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FDA Approves Morcellator Bag

For decades, a device known as a morcellator was used in tens of thousands of hysterectomies and uterine fibroid removal procedures. The power morcellator ground body tissue into small fragments, allowing for its easy removal. As a result, women undergoing hysterectomies and fibroid removal procedures had faster recovery times.

There is one critical flaw with morcellation, however. For women who had undiagnosed uterine cancer, the morcellator would spread the cancerous tissue throughout the abdomen. A relatively treatable Stage 1 cancer would turn into Stage 4 cancer within weeks. Very often, women would die as a result. The Food and Drug Administration (FDA) estimates that roughly 1 in 350 women undergoing morcellation had undiagnosed uterine cancer.

In 2014, the FDA issued a black box warning on morcellators. Furthermore, more than 100 individuals and families brought claims against the manufacturers of these devices. Recently, however, the FDA approved the use of a "tissue containment system" that could prevent the spread of cancerous tissue. This device, known as the PneumoLiner, was created by Advanced Surgical Concepts, Inc., an Irish company. While the device is intended to prevent cancer from spreading, the Pneumoliner has a warning stating "The use of this containment system has not been clinically demonstrated to reduce this risk."

Despite approval, the FDA maintains its opposition to morcellation

The FDA appears to be giving the public mixed messages on morcellation. While it has approved this device, it has not lifted its black box warning on morcellation. The FDA has approved the use of the Pheumoliner in limited instances and maintains that morcellation is not appropriate for the vast majority of women. Despite these warnings, it remains to be seen whether this device will increase the use of morcellation.

Dozens of families are settling morcellator claims. If you have been injured or lost a loved one, you need to act.

As stated above, more than 100 individuals and families filed claims in federal court against Johnson & Johnson for the harm caused by power morcellators. In recent months, Johnson & Johnson has been settling these claims. If your cancer spread due to morcellation, or if someone you love has died or been harmed due to power morcellation, you may be entitled to compensation.

Based in Washington, D.C., the attorneys of Fay Law Group, P.A. maintain a national practice. We are part of this litigation, and are ready to help you take action in support of your claim. Call 800-522-2715 to set up a free consultation.

Source: FDA approves morcellator bag to prevent cancerous tissue spread, by Michelle Llamas, drugwatch.com

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