After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. (Kendra Stanley-Mills for KHN) Image source.

Comments by Brian Shilhavy
Editor, Health Impact News

Last year (2018) Netflix produced a documentary about corruption in the medical device industry, which is a 300 BILLION dollar a year industry worldwide.

Industry insiders boast that the medical device industry has more power than Big Pharma, and is more powerful than most governments around the world. See:

Is the Medical Device Industry More Powerful and More Corrupt than the Pharmaceutical Drug Industry?

Watch the two and a half minute trailer for the Netflix documentary, The Bleeding Edge.

Earlier this month (March, 2019), Kaiser Health News published an investigation into the FDA and their public database that tracks medical device failures.

Their investigation found that the FDA maintains a hidden database that records malfunctions of medical devices that is not available to the public.

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

Here is the Kaiser Health News report:

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark.

By Christina Jewett
Kaiser Health News

Excerpts:

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows.

Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety.

Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research.

She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations.

“Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly.

“If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Read the full article at Kaiser Health News.