Product News and Recalls

Radiological devices had FDA whistle-blowers concerned

Six U.S. Food and Drug Administration doctors and scientists who claim the agency retaliated against them said they were trying to raise valid concerns about medical devices of unproven effectiveness, The Washington Post has reported.

The doctors and scientists, who worked in the office charged with reviewing medical devices, have filed suit in federal court alleging that the FDA monitored their personal e-mail accounts, and used information obtained that way to harass and improperly dismiss them.

According to The Washington Post, they first raised concerns within the FDA in 2007, and also notified Congress, the White House and the U.S. Department of Health and Human Services inspector general.

Their concerns involved the agency’s approval or pending approval of at least a dozen radiological devices that posed risks to millions of patients. According to the doctors and scientists:

  • Three of the devices risked missing signs of breast cancer.
  • One device risked falsely diagnosing osteoporosis, which could lead to unnecessary treatments.
  • One ultrasound device could malfunction while monitoring pregnant women in labor, and risk harm to the fetus.
  • Several devices for colon cancer screening used so much radiation that they risked causing cancer in otherwise healthy people.
  • A senior manager approved a computer-aided imaging device that searched for signs of breast cancer after a team of experts had rejected it three times.

A number of public and private agencies have faulted the FDA in recent years over its approval process for medical devices, which critics claim is dangerously lax.

FDA policy allows for the approval of medical devices that haven’t been safety tested in humans, based on their ostensible similarity to devices already on the market.

Transvaginal mesh, used to treat urinary incontinence and pelvic organ prolapse, was approved as a result of that policy. Since then, patients have complained about health problems from the device’s failure, including perforated organs and extreme pain.

A type of metal-on-metal hip implant manufactured by DePuy Orthopaedics and approved under the FDA loophole was eventually recalled in 2010. But thousands of patients reported health problems including early failure that made second surgery necessary, and complaints of metal particles breaking off and getting into the bloodstream.

See the report here: