FDA Not Likely to Ban Hysterectomy Machines, Says Doctor

Wednesday, November 12, 2014

The doctor leading the charge against the use of power morcellator devices for hysterectomies and myomectomies says the FDA is likely to add restrictions, but will not ban their use.

Dr. Hooman Noorchashm, a cardiac surgeon, began a full-time effort last fall to bring the dangers of the surgical devices to light after his wife, anesthesiologist Dr. Amy Reed, developed accelerated uterine cancer following a laparoscopic fibroid removal.

In the year since, the FDA has opened an investigation into the machines, the primary manufacturer has stopped selling them, and the American Medical Association has warned of their risks.At the heart of the debate is whether the slim morcellator blades, which ground up tissue for easier removal and smaller incisions, also spread undetected cancer cells.

The AMA study found 1 in 370 women who have the procedures may have early-stage uterine cancer that is impossible to detect, but that is greatly accelerated when minced up and spread to nearby areas.

In April, the FDA said the odds might be closer to 1 in 350. A panel assigned to investigate the risks suggested options ranging from greater warnings to patient release forms to a full ban, but the agency has yet to make a decision.

However, groups representing the doctors who profit from performing a high number of the surgeries, as many as 75,000 a year until this year, have come out in their defense. They say the chances of undetected cancer are closer to 1 in 7,500.

The good news is, after surgery and six rounds of chemotherapy in the past year, Dr. Amy Reed no longer shows signs of her uterine cancer. However, others haven’t been so lucky.

Now, in a recent interview, Dr. Noorchashm says the power struggle within the FDA will keep it from banning morcellator devices in hysterectomies.

He explained that the agency’s Center for Devices and Radiological Health (CDRH) is promoting a plan to put morcellators on probation, while its Office of Policy and Planning wants more aggressive action aimed to protect patients.

Caught in the middle are patients and doctors, who don’t have guidance on what route to take if a hysterectomy or fibroid removal is needed.

Those who’ve developed cancer after undergoing a laparoscopic hysterectomy or myomectomy with a morcellator may also have legal rights to significant financial help. Lawyers have begun filing lawsuits against the manufacturers for failing to warn of the deadly risks.

DrugNews will keep you updated of any new research or FDA action regarding hysterectomy morcellators. If you have further questions, or need help selecting a lawyer, contact us today.


Sources:

Saxena, V. Power Morcellation Ban Unlikely, But Other FDA Restrictions Coming Soon. Fierce Medical Devices. (November 7, 2014). Retrieved from http://www.fiercemedicaldevices.com/story/power-morcellation-ban-unlikely-other-fda-restrictions-coming-soon/2014-11-07

morcellator
morcellator
device

Other drugs and devices in the news:

Thursday, January 17, 2019
3M Earplugs
3M Knowingly Harms Troops: Supplies Defective Combat Earplugs

Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.

Monday, October 8, 2018
Essure
FDA Adds Restrictions to Use of Essure Birth Control Implants

The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.

Get in touch with us.

Call, email or live chat with us today to see how we can help.

Need a quick answer? Call us!
Reach out to us by email.
We are here to help now