Here are seven points:
1. Sponsors of the legislation, “Medical Device Guardian’s Act,” introduced the bill after there was a lag in public awareness concerning the risk of the laparoscopic power morcellator.
2. The FDA presently requires device manufacturers and hospitals to report serious injuries and deaths linked to medical devices. The sponsored legislation would also require physicians and physicians’ offices to report device risks.
3. The legislation protects physicians from plaintiffs in a civil case using their reports against the physicians.
4. Nearly two years ago, the FDA called for a black box warning for the surgical device, with the agency saying the device could potentially spread a uterine cancer during procedures, particularly hysterectomies.
5. Literature concerning the device risk has been circulating since the 1990s, but it took the FDA almost 20 years to receive a report. Amy Reed, MD, a physician at a Boston hospital, was the first to report the device’s risk to the FDA in 2013.
6. Johnson & Johnson has settled more than 100 legal claims as well as lawsuits pertaining to the device’s risk of cancer. The device company ceased all the device’s sales in April 2014 and took it off the market that July.
7. Boston-based Brigham and Women’s Hospital have confirmed two cases in which the device spread cancer. Initially, hospital officials said the two cases were not reportable as the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences.” However, the hospital has since reported both cases, according to a hospital spokeswoman.
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