Despite Possible Spread of Cancer, Gynecologists Urge FDA to Reconsider Stance on Power Morcellators
However, the FDA received reports that women who had undergone surgery with power morcellators were being diagnosed with cancer – especially uterine cancer after fibroid surgery.
Power morcellator surgery is supposed to be a simple, non-invasive procedure in which the laparoscopic device is used to find fibroid tissue in the uterus. Once located, the morcellator is used to grind fibroids down to 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, could 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.
Johnson & Johnson, producers of the power morcellators, have ceased production while the FDA investigates the potential cancer-causing problem. At the same time, many insurance companies, such as Blue Cross Blue Shield and Highmark Insurance, have ceased covering power morcellator surgeries. The University of Pittsburg Medical Center (UPMC) was one of the first university medical systems to refuse to treat patients who wished to undergo power morcellation.
However, gynecologists argue that morcellators are the best tool for hysterectomies and removal of uterine fibroids. The surgery is, despite the cancer risks, minimally invasive, which leads to shorter hospital stays and faster recovery times. Gynecologists criticize the FDA for “spooking” women about morcellators, when it could be the best health option for many women with chronic fibroid pain or who need at least a partial hysterectomy.
Fortunately, after the FDA’s concerns about morcellation, gynecologists and surgeons have begun clearly discussing the risks and benefits of morcellators with their patients.
“I always caution and say, ‘It doesn’t mean you’re not going to be the one,’ ” to have undiagnosed cancer, said Atlanta gynecologist Dr. Michael Randell. He also tells his patients that, so far, he has never seen a case of uterine cancer caused by fibroid removal surgery.
Still, many doctors are on board with the FDA’s criticism, and have witnessed cases of morcellator-caused cancer. “I see these patients—it’s terrible,” said Mark Wakabayashi, co-director of the Gynecological Cancers Program at City of Hope hospital near Los Angeles. “That makes no sense to think that when you cut through these cancers that you don’t do harm. That’s actually kind of scary.”
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.