Allergan Inc., the maker of the wrinkle treatment Botox, received a U.S. government subpoena over its gastric banding device for obesity.
Allergan received the subpoena from the Department of Health and Human Services’s Inspector General this month, the company reported today in a filing. Bonnie Jacobs, a spokeswoman for Irvine, California-based Allergan, acknowledged the subpoena but declined to comment further.
Allergan generated $203.1 million of its $5.42 billion revenue last year from devices for obesity. The company acquired the product, called Lap-Band, in 2006 with its purchase of Inamed Corp. The adjustable silicon band helps people lose weight by reducing the amount of food their stomachs can hold.
In January, House Democratic lawmakers called for hearings on medical devices including Lap-Band, following a study in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long-term complications.
The Food and Drug Administration approved the device in 2001 for patients who were at least 100 pounds (45 kilograms) overweight, had a body mass index of at least 40, or an index of 35 with obesity-related conditions such as heart problems. Allergan gained clearance in February 2011 to expand marketing of the device to people with lower body mass indexes and at least one obesity-related condition.