Public Broadcasting should be commended for trying to explain a very important issue that most Americans do not understand – until it happens to them. A “Need to Know” broadcast, explores the mysterious world of medical devices. Most Americans imagine their Food and Drug Administration (FDA) is protecting them from dangerous devices. They would be wrong.
For example, in Australia, which tracks hip and knee replacements post-surgery, the defective DePuy ASR hip was taken off the market after it was linked to early failure and years before it was removed in the U.S. That’s because we do not track adverse events after a device is put in a patient – sort of a head-in-the-sand approach to medical device monitoring.
The magazine style story, delivered by Dr. Elizabeth Senay introduces us to Linda Gross, who used to work as a nurse in Watertown, South Dakota.
Linda enjoyed outdoor activities, hiking, fishing and camping with her husband and three boys. She enjoyed her job as a hospice nurse. All of that came to a halt when she went in to have surgery to correct problems urinating and defecating. Part of her rectum was pushing into the vagina and so she had the Gynecare Prolift implanted. Made by Ethicon, a Johnson & Johnson company, Gross was assured it would be the solution to her prolapse problem.
More than 400 medical procedures later, she now spends most of her days in bed, reclining, the only position that offers some relief from chronic, constant pain. For six years she has had to catheterize herself to urinate. She has had 22 surgical procedures and says she called the manufacturer, Johnson & Johnson at least five times to seek some help. She got none.
Gross recently sued Ethicon and won $11.1 million in compensatory and punitive damages against Ethicon, which is appealing.
About 90% of the 3,000 to 4,000 medical devices approved for the U.S. market are cleared with no FDA assurances for safety or efficacy and no requirement for clinical trials, unlike pharmaceutical regulation. Unfortunate Americans find out after-the-fact about this safety loophole.
Ethicon says its Prolift is among the most studied surgical meshes and it was the “substantial equivalent” to another similar device already being sold. That is the standard a manufacturer must use to gain approval for its new device, showing through an exchange of paperwork that the new device resembles another.
That is little comfort to the thousands of women injured by transvaginal mesh as well as thousands injured by medical devices that received a cursory glance before being sold to the unsuspecting public.
With minimal initial oversight, then no ongoing monitoring of adverse events and complications after surgery, U.S. consumers are left with a Wild West approach to medical device regulation – they may be safe, then again they may not be.
Some hope is on the horizon. The FDA is working on a unique number like a bar code that is found on food products and in your car in the form of a VIN number. When a complication occurs and it is reported, the FDA will be able to more quickly identify the problematic device. The medical device industry says this surveillance will increase costs and slow innovation. Increase costs to whom? Not to Linda Gross who has spent her family’s life savings trying to get well and then some.
Improving safety can only improve innovation and protect the lives of countless unsuspecting Americans.