Power Morcellators Pulled from Global Markets

Three companies have recalled their power morcellator devices due to recent national concerns over their safety. These devices, used in hysterectomies and other procedures, are now linked to a serious risk of uterine and abdominal cancer.

As we previously posted on our blog, the FDA issued a warning on April 17th urging doctors not to use power morcellators during laparoscopic hysterectomy operations for uterine fibroid removal. The agency reported that one out of every 350 women who underwent uterine fibroid removal had undiagnosed sarcoma, and one out of every 500 had leiomyosarcoma, another form of uterine cancer.

Power morcellators are medical devices that have grown increasingly popular in recent years during laparoscopic hysterectomy and myomectomy procedures. This tool allows the surgeon to cut up the uterus or uterine fibroids, removing tissue through a tiny incision in the abdomen. This is believed to reduce the risk of complications associated with traditional-type of open procedures, minimize scarring and reduce recovery times.

In 2012, published studies revealed that power morcellation procedures were causing devastating illnesses to women throughout the country. In many cases, morcellation has succeeded in spreading undetected cancerous tissue beyond the uterus, making it more difficult to treat. When the power morcellator breaks the tissue into tiny pieces, these small cancerous pieces can travel throughout the body, unbeknownst to the patient or the doctor, and eventually grow into a cancerous growth.

Some manufacturers have said the morcellator procedures will not occur unless the surgical team uses a bag to contain all fibrous and uterine tissue, to help prevent the spread of potentially cancerous tissue.

But many hospitals have banned the use of power morcellators altogether.

In August 2014, two U.S. senators asked the FDA to remove all power morcellator devices from the market. The two senators wrote a joint letter to the federal agency, citing recent studies from Brigham and Women’s Hospital in Boston, which found that the actual risk of cancer spread is nine times greater than patients are currently told.

This is the same study that caused Johnson & Johnson (J&J) to recall three models of power morcellators from hospitals worldwide in April. The FDA has urged all doctors to stop using power morcellators in gynecological procedures. However, the agency has not issued a total ban on these instruments.

Power morcellators are used in spleen and renal surgeries, as well, although they have not been linked to cancers in these organs. A spokesperson for J&J recently told reporters that the risks and benefits of these devices remains unknown, and the decision to remove them from global markets was prompted by an FDA meeting in July 2014.

A growing number of women and families are pursuing uterine morcellation cancer lawsuits against the manufacturers of the devices, alleging inadequate warnings and information provided to patients and the healthcare industry.

There are many ways to remove uterine fibroids without the dangers of power morcellators. Sometimes the quickest way is not always the best way.

If you or a loved one underwent a procedure using a power morcellator and have since been diagnosed with cancer, you may be entitled to compensation for your damages. Contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878) to discuss your options.

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