U.S. Health Insurer to Require Pre-Approval for Doctors Performing Power Morcellator Surgery
UnitedHealth is now requiring doctors, facilities and health care providers to notify them before performing certain types of hysterectomies, which may include those incorporating a power morcellator, so the insurer can assess whether it’s necessary.
According to a statement issued on February 26th, UnitedHealth Group Inc. said it won’t approve the surgery if it is determined that one isn’t medically necessary. These new guidelines are based on a recommendation from the American Congress of Obstetricians and Gynecologists in 2009 that certain “keyhole” laparoscopic procedures may result in more complications and less optimal outcomes. The company said new regulations will go into effect April 6, 2015.
The United Health decision is noteworthy, given the amount of hysterectomies that are performed in the U.S. each year. In the early 2000s, the Centers for Disease Control estimated that 600,000 are received by women annually.
FDA Issues Significant Warning about Power Morcellator Risks
The decision also comes at the heels of a U.S. Food and Drug Administration (FDA) alert on November 24, 2014 that gynecologic procedures involving a power morcellator, which cuts up uterine tissue so that it can be more easily extracted through the uterus, are inadvisable for most women. This is amid speculation that the device may spread uterine sarcoma and other cancers outside the uterus and into other parts of the body. Among other things, the FDA said in the November 2014 notice that approximately 1 in every 350 women undergoing a laparoscopic hysterectomy may have undiagnosed cancer cells prior to surgery that may only be detected when they are removed and biopsied. The agency also ordered that all morcellator manufacturers add black box warnings to all their devices to adequately notify women about their possible association with the spread of cancer.
The FDA issued its first warning about uterine morcellation in April 2014, which preceded the decision from Johnson & Johnson and its subsidiary, Ethicon Inc. to stop selling power morcellators it had on the market. That July, the companies took that decision a step further by completely removing its devices from the market altogether.
Considering a Power Morcellator Lawsuit? Contact Us.
Call a power morcellator lawyer at Bernstein Liebbhard LLP for advice on filing a lawsuit that alleges uterine sarcoma or another type of cancer. Our Firm’s attorneys can be reached directly at (877) 779-1414.