Doctor Fears for Patient Safety After Lap-Band Surgery
Dr. Neelu Pal was fired from New York University’s Medical Center after raising concerns and calling patients warning them of the dangers of Lap-Band surgery in January 2006. Her concerns were not about the gastric band device itself, but the lack of care given after surgery and incomplete or inaccurate medical forms taken prior to surgery. She has filed a wrongful termination lawsuit, which is still pending, and is now pursuing a career in law.
A gastric band is an inflatable silicone band placed around the top portion of the stomach to create a pouch that restricts food intake. Several companies make the bands, with the industry leader being Allergan, the manufacturer of the trademarked Lap-Band TM.
After the death of one patient and complications suffered from others, Dr. Pal described the facility as a “hectic Lap-Band factory”, saying that during her three months at NYU Langone Medical Center’s Surgical Weight Loss Program in late 2005 and early 2006, two surgeons, known as pioneers in the field, implanted gastric bands into as many as 20 patients in a single day.
"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.
In general, high-volume bariatric centers have lower in-hospital mortality for all weight loss surgery operations. 30-day readmission rates for complications after bariatric surgeries are also lower at high volume facilities. However, the first few weeks after surgery are critical for reducing the incidence of complications and physicians are urged to monitor patients carefully.
Some of Pal’s allegations have been corroborated by a New York State Health Department investigation. In 2006, the department found that Dr. George Fielding falsified data on one patient, a 14-year-old boy enrolled in an FDA-authorized study looking at the use of gastric banding in obese teens. (Currently the Lap-Band is approved only for adults, except in the case of clinical trials.)
A week after the teen’s Lap-Band surgery, he developed an infection with an abscess, a common complication. Upon return to the NYU facility, Fielding performed an appendectomy, although there was no evidence of appendicitis. Today, the teen and his father are involved in a lawsuit with the program. NYU has maintained no wrongdoing, just a misinterpretation of operative findings. The university’s plan to correct the issues was accepted by state regulators.
Another report found that Fielding has also been cited for failing to address a post-operative patient’s persistent lack of urine output. The patient went into cardiac arrest and died 36 hours later. The report also stated that Dr. Christine Ren, another bariatric surgeon at NYU, permitted two surgeons to practice for four months without the appropriate licenses. She has received a letter of reprimand for “professional misconduct”.
Despite the reports of misconduct, the NYU Langone Weight Management Program remains a “Center of Excellence”, a designation by the Surgical Review Corporation, an entity of the American Society for Bariatric and Metabolic Surgery. The criteria for the certification is extensive, including the completion of a minimum of 125 bariatric surgeries each year, a low post-operative complication rate, and evidence of a multidisciplinary plan of care both before, during and after any weight loss surgery.
Surgical Review Corp CEO Gary Pratt said that he was unaware of the incidents and the NYSHD report. He said the corporation's reviews maintain the highest standards with the goal of advancing the safety and efficacy of bariatric surgery.
The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight. It is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.