Power Morcellator Lawsuits Question FDA’s 501(k) Approval Process

November 14, 2015 – – Tracey & Fox reports on details of current power morcellator lawsuits, which bring to light questions regarding the FDA’s 501(k) approval of the product. The lawsuits, which have experienced a recent surge in number, all commonly claim that power morcellator surgical tools can spread cancer in women undergoing hysterectomies or myomectomies. The lawsuits bring forth many new questions regarding the U.S. Food and Drug Associations initial approval, especially due to the fact that the tool was “fast tracked” during its approval process. Now, 20 years after this approval, the FDA has issued warnings linking the drug to the potential for spreading and upstaging cancer.

The FDA’s 501(k) approval process enables manufacturers of medical devices to “fast track” the product’s approval, skipping clinical trials. This is an option if the manufacturer is able to show that the new device is substantially similar to a device currently approved and on the market. Over the last 24 years, according to a report by the Wall Street Journal, the FDA approved 10 power morcellator devices under this 501(k) process.

Today, the approved power morcellator devices are the subject of an increasing number of lawsuits and warnings from the FDA. The tools, used during gynecological surgeries, are designed to enter a woman’s abdomen through a small incision. Once inside, they use small, spinning blades to tear apart uterine and uterine fibroid tissue. The problem is, however, as alleged by the many lawsuits surrounding the product, when the tool tears tissue, it can uncover previously hidden cancer cells, tear these cells out, and spread them throughout the body. This causes patients who may have been previously unaware that they had cancer, to suddenly be diagnosed with aggressive and widespread cancer post-surgery, significantly impacting their chances of survival.

As allegations continued to appear over time, 12 members of Congress requested that the United States Government Accountability Office review the FDA’s prior approval system of the power morcellator tools. According to a report by the Wall Street Journal, these legislators noted concerns that the approval system had become too lax, and that studies had pointed to a significant problem with power morcellators well before the FDA’s warning discussed a potential link to increased risk for spreading cancer.

Currently, lawsuits regarding power morcellators continue to be filed, and the attorneys at Tracey & Fox are working to ensure that everyone involved is able to explore their legal rights. Women who have undergone hysterectomies and myomectomies using the device, and who were subsequently diagnosed with cancer may be entitled to compensation. Tracey & Fox offers free consultations for these individuals.

For additional information concerning power morcellator tools or lawsuits, or to ask questions, please contact Tracey & Fox by calling 713-322-5375.

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Contact Tracey & Fox:

Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002

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