The FDA recently approved Allergan’s Lap-Band weight loss surgery (which is a form of what is known as bariatric surgery). By its 8-2 vote, the FDA cleared the way for patients who are significantly less obese (BMI of 30) than those who would have qualified for weight loss surgery before this recent approval.
Knowing that this controversial clearance vote was on the horizon, major news networks aired stories on the pro’s and con’s of “broadening the base” of patients, who would now qualify. Here’s a report by ABC News’ Diane Sawyer in December 2010. (Sorry about the lead-in ad. If it were not a good report, I would have found something “ad-less” to present the issue!)
With the FDA’s announcement came somewhat of a firestorm of criticism. As reported locally in the Baltimore Sun (actually written by Thomas H. Maugh II of the Los Angeles Times), the approval has raised “concerns” by many in the medical community, who fear that this surgery will now be seen as a “quick fix” to the obesity plague in this country.
“I’m very concerned,” said Dr. Ted Khalili, former director of bariatric surgery at Cedars-Sinai hospital and founder of the Khalili Center for Bariatric Care in Beverly Hills. “You can’t be driving down a street and have a flashbulb go off and think that this will be an easy fix.”
What Dr. Khalili seems to be referring to is a marketing drive that directs patients to clinics that perform the procedure using the Allergan device. Here’s (to the right) a photo that shows exactly what this is all about.
Patient deaths following procedure lead to litigation in California
Maugh reports in his piece in the LA Times that four patients have died following the Allergan lap-band procedure. Lawsuits have followed. In a related article by another Los Angeles Times reporter, some details emerge.
Laura Faitro of Simi Valley died July 26, 2010, five days after surgery at Valley Surgical Center in West Hills. Three other patients have died shortly after surgery at an associated center in Beverly Hills, relatives have alleged in lawsuits and interviews.
Supporters speak out as well
While there are many who have decried the FDA’s approval and the lowering of the qualification standards to undergo this new lap-band procedure, there are certainly those who are in support of its potential therapeutic effects:
For those with Type 2 diabetes, the Lap-Band could be an immediate fix. “This operation takes about an hour, and two days in the hospital, and these people go off their diabetes medication. It’s unbelievable,” Dr. Walter J. Pories, a professor of surgery at East Carolina University and a leading researcher on weight-loss surgery, said in this L.A. Times report.
All surgery – including this new lap-band procedure – has significant risks
Whether one should consider taking advantage of this new procedure is a matter between the patient and his/her surgeon. After advising that not all risks or complications of undergoing this new procedure are listed in its website overview, the product’s manufacturer, Allergan, provides the following information:
Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
While many people seem to be intrigued by a “quick fix” surgical method of weight loss, some necessary clearance hurdles stand in the way – and should! Allergan is requiring all surgeons who want to order and perform surgery with the manufacturer’s new device “to first complete a comprehensive proctorship and training program, have advanced laparoscopic skills and (we believe this is key) have the staff and resources needed to comply with the long-term follow-up requirements of obesity procedures.”
I would add here that in our experience of handling lawsuits involving catastrophic injuries and death claims following bariatric procedures, issues relating to selection of proper surgical candidates and post-procedure follow-up and compliance have many times been at the core of these cases.
Not a “quick fix” replacement for exercise, diet and possible medication
As anyone who has been involved in any manner with issues relating to bariatric, weight-loss surgery, this is not the first step to be taken toward losing weight. Sure, it sounds enticing to go into a clinic or hospital, have a one hour procedure, and all your weight issues are a thing of the past. First of all, that is not how this works at all. Pre-procedure clearance does and must be taken seriously and not be a mere sham.
There is no doubt that there is a financial benefit for the providers of this procedure; it is reported that it will cost approximately $25,000 for the device, surgeon and operating room costs. It is also said that many insurance policies may cover all or part of this cost. That being said, even Allergan cautions that this is not a drive-by way to achieve weight loss. Read its Lap-Band System Fact Sheet and Lap-Band Labeling and Safety Information if you are interested in knowing more about the indications, alternatives, risks, benefits and advantages of this newly approved system. In addition, make certain that the surgeon you are consulting meets the qualifying standards of the manufacturer. Ask questions – it’s your body, your life.
As a side note, in case you are wondering if your BMI qualifies you for consideration of this procedure, here’s a handy BMI calculator made available online by the National Heart Blood Lung Institute – Calculate your BMI.
Know anyone who has had this or other forms of weight loss surgery?
If you or someone you know has undergone a procedure involving this new device by Allergan, share your story with our readers. If you or someone you know has undergone bariatric surgery, we also invite you to please share your story of how this worked for you or those you may know. Has it changed your or their life? If so – for the better or worse?