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

FDA Panel Divided on Morcellators for Fibroids

Published on Aug 11, 2014 at 8:53 am in Product Liability.

Kentucky Medical Device Attorneys Last week, the U.S. Food & Drug Administration convened an advisory panel to consider action on the device known as a laparoscopic power morcellator. In April, the FDA warned that use of the device could spread the cancerous tissue leiomyosarcoma into other areas of the body. At that time, the FDA elected not to ban the procedure, but urged doctors and patients to weight the risks and benefits.

Pros & Cons of Laparoscopic Morcellators

The FDA estimates about 60,000 laparoscopic power morcellation procedures are performed each year. They are used primarily to remove uterine fibroids, which are noncancerous tissues on the lining of the uterus, and for certain hysterectomies.

The morcellator basically grinds up the material, and using it with a laporascopic procedure, means it can be removed with only a tiny incision. Experts have notes that in gynecology, as with other medical practice areas, laparoscopic techniques offer a quicker recovery, less postoperative pain, and fewer wound complications.

The problem is that masses that appear to be benign uterine fibroids may turn out to be cancerous – but so far doctors have now found a way to detect the presence of cancer before the procedure. For the one in 350 patients who do have cancer, the procedure may spread it into your abdomen, with life-threatening consequences.

FDA Panel Weighs Risks

The FDA panel was made up of 15 members, which included oncologists, gynecologists, and other specialists. The panel’s goal was to consider whether the procedure should be outright banned, or allowed for those patients fully informed who choose to assume the risks.

In two days of testimony, conflicting recommendations were heard. Some panelists suggested the FDA issue a “black box” warning on the devices – which is the strongest action available short of a ban.

Others supported a ban, pointing out there is no safe way to utilize the procedure.

Still others pointed out that some women may still want the option of the procedure, especially if they want to preserve their fertility options.

Some have suggested that an encasing tissue be used so that the cut up material can’t spread. However, the panel reviewed that issue and agreed it found  “no evidence to show that containment bags … reduce the risk of spreading malignant tissue.”

According to Web MD:

“The FDA hasn’t set a decision date on the use of power morcellator devices. The agency isn’t obliged to follow the advice or recommendations of its advisory committees but usually does so.”

Meet Your Team

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.

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.

Legal & Firm News

Car Accident Soreness: What to Expect in the Weeks After a Crash

The moments following a car accident are filled with adrenaline, so much so that even if you’re injured, you may not experience pain. But as your body adjusts and your brain’s chemicals return to their normal state, the pain is likely to start. So even if you seek medical attention and have your injuries treated, […]

Read More

Multi-Vehicle Accidents: Who Pays for Chain Reaction Crashes?

You’re driving down the road on your way to work in heavy traffic. Everything seems standard for your morning commute until you’re sideswiped by a passing vehicle and subsequently rear-ended by the car behind you when you brake. Emergency responders arrive at the scene, and you’re treated for your injuries and told to follow up […]

Read More

5 Questions to Ask During a Free Case Consultation

If you’ve been injured in an accident and are looking to pursue compensation from the at-fault party, you may not know where to turn. Fortunately, personal injury lawyers can help accident victims file a strong claim that proves a monetary award is owed.

Read More