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Power Morcellation Recall Information

Women undergoing laparoscopic myomectomies and hysterectomies should be aware of a serious cancer risk. Using medical devices known as power morcellators during these surgeries can cause undetected cancer tissue to spread to other neighboring parts of the body. The serious nature of this risk has prompted government agencies to warn doctors and the general public of the risks. Manufacturers have moved to suspend power morcellator sales worldwide. This article provides a general overview of the problem and considers the possibility of a power morcellation recall.

How Power Morcellators Work

Power morcellators are medical devices that perform a specific function during laparoscopic surgery. During surgery, a power morcellator is used to cut up targeted pieces of tissue inside the body. This allows for tissue to be removed from the body without the need for large surgical incisions. Once the targeted tissue is cut up into smaller pieces, it can be laparoscopically removed using a small incision into the abdomen. This process allows for organs, growths, and other tissue to be removed using less invasive surgical techniques. The result can be shorter surgical procedures, shorter patient recovery periods, and less scarring on the abdomen following surgery.

The Power Morcellation Problem

Myomectomies involve the surgical removal of uterine fibroids from the uterus. These benign growths are common among women and usually don’t require surgical removal. Hysterectomies are more significant procedures involving the entire removal of the uterus. There are a variety of reasons why women undergo hysterectomies, some related to cancer and some unrelated to cancer. Power morcellators have been used in both of these procedures to reduce the need for larger incisions into the patient's abdomen.

The problem with power morcellation comes from the risk of undetected cancer cells in the uterus. An estimated 1 in 350 women undergoing these procedures has undetected uterine sarcoma, a form of cancer affecting the muscle and supporting tissue of the uterus. Power morcellation can inadvertently cut up cancerous tissue along with the targeted tissue. When this occurs, cancer cells can spread to neighboring parts of the body. This can significantly worsen the long-term outlook for patients.

FDA Alert

The U.S. Food and Drug Administration (FDA), the federal agency responsible for the safety of medical devices, has already taken action. In April 2014, the FDA warned doctors and the public that laparoscopic power morcellation shouldn’t be used in myomectomies and hysterectomies. The agency specifically cited the risk that power morcellation could unintentionally cause undetected cancer cells to spread in the pelvis and abdomen. While the likelihood of this occurring is limited to an estimated 1 in 350 patients, the serious nature of the problem prompted the agency to officially discourage the use of power morcellators during these two procedures.

FDA alerts carry considerable weight within the medical community, with the public, and with consumer attorneys. They also attract widespread media attention. Many manufacturers will take action once serious questions about the safety of their products are raised in public. The controversy surrounding power morcellators is no exception.

Potential Power Morcellation Recall

The FDA's alert prompted some manufacturers to take action. Shortly after the FDA's alert, Johnson & Johnson suspended the sale of its power morcellator units worldwide. The company announced that this was merely a temporary suspension until more definitive information about the problem became available. Companies often temporarily stop selling a product before taking more permanent action. However, three months later, Johnson & Johnson voluntarily withdrew the power morcellators from the market. Johnson & Johnson has sent letters to the doctors and hospitals who ordered their three models of power morcellators: Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma, asking them to return the power morcellators to the company.

A voluntary market withdrawal by one manufacturer is different from a recall imposed by the FDA. The potential for a recall still exists. The FDA is currently evaluating data to learn more about the risk that power morcellators pose to patients undergoing myomectomies, hysterectomies, and other surgical procedures. This evaluation may eventually prompt the FDA to request all manufacturers to initiate voluntary recalls of their power morcellators. In the meantime, if you've been injured as the result of a power morcellation procedure, it's in your best interests to consult with a product liability attorney.

Next Steps
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