Three New Peer-Reviewed Studies in the United States Show the Lap-Band System's Strong Outcomes with U.S. Patients

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Updated: 12:55 PM EST INAMED Health: Three New Peer-Reviewed Studies in the United States Show the Lap-Band System's Strong Outcomes with U.S. Patients

SANTA BARBARA, Calif.--(BUSINESS WIRE)--03/29/2004--INAMED Health, a division of INAMED Corporation (Nasdaq: IMDC):

-- Weight loss with the less invasive LAP-BAND(R) System can equal that of gastric bypass surgery

-- Recovery time significantly less than other bariatric surgical procedures

-- U.S. LAP-BAND(R) System outcomes expected to be comparable to positive European and Australian results

INAMED Health, a division of INAMED Corporation (Nasdaq: IMDC), announced today that it is hosting a press conference on April 1, 2004 at 10:00 am MST to discuss new U.S. peer-reviewed clinical publications on its BioEnterics(R) LAP-BAND(R) System at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) in Denver, CO.

"These recent publications further demonstrate the safety and effectiveness of the LAP-BAND System," said Nick Teti, Chairman, CEO and President of INAMED Corporation. "We now have expanded U.S. data in line with the excellent long-term international data that have been accumulated over the past 10 years. This will be key in broadening the acceptance of this procedure with the medical and surgical community, as well as helping the insurance companies and third party payers feel confident about Lap-Band as a covered benefit."

Since its approval by the Food and Drug Administration in June 2001, the company's LAP-BAND System, a breakthrough device for surgical weight loss, has transformed over 20,000 lives in the United States. It is the preferred weight loss surgery procedure internationally and more than 120,000 procedures have been performed worldwide since its market introduction in the mid-90's. The advantages of the laparoscopic LAP-BAND System (sometimes referred to as Gastric Banding) procedure are well documented:

-- Up to ten times safer than other weight loss surgery options(1)

-- Shorter hospitalization (usually less than 24 hours) and recovery time

-- Least invasive surgical option

-- Avoids stomach stapling and intestinal re-routing

-- Only adjustable weight loss therapy

-- Only easily reversible weight loss procedure

Using prospective data collected after evaluating morbidly obese patients who underwent the laparoscopic LAP-BAND System surgery, the consensus is that the LAP-BAND System has much to offer the severely obese (a patient population approaching 15 million in the United States). The data shows effective clinical weight loss with a lower complication rate and less serious complications than with the gastric bypass surgical procedure. Furthermore, recent studies demonstrate that as patients lose weight, comorbid conditions (such as type II diabetes, hypertension, gastric esophageal reflux disease (GERD), and dyslipidemia) improve, and post-operative complications are generally minor.

"With up to 36 months of follow-up, the LAP-BAND System provides good weight loss and significant reduction in obesity-related illness," says Dr. Hadar Spivak (Houston, TX), referring to his recent study of the Lap Band System. "Complications associated with the LAP-BAND System are generally minor compared with those seen with other more aggressive weight-loss procedures. Given the excellent weight loss results and the low complication rates, I believe that the LAP-BAND System should be in the first line of choices for U.S. patients." Dr. Spivak added.


-- "Favorable early results of gastric banding for morbid obesity; the American experience." Ren CJ, Weiner, M, Allen JW. (Surg Endosc 2004 Feb 2; 17(12))

Based on one-year follow-up on 99 patients, the study shows an average loss of 44.3% excess body weight, which leads to the conclusion that laparoscopic gastric banding has much to offer the morbidly obese. "We presented data showing weight loss and acceptably low complications rivaling gastric bypass," says Dr. Christine Ren (New York University Medical Center, New York, NY). Additionally, according to Drs. Ren, Weiner and Allen, these results parallel success with this device outside America, supporting the study of Drs. H. Spivak, F. Anwar, S. Burton, C. Guerrero and A. Onn and an earlier study by Dr. Richard Rubenstein (references in chart).


