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Study Supports FDA Concerns about Power Morcellators

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Every year about 50,000 women have their uterus removed to prevent the possibility of uterine cancer. Most will undergo a minimally invasive procedure called power morcellation, which “uses a device to cut uterine tissue into pieces before removal through small incisions made during minimally invasive surgery.” NYT

Back in April the FDA issued a warning about the use of power morcellators   and earlier this month reissued that warning after a two-day government hearing.   Most of the doctors present at the hearing agreed there is some degree of risks, however the American Congress of Obstetricians and Gynecologists maintains that morcellation may be the safest option for most women.

Last Tuesday the Journal of the American Medical Association  released results of a study by doctors at Columbia University that adds support to the FDA’s concerns about the use of the power morcellator.  “Jason D. Wright, lead author of the study and chief of the gynecologic oncology division at the Columbia University College of Physicians and Surgeons, and his colleagues used a large insurance database to identify more than 36,000 women who underwent a hysterectomy using a power morcellator at 500 U.S. hospitals from 2006 to 2012. Undetected uterine cancer was found in 99 of these patients, or 1 out of every 368 women in the database.”

This study provides more recent statistics than those used by the FDA and validates the concerns about power morcellation. The study also found age to be the greatest risk factor for uterine cancer, increasing sharply from age 50 to 65 and up.

Morcellation proponents argue that the benefits of the procedure greatly outweigh the risks.  The benefits include a smaller incision, fewer complications and shorter recoveries.  On the flip side, opponents call the risk of spreading cancer cells too high, especially when there are alternatives that are reasonable and safe.

Early last month, Johnson & Johnson withdrew  laparoscopic power morcellators from the market.  Johnson & Johnson is expected to notify customers via letter to return the devices.

The debate seems to center around convenience as much as it does patient health and safety.  No one really wants to undergo surgery and few women would eagerly opt for being cut open if a less invasive, faster option is available—particularly if it means a shorter recovery time. But, if the possible risks include the possibility of an undetected cancer which can be spread due to a procedure the conversation needs to change. We will hear more in the upcoming months as doctors continue to study available data and work to find safer ways to effectively treat uterine cancers and fibroid tumors. For now the FDA has a little more evidence to back up its claim that the use of power morcellation should be undertaken with the utmost caution.