Paul Tassin  |  September 27, 2016

Category: Legal News

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surgeryA new study shows use of power morcellators has decreased significantly since the FDA warned that they can be a cancer causing medical device.

The study was published in the Journal of the American Medical Association in August 2016. Researchers collected data on over 200,000 women who underwent a hysterectomy, looking for changes in the way surgeons perform hysterectomies following the FDA’s 2014 warning.

They report finding a decline in the rate of minimally invasive hysterectomy.

The researchers reported that abdominal hysterectomies have increased, with no noticeable increase in the rate of complications.

The use of power morcellation in these surgeries dropped considerably within a two-year period surrounding the issuance of the FDA’s warning, according to the researchers’ findings.

In 2013, power morcellation was used in nearly 14% of laparoscopic hysterectomies. That figure dropped to 3% by 2015.

The researchers cautioned that women who undergo surgery using morcellation are still at risk for cancer. “There is a risk of malignancy in women undergoing morcellation, and caution should be used with the procedure,” according to lead researcher Dr. Jason Wright of the Columbia University College of Physicians and Surgeons.

Dr. Wright also noted that despite the increased publicity depicting power morcellators as a cancer causing medical device, the rate of cancer has remained largely unchanged.

Power Morcellators as a Cancer Causing Medical Device

Power morcellators are devices used in laparoscopic surgery to cut tissue into smaller pieces that are easier to remove. They first earned FDA approval in 1995.

In recent years, power morcellators have seen frequent use in gynecological laparoscopic surgery like hysterectomies and myomectomy, the surgical removal of fibroid tissue.

Laparoscopic surgery is a less invasive alternative to other surgical methods, such as open abdominal surgery.

Patients undergoing hysterectomy may also have a third alternative of performing the surgery through the vagina. Laparoscopic procedures generally offer benefits like shorter post-operation recovery time and a lower risk of infection.

Trouble can happen when these devices are inadvertently used to cut into undetected cancerous tissue.

Power morcellators work by shredding tissue using rapidly-spinning blades. These blades can leave behind minute particles of tissue that can migrate elsewhere within the patient’s body.

If this tissue is cancerous, its migration can cause that cancer to spread and rapidly upstage.

The FDA issued its warning in April 2014 and updated it later that November.

In its announcement, the agency warned that when used in gynecological surgery, the laparoscopic morcellator may be a cancer causing medical device.

Adding to the risk is the fact that uterine cancers are notoriously difficult to detect prior to surgery.

The FDA says that there is still no reliable method for predicting or testing whether a woman who has fibroids may also have a uterine sarcoma. By the FDA’s estimates, about one in 350 women who undergo a hysterectomy or myomectomy has a uterine sarcoma that goes undetected.

The FDA now says power morcellators should not be used in patients who are peri- or post-menopausal or are candidates for “en bloc” tissue removal.

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