FDA: Podcast - Watchdog or Lapdog?

Jane Akre
June 5, 2021
Madris Tomes Kinard, Device Events

Mesh Medical Device News Desk, June 5, 2021~ MND Podcast with Madris Tomes-Kinard on the FDA and whether it has what it needs to do an adequate job of patient safety.

Just who is in charge? And how can citizens mobilize to bring attention to their troubling medical device?

Madris Tomes Kinard is a former FDA IT project manager who left the agency to focus on patient safety and medical devices.

Kinard is the system architect of Device Events, a database she created to make FDA adverse event reports much more accessible to the public and consumers, the media, hospitals, doctors, and lawyers.

With more than 11 million adverse event reports collected by the FDA, the agency has trouble identifying any early warning signs of trouble. The problem is simple - there are more devices are on the market while there are fewer eyes to watch them.

For example, Australia saw the problems with metal-on-metal hips long before the U.S. did, meaning patients were needlessly injured because we are not paying attention. 

"There are a lot more devices on the market now they haven’t matched that with post-market funding from Congress. The FDA doesn’t have enough people to read these reports coming in. When we spoke 5 yr. about 65k a month and that has doubled. The FDA has 11.1 million ae reports and not enough analysts to read and act on them" ~ Madris Kinard 

Madris spoke to Mesh News Desk in this interesting podcast.  Some of its contents including:

  • There’s been a drastic spike in hernia mesh cases reported since 2017, currently at 51,000 adverse events (complication) reports. 15,000 in 2019 alone!
  • Manufacturers pay for the FDA surveillance of their medical device. The agency is severely underfunded.
  • Under the U.S. system, manufacturers are supposed to report any complications with their own devices, which is a flawed system

  • Doctors must report a problem with a device to the manufacturer, not the FDA directly. It may or may not be passed on.

  • Under this system, with the Essure birth control device, three were 32,000 reports that never made it to the FDA at all

  • Recalls are led by the manufacturer, not demanded by the FDA

  • Essure women worked to have a Congressional hearing- she suggests how to get that done.

  • An estimated 14% of medical device complication events in the real world make it to the FDA, according to the Office of Inspector General.

  • There were 60,000 reports of complications with transvaginal mesh in 2013

  • There’s been a spike in spinal cord stimulators due to the opioid crisis - deaths, heart attacks due to the excessive stimulation of your nervous system.

  • There’s been a spike in complications with dental implants, 300,000 adverse event reports, specifically those made with the alloys such as cobalt and nickel

  • Adverse events must be reported to the FDA MedWatch division with follow-up by the patient and updates on your condition to help the agency understand your complication.

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