FDA Unlikely to Ban Power Morcellators Despite Cancer Risks to Patients
Despite statements from the FDA urging caution when using power morcellators to perform fibroid surgery, hysterectomies, or other non-invasive gynecological surgeries, the safety regulator is unlikely to outright ban the devices.
“To do no harm, a lot of hospital systems have banned or taken the product off the shelf,” Dr. Chris Walker said in a statement regarding power morcellators. In fact, some insurance companies like Blue Cross / Blue Shield have filed lawsuits against Johnson & Johnson, a manufacturer of morcellators. Highmark, Inc, one of the US’s largest Blue Cross / Blue Shield insurance companies, stated that as of September, it would not cover any gynecological surgeries involving the power morcellators, because of the likelihood that the devices could spread undetected cancer.
Johnson & Johnson, producers of the morcellation devices, have ceased production while the FDA investigates the potential cancer-causing problem.
Morcellation 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 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, 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.
“My impression is that inside the FDA there are two groups of individuals: individuals who are more interested in advocating for industry interests and individuals who understand that the position of the FDA should be to protect patient safety and ensure patient safety. Those two groups of people are basically struggling,” said Cardiac surgeon Hooman Noorchashm, who is leading the fight to ban power morcellators.
On October 9th, plaintiff Lisa Nielson filed a lawsuit against Gyrus ACMI LP, another power morcellator manufacturer, because she believes the device used in her hysterectomy released cancer into her system and led to the development of several tumors in her abdomen.
Another plaintiff, Brenda Leuzzi, died in October of this year after she and her husband, George, filed a lawsuit against Johnson & Johnon’s Ethicon division after the company’s power morcellator device was used during Leuzzi’s surgery. She had undiagnosed uterine cancer that spread through her body after her surgery, and led to her untimely death. She was 44 years old.
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