Dear FDA: Keep Your Boxed Warning about Power Morcellators in Place

There are some very serious side effects associated with the use of power morcellators – side effects that the Food and Drug Administration started investigating in June of 2014. It has been more than a year and half since that initial advisory panel, and in that time the FDA has revised its “black box” warning about the dangers of the device. By revising the warning, the FDA hopes to promote a conversation with patients and their doctors about those side effects, which could potentially save hundreds if not thousands of lives.

What does the FDA warning say?

Because of the risk posed by power morcellators, the FDA’s current black box warning states this:

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids” (emphasis ours).

Not everyone is happy about the revisions, however: “48 gynecologists, gynecologic oncologists, surgical oncologists, department chairs and women’s health advocates said in the letter that they believe the agency’s decision, although well-intentioned to protect against the spread of a rare form of uterine cancer, was based on incorrect data, and it could require tens of thousands of women with benign fibroids to undergo major abdominal surgery each year.”

Now the debate is on: does the FDA rescind its warning, putting some women at risk of having cancerous tissue spread throughout the body, or do they keep the warning in place and risk “forcing” women into complicated surgical procedures? The answer will not be simple.

What are the problems with power morcellators?

When a women has uterine fibroids, or needs a hysterectomy, she has two options: she can undergo abdominal surgery, which needs a long recovery time and puts her at risk of surgical complications – or she can opt to have the procedures done with a power morcellator, a minimally invasive device that breaks down the tissue and vacuums it out. While the choice might seem obvious, there is one major drawback to power morcellators; namely, that they do not always manage to suck out all of the tissue.

In a perfectly healthy woman, that tissue is not an issue. However, if the woman has cancerous fibroids that were not detected before the procedure, that cancerous tissue can and will spread throughout her body. Uterine sarcomas are an especially insidious form of cancerous tissue which cannot be detected until after the procedure has been done. This is because they mimic regular fibroids so well, that there is no way to tell if they are cancerous. Because they are so aggressive, they are likely to metastasize quickly once the tissue is cut loose into the body.

In other words, the only way to tell if a woman has uterine sarcomas instead of (or in addition to) fibroids is to let the cancer spread.

What can you do if you developed cancer after a procedure with a power morcellator?

If you had a hysterectomy or had uterine fibroids removed by a doctor who used a power morcellator, the first thing you want to do is go back to your doctor to be screened for cancerous tissue. If your doctor finds that tissue, you may be able to pursue compensation to help you cover your medical bills and your lost wages, as well as your pain and suffering.

To better protect our clients here in Maryland, Plaxen Adler Muncy, P.A. is teaming up with attorneys around the country to build a network of legal resources for victims. We understand what it takes to create a successful claim for compensation in medical malpractice and personal injury cases like these, and we will be your guides through the process. If you have questions, or if you wish to speak with an experienced Maryland medical products liability lawyer about your circumstances, please contact Plaxen Adler Muncy, PA by calling 410-730-7737 or by filling out our contact form. You do not have to be alone in this difficult time. We will fight for justice so you can focus on your family and your recovery.

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