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When Did The FDA Know That Power Morcellators Cause Upstaged Cancer?

For nearly two decades, physicians across the United States used power morcellators in hysterectomies and to remove uterine fibroids. This device promoted faster recovery times and allowed for hysterectomies and fibroid removal to be conducted on an outpatient basis. For women with undiscovered uterine cancer, however, undergoing morcellation was often fatal.

The reason for this is because when the power morcellator grinds and removes tissue from the body, it cannot remove all of the tissue. When an undiagnosed uterine cancer (leiomyosarcoma) is ground into small pieces, these fragments will spread throughout the abdominal cavity. As a result, Stage 1 cancer, which can typically be treated with an early diagnosis, can turn into Stage 4 cancer in a matter of months or even weeks.

Despite these risks, the Food and Drug Administration (FDA) approved more than 10 morcellators from various companies through its fast-track process. This process, known as the 510(k) process, allows for medical device companies to approve "substantially similar" devices without controlled testing.

When Were The Risks Of Morcellation Known?

When the FDA approved the first morcellator in 1991, it was widely accepted that cutting cancer into pieces would lead to it spreading throughout the body. Therefore, the risks associated with morcellation should have been known at the outset. However, most gynecologists believed that uterine cancer was rare, impacting as few as one in 10,000 women.

Studies showed a much higher risk. According to a Wall Street Journal article titled How FDA Approved Hysterectomy Tools It Now Disfavors, a 1990 study at a Los Angeles hospital found that roughly one in 200 with uterine fibroids had uterine cancer. A 1994 study showed that one in 444 women with uterine fibroids also had uterine cancer. Studies in 1999 and 2008 showed that one in 462 and one in 253 women with uterine fibroids had undiagnosed uterine cancer as well.

Despite these studies, for years the FDA did nothing to warn women of these risks or to remove morcellators from the market. In fact, until recently, the FDA did not have any concerns with the power morcellator. The FDA did not begin researching the link between morcellators and cancer until December 2013. In November 2014, it finally warned doctors they should not use power morcellators in hysterectomies and in the removal of uterine fibroids.

The Costs Of Inaction

The FDA 510(k) process made certain that the morcellator never underwent the testing it should have. Furthermore, despite study after study showing that many women were at grave risk, the FDA failed to act. The FDA is far from the only culprit in this tragic set of events. The many companies that created morcellators developed a product that upstaged cancer, leading to the needless deaths of many women.

Currently, dozens of families are seeking justice against one of the makers of power morcellators. Litigation against Ethicon, one of the companies that created power morcellators, is taking place in federal court in Kansas. If your cancer has been upstaged due to power morcellation, or if you have lost a loved one, you need to look at all of your options. Fay Law Group, P.A., is devoted to helping individuals and families hold these parties accountable.

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