Pharmaceutical

Medical device makers failed to warn of cancer-spread risk with power morcellation

morcellator Medical device makers failed to warn of cancer spread risk with power morcellationJust one year ago, most doctors were touting the benefits of laparoscopic power morcellation for the removal of uterine fibroids or entire uteruses. Now, evidence shows that the procedure may spread cancer and worsen a woman’s odds of survival.

Power morcellators are surgical tools that mince fibroids or entire uteruses inside the body and then remove the tissue through a small incision in the abdomen. Less invasive than open surgeries, power morcellation also leaves less scaring and offers shorter recovery. As many as 50,000 procedures using power morcellators were performed each year in the United States until recent months, when the Food and Drug Administration (FDA) strongly discouraged the procedure for most women.

What studies began to reveal was that while power morcellation was safe in most cases, in rare instances women who underwent the procedure were later diagnosed with a type of uterine cancer known as uterine sarcoma or Leiomyosarcoma. The device didn’t cause the aggressive form of cancer. Instead, the procedure allowed bits of cancerous tissue to spread within the abdomen and seed new cancer growth, making the disease more difficult to treat.

After delivering her sixth child, Amy Reed developed symptoms related to uterine fibroids that required a hysterectomy. Her doctor recommended she have the fibroids removed by minimally invasive power morcellation. A week after surgery, Amy was diagnosed with Leiomyosarcoma.

The FDA, as well as Health Canada, issued a warning about the devices, but for many women like Amy, the warning comes too late. Manufacturers of power morcellators are facing mounting lawsuits from women and their surviving family members claiming the companies knew the cancer-spread risk with the surgical tools but failed to warn physicians or patients, and instead continued to market the dangerous morcellators.

Source: CBC Radio