Have You Been Injured? We're Ready to Fight for You.

Is The FDA Playing Politics with Power Morcellators?

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

Dangerous Medical Procedure The 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.”

Free Case Evaluation

At Thomas Law Offices, our personal injury attorneys recognize that our potential clients are likely going through some of the most difficult times of their lives. We don't want you to have to worry about paying out of pocket for legal advice when you're just starting to learn your legal rights and options. That's why we provide free case evaluations. We'll offer our expert advice about your potential case and walk you through how we can help you.

Call us or fill out the form below to tell us about your potential case and a personal injury lawyer will get back to you as quickly as possible.

Meet Our Founder

Tad Thomas - Trial Lawyer

Tad Thomas

Managing Partner

Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

After graduating with his law degree in 2000 from Salmon P. Chase College of Law at Northern Kentucky University, Mr. Thomas immediately opened his own private practice and began representing injury victims.

In 2011, Thomas Law Offices was established in Louisville, Kentucky. Over the past decade, Mr. Thomas has expanded his firm and now has offices in three additional locations: Cincinnati, Ohio, Columbia, Missouri, and Chicago, Illinois. He is also a frequent lecturer on topics like trial skills and ethics and technology.

Legal & Firm News

When Prior Authorization Leads to Harm Caused by Delayed Care

In March 2023, the American Medical Association (AMA) released the results of a survey conducted on the impact of health insurance prior authorization (PA) on patient care and outcomes. The survey results revealed shocking information about the extent to which health insurance companies control the type of medical care patients receive. At Thomas Law Offices, […]

Read More

How Do I Sue a Hospital for Medical Negligence?

Medical errors and other types of health care professional negligence have soared in recent years. Data recently published by the National Institutes for Health (NIH) shows that at least 251,000 patient deaths are estimated to be attributable to physician mistakes or other types of medical errors annually. Countless others fall ill or suffer injuries while […]

Read More

Ohio Car and Booster Seat Laws

According to the National Highway Traffic Safety Administration (NHTSA), traffic crashes are the leading cause of death and disability for children (aged 0-14) in the United States. But most of these deaths can be prevented. When we put our children in the car, we owe it to them to give them the safest experience possible. […]

Read More
Tad Thomas on The National Crime Victim Bar Association
National Civil Justice Institute - Trustee
Tad Thomas on Lawyer Minds
Tad Thomas on American Association for Justice
Southern Trial Lawyers Association
Illinois Trial Lawyers Association
Ohio Association for Justice
Kentucky Justice Association
Fellows of the Litigation Counsel of America
Martindale Hubbell Preeminent
2021 Public Justice Member
AAJ Masters of Trial Law: Champion