Pharmaceutical

Lap-bands not thoroughly tested before approved for use

fda logo Lap bands not thoroughly tested before approved for useTwo new studies published in the New England Journal of Medicine are touting the benefits of bariatric surgery in obese patients for the quick lowering of blood sugar levels that has resulted in the reduction or elimination of patents’ need for insulin or diabetes medications. But the latest issue of Consumer Reports magazine is warning people that devices, including those used in some bariatric surgeries, may not be thoroughly tested and can pose a danger to consumers.

Bariatric surgery includes a variety of procedures designed to make patients feel full faster, and thus eat less. These surgeries involve reducing the size of the stomach either with an implantable medical device (gastric band), through the removal of a portion of the stomach, or by resecting and re-routing the small intestines to a small stomach pouch (gastric bypass surgery).

Gastric bands, or Lap-Bands, are considered moderate risk medical devices. Unlike high risk devices or prescription drugs which are put through rigorous clinical trials to determine safety and efficacy before being approved by the Food and Drug Administration (FDA), moderate risk devices can quickly gain approval if they are similar to devices already on the market. A staggering 90 percent of medical devices are approved under this plan. Including Lap-Bands.

What could possibly go wrong? Just ask Lisa Wilson. In 2009, the then-46-year-old underwent bariatric surgery in which a Lap-Band adjustable gastric band was implanted in her stomach. The band reduces the size of the stomach to make it difficult to eat large amounts of food, but Lisa’s band was so small she had trouble even eating small amounts of food. She was throwing up everyday.

Despite the complications, Lisa continued with the Lap-Band, until an endoscopy in 2010 showed that the band had cut into her stomach lining. It had to be removed. But the surgery proved dangerous too. Lisa developed a post-surgical infection that resulted in an eight-day hospital stay.

“If Lisa Wilson had seen the lone study on which the approval was based, she might not have been surprised by her problems. Of the 299 people in the study, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight,” Consumer Reports reported.

Consumer Reports is pushing for more government oversight of medical devices and the elimination of the expedited approval process without clinical trials.

Source: Consumer Reports