FDA Issues Stronger Warning Against Power Morcellator Cancer Problem, But No Recall
After first issuing a warning against power morcellators, especially when used in uterine fibroid removal surgery, the FDA has strengthened its warning regarding the device’s potential to spread undetected cancer into other organs in a woman’s body. Despite the warning, the federal regulatory agency has not issued a recall for the devices.
Morcellation, the type of surgery involving power morcellators, is supposed to be a simple, non-invasive procedure in which the laparoscopic device is used to find fibroid tissue in the uterus, and grind it down so that it may be removed through a small incision in the abdomen. Uterine fibroids can cause pain and annoyance with menstruation, so many women choose to undergo the surgery to reduce those complications. However, grinding down fibroids, which are assumed to be non-cancerous, can actually cause the spread of cancer when a tumor is ground down.
According to FDA estimates, as many as 1 in 350 women have undetected uterine cancer that can look like fibroids, and the cancerous tissue can be ruptured with power morcellator surgery. The previous rate was estimated at 1 in every 7,000 women.
Power morcellators have also been used for less-invasive hysterectomies, but the FDA has become concerned that use of those devices in that type of surgery can also cause serious personal injury, and spread undetected uterine cancer throughout the abdominal cavity.
On Monday, November 24th, the FDA said that the “vast majority” of women with uterine fibroids should not undergo power morcellator surgery to remove the problem, due to the potential of undetected uterine cancer being spread.
“Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids,” the agency said in a statement. “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”
The FDA recommends using a “boxed warning” for all power morcellators, and will issue guidelines for when the devices can safely be used in patients.
Some gynecologists disagree with the FDA’s guidance, and says that some of what the FDA has stated about power morcellators is misleading.
The main problem is not the tool itself, but the fact that there are no good tests to distinguish between a uterine fibroid, which is benign, and a cancerous tumor. “The overwhelming majority of fibroids are totally benign fibroids,” said Dr. Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists, who disagrees with the FDA’s decree against power morcellators.
“The FDA’s primary concern is the safety and well-being of patients, and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the agency’s news release. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
The Strom Law Firm Protects Citizens Harmed by Delayed Defective Product Recalls
The attorneys at the Strom Law Firm keep a close watch on recalls of dangerous and defective product recalls in the US. We aim to protect our clients’ health and safety, and hold manufacturers to the highest possible standard of safety. If you or a loved one have experienced severe, life-limiting side effects from a defective product or drug, and believe that your pain stems from a product recall that came too late, you may be entitled to compensation. The Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.