Research supports FDA warning about a medical device that could spread cancer
|
Version 0 of 1. Medical researchers have found new evidence to support government agency concerns that a surgical device commonly used in hysterectomies could inadvertently spread hidden and potentially fatal cancers in women. A study by doctors at Columbia University, published Tuesday in the Journal of the American Medical Association, found that nearly 1 in 370 women who undergoes a hysterectomy using a surgical device called a power morcellator is found to have previously undetected uterine cancers. The power morcellator has been the focus of debate since the Food and Drug Administration discouraged its use in April, saying that 1 in 350 women undergoing hysterectomy or surgery to remove benign growths known as fibroids had uterine cancer their doctors hadn’t detected. The device is used to mince large masses of tissue inside the body so the material can be extracted through small incisions. If cancerous cells are present, morcellation can spread them to other parts of the woman’s body. The FDA’s main concern was undetected uterine leiomyosarcoma — a rare and aggressive form of cancer. A number of women diagnosed with Stage 4 ULMS weeks after morcellation, and relatives of morcellation patients who had died from the cancer, spoke out about their experiences. But at an FDA hearing on the role of the device in July, many gynecologists and physicians’ groups said they were skeptical and argued that the benefits of the minimally invasive procedure outweighed the risks. The researchers say their findings add weight to the government’s case. “This is an answer to some of those criticisms and might mitigate the concerns of those who disagree with the FDA figures,” said Jason D. Wright, lead author of the study and chief of the gynecologic oncology division at the Columbia University College of Physicians and Surgeons. “With the FDA figures, they used older studies that just looked at pathology reports for women who underwent hysterectomies — this is a study of recent patients, and also these are numbers specific to women who actually underwent an electric power morcellation,” he said. Wright 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. Doctors who support the continued use of morcellators have argued that the risk of hidden cancer is low for younger women and that morcellation remains a safe option. But Wright and his colleagues found that 32 percent of the morcellation patients found to have undetected uterine cancer were younger than 50. The American Congress of Obstetricians and Gynecologists said in a statement Tuesday that it welcomed the research but noted that endometrial cancers are easier to detect preoperatively. “ACOG continues to recognize that power morcellation can be a treatment option for certain women,” said spokeswoman Kate Connors. The study recognized that it was unable to determine the long-term outcomes for women with undetected cancer who underwent morcellation. The study urged doctors to fully communicate the risk to their patients before surgery. caelainn.hogan@washpost.com caelainn.hogan@washpost.com More from The Washington Post: FDA weigh risks of potentially cancer-spreading device FDA warns against procedure to remove uterine fibroids A common problem few women want to talk about |