Health insurers want tighter approval and monitoring of medical devices
Posted on Monday, April 27th, 2015 at 10:42 am by Williams Hart | Updated: Thursday, March 7th, 2019 at 5:05 pm
In a letter addressed to Sen. Bob Casey on April 14, a large group of health insurers called for tougher approval and monitoring of medical devices, according to a report by The Wall Street Journal.
The demand was in light of a growing number of uterine cancer diagnoses associated with laparoscopic procedures involving power morcellators. Some studies have shown using the medical device may cause undetected cancer tissues to spread in the uterus. The health insurance group America’s Health Insurance Plans said the U.S. Food and Drug Administration (FDA) needs to amend its 510 (k) process–a pre-market process that aims to prove that a medical device is as safe and as effective as a device already approved for the market.
A uterine cancer diagnosis can be frightening and overwhelming. If you believe your health condition has resulted from a power morcellator, the legal team at Williams Hart might be able to help you file a claim against the manufacturer involved. Call us at (713) 352-7071 to learn about your legal options today.