Dear friends,

What are the health consequences when the Lap-Band - an implanted weight-loss device - deteriorates? Will aging Lap-Bands cause serious health problems?  And does implanting a Lap-Band actually improve a person’s health?   

The Network asked these questions last year when the Food and Drug Administration (FDA) was considering expanded use of the Lap-Band, an implanted weight loss device intended for long-term use, based on just three years of data. Unfortunately the agency didn't require Allergan, the Lap-Band’s manufacturer, to answer the questions before it approved an expanded use of the device.

That expansion more than doubled the size of the market, potentially exposing millions more women to the risks of Lap-Band surgery.  And now, a recent study has proved that the Network’s concerns about long-term safety and effectiveness were right on target!

The study, published in the Archives of Surgery, examined outcomes for people who had Lap-Bands implanted for longer than the people in the studies the FDA considered – sometimes as long as 12 years. To evaluate both safety and effectiveness, the researchers looked at the number of complications and reoperations, as well as the device’s effect on obesity-related health conditions such as hypertension and diabetes. The findings are dramatic:

• almost one in three people experienced band erosion;
• almost half had to have their bands removed;
• between band removal and band adjustments nearly 60 percent of people had at least one reoperation; and
• the study also found no beneficial effect on high blood pressure and diabetes – health problems that people who undergo weight-loss surgery commonly hope to address.

Even before the study, weight-loss experts suspected there were problems with the Lap-Band – signaled by a drop in use in Europe – but the lead author, a weight-loss surgeon, told The New York Times the results “are worse than we expected.”  But while use of the device continues to decrease in Europe, it is on the rise in the United States, fueled by the recent FDA-approved expansion of the market.

In January, we asked you to join us in telling the FDA to reject the expansion of the Lap-Band, but the agency didn’t listen.  The new findings give the FDA another chance to do the right thing.  At a minimum, this should put an end to Allergan’s pending application to permit use of the device in children as young as 14 years old! But we hope the FDA will do more; it should rescind the approval it granted to expand Lap-Band use and take immediate steps to be sure that every patient considering a Lap-Band is fully informed about the risks of the device revealed by this new research.  Finally, the findings lend support to the Network’s position that implanted devices should not be approved without evidence of long-term safety and effectiveness – an approach that we urge the agency to adopt in the future.


Thank you,

 
Cindy Pearson
Executive Director

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