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Americans trust the FDA to make sure medical devices are safe and to act swiftly if problems arise. But a year-long investigation by KFF Health News and CBS News revealed that a series of FDA-cleared products, both implanted in the human body and used to treat chronic diseases, have been suspected of contributing to thousands of injuries and patient deaths.
In a torrent of lawsuits, patients accuse Florida device maker Exactech of hiding knee and hip implant defects for years. The company denies the allegations.
Thousands of medical devices are sold, and even implanted, with no safety tests.
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.
The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U.S. patients as of 2005. It took 15 years to recall the devices. Many fractures could have been avoided.
A venous needle dislodgment is a rare dialysis complication that can kill a patient in minutes. Some experts worry those who treat themselves at home are at increased risk.
A dental device called AGGA has been used on about 10,000 patients without FDA approval or proof that it works. In lawsuits, patients report irreparable harm. The AGGA’s inventor and manufacturer have denied all liability in court.
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KFF Health News and CBS News recently reported that multiple lawsuits allege the device has led to grievous injuries to patients’ mouths, resulting in loss of teeth.
A KHN and CBS News investigation found that a dental appliance called the AGGA has been used by more than 10,000 patients, and multiple lawsuits allege it has caused grievous harm to patients.
The FDA’s interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.
Daniel Chang
Brett Kelman
Fred Schulte
Nicole Keller, CBS News
Anna Werner, CBS News
Holly Hacker
Eric Harkleroad
Matt Pendleton
Ash Ponders
Oona Tempest
John Hillkirk
Kelly Johnson
Sabriya Rice
Eric Harkleroad
David Hicks
Lynne Shallcross
Oona Tempest
Lydia Zuraw
Terry Byrne
Gabe Brison-Trezise