Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families FDA Advisory Committee Meeting on Gastric LAP-BAND

Thank you for the opportunity to speak today.

The National Research Center for Women & Families is dedicated to improving the health of adults and children.  Our nonprofit center does not accept funding from companies that make medical products, so I have no conflicts of interest.

My perspective is as a researcher trained in epidemiology at Yale Med School, with experience doing research at Vassar and Harvard.  I am also a fellow at the University of Pennsylvania Center for Bioethics.

We all know that obesity can kill, and that most weight loss strategies don’t work.  The data on the LAP-BAND are impressive in terms of weight loss in the short-term.  However, the data don’t tell us much about the impact on health for people who are not extremely overweight.

The results suggest that in the short term, LAP-BANDS are great for some patients, and bad for others.  The problem is that we can’t predict who will benefit in the short-term, and we know even less about the long-term risks and benefits.  The research shows there were many adverse reactions, and many patients needed additional surgery, even within 2-3 years.  Implants tend to fail over time.  What happens when lap bands deteriorate?  Will aging lap bands cause even more serious health problems?  We need better information about that before this product merits expanded approval.

The sponsor provided two studies.  One is a 3-year study of about 180 patients with the original BMI criteria from 2001.  The second has only 149 patients from the new target weight group, with complete data provided at year 1.  Data provided at year 2 are not complete.

There are several problems with the data:

  1. The samples are too small and do not include enough men or enough African Americans or Hispanics.  The new sample should be much larger than 150 patients, and the number of minority patients should be large enough for meaningful subgroup analyses.  An AHRQ report found that men were almost three times as likely to die from bariatric surgery as women.  In the Allergan study, men had less success than women.  We need better research to determine whether men don’t do as well when confounding variables such as weight and illnesses are statistically controlled.
  2. The data are too short-term to determine long-term safety. Implanted devices often work well for a few years, and then problems arise.  Even 5 years would be inappropriate for a product that has been on the market since 2001.  Allergan should provide 10-year data based on their original sample, and they should have started a much larger post-market study that could have provided at least 8 years of data by now.  The fact that Allergan bought the company from Inamed does not excuse the lack of data.
  3. We need to know the impact on health, not just weight loss and quality of life.  We need to compare the risks and benefits for women and men in the previously approved BMI groups AND the newly proposed BMI groups.  We need those data in the short-term and the long-term, but especially the long-term.  Other published studies found a substantial proportion of lap bands were removed within 9 years.  Why weren’t those studies included in the FDA summary for this meeting?

Even more important are the exclusion criteria, presented on page 9 of the FDA memo.  One of the criteria is that patients not have a personal history or family history of autoimmune diseases.  That’s reasonable and has been used for other silicone implants as well, because of concerns that the implant could exacerbate autoimmune problems.  That exclusion criterion was used for the original study and it’s unclear whether it was consistently used for the new study.  However, if people at risk for autoimmune diseases are excluded from the sample, they need to be excluded from any FDA approval as well, and a black box warning is needed. Currently, the Allergan “LAP BAND Fact Sheet” does not mention autoimmune diseases.

In their newly proposed label, Allergan indicated a “caution” – not a warning — for patients with autoimmune diseases or symptoms, and did NOT mention a family history of those conditions.  That is completely unreasonable since the company intentionally excluded those patients from their 3-year study.

We know from talking to patients and seeing online patient discussions that some patients know nothing about the potential risk for people with a history of autoimmune diseases, and doctors are also inconsistent on this issue.

African American women and Hispanic women are especially vulnerable to lupus and several other autoimmune diseases.   Is the LAP BAND safe for them?  We can’t answer that question because so few were studied.

Yesterday I received an email from Jessica Resas, a woman in Texas who had lap band surgery last year.  She was very happy with her lap band for 6 months, and lost 134 pounds!  That would make her a great success story – except that since that time, she’s become increasingly ill, her medical expenses have piled up, and she now describes herself as sicker than she has ever been in her life.  She has many debilitating symptoms, was just diagnosed with Hashimoto’s disease, and has been tested for many other autoimmune diseases.

Her sister has lupus and even before her surgery she had thyroid problems.  Her doctor knew her medical history of these autoimmune diseases before her surgery but he never mentioned that the lap band had intentionally not been tested on patients who had autoimmune symptoms or family members with autoimmune diseases.

She asked me to read her statement.  If there is time, I hope you will ask to hear it, it’s brief.  She was too ill to travel here today, and, like most people, she had no idea that this meeting was taking place since she does not read the Federal Register.  I think it is unfortunate that patients who are success stories with lap bands are encouraged to testify by their doctors and even have their travel expenses paid, but patients like Jessica were not told about today’s meeting and not paid to be here.

I will leave you with her conclusions.  She says: “If I could get back the days before the lap band, where I laughed everyday with my family …and coworkers, and [did not feel]  sick every single minute of the day, I would trade it back in a heart beat.

“Please advise me of what I need to do to verify if my issues are due to a reaction to the lap band, and if I remove it will the symptoms disappear? …I don’t want to become debilitated to the point that I can’t work or function. I have a 70-year old mother to look after.”

Jessica’s autoimmune symptoms may be caused by her lap band, or might night be, but we need research to find out.

In summary, we need better research before we expand the use of gastric lap bands to a much larger group of people, no matter how desperate they are to lose weight.  We do them no favors by making a device available before it has been adequately tested for long-term safety.  This is especially important because insurance companies sometimes will pay for only one bariatric surgery, and won’t pay to have a problem LAP-BAND removed.

I urge you to vote against expanding approval and I urge you to vote for black box warnings for patients with a family history or personal history of autoimmune diseases or symptoms.