At FDA, a new goal, then a push for speedy device reviews
WASHINGTON (AP) — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices.
"We don't use our people as guinea pigs in the U.S.," Shuren said, holding firm as the new director of the U.S. Food and Drug Administration's medical devices division.
FDA’s ‘flawed’ device pathway persists with industry backing
WASHINGTON (AP) — Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.
Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.
Insulin pumps have most reported problems in FDA database
DESTIN, Florida (AP) — When Polly Varnado's 9-year-old daughter was diagnosed with Type 1 diabetes, it didn't take long for the family to hear about insulin pumps.
In September 2012, the girl picked out a purple one — her favorite color.
Over the next seven months, she proceeded to be hospitalized four times in a McComb, Mississippi medical center with high blood sugar. But when Varnado asked about all her daughter's problems, she said, her doctor blamed user error.
Breast implants reveal problems in tracking device safety
WASHINGTON (AP) — To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.
Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA's system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.
Improving medical device tracking a slow, imperfect process
WASHINGTON (AP) — For nearly two decades, health advocates have pushed to standardize the way medical devices are tracked and studied.
They eventually landed on a solution that others, including other parts of the medical industry, already had adopted — a unique code to help track the type, manufacturer and other key information about a device.
In 2007, Congress asked the U.S. Food and Drug Administration to create the system, and the FDA passed a final rule establishing it in 2013.
Spinal-cord stimulators help some patients, injure others
COLUMBIA, South Carolina (AP) — Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.
It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new."
Spinal-cord stimulators mean big business for device makers
Few medical devices hold as much potential for explosive growth as spinal-cord stimulators , especially in the United States, where they are being pushed as the answer to the country's opioid epidemic.
The global market for spinal-cord stimulators has grown from $300 million in 2001 to nearly $2 billion in 2017, according to an estimate by Nevro, a Redwood City, California, company that manufactures the devices.
Supreme Court sets high bar for medical device lawsuits
The tiny balloon was supposed to stretch open a blocked artery on Charles Riegel's diseased heart. Instead, when the doctor inflated the balloon, it burst.
The patient went on life support but survived. His lawsuit against the manufacturer of that arterial balloon did not.
The U.S. Supreme Court ruled in favor of Medtronic, among the world's largest makers of medical devices, setting a precedent that has killed lawsuits involving some of the most sophisticated devices on the market.
How global journalists investigated medical device safety
More than 250 journalists in 36 countries representing more than 50 media organizations, including The Associated Press, spent nearly a year examining the safety of medical devices , such as how they are tested, approved and monitored by regulatory agencies.