The Food and Drug Administration has come under scrutiny for its approval and oversight of medical devices. In particular, metal-on-metal hip implants, plastic mesh for pelvic surgery, surgical staplers and some implanted heart defibrillators have been recalled due to safety concerns. You can listen to our podcast and public radio broadcast with Jeanne Lenzer, author of the book “The Danger Within Us.” In this work she documents the FDA’s lax medical device approval process. There have been way too many defective medical devices allowed on the market. Here’s a link to “Show 1123: What Are the Unexpected Dangers of Medical Devices?” Now, a new FDA scandal has emerged.
Did the FDA Cover-Up Defective Medical Devices?
Kaiser Health News has uncovered a hidden database where a manufacturer was allowed to report 50,000 troublesome incidents with its heart defibrillator away from public view. The device is the Sprint Fidelis, which was recalled more than a decade ago.
What Went Wrong with Sprint Fidelis?
Before it was recalled, more than a quarter million people received this implanted heart defibrillator. It was supposed to sense life-threatening arrhythmias and shock the heart back into normal rhythm.
Unfortunately, sometimes the wires (“leads”) broke or shorted out. People might be shocked when they didn’t require it. Other times a device did not fire off when it was supposed to. An article in the Journal of the American College of Cardiology (March 22, 2016) notes that:
“The implantable-cardioverter defibrillator (ICD) lead is the most vulnerable component of the ICD system. Despite advanced engineering design, sophisticated manufacturing techniques, and extensive bench, pre-clinical, and clinical testing, lead failure (LF) remains the Achilles’ heel of the ICD system. ICD LF has a broad range of adverse outcomes, ranging from intermittent inappropriate pacing to proarrhythmia leading to patient mortality.”
To us, these clinical terms do not describe the horror of this medical tragedy. Imagine walking around with a device in your chest that could zap you into an irregular heart rhythm that could kill you. Knowing that the defibrillator could discharge inappropriately could lead to overwhelming fear and anxiety.
Stories from Readers:
Here are actual reports from visitors to this website:
Danny in Bossier City, LA writes:
“I had a mangled double hernia operation. The surgeon used mesh to make the repair. It has ruined my life. The mesh creates intense unbearable nerve pain each and every day since that operation in 2003.
“Even though I have tried to get help and some compensation I have been advised that because of the statute of limitations I am not eligible. An attempt to undo the problem revealed that the mesh is so entangled in my abdomen that it cannot be fixed. The pain is indescribable.”
Cathie in Missouri shares her daughter’s story:
“My daughter had the mesh surgery many years ago. She has complained about it ever since. She has stomach pain, sex pain, and even her husband said it hurts him during sex. I hope something can be done to help her.”
Tim shares his perspective as a health professional:
“I am patient facilitator. I have helped manage spinal surgeries with a neurosurgeon for more than 10 years. I have seen many devices come and go in spine surgery. Many of them had FDA approval, only later to be taken off the market for poor long-term performance. Many of the devices had fundamental design flaws.”
Hiding Reports About Defective Medical Devices!
It’s bad enough that the FDA has allowed flawed medical devices like hip transplants, plastic mesh, staplers and implantable heart defibrillators on the market. Perhaps even worse, though, is a report from Kaiser Health News (KHN) that the agency allowed manufacturers to hide this information from public view. The investigation (May 3, 2019) from KHN was titled:
“FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices”
It starts with this mind-boggling sentence:
“The Food and Drug Administration announced it is shutting down its controversial ‘alternative summary reporting’ program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.”
An earlier report from KHN documents issues with surgical staplers and other defective medical devices (March 7, 2019). Here is a key finding: A surgeon in Pittsburgh, Dr. Douglas Kwazneski, was performing an appendectomy when
“something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.”
He checked the FDA’s database to see if others had reported similar findings. Nada!
KHN reports that:
“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.”
MAUDE and Defective medical devices:
What should have happened with reports about defective medical devices? Normally, if a piece of equipment causes a problem, doctors, patients or the maker can report this to an FDA database called MAUDE. That stands for Manufacturer and User Facility Device Experience. The fact that the FDA offered device makers a way to provide alternative summary reports that could not be easily accessed has shocked physicians, public safety experts and patient advocates.
Are you shocked or have you become so cynical that you just assume the FDA is no longer on the side of patients? Share your thoughts in the comment section below.
Listen to our interview with Jeanne Lenzer about her book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. You can listen by clicking on the green arrow above Jeanne’s photo or by downloading the mp3 file. If you have access to Netflix you may want to watch the documentary, Bleeding Edge. Here’s a trailer.