Under close FDA supervision, medical implants and drugs undergo meticulous testing and are scrutinized at every step to ensure quality and safety. At the same time, surgeons undergo countless hours of training to learn the proper techniques/procedures to safely and correctly install such devices. Like any industry, the medical industry is not immune to mechanical failure and human error.
As a mechanical engineer with more than 30 years of experience with medical implant testing and litigation support, I’ve seen more than my share of horror stories. I’ve seen implant bone screws broken by being overly torqued, joint replacements show premature wear, stabilizing rods improperly installed—and much more.
But just when I thought I’d seen it all…
It is not uncommon for a surgeon or doctor—or anyone, for that matter—to seek to develop and sell an innovative new product or to improve upon an existing design. After all, this is how advancements are made. In most cases, a new concept will go through multiple stages of design and refinement often followed by CAD model analysis, prototyping, and extended laboratory testing – all to validate design and structural integrity. A next step might involve surgically implanting the device in a cadaver to proximate actual real-world usage; again, all well in advance of final FDA approval.
While we might sometimes become frustrated with the time it takes for a new drug or device to be approved for use, let’s be clear that the process is in place to protect the patient, surgeon, manufacturer, and medical industry as a whole. The last thing anyone needs is a rogue surgeon installing untested and unapproved medical devices in trusting patients. Sound obvious right?
I thought so too until I received a call from a surgeon several years ago, with what seemed like a fairly routine request:
- Review a new spinal stabilization device he had “invented”
- Test the device
- Report the results
A short time later, an envelope containing an x-ray arrived. I nearly fell off of my chair. I was looking at a spinal column wrapped with wires held in place with anchor screws. The twisted wires ran from the mid-back down to the lower lumbar area. As a structural engineer, I knew immediately that the “device” was severely flawed. Placing wires in contact with soft tissue was an invitation for slicing and gashing. If that wasn’t bad enough, a closer inspection revealed that the implant was not performed on a cadaver as I had originally assumed, but rather in-vivo!
I called the surgeon to express my concerns. What he had done was highly illegal, unethical, and structurally flawed. He explained that his design combined two FDA approved components – wires and anchor screws. In his mind he had simply combined the materials to create a breakthrough new implant/treatment.
This horror story was the result of a rogue surgeon attempting to short cut the system. He was more interested in making a name (and some money) for himself than the safety of the patient. Instead, he opened the door for malpractice litigation against himself and any hospital with which he was affiliated. While it’s true that the spinal fixation device did consist of FDA approved components, systems must obviously be tested and approved within the context of a complete system as intended by the design.
Unfortunately, I’m unsure of the current condition of the patient. Hopefully he was able to have the wires and anchors safely removed. As for the surgeon, I can report that he has left the country and is no longer practicing medicine — at least in the U.S.
John McCloy has plenty more disturbing details about implants gone wrong:
Look out for more horror stories in the future! Find more information on Engineered Assurance here.