HCA Bans All Power Morcellator Surgeries Due to Cancer Risk
HCA Holdings Inc, the largest for-profit hospital chain in the United States, said that it would stop performing power morcellator surgeries for uterine fibroids or hysterectomies due to the risk of spreading uterine cancer to other organs.
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, 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 the 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.
“We are implementing a prohibition of the use of power morcellation in laparoscopic uterine surgery,” an HCA spokesman said Tuesday in an email.
Although the FDA has investigated the complaints against power morcellators, and found that the surgery could be potentially harmful, the federal regulator has not issued a safety recall for the devices, instead increasing the urgency of its safety warning against the devices. Johnson & Johnson, one of the largest manufacturers of power morcellators, has voluntarily recalled their devices for further investigation.
The FDA added to its warning that gynecological surgeons should use other surgical techniques to remove uterine fibroids or perform hysterectomies on women who were peri- or post-menopausal, because the risk of undetected uterine cancer is greater among that age group.
However, many gynecologists have spoken out against the FDA’s warning, saying that it is difficult to diagnose uterine cancer from fibroids and power morcellator surgery is not at fault.
“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.
The Strom Law Firm Protects Citizens Harmed by Delayed Defective Product Recalls
The Institute of Medicine released a report stating that more than one million people are seriously injured every year by defective medical devices in the nation. Just in 2002, the Food and Drug Administration said they heard more than 11,000 reports of hazardous circumstances surrounding medical devices.
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.