More than 1,000 Americans a week get steel screws implanted in their spines to fight back pain, although the devices are not government-approved and studies show they may cause more harm than good, a consumer advocate charged Tuesday.
Public Citizen petitioned the Food and Drug Administration to ban the screws and accused the agency of negligence for not cracking down on allegedly illegal and unethical use of the devices."This has got to stop," said Public Citizen's Dr. Sidney Wolfe. "It is a major and dangerous racket being perpetrated on patients in this country."
At issue are orthopedic devices called pedicle screws, long hardware that is literally screwed into the bones of the back. Doctors think the screws may help heal spinal fractures or severe spinal degeneration, although the FDA has not approved them for use anywhere except in strictly controlled clinical trials.
But because screws are approved for use in leg and arm bones, doctors can buy them for other, unapproved purposes unless the FDA specifically bans it. So 50,000 to 70,000 Americans get the treatment every year, many for such common ailments as chronic low-back pain.
Complaints about the screws aren't new - more than 600 people who say they were injured or disabled by them have joined a class-action lawsuit, and the FDA warned seven manufacturers last year to stop illegally advertising the experimental devices.