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Morcellators are surgical devices used in laparoscopic surgery. This type of medical procedure – surgery conducted with cameras and tiny incisions – is used for the removal of internal masses by breaking up (or morcellating) the masses into smaller pieces so that they can be more easily removed. Power morcellators are long, bladed instruments that can be inserted into the abdomen via a small incision. The morecellator cuts the uterus or other tissue into smaller pieces that can be easily removed through the small incision. Morcellation procedures are not unlike laparoscopic surgeries, and as such can be preferable to other options because they minimize scarring.
These medical devices, manufactured and distributed by a variety of different companies, are often used on women in gynecological procedures. The Department of Justice and the FBI are investigating the devices to find out when the tool’s largest manufacturer, Johnson & Johnson and its Ethicon unit, knew about the dangers. While J&J pulled their device from the market last July, many other manufacturers continue to sell the morcellators.
An FDA safety warning was issued in April 2014 regarding potential hazards of morcellation. In its warning, the FDA announced it discourages use of laparoscopic power morcellation for removal of the uterus or uterine fibroids because it posed a risk of spreading cancerous tissue. Subsequently, the FDA gave the dangerous medical devices a “Black Box” warning in November 2014, advising surgeons to stop using the morcellators when operating on most women.
With uterine sarcomas and other forms of uterine cancer, the malignant cells are often hard to see, so the breaking up of tissue can spread cancer unknowingly throughout a woman’s pelvic region. There is in fact no way to know if malignant cancer cells are present prior to the use of morcellation, as confirmed by the Society of Gynecologic Oncology, making it impossible to tell if morcellation should be avoided or not in certain patients.
In addition, healthcare providers have been discouraged from using morcellators for hysterectomies or in women with known or suspected cancer. According to the FDA’s warning, an estimated 1 in 350 women who undergo a hysterectomy or removal of uterine fibroid tissue has an undetected uterine sarcoma that poses a significant risk if morcellation is used.
If you or someone you was diagnosed with uterine cancer after an operation using a morcellator, you have a limited time to act. Contact Kirkendall Dwyer immediately to discuss your potential case.