Pharmaceutical

Major hospital chain bans power morcellation for gynecological surgeries

morcellator Major hospital chain bans power morcellation for gynecological surgeriesHCA Holdings Inc., a for-profit chain of about 160 hospitals and 115 surgery centers in 20 states, announced it will no longer perform gynecological surgery using a laparoscopic power morcellator tool after the Food and Drug Administration (FDA) warned that using the surgical device could spread cancer and worsen a woman’s odds of survival.

Power morcellators are drill-like surgical tools that are used to mince uterine fibroids or entire uteruses inside the body and remove them through small incisions in the abdomen. Since the tools were introduced in the 1990s, they have been favored by many doctors because they are less invasive, require less recovery, and leave less scar tissue than more traditional open surgeries for hysterectomies or myomectomies, or the removal of uterine growths. About 50,000 of these procedures using power morcellation are performed each year.

Uterine fibroids are benign, but in rare cases a type of uterine cancer known as uterine sarcoma could be embedded in the uterus or fibroids. If cancer is present, morcellaton can leave bits of cancerous tissue that can seed and lead to additional cancerous growths, making the cancer more difficult to treat. There are no reliable ways to detect this type of cancer without first removing the uterus or uterine growths.

In December 2013, the FDA began investigating cancer-spreading risks with the devices and in April the agency discouraged morcellation procedures. Last month, the FDA announced that the devices should not be used in the “vast majority” of women because of the cancer-spreading risks. The FDA also ordered manufacturers to add a black box warning to the devices explaining this risk.

The FDA did not ban the surgical tools outright despite pressure to do so. The agency said in some instances power morcellation for fibroid removal would be acceptable, for example for young women who want to preserve their uterus, as data suggests these women face a lower risk of uterine sarcoma.

Experts say HCA Holdings’ move to ban power morcellation for gynecological procedures marks a significant shift in the heated debate whether to keep the surgical tools on the market.

Source: WSJ