Latest KFF Health News Stories
Florida Medical Device Maker Exactech Declares Bankruptcy
The company faces more than 2,000 lawsuits alleging it sold defective knee and hip implants.
From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business, and regulation of medical technology.
FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device
Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
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.
Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.
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.
Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.
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.
‘It Was a Bloodbath’: Rare Dialysis Complication Can Kill, and More Could Be Done To Stop It
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.
Feds Launch Criminal Investigation Into ‘AGGA’ Dental Device and Its Inventor
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.
FDA Evaluates ‘Safety Concerns’ Over Dental Devices Featured in KHN-CBS Investigation
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.
FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm
The FDA’s interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.
This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.
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.
