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Media - FDA Approval Delayed |
News 27
June 2000
This
site is not meant to replace your Doctor's advice. The advice on this
site is from other wls patients and may not be relevent in your case or
even harmful. |
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The transcript of the
FDA meeting is HERE June 16, 2000 Anti-obesity device up for US panel review Inamed Corp., a maker of breast implants, wrinkle-fighting injections and other cosmetic products, will try to persuade US advisers Monday to endorse its adjustable stomach band for treating severe obesity. With the Lap-Band System, surgeons place a plastic band, about the size of a wrist watch band, around the top of the stomach to section off a smaller portion. When food fills the smaller stomach pouch, a patient should feel full with fewer calories than usual and lose weight. Implanting the band is less invasive and causes fewer complications than stapling or bypasses used to reduce stomach size, said Michael Doty, Inamed's chief financial officer. Slippage of the band, which can be corrected through surgery, has been the most common problem, Doty said. Also, the lap band, made by Inamed unit BioEnterics Corp., can be adjusted without surgery through a port placed just under the skin in the upper abdominal muscles. "We've been selling this product in Europe since 1993, and it has essentially replaced all the alternative procedures," Doty said. On Monday, an advisory panel is scheduled to review results from company studies and recommend whether the Food and Drug Administration (FDA) should approve the band for sale in the United States. The committee's opinion is important because the FDA usually follows its panels' advice. California-based Inamed, a leading maker of breast implants, focuses on "lifestyle" products including devices for plastic and reconstructive surgery and a treatment for urinary incontinence. John Calcagnini, an analyst with CIBC World Markets who has a "strong buy" recommendation on Inamed stock, said the lap band could become a big seller for the company, which he described as well-positioned as the aesthetic surgery market. Annual US sales of the lap band could peak at $100 million, Calcagnini said. "It's minimally invasive, reversible and adjustable," he said. "We think this has the potential to be a real blockbuster for this company." Wednesday, June 21, 2000 Panel Votes No on Obesity Belt An advisory panel to the U.S. Food and Drug Administration voted against approval of an obesity belt they say has yet to prove its safety and efficacy. The belt has been used in Europe since 1993 as an alternative to gastric bypass surgery, but this week the panel's 6 to 4 vote will likely set back the obesity belt's availability in the United States. The advisory committee says there's not enough clinical trial data to prove that Lap-Band, manufactured by Bioenterics Corp., is safe or effective. According to CNN reports, four of eight U.S. medical centers testing Lap-Band had to halt trials because of severe side effects ranging from infection to esophageal problems to leakage. Lap-Band is surgically implanted in the patient and rests where the stomach attaches to the esophagus. The belt can be implanted through a small incision in the abdomen. Once in place, the belt is inflated with silicon or air. The belt helps make patients feel fuller sooner; they can experience physical discomfort if they continue to eat after feeling full. This device is meant only for persons who are morbidly obese. Obesity is a major public health threat in the United States where more than half of all Americans are either overweight or obese. Government standards classify obesity as a body mass index -- a calculation based on height and weight -- of 30 or higher. Obesity is a major risk factor for heart disease, diabetes, some types of cancer and other chronic ailments. Tuesday, June 20, 2000 FDA advisory panel votes against approval of anti-obesity device The Gastroenterology and Urology Devices Advisory Committee to the Food and Drug Administration voted Monday against recommending that the FDA approve BioEnterics Corporation's Lap-Band Adjustable Banding System for weight reduction in patients with severe or "morbid" obesity. The Lap-Band device, approximately the size of a wristwatch, is composed of a silicone, inflatable inner shell encased in a silicone elastomer band with a buckle-style closure. The device is implanted around the top of the stomach. Making the active part of the stomach smaller means that the patient feels full after eating less food, according to the company. The Lap-Band procedure is intended only for those patients with a body mass index (BMI) of 40 or greater or those with BMI of 35 or greater and another medical disorder such as diabetes, high blood pressure, or arthritis. Candidates for Lap-Band also must have 100 pounds excess body weight and have unsuccessfully tried more conservative treatments for obesity. While the Lap-band procedure shares a common therapeutic goal with its surgical counterparts, that reserving only a portion of the stomach for food ingestion will cause the patient to feel satisfied earlier and, as a result, take in fewer calories, the less-invasive Lap-Band therapy is associated with less peri-operative/post-operative illness and death than surgical obesity therapies, the most common of which is gastrointestinal bypass procedure. Proponents of the Lap-Band procedure also claim that it does not result in the nutritional deficiencies commonly linked to surgical treatments. Another advantage includes the Lap-Band's post-operative adjustment capability, allowing the introduction or removal of saline to adjust the size of the stomach pouch. Those clinical benefits of the Lap-Band notwithstanding, the advisory panel voted six to four against approving the device based on what the panel felt was insufficient patient follow-up. The panel felt that such data would provide a better understanding of the long-term implications of a relatively high number of adverse events associated with the device, many of which were related to implantation of the device itself. In fact, in US clinical studies, while patients receiving the Lap-Band experienced an average of 38% excess weight loss, or about 17% of their initial weight, about 90% of those subjects also suffered at least one adverse event. In addition, one-third of the patients required subsequent surgical intervention, in the form of revision or removal of the device. Device-related problems requiring surgical intervention involved 22 surgical revisions, 48 removals of the Lap-Band and 20 potential revisions. In addition, there were two deaths among study participants, including one death resulting form a drug overdose and another fatality after the patient underwent a subsequent gastrointestinal bypass. BioEnterics, a subsidiary of breast implant manufacturer Inamed, had originally planned a 3-year follow-up of study subjects receiving Lap-Band therapy, but presented data generated by only a 2-year patient follow-up data to the panel. Representatives from BioEnterics, however, noted that the risk of the band's erosion into the stomach was the original grounds for planning a 3-year patient follow-up and that the post-operative rate of erosion, and rates of other adverse events associated with the Lap-Band, have been low. Officials also noted that the company has collected "definitive information on 239 subjects" thus far and that post-operative subjects' weight has remained stable, although admittedly not at the rate of those who undergo the surgical procedure. Citing those statistics, BioEnterics representative Ellen Duke asked the panel, "What will we learn from a 3-year follow-up?" The data underlying the panel's decision involved two major studies, one in the US and one spanning testing centers in Mexico, Belgium, France and Australia. The US clinical study was done at eight centers, with an enrollment of 299 patients, of whom 85% were female. Of the total subject pool, 259 patients received the device via laparoscopy and 33 via conventional open surgery. Seven subjects were converted to the Lap-Band from a previous restrictive device. The study's primary endpoint was percentage of excess weight loss, with secondary end points of BMI reduction and enhanced quality of life. The average patient in the US weighed in at 292 pounds, at an average of 155 pounds above ideal body weight, with a mean BMI of 47.4. The advisory panel also recommended that, if the Lap-Band device is eventually approved, BioEnterics should conduct a 5-year postmarket follow-up on patients receiving treatment. Members also advised that, if cleared, the device should include labeling that warns patients of the possibility of having to undergo subsequent surgical intervention and of any possible drug contraindications.
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