Two Philadelphia women recently filed lawsuits alleging that they developed cancer after power morcellators were used during their laparoscopic hysterectomy procedures. The Philadelphia women allege in their lawsuits that the manufacturer of the laparoscopic power morcellators used in their robot-assisted surgical procedures, Olympus Corporation and its subsidiary, Gyrus ACMI, failed to warn of the cancer risks associated with the use of power morcellators, failed to design the morcellators so that they do not spread undetected cancer cells, and misrepresented the morcellators as being safe to use.
Power morcellators are used to break up tissue so that the tissue may be more readily removed from the body. Many power morcellator cancer claims allege that an unintended effect of using power morcellators is that undetected uterine cancer cells are spread into the pelvic and abdominal cavities where they may spread throughout the body.
The FDA issued a safety communication regarding power morcellators on April 17, 2014, which it revised on November 24, 2014, which stated, in part:
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
If you or a family member had surgery during which a power morcellator was used and you were subsequently diagnosed with cancer, you should promptly seek the legal advice of a power morcellator claim attorney in your U.S. state who may investigate your morcellator claim for you and represent you in a defective medical device lawsuit, if appropriate.
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