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FDA Panel Divided on Morcellators for Fibroids

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

Kentucky Medical Device AttorneysLast 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.”