-- "Comparison of Recovery Time after Open and Laparoscopic Gastric Bypass and Laparoscopic Adjustable Banding." Barry. L. Fisher, MD, FACS (Obesity Surg 2004, 14:67-72)

In a study of 60 randomly selected bariatric surgery patients, there is a significant difference in the length of hospital stay among three procedures. "LAP-BAND System patients remained in the hospital the shortest time, averaging 1.3 days, with open Roux-en-Y gastric bypass patients remaining hospitalized 3.4 days, and Laparoscopic Roux-en-Y gastric bypass 2.5 days," says Dr. Barry Fisher (Las Vegas, NV).

Regarding return to normal activity, patients undergoing open or laparoscopic Roux-en-Y gastric bypass report no significant difference in the number of days between surgery and the day they return to normal activity (open = 17.6; lap = 18.2). LAP-BAND System patients return to normal activity in significantly less time (7. 2 days). Dr. Fisher also found that LAP-BAND System patients report fully recovering from surgery within 16 days, while laparoscopic Roux- en-Y gastric bypass patients generally take 3 weeks, and open Roux-en- Y gastric bypass patients take almost a month. Dr. Fisher concludes that LAP-BAND System patients return to normal activity levels earlier than gastric bypass (GBP) patients, irrespective of GBP surgical approach. The LAP-BAND System patients also report recovering from surgery significantly sooner than open Roux-en-Y GBP patients. Perceived differences in recovery time between open and laparoscopic Roux-en-Y GBP patients do not affect their time to resumption of normal activity. "Additionally, we are now seeing 60% average excess body weight loss at two years in the 170 LAP-BAND patients on whom we have operated since August 2001," said Dr. Fisher.


-- "The LAP-BAND System in the United States: One surgeon's experience with 271 patients." H. Spivak, F. Anwar, S. Burton, C. Guerrero and A. Onn (Surg Endosc 2004 Feb)

The LAP-BAND System is considered the preferred bariatric surgery procedure in many countries and is rapidly gaining acceptance in the United States. The purpose of this study was to examine the experience with this procedure in the United States, which showed outcomes data emerging in the U.S. that parallels the European and Australian experience.

After monitoring 271 patients who underwent LAP-BAND surgery between November 2000 and September 2002, results show:

The mean body mass index (BMI) decreased from a baseline of 45.3 to:

-- 36.5 at 12 months

-- 35.9 at 18 months

-- 35.1 at 24 months

Mean excess weight loss (EWL) achieved was:

-- 40% at 12 months

-- 43% at 24 months

-- 47% at 36 months

According to Dr. Spivak, "Recently reported U.S. results are parallel to results achieved in Europe and Australia. There is no reason to expect the long-term U.S. results to be different than the international results."

Following is a chart of results from studies around the world:

A Sample of Published Results % of Excess Years of # of Patients

From Around the World: Weight Loss Patient Studied

Follow Up


Favretti et al, Italy(2) 49% 3 830


Fielding et al, Australia(3) 68% 3 620


O'Brien et al, Australia(4) 53% 3 706


Rubenstein, et al, US(5) 53.6% 3 63


1. The Australian Safety and Efficacy Register of New Interventional

Procedures - Surgical (ASERNIPS) 2002

Rubenstein R. Obes Surg 2002; 12: 380-384.

2. Favretti, et al. Laparoscopic LAP-BAND: A 7-year Experience

Involving 830 Patients (abstract). Obesity Surgery 2001; 11: 160.

3. Fielding G. LAP-BAND Experience with 620 Cases over Forty-Five

Months. (abstract) Obes Surg 2000; 10: 143.

4. O'Brien P., Dixon J., Brown W., Schachter L., Chapman L., Burn

A., Dixon M., Scheinkestel C., Halket C. Sutherland L., Korin A.,

Baquie P., The Laparoscopic Adjustable Gastric Band (LAP-BAND(R)): A

Prospective Study of Medium Term Effects on Weight, Health and Quality

of Life, Obesity Surgery, 12, 2002, 652-660.

5. Rubenstein R. Laparoscopic Adjustable Gastric Banding at a U.S.

Center with Up to 3-YearFollow-Up, Obesity Surgery, 12, 2002, 380-384.

source: INAMED Corporation