MEMPHIS, Tenn. — Starting Friday, April 15, Aetna, the nation’s third largest insurance company, will stop covering hysterectomies and myomectomies that involve laparoscopic power morcellators.
It’s been discovered that the technique to remove fibroids can spread hidden cancer.
The Food and Drug Administration first issued a warning about power morcellation last April, and updated that in November of 2014.
The On Your Side Investigators decided to dig deeper and find out what women should ask their doctors.
48-year-old Maudie Catron has a story millions of women can relate to.
“I was at the age of 25 when I started having longer menstrual periods, cramps were worse than normal,” said Catron.
Catron, like her older sisters, and several female, relatives was suffering from symptoms related to uterine fibroids.
Fibroids are benign tumors that grow in a woman’s uterus.
Some can be as small as a pinpoint, while others are as big as a baseball.
“The pain was just ridiculous,” Catron told WREG at a certain point.
So after several years of monitoring, Catron had a procedure to remove the fibroids, but keep her uterus intact, called a myomectomy.
“It was okay for the first three years,” she said. “Then I started seeing the same symptoms again.”
Catron had already discussed the potential of additional surgeries with her doctor.
Over the course of roughly 15 years, she had two myomectomies, along with embolization, which blocks blood flow to fibroids.
That still wasn’t enough.
“I had a robotic hysterectomy,” Catron said.
Catron did have some complications after two of the procedures, but overall did fine.
The same can’t be said for all women.
Dr. Barbara Duncan-Cody is a gynecologist in Memphis.
She’s seen hundreds of patients with uterine fibroids and used multiple methods to surgically remove them when necessary or simply treat the symptoms.
One technique she’s never used is laparaoscopic power morcellation.
Dr. Duncan-Cody explained how morcellation works.
“They’re round, they’re hard, some like rocks and that’s a technique that’s used to remove that hardness,” she said.
Dr. Duncan-Cody said the device basically breaks up the fibroid.
In the process, however, experts have now learned that using that particular technique can be dangerous.
Uterine tissue can contain unsuspected cancer and breaking up that fibroid could spread those cancerous cells to other parts of the body.
According to the FDA, this is happening in an estimated one in 350 women.
Since last year, the FDA has issued two warnings against using power morcellators in myomectomies and hysterectomies.
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Ethicon, a Johnson & Johnson company, halted sales of power morcellators and later pulled the rest off the market.
The FDA also now requires makers to include a warning label which in part states:
The FDA warns that 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 agency also said patients need to be informed of the risk.
“You need to ask the person who’s going to be doing your surgery, are you planning to do this?” Dr. Duncan-Cody added.
Experts said patients should discuss the risks and benefits of all treatment options, including those which don’t involve surgery.
Women who’ve already had a hysterectomy or myomectomy, and tests of tissue for cancer were negative, don’t have to do anything different. Routine follow ups are fine.
An FDA spokesperson said the agency will continue to monitor adverse reports.
Dr. Katherine Hartmann is an Obstetrician-Gynecologist, Epidemiologist and Deputy Director for the Institute of Medicine and Public Health with Vanderbilt University Medical Center.
She said as the government reviews those negative incidents, it’s also important to gather information from women who’ve had positive outcomes to truly understand what’s at stake.
“We’re just sitting and being cautious, which is what you should do in medicine and saying, we need more data and until we know for sure our patients are safe, we can wait.”
“We’re about to launch this study of which characteristics of the fibroid could flag you to not use that device as opposed to what things might be very re-assuring that there’s low risk,” Hartmann explained.
Despite, the number of surgeries Catron’s had to address her fibroids, she’s glad that unlike previous generations, she at least had options.
“I’m here, I’m healthy behind it and I can tell someone else about it,” said Catron.
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