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Movement to Ban Power Morcellation Gains Traction

doctors in surgeryThe use of power morcellators has come under increasing public scrutiny recently, following recommendations against their use from the FDA and a public awareness campaign launched by Drs. Amy Reed and her husband, Hooman Noorchashm. Some patients have already filed lawsuits against the manufacturers, claiming the devices led to the spread of life-threatening uterine cancer.

Drs. Reed and Noorchashm recently gained the support of some powerful allies in their fight against power morcellation. America’s Health Insurance Plans (AHIP), a trade association, and two congressmen from the doctors’ home state of Pennsylvania have joined forces with the duo to call for an end to power morcellation.

Congressmen join the cause

Sen. Robert Casey Jr (D-PA) and Rep. Michael Fitzpatrick (R-PA) have tried to start a dialogue with the FDA, asking why the agency has yet to ban the use of power morcellators altogether despite urging healthcare providers to discontinue usage. The FDA also updated the warning label for power morcellators. In his letter to then FDA Commissioner Margaret Hamburg, MD, Rep. Fitzpatrick noted that, “the avoidable nature of this potentially deadly hazard and unwillingness of industry advocates and many gynecologists to abandon this practice. (Power morcellators) may have caused the unnecessary or premature deaths of many hundreds (if not thousands) of American women for over two decades.”

Sen. Casey added some very pertinent questions to his letter to the FDA, asking the commissioner when and how the safety concerns first came to the attention of the FDA; what information the FDA has collected about adverse events related to power morcellators; and whether these adverse events have been definitively associated with a particular brand of power morcellator.

A spokesperson for the FDA, in response to a request for the FDA’s answers, noted that the agency was only responding directly to the congressmen. The congressmen sent their letters to the FDA on February 19, 2015. As of yet, power morcellators have still not been banned from use, which means that more unsuspecting patients may be at risk.

These women may only discover the uterine cancer risk of power morcellation after it’s too late. The numbers of power morcellator lawsuits could rise in the near future.

Life-threatening problems caused by power morcellators

The dangers associated with power morcellators are not necessarily because of the devices themselves, but rather, with an unintended consequence of gynecologic surgery. Laparoscopic power morcellators are used during hysterectomies and myomectomies. The former involves the removal of the uterus, while the latter involves the removal of uterine fibroids. In both procedures, power morcellators work by essentially tearing the large masses of tissue into tiny pieces, which can then be removed through small incisions. This allows patients to opt for minimally invasive surgery, rather than open surgery.

However, as Dr. Reed only learned after her gynecologic surgery, power morcellation can spread an existing malignancy far beyond its point of origin. In other words, as the power morcellator divides the tissue mass, it can cause cancerous cells to be propelled into other structures. This means that a woman with a previously undiagnosed stage one uterine sarcoma may come out of the surgery with stage four cancer, which has a far grimmer prognosis. In these cases, the patient or her surviving family members may choose to file a morcellator lawsuit against the manufacturer.

Medscape, Two Congressmen Turn Up Heat on Power Morcellators,
FDA, FDA warns against using laparoscopic power morcellators to treat uterine fibroids,