FDA Warns Morcellation May Spread Cancer

In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning about the risk of a morcellation hysterectomy spreading undetected uterine cancer into a woman’s abdomen and pelvis.

Power morcellators are used in more than 50,000 minimally invasive hysterectomies each year to slice the uterus into tiny fragments that can be easily removed through a small laparoscopic incision.

In the event a uterine fibroid is actually an undetected sarcoma,the patient is at risk of the cancer spreading during morcellation. According to a recent study published in the Journal of the American Medical Association (JAMA),about one in 368 women have an undetected sarcoma that can be upstaged during morcellation.

Neither the FDA nor Johnson & Johnson(J&J)have issued an official morcellator recall, but J&J did announce a worldwide withdrawal of all Ethicon morcellators shortly after JAMA published the study about morcellation cancer risks.

The FDA is advising doctors to avoid using morcellators during hysterectomies and carefully consider all other treatment options. The agency is urging women considering a hysterectomy to discuss all available treatment options to determine which treatment is right for them. The FDA is also recommending that all women who have undergone a morcellation hysterectomy contact their doctor to schedule a routine follow-up visit.

Women who were diagnosed with cancer after a morcellation hysterectomy may be eligible to file a morcellation lawsuit and should contact a lawyer.

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Adrianne Walvoord Webb, Esquire

Licensed since 2007

Member at firm Anapol Weiss

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Licensed since 2007

Member at firm Anapol Weiss

RECENT POSTS

  • Morcellation Cancer Risks Reaffirmed
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    AlloDerm is processed, donated human tissue commonly used in oral, cosmetic, dermatological and reconstructive procedures. When AlloDerm is implanted in hernia repair surgeries, the tissue can fail and cause hernia recurrence or other problems. Last week, Anapol Schwartz partner Sol Weiss talked with Lawyers.com about the serious issues associated with AlloDerm failure. Anapol Schwartz is a leader in ... Read more

  • Recalled Kugel Mesh Patches
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    Approved by the FDA in 2006, Bard Davol’s synthetic Kugel Mesh has been used in countless hernia repair surgeries. However,  in 2002, shortly after the large and extra large models were released, patients who were implanted with Kugel Mesh during their hernia repair surgery began complaining  of  the rings in the device breaking, causing injuries ... Read more