FDA approves new LAP-BAND (R) qualification guidelines

[Wheetsin 714]

I lost this in my inbox for a while, but in case any of you patiently waiting for approval, or trying to meet approval requirements haven't heard:

Dear (Wheetsin's name removed),

We are pleased to announce that today the FDA approved the expanded use of the LAP-BAND® Adjustable Gastric Banding System.

The new indication statement for the LAP-BAND® now reads as follows:

The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related co-morbid conditions.

It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. 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 LAP-BAND® System is now the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35 with one or more obesity related co-morbid conditions.

This is EXCELLENT news for potential patients. Adding the BMI 30-35 patient segment opens the LAP-BAND® up as a possible option to over 26 million1 NEW patients that previously could not qualify for surgery.

This also means the LAP-BAND® is now indicated for those who are 30 lbs or more over their ideal weight with a BMI of at least 30 kg/m2with one or more obesity related co-morbid conditions.

Thanks to this expanded indication, more people than ever before will be able to manage their weight with the LAP-BAND® and can look forward to a healthier life ahead. This expanded indication comes at a time when obesity continues to rise and the health implications associated with it are becoming ever more evident.

With this new indication, the same device that has helped to change the lives of more than 650,0002 people worldwide is now available for even more people than ever before.

But the FDA approval is just the beginning. Now more than ever we have to educate people on the benefits of weight loss surgery and the safety and efficacy of the LAP-BAND® to ensure that all motivated potential patients are well informed about this life changing procedure.

We encourage you to get the word out to the many people who follow your blog or visit your web site.

We hope you all are as excited as we are about this expanded indication.

Regards,

(Allergan contact's name removed)

Allergan Health

[honk 780]

I ask my doctor's office if they are seeing more people coming in due to this change. I was told not yet because it does'nt really matter what the FDA says since most people use insurance and the insurance company decides who they will approve.

[Wheetsin 714]

It actually does matter. If the FDA doesn't approve it, insurance companies won't cover it, so it's the fundamental first step toward reforming requirements. But when the FDA approves things, historically insurance companies adopt their baseline requirements. There are some exceptions, but this isn't among the things that normally applies to.

Changing coverage guidelines, requirements, SPDs, etc. is not a fast process. It certainly won't happen in a month (I think I got that email 2/17). But eventually... and with enough success that there's ROI, change happens.

[PWoo10 7]

I'm still patiently waiting. Has anyone heard of any BCBS changing policies yet over the new FDA guidelines?

[Wheetsin 714]

All I have heard lately - and this is more through the grapevine/not official - many or most of the insurance companies are looking at excluding bariatrics alltogether, or imposing a "once in a lifetime" limitation that would include prior self-pay procedures. That's scary stuff!

[MelindaH 3]

I'm still patiently waiting. Has anyone heard of any BCBS changing policies yet over the new FDA guidelines?

I have BCBS Federal/ They will consider a BMI between 35 amd 40 if you have co-morbities. There are several hoops that you have to jump through. Have you been in contact with your insurance recently. I would appreciate any feedback. I am in the process of a work up for the lap band. Mine is 37.4 but I have been diagnosed with arthritis, DDD, GERD, HTN, am a pre diabetic and have sleep apnea. I have already had both knees replaced. I am hopeful for surgery in late Sept or early Oct. But I am nervous. My BMI is at 37.8. Keep us posted and all the best to you.

Melinda