Safety Concerns over Power Morcellators Due to Cancer-Spreading Risks

Power morcellator have been under public scrutiny in the past few years in light of its cancer-spreading risks. These concerns were brought to light by Dr. Amy Reed, who underwent a procedure using a power morcellator, only to discover that the device had spread a hidden uterine cancer. She developed advanced cancer shortly after her procedure, and has since been a patient advocate. She and her husband, also a physician, have made it their goal to raise awareness about the issue and implement stricter regulations.

Power morcellator are often used during laparoscopic, or minimally invasive, procedures. They mince up the tissue so it can be removed easily through small incisions. Patients who underwent a procedure such as a hysterectomy or myomectomy (fibroid removal) using a power morcellator typically have short recovery times and minimal scarring, although the best way to tell if this device was used is to check with your surgeon. Another possible sign may be if a patient is suddenly diagnosed with an aggressive uterine cancer shortly after the procedure.

In some women, what appears to be a fibroid is actually a type of cancer called a uterine sarcoma. Unfortunately, this cancer cannot be reliably detected prior to surgery. In 2014, the U.S. Food and Drug Administration (FDA) issued a safety alert warning that 1 in 350 undergoing a procedure with a power morcellator had an unsuspected uterine sarcoma. The agency updated the label to include a “black box” warning”. The notification stated that use of a power morcellator in these patients could significantly worsen their prognosis.

There has been criticism over the delayed awareness surrounding power morcellators, since studies showed the devices could spread a hidden cancer years before the FDA released its warning. The Government Accountability Office is now investigating the issue. The issue has also prompted lawmakers, who say it should not have fallen on Dr. Reed to identify this problem, to take action. U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) proposed a new bill called the “Medical Device Guardian’s Act”, which would require physicians to report deaths and injuries related to medical devices. Currently, only manufacturers and hospitals are required to report this. Sponsors of the bill also say it would prevent these reports from being used against doctors in civil lawsuits.

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