Controversy surrounds gynecologic device known as morcellator - KCTV5

Controversy surrounds gynecologic device known as morcellator

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KANSAS CITY, MO (KCTV) -

It's a procedure most Kansas City metro hospitals won't do because of FDA warnings, but the University of Kansas Hospital says there are benefits to using a gynecologic device called a morcellator.

It's used in a minimally invasive surgery to remove fibroids or perform a hysterectomy.

“It allows us to do all the surgeries through smaller incisions which means patients have a faster recovery time, decreased wound infections, decreased complications. They can get back to life much quicker than if they needed a bigger incision,” said Dr. Kimberly Swan, gynecologic surgeon at the University of Kansas Hospital.

That's why Swan's patient Heather chose the morcellator. Her fibroid was causing painful symptoms and she needed surgery, but it came at a busy time in her life.

“I'm finishing up school. I had surgery at the beginning of my semester,” said Heather, who didn't want her last name used.

Fibroids are rarely cancerous, affecting one in 350 women, according to the FDA. But one Philadelphia family said that one case was them and the morcellator made Amy Reed sicker.

“We opted for a complete hysterectomy, but the way they did the surgery, they cut it up rather than removing my uterus whole. They spilled the tissue all over,” Reed said.

Reed and her husband Hooman Noorchashm are Harvard trained doctors - Reed, an anesthesiologist, and Noorchashm, a thoracic surgeon.

The two didn't know she had cancer before the hysterectomy two years ago. They say as soon as they learned about her aggressive form of cancer and found out the doctor had morcellated the uterus, they immediately knew it would spread.

“The FDA is essentially approving devices for marketing which have not undergone stringent enough safety testing, which means there will be other examples like the morcellator out there hurting people being used by licensed physicians in standards of care,” Noorchashm said.

The couple has spent the past two years fighting the FDA to pull the device. The FDA didn't. 

Instead, it issued the most serious alert called a “Black Box Warning,” and urged doctors using a morcellator to use a containment system to keep particles from flying inside the body.

Noorchashm said he's now focused on changing the system in which medical devices are monitored after approval. He just returned last week from a round table discussion with the FDA about ways to improve it's unenforced self-reporting laws.

“It's that minority subset that are blowing through the system because of lack of oversight and found to be unsafe and causing great harm. The cost of it is to the families and to the insurance infrastructure,” Noorchashm said.

The bag used to contain fibroids at the University of Kansas Hospital is generally used for tissue removal. It isn't FDA approved for this particular use.

Swan carefully stuffs the bag into the patient's belly before placing the fibroid inside the container. Once the bag is secured, the morcellator breaks up the growth, all tissue is then contained inside the bag.

Noorchashm fears the morcellator blades could puncture the bag and leave holes the tissue can leak through.

“We comply with every one of the guidelines that the FDA puts forth as a selection process for which patients are appropriate,” Swan said.

Swan said women who are menopausal, have known cancers or someone who has small enough growths that can come out whole through small incisions should not be considered for morcellator use.

“I'm very up front with them. I say, ‘Here's the procedure, I think you're a candidate for it, here are the risks, here are the benefits,'" Swan explained.

For Reed, a mother of six, her cancer was under control until last year when doctors discovered cancer on her spine. They successfully removed it and she has undergone radiation to keep it from spreading.

“Even if you think you don't have cancer, it's still a bad tool. I mean, it still hurts people. People have chronic conditions from healthy tissue sprayed all over,” Reed said.

In Kansas City, doctors at St. Luke's hospitals no longer use the device. A morcellator manufacturer says HCA-Midwest hospitals have also stopped using them, but HCA would not comment when KCTV5 asked about its policy.

You can read the full FDA warning at this link.

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