After investigating those risks for nearly a year, the agency slapped its strongest warning on the label to advise against using power morcellators in the vast majority of gynecological surgeries.
The investigation began in December 2013, after the WSJ highlighted case reports linking power morcellators and uterine surgery.
However, power morcellators have been on the market since the early 1990s. The FDA approved the first device in 1991, after Cook Medical Inc. submitted a 510(k) application claiming it was “substantially equivalent” to hand-operated morcellators.
The 510(k) approval process allows manufacturers to skip expensive rigorous clinical trials so long as the device is equivalent to another device on the market. Last year, the FDA used this process to approve 99% of the 3,000 medical device applications it received, including controversial devices like vaginal mesh and metal-on-metal hip implants.
The problem is that minor changes can sometimes result in major differences — especially in practice. As early as 1995, application documents indicate that Daniel Schultz, an FDA medical officer, warned that the tool could raise dangerous cells. According to the WSJ:
“The same day, he wrote in a summary for the record that the device ‘must be used with an appropriate tissue extraction bag for malignant and other tissues which are potentially harmful if disseminated within a body cavity.’”
In practice, power morcellators were almost never used with protective surgical bags. The bags were designed to be used with hand-held morcellators, and they were too flimsy and cumbersome to be used effectively with the power morcellators.
Another difference was that power morcellators were commonly used in robotic surgery, which skyrocketed in popularity in the mid-2000s. This substantially increased the number of women who were treated with a power morcellator.
Do I have a Morcellator Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer after a hysterectomy or fibroid surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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