Tuesday's Virginian-Pilot featured a front-page story I already knew all too well. In a nutshell, the story is that no one involved in the manufacture, regulation, sale or implantation of medical devices has a complete handle on ensuring that the devices are safe.
The article relates case after case in which surgeons did not get the news that a device had been recalled, when ignorance of a product defect caused patients months of unnecessary pain, and when a recall notice was so garbled that no one could take meaningful action. While the U.S. Food and Drug Administration does review and register medical devices before the products reach patients, the agency has few resources to follow-up on safety issues. Often, the information the agency does have on device safety issues reaches doctors, surgeons, suppliers and patients only in dribs and drabs.
- Medical Device Recalls Have Doubled in 10 Years
- Recall of Depuy Hip Implant in Virginia and North Carolina
- Why Do Medical Devices Fail?
Hundreds of thousands of patients have medical devices ranging from replacement hips and knees to bone braces and pins implanted each year. Unfortunately, some of these surgeries result in further injury to the patients, either because of medical malpractice or malfunctioning or faulty equipment.
My colleagues and I have spent more than 20 years representing patients harmed by medical devices and surgical errors. My hope is that the increased attention brought to the issue of medical device safety will help protect patients from harm moving forward.
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