach and create restriction limiting the intake of food. It also has the effect of satiety or fullness so that a patient is full much earlier than they would otherwise be and loses the desire for food and eats much less. They can hold about as much as maybe a big ping-pong ball or a small golf ball."

Roberta Speyer: "Oh, I don't know, sometimes I think I'm eating maybe a croquet ball. I don't know, I felt like I was eating a little more and I stopped losing weight so I had a fill today. It's very minor but it immediately affected the amount of food that I could consume so I think I'm going to have some help now in losing that last thirty pounds I want to get rid of."

Don Mills: "A fill means that she's gone to the doctor and he's injected some saline into the band filling it a little tighter. The band can be filled as tight as necessary to restrict the food intake but it can also be opened up in the event that the patient needs more nourishment, say, during an illness or pregnancy."

Roberta Speyer: "That's also very interesting; you're talking about pregnancy because on OBGYN.net we're very concerned with obstetric and gynecologic care. A lot of these types of procedures are very invasive and result in malabsorption of a lot of the nutrients and people really should not do those procedures if they're planning on getting pregnant. You've had some very good cases already with some of the patients that were in the clinical trials, in Europe, and Mexico that got pregnant after this procedure, haven't you?"

Don Mills: "Yes, one of the co-morbidities of morbid obesity is infertility. When one loses, the weight fertility increases and improves and patients do become pregnant."

Roberta Speyer: "Besides we look so good; we're getting chased around a little bit more than we were before."

Don Mills: "That's true."

Roberta Speyer: "So then you can open this up, I have it clamped here, not shut. But it can be opened so that you have literally no restriction and you can increase your intake of food during the pregnancy."

Don Mills: "During pregnancy or illness, that's right."

Roberta Speyer: "And then close it back down again."

Don Mills: "It can be closed down and as a last result the band is reversible, meaning, if it's taken out, the anatomy returns to its normal place. There's no permanent disruption of the stomach or the intestines."

Roberta Speyer: "So for a lot of people that are watching this interview and might be looking into having this surgery, there are a lot of doctors and centers that are being ramped up in the United States to do this. But because of the need for the quality assurance, the rigid training, and proctoring where one surgeon who's done many of these procedures goes in and shows another surgeon how to do it, there is more people looking to have the surgery than there are centers. I would like to just mention that I had my surgery before it was approved in the United States in Germany with Dr. Rudolf Weiner. Most of the people I've met tonight had their surgery in Mexico with Dr. Kuri, Dr. Rumbaut, or some very good surgeons down here that are highly trained and are actually the surgeons that are doing some of the proctoring."

Don Mills: "That's correct."

Roberta Speyer: "The European, Australian, and Mexican surgeons are the ones that are doing the training for the U.S. surgeons so that is an option for people if they want to get this surgery and they don't feel that they can wait until it is available in a center near them."

Don Mills: "That's correct, there are surgeons outside of the U.S. Our quality extends not only from the product to the surgeons in the results that we anticipate from a good quality surgery from a surgeon that's well informed. So the band is not sold to just every surgeon that might want to do the procedure. As I mentioned earlier, the surgeons are selected carefully, then trained, and then they're proctored so that's a fairly lengthy process in terms of setting up each site. We're expecting and looking forward to having a hundred sites operational by the end of the year 2001. Before we get to June of 2002 we'd like to have two hundred sites up and operating. It is a fairly lengthy process from surgeon selection, surgeon training, and in proctoring. This is all in an effort to get the best results possible from each and every surgery."

Roberta Speyer: "I know that there are many different ways for people to lose weight, and many different solutions for different people. This was the solution I chose and I've had a very positive outcome. I wanted to discuss it and share it with our viewers and our people at OBGYN.net especially our Ob-Gyn physicians who many times are the only physician a woman might see as her primary care physician in the United States when she goes in for her annual, her pap smear, and her mammogram. Because it's a new procedure, a lot of doctors may not be entirely familiar with it and confuse it with some of the more invasive surgeries. We hope through this film and through some of the other outreach programs you're doing they'll be able to realize that there is another alternative and perhaps recommend their patients to a bariatric surgeon, and refer them out to explore this. What do you think about that?"

Don Mills: "I do think they should talk to their primary care physician first, and we're making an effort to see that the primary care physician, Ob-Gyn's, as well as family practice doctors are informed about this procedure but there's a lot of them out there and that process goes fairly slow. But they should certainly consult their family practice physician and if they or their physician want to contact us we'll refer them to the three surgeons closest to them, and they can contact all three or any one of them to learn more about the procedure." 

Roberta Speyer: "We're going to attach a link to this interview, Don, especially not just my story which of course is riveting and interesting but the actual surgical tapes showing how the surgery is done inside with the voice over by the surgeons. Any of the doctors who would like will have a link on the site to that and we'll also put up some information about how you can contact BioEnterics directly if you think this is something that you'd like to learn more about and perhaps be able to be informed when your patients come in and they've seen it on a show on TV or read about it in a newspaper. You can then give them some information and perhaps get them to a bariatric surgeon in your area that might be able to help you assess if it's the right thing for them."

Don Mills: "Sure, we do have quite a number of patient education pieces which you can distribute to your patients but more importantly there's over 300 medical journal reports in the medical literature on the LAP-BAND® Gastric Banding System so it's not really a new procedure. It's only new in the U.S. with over 65,000 procedures internationally having been performed."

Roberta Speyer: "Really, it's that many - 65,000. Of course we on OBGYN.net have access to the Cochrane database and Medline so there's certainly plenty of opportunities to research this. As Don has said, this is new in the United States but it's not new globally and of those 65,000 cases there has been an extremely low rate of mortality or morbidity, has there not?"

Don Mills: "Yes, there has."

Roberta Speyer: "The highest rate would probably just be trocar injury, wouldn't it, because the procedure itself does not tend to have a lot of complications?"

Don Mills: "There aren't a lot of complications but like any procedure and when you have that many patients and a number of different surgeons there are some minor complications and even some more major complications from time to time. There have been patients who've had bands removed - that's probably the worst complication but those cases are few and far between; it's not a high percent at all. We do have those statistics for anyone that wants to read them and review them."

Roberta Speyer: "I really appreciate you taking the time to talk to us. I have to show everybody what Don gave me because it's so cute. It's my little BioEnterics stomach pin with a little rubber-band around the top."

Don Mills: "It's a LAP-BAND®."

Roberta Speyer: "A little LAP-BAND®; thank you Don so much for sharing this story with us."

Don Mills: "You're welcome, thank you."

Roberta Speyer: "And thank you for helping me get this surgery. Don was one of the people that was around when I was researching this and helped us put this whole presentation on OBGYN.net. I'd like to thank you personally and thank you for the 8,000 people who have watched that and used that as a way to help make their decisions."

Don Mills: "You're a model patient."

Roberta Speyer: "He's so sweet."