FDA and Lawyers Warn Cancer Patients of Morcellator Risks

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(Newswire.net — September 7, 2015) –It’s been nearly a year since the U.S. Food and Drug Administration (FDA) issued a warning about the use of power morcellators and their relationship to uterine fibroids in surgical procedures. However, the debate and controversy surrounding these devices is still raging – both in courtrooms and hospitals. For doctors, patients, and their family members, it’s important that a definitive conclusion is reached. Either power morcellators need to be banned by the FDA, or they need to be deemed safe.

The Problem with Morcellators

Technically speaking, there’s nothing wrong with power morcellators themselves. The devices work as advertised – cutting up large pieces of tissue into more manageable sections that can easily be removed from the body in a minimally invasive fashion. It’s what the device does when it comes into contact with undetected malignant cancer cells that’s troublesome and potentially deadly.

It’s been determined that when morcellators come into contact with cancer cells, they can actually spread those cells into other regions of the body that it previously had not reached. This is what led the FDA to release a warning in 2014. The Safety Communication officially warned against the use of power morcellators during myomectomies and hysterectomies after it was determined that 1 in 350 women undergoing these treatments had undiagnosed malignant cancer.

Aftermath of FDA Warning

“In the aftermath of the FDA warning, successive hearings and recalls, hospitals, medical facilities and surgeons are avoiding using power morcellator devices,” Rosenfeld Injury Lawyers point out. “This is because there is still no reliable way to test the patient for fibroid tumor cancer.”

While Johnson & Johnson, the leading manufacturer of power morcellation devices, has recalled its devices and asked users to return any units they own, there’s still a great division among surgeons, health care facilities, and manufacturers regarding what to do.

Patients are obviously outraged and healthcare providers are annoyed over the fact that they’ve been placed in harm’s way for using a supposedly safe device. But according to Shezad Malik, MD, JD, the origin of the problem goes back to the pre-market testing requirements.

Power morcellators fell under the controversial 510(k) program which say manufacturers only need to show that devices are “substantially equivalent” to similar devices already on the market As a result, power morcellators were approved without any safety testing whatsoever.

Black Box Warning

In addition to releasing a written warning, the FDA has also added an official Black Box Warning – which is the strongest warning that can be placed on an approved medical device. Doctors are now required to discuss potential dangers with patients, and the FDA has formally directed surgeons not to use power morcellators with women near menopause or post-menopause.

Many women have already filed lawsuits in federal courts and many more are expected to file their own claims in the coming months. With so much negative backlash, and much more risk than reward, it’s a wonder that the FDA hasn’t come out and placed a total ban on the use of power morcellators.

The Society of Gynecologic Oncology, though, is one such body that still supports the use of morcellators. “The FDA would not approve a device using such low-quality retrospective data,” the official statement reads. “It is concerning that the FDA would now consider banning a device with a similar low level of evidence.”

The Future of Power Morcellators

As you can see, the issues surrounding power morcellators have yet to be sorted out. The FDA has taken a stance, but some believe it isn’t strong enough. Others believe it’s based on weak evidence and hasty decision-making. Everyone is entitled to their own opinions, but something needs to be done. Either the FDA should implement a full ban on the devices, or they need to invest in studies that provide stronger evidence of the risks that do or do not exist.