Although there have been changes to the weight loss device since its introduction, an older version of the <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Lap-Band device can lead to significant complications over time, say Belgian researchers.
By placing a silicone band around the upper stomach, Lap-Band restricts food intake, a popular weight loss alternative. But, according to Reuters Health, the Belgium research team discovered that up to half of the patients, observed for at least 12 years, had to undergo band removal, said Reuters Health. In over 25 percent of the cases, the band ate through the patientsâ€™ stomach wall.
“The high failure rate of (Lap-Band surgery), at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation,” Dr. Jacques Himpens of the Saint Pierre University Hospital in Brussels and colleagues wrote in the Archives of Surgery, quoted Reuters Health.
“This is what I was worried about,” said Dr. Mary Brandt, head of the pediatric surgical program at Texas Children’s Hospital in Houston, quoted Reuters Health. Dr. Brandt is a long-time Lap-Band critic. “I think these data support my opinion that lap band is not the right operation for adolescents,” she told Reuters Health in an email.
Lap-Band maker, Allergan, said that the device has been used in over 500,000 surgeries worldwide. According to Reuters Health, Allergan, dominates mostâ€”over 2/3rdsâ€”of the $300-$400 million market. In its email to Reuters Health, Allergan argued that the surgical technique studied in the review and the Lap-Band device have both changed and that the study only looked at 151 patients from one hospital and that the team was only able to test half of the patients.
Four out of every ten patients in the study did undergo a â€œmajor complicationâ€ as a result of the surgery, including the band entering the stomach or the stomach pouch growing, said Reuters Health, which noted that about six out of every ten patients in the study group had to go through a second operation.
Last month we wrote that with a lot of flourish, the Lap-Band device was approved for expanded use in patients who are only modestly obese by the U.S. Food and Drug Administration (FDA), despite a lack of safety data. The FDAâ€™s approval of an application by Allergan to broaden its Lap-Band demographic based on just one year of study with 149 participants and only partial information, said the LA Times. Ironic, considering Allergan criticized the Belgian study for using data from 151 patients.
In an earlier report, the LA Times pointed out that it seemed as if the agency did not take into consideration the device makerâ€™s illegal marketing tactics for its blockbuster drug, Botox. Allerganâ€™s past with Botox is noteworthy. This September, Allergan pleaded guilty to one criminal misdemeanor count of â€œmisbrandingâ€ Botox and agreed to pay $600 million for fines and penalties over federal charges, said the LA Times.
Among other activities, Allergan created programs as far back as 2003 to teach doctors how to bill for unapprovedâ€”off-labelâ€”Botox uses, audited physician billing records, created a Botox Reimbursement Hotline, lobbied government healthcare programs for expanded off-label coverage, conducted physician workshops and dinners, paid doctors for attendance at â€œAdvisory Boards,â€ created an â€œindependent neurotoxin education organizationâ€ to increase Botox use off-label, and implemented its â€œCD/HA Initiativeâ€ (cervical dystonia/head-ache), said Consumer Affairs previously. The initiative was meant to target headache patients for Botox use, billing the treatment as if the headaches resulted from the rare CD, which only afflicts about 27,000 people in the U.S. The ploy worked. During 1999-2006, Botoxâ€™s CD-HA sales grew by a massive 1,407 percent. By 2007, total Botox sales exceeded $500 million; over 70 percent for unapproved uses, said the government, wrote the LA Times previously.