Pharmaceutical

FDA warning about cancer spread with morcellator gynecological tool comes 20 years too late

morcellator FDA warning about cancer spread with morcellator gynecological tool comes 20 years too late For many people, the Food and Drug Administration’s warning to physicians to stop using a morcellator, a type of surgical tool used in about 50,000 gynecological procedures annually in the United States, seemed to come out of nowhere. But the message was startling: Use of the device could result in the spread of hidden cancer and, ultimately, worsen the odds of a patient’s survival.

The warning was issued last month after multiple cases emerged this year of women whose cancers were worsened after undergoing hysterectomies or myomectomies (uterine fibroid removal) with a surgical tool known as a laparoscopic power morcellator.

Power morcellators are usually fitted with a tube-like blade that chops up uterine growths or entire uteruses inside the body and removes them through a small incision in the abdomen. The procedures are preferred by most doctors because they are less invasive, leave less scar tissue, and offer less recovery time than traditional open surgeries.

What researchers have learned is that in rare cases a type of uterine cancer known as uterine sarcoma is present in the uterus. In these cases, morcellation can spread bits of cancerous tissue throughout the abdomen, seeding new tumors and making the disease more difficult to treat. Since there is no reliable way to detect uterine sarcoma without first removing the uterus or the fibroids, doctors were essentially playing a game of Russian roulette with patients every time they performed surgery with the devices.

Since 1991, when the tools were first introduced, the FDA has approved at least 10 morcellators from various manufacturers including Johnson & Johnson. The surgical tools were approved under an expedited process that allows medical devices to reach the market faster if similar products are already on the market. Some researcher say that the power morcellator tragedy is just another example of an approval process that allows medical devices on the market before their safety and efficacy has been thoroughly tested.

It took more than two decades for the adverse events associated with power morcellation to come to light and lead to FDA action. The warning, however, is too late for many. Victims of power morcellator cancer spread and surviving family members continue to petition the agency to ban the devices. Dozens have taken their fight against manufacturers to court, filing lawsuits claiming the medical devices companies failed to warn patients of the serious risks.

Source: WSJ