Sources are reporting that the Food and Drug Administration (FDA) is recommending loosening eligibility for a device implanted to aid weight loss in obese patients: the Lap-Band manufactured by Allergan. In a preliminary vote, the FDA advisers that oversee this type of medical device voted overwhelmingly to allow more patients who are less overweight or obese to be allowed to try the Lap-Band surgery.
Currently, only patients with a body mass index (BMI) of 40 or higher, or 35 or higher with one related health condition are eligible for the surgery because of its risks. The new FDA recommendations would allow patients with a BMI of 35 or 30 with one related health condition to be eligible for the surgery.
The Lap-Band is basically an adjustable ring that is placed around the stomach. It is filled with saline to create tension that restricts the amount of food that can be eaten comfortably. The surgery can be reversed and has lower risks than the more common gastric-bypass surgery, although reports of a few deaths in the U.S. after Lap-Band surgeries have already been reported by various news sources.
The Lap-Band is frequently used for obese patients in Europe and Australia.
What Are the Risks of Lap-Band Surgery for Obese Patients?
The Center for the Treatment of Obesity at the University of California-San Diego has outlined the risks of the lap-band surgery as compared to the risks of other weight loss procedures. The lap-band surgery does not requiring cutting, stapling or bypassing so the risk of infection is much lower than for other types of gastric surgeries. But the lap-band surgery, like any invasive surgery, is not without risks including:
- Reflux and vomiting
- Band slippage
And the lap-band surgery is not foolproof as some people may not lose weight with the device or they may regain weight if eating behaviors are not also changed after the Lap-Band surgery.
Connecticut Hospitals Get in Line for Piece of Lap-Band Pie
While the FDA has yet to formally approve the Lap-Band for more widespread use, Connecticut hospitals and others around the nation are getting in line for a piece of what could be an incredibly lucrative pie. Federal research indicates that the FDA's new recommendations could open up the procedure to about 27 million Americans. As many overweight and obese Americans look to lose weight and avoid serious health risks and costs that come with obesity, the Lap-Band surgery, with its relatively lower risks, may be appealing.
Connecticut hospitals, eager to grab a share of low-cost, potentially high-demand surgeries, have already invested heavily in weight loss alternatives with new units, therapies and treatments. Now, with the Lap-Band, Connecticut bariatric units will have another alternative to offer patients.
Weight loss centers and bariatric units may have to have sharp elbows to compete in what could be a crowded market. Timothy Erhlich, medical director of the Derby, Connecticut, hospital's new bariatric unit, was quoted by HartfordBusiness.com as praising the Lap-Band because doctors will be able to "hone" in on a new group of patients that haven't had treatment alternatives in the past.
Some medical device industry experts question whether the Lap-Band will be able to take off though. The Lap-Band itself is relatively cheap, at about $3,000 per device. But the surgery can cost between $14,000 and $20,000. The high cost of the Lap-Band surgery has put it out of reach for many obese patients. Some insurers do not cover it now, and even if the surgery is covered by an insurer, the patient may still have a large co-pay.
In fact, some industry experts have mused that Allergan, the maker of Lap-Band, may never turn a significant profit because of the failure of employers to allow coverage of the Lap-Band in their group plans. But if the device gains more popular appeal through greater use, more employers may be willing to cover it and a greater number of patients will have access to the Lap-Band surgery.
Is FDA's Reconsideration of the Lap-Band Politically Motivated?
So far, no medical expert has described the Lap-Band surgery as anything more than a lower-risk alternative to other bariatric surgeries. But Allergan has significant incentives for getting the FDA to allow a greater use of the Lap-Band. The FDA has been accused of approving medical devices for other than health reasons. In fact, the FDA has accused some of its own advisers of caving to political pressure to approve a medical device at least once in the past.
But the FDA has also been vigilant in scrutinizing several weight-loss drugs that were up for approval earlier this year, so its priority in protecting patients who are sometimes desperate for a weight-loss alternatives should be in line. Unfortunately, the FDA's reputation has been tarnished by the admissions of political lobbying, several high-profile medical device and drug recalls and perceived difficulty in regulating the pharmaceutical and medical device industries as a whole.
Many elective surgeries have great benefits for patients, but they also carry risks. Doctors, hospitals, and treatment centers have the obligation of disclosing all known risks related to elective procedures. If you have suffered complications after an elective surgery, contact an experienced personal injury attorney in the event you may have been the victim of medical malpractice.