FDA Panel May Expand Lap-Band to Smaller Waists

[Guest guest]

An FDA advisory committee will meet Friday to review Allergen's application

to extend approval of its Lap-Band device to include millions more people.

The Lap-Band is a safe and effective weight-loss option for people who are

less overweight than those who currently have the stomach-constricting

device surgically implanted.

The device is currently approved for people who are at least 100 pounds

overweight or have a BMI of at least 40, or a BMI of at least 35 with other

comorbidities such as heart disease. The company is looking for approval to

lower those BMI cutoffs to 35 and 30 respectively.

To win approval for the new indication, Allergen submitted a single-arm

study of 143 patients with the lower body mass index.

All 143 had significant reductions in weight and BMI after one year, with

only 37% still meeting the criteria for obesity, leading FDA staff reviewers

to conclude the device is safe and effective to help people with lower BMIs

lose a significant amount of weight safely.

After one year, eight in 10 Lap-Band recipients lost at least 30% of their

excess weight, and 66% lost at least half.

Mean weight at the start of the trial was about 215 lbs; after a year, the

mean had dropped to 175 -- representing an average weight loss of about 40

lbs (*P*<0.0001).

Mean BMI decreased from 35 to 28.8 (*P*<0.0001).

Patients also reported significantly improved health-related quality of life

at both six and 12 months.

Although there were no major safety concerns, about 70% of patients

experienced some sort of adverse event during the trial, but most were mild,

including vomiting and gastroesophageal reflux disease.

There was one occurrence of band erosion, and seven patients required one

reoperation in the first year.

FDA reviewers said the safety data was the same or better than the data from

the early Lap-Band trials that were the basis for initial approval of the

device.

The Lap-Band is an adjustable silicon band that is implanted through tiny

incisions around the upper stomach. It works by reducing stomach capacity

and thus the amount of food it can hold. It is a less invasive procedure

than gastric-bypass or stomach-stapling, but is also less effective, FDA

reviewers noted.

Using the currently approved BMI of 40, a 5'9 " man who weighs 271 lbs, and a

5'4 " woman who weighs 233 lbs would both qualify for the Lap-Band.

If the FDA approves the lower threshold BMI of 35, that 5'9 " man could weigh

just 237 and a 5'4 " woman 204 to be eligible for the procedure.

If the hypothetical man and woman happened to have additional health

conditions related to obesity, the man would only have to weigh 203 to be

eligible for the Lap Band, and the woman would have to weigh at least 175

lbs.

Notably, the trial included only 14 men, several of whom had the device

removed before the study ended. When it meets on Friday, the FDA's

Gastroenterology and Urology Devices Panel will discuss whether the gender

imbalance in the study is a concern.

Most of the weight loss is expected to occur within the first year after a

patient has the Lap-Band implanted. However, the device appears able to help

patients maintain a stable weight and " thus, may have a potential to

significantly impact comorbidities that are frequently associated with

obesity, " FDA reviewers said.

If the lower threshold is approved, the Lap-Band label would state that the

device is only to be used in adults who have failed " more conservative

weight reduction alternatives, such as supervised diet, exercise, and

behavior modification programs. "

It would also note that " patients who elect to have this surgery must make

the commitment to accept significant changes in their eating habits for the

rest of their lives. "

The panel will vote on whether the data warrant the expanded indication. The

FDA is not required to follow the advice of its advisory committees, but it

often does.

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Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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