The maker of the LAP BAND that can be used to tighten around a patient’s stomach to reduce food intake has agreed to a multi-million dollar fine based on the claim it knowingly sold these devices with defective access ports, and promoted the LAP BAND for uses not approved by the FDA. The access ports are to be used by physicians to add or remove saline fluid to adjust the band to expand or shrink the size of the stomach pouch.
The US Attorney alleged that the company knew of and concealed the defects so that physicians would continue to use the bands. As this is not uncommon where the hugely profitable medical device market is concerned, the manufacturer was shown to have “knowingly advertised, marketed, and distributed the LAP-BAND for use in two procedures” that “were not reasonable and necessary for the diagnosis or treatment of an illness or injury.” To help them get away with this, Allergan provided payments to health care professionals to hold workshops and training events where the un-approved uses were promoted.
This particular misbehavior was exposed by a whistleblower – an insider who reported the fraudulent use of federal money to pay the company for these improper uses or defective items.
LAP BANDs are promoted as a safer and easier alternative to gastric by-pass surgeries for people who cannot and must lose weight otherwise. However, our office sees these cases where physicians are careless in how they install the bands or fail to listen to their patient’s reports of serious problems if the bands erode into the stomach walls or have failures.
We are glad to speak to whistleblowers- people inside who have information to help the health of the public because a company is falsely billing Medicare or Medicaid. And of course, if healthcare workers fail to listen and correct their mistakes, we have been listening and helping for decades.