After dealing with safety concerns, congressional scrutiny, lawsuits and other complaints, Allergan ($AGN) abandoned plans to pursue expanded use of its Lap-Band anti-obesity device in the U.S. teen market.
Bloomberg reports that the company isn't explaining its decision concerning the device, a silicon band that helps people loose weight by tightening around a patient's stomach, reducing the amount of food that can be eaten. A company spokeswoman insisted to the news agency, however, that the Lap-Band system remains safe despite complaints and other concerns to the contrary.
"The Lap-Band AP system has an 18-year safety and effectiveness record with more than 650,000 procedures performed to date and adverse events reported in less than two percent of patients," Naziah Lasi-Tejani told Bloomberg.
In the short term, Allergan may have a missed opportunity here, despite the pushback it received. It is widely accepted now that obesity rates will continue to increase in the coming years, and Centers for Disease Control and Prevention statistics cited by Bloomberg note that U.S. obesity rates with children and teens is now at 17%, triple the rate since 1980. Overall, those numbers from the CDC also note that obesity-related medical costs in the U.S. soared to $147 billion in 2008 alone, and a third of all U.S. adults are obese.
But the pushback has been intense for the fairly lucrative product Allergan acquired after buying its creator, Inamed, in 2006. Health groups have warned that a child or teen faces health risks from a Lap-Band because their bodies are still developing, and they cautioned that its effectiveness in this group of patients would be mixed. Recent research has also hammered the product as well. Bloomberg cites an Archives of Surgery study, in particular, that concluded almost 50% of patients with a gastric band implant either didn't lose weight or had to have the device removed in about 6 years. About 40% of implant patients also faced long-term health problems.
Congressional scrutiny continues to escalate, as the article notes, with some calling for hearings to explore whether the FDA took adequate safety steps with the Lap-Band approval. Earlier this year, the inspector general of the Department of Health and Human Services slapped a subpoena on the company regarding the Lap-Band device, though Allergen declined to disclose details. Lawsuits are adding to the pressure. The story explains that a number of plaintiffs--including patients and the families of deceased patients--allege that doctors are implanting Lap-Band on patients who aren't healthy enough to handle the procedure.
- read the Bloomberg story