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Is The FDA Playing Politics with Power Morcellators?

Published on Nov 25, 2014 at 2:28 pm in Product Liability.

Dangerous Medical ProcedureThe doctor who launched a public campaign against the power morcellator device has published an email accusing the US Food & Drug Administration of dodging the problem.

Doctor Hooman Noorchasm is a cardiac surgeon. His wife, Amy Reed, an anesthesiologist, undertook a procedure with a laparoscopic power morcellator last year that likely spread deadly cancer throughout her body. After Dr. Noorchashm’s public campaign to raise awareness of the dangers of the device, the FDA eventually issued a warning in April.

The devices had been widely used to remove the uterus (hysterectomy) or fibroids (myomectomy). The devices appeared to be a great alternative to traditional surgeries, allowing surgeons to work with a small laparoscopic incision, which is far less invasive and affords quicker recovery times.

The problem comes for women with what appear to be benign fibroids, that turn out after the surgery to be a deadly form of cancer, called leiomyosarcoma. In many of those cases, the prognosis is worsened after the morcellator has sliced up the cancerous tissue and spread it to other locations. Those cancers masquerade as benign fibroids and doctors can’t know in advance what they’re facing.

Part of the current debate is over the prevalence of this cancer. The AMA and FDA estimate that about 1 in 350 or 1 in 370 women will have cancerous tumors – this number is far higher than previously thought.

Will the FDA duck with a “probation”?

Dr. Noorchasm sent an email to FDA officials earlier this month, suggesting it was planning to institute a “probationary period” instead of banning the device from the marketplace.

A debate rages in the industry – some suggest in part due to the high profits surgeons make off of doing a high volume of laparascopic morcellation procedures. Whatever the motive, Dr. Noorchasm says, “Gynecological leadership have responded in overall denial.”

Noorchasm argues that if the FDA knew of a food or drug that caused a similar mortality rate, it would be subject to an immediate recall. “I will remind the FDA regulators of their primary responsibility to protect patients, not industry interests.”

Noorchasm alludes to what is apparently an internal debate within the FDA. He says one group advocates for industry interests and the other wants to protect patient safety. Noorchasm has heard that one faction is proposing to avoid a ban by instead instituting a “probationary period” for the device.

Noorchasm suggests this is a political that doesn’t really do anything while allowing the FDA to claim it has taken some action.

At least one gynecologist has gone on record favoring a ban. Robert Graebe, Director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center told The Wall Street Journal, “Other members of the field favor strict action against power morcellators. What you do about it is: you stop. It’s not worth playing Russian roulette with the patient.”