The Safety Issue of Gastric Bands on Teens

Special report: Targeting teens for gastric bands – Today’s Reuters

Pal had previously raised her concerns with hospital officials, complaining — to no avail — about the lack of care given after surgery and incomplete or inaccurate medical forms that were taken prior to surgery.

She was fired weeks after hospital authorities learned she had contacted patients in January 2006. She has filed a wrongful termination lawsuit — the case is pending — and enrolled in law school. Pal, who came to the United States from India a little over a decade ago to practice medicine, says she has been blackballed from her chosen profession.

The NYU bariatric surgery practice where she worked is widely considered one of the world’s most experienced. But in an interview with Reuters, Pal described the facility as a hectic Lap-Band factory.

“My impression at the time was that the practice was disorganized, but once I knew more about the system, I could see what they were trying to do was get as many patients on to the operating table as possible,” she said.

During her three months at NYU Langone Medical Center’s Surgical Weight Loss Program in late 2005 and early 2006, two surgeons — Dr. Christine Ren and Dr. George Fielding, who are married — implanted gastric bands into as many as 20 patients in a single day, according to Pal.

Known as pioneers in the field, Fielding and Ren are also paid consultants of Allergan Inc, the Botox and breast implant maker which is the leading manufacturer of the gastric band. Though rivals have been gaining, Allergan’s Lap-Band still commands more than two-thirds of a $300 million to $400 million market.

To critics, Pal’s allegations — some of which were corroborated by a New York State Health Department investigation around that time — underline the potential risks that go along with the industry’s rapid growth. And the business could soon swell even more if U.S. regulators grant permission to perform the procedure on the nation’s bulging ranks of overweight teens.

Ren was an investigator in an Allergan-sponsored clinical trial studying the use of bands on teens. And the company has an application with the U.S. Food and Drug Administration seeking approval to market the device to teens as young as 14. A decision could come any time.

Winning regulatory approval for the gastric band in teenagers would allow the companies that make the devices — Allergan, Johnson & Johnson and others — to target that specific age group. Today, regulators consider performing the procedure on teens “experimental” as it has not been approved for that age group. But, like any device, it may be used on teens at a doctor’s discretion.

Allergan declined to comment on Pal’s lawsuit or disclose how much it pays the surgeons, though the company did confirm that both remain on the payroll.

Through a NYU spokeswoman, Ren and Fielding — who have been the subject of some controversy — declined to be interviewed for this article, also citing the lawsuit.

But in some medical circles, concern over gastric banding for teenagers is growing nearly as fast as American waistlines. In particular, some doctors worry about the device’s long-term safety and effectiveness.

By Debra Sherman, CHICAGO | Mon Jul 26, 2010 9:08am EDT

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