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On Special Assignment: Medical Device Dangers - KPAX.com | Continuous News | Missoula & Western Montana

On Special Assignment: Medical Device Dangers

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MISSOULA -

Most of us trust that when we go 'under the knife' for a surgical procedure, things will go smoothly and we'll feel better quickly, but that doesn't always happen.

The U.S. Food and Drug Administration tracks problems with drugs and medical devices and alerts doctors and patients that something is wrong so that it can be taken off the market or used only in specific situations. 

But that information doesn't always come fast enough. Jill Valley went On Special Assignment and found what happens when those warnings come too late.

"It's going to be so hard for my daughter. It's hard for me, but I feel so bad for her because she doesn't have her mom," Ray Curtis said.

This Christmas will be the first that the Curtis family will spend without their beloved Nancy -- a wife, mother and popular teacher at Missoula's Sentinel High School. Her photos, her spirit, her love still fill the family home.

Nancy died last December, two years after what was supposed to be an easy, common even simple procedure to remove uterine fibroids. Her family had no idea that surgery was her death sentence.

"The physician said 'well, this will be easy, routine, we'll do it laparoscopically, robotically'. I don't think we heard it at the time -- a morcellator," Ray said.

A power morcellator is a device that dissects a fibroid or uterine tumor to remove it. But in 2014 -- eight months after Nancy's surgery -- the FDA issued a warning if this device it's used in women with undiagnosed uterine cancer there is a risk the morcellator can essentially stir up cancer cells and spread them throughout the body.

That's what happened to Nancy. Within a month, her small, previously undiagnosed cancer went quickly from Stage One to Stage Four very quickly and she was in for the fight of her life. In less than two years she died at the age of 53.

The Curtis family had no idea the danger the morcellator posed.

"Initially, I think doctors though this happens occasionally. Now the FDA said there's a 1-in-350 chance this can happen to them..a lot more common than we initially thought," Andy said.

Common enough that Nancy's story got the attention of Montana Congressman Ryan Zinke who is co-sponsoring the Medical Device Guardian Act requiring doctors to report unsafe medical devices to the device manufacturer and the Food and Drug Administration so they don't linger on the market, hurting people.

"With pharmaceutical companies, what's important is transparency, making sure they're held accountable like all corporations. This bill does that. It's an important health care issue, especially women's health as we look at the changes in frontier states like Montana," Zinke said.

Crystal Combs is 37 with four children and back in 2005, she opted for the implantable permanent contraceptive device called Essure. It's a procedure where coils are implanted into a woman's Fallopian tubes to create scar tissue, preventing pregnancy. The non-surgical procedure seemed perfect until she started experiencing odd symptoms.

"Bone pain, migraine, hair falling out, joint pain -- I was always sick. A cold would put in in bed for two weeks," Combs said.

Miserable, she stumbled upon a Facebook page called Essure problems where more than 30,000 other women claim Essure has terrible side effects.

Just last month, the FDA finally released a black box warning for Essure alerting doctors and patients there are significant side effects. It's the sternest warning a drug or medical device can get while remaining on the market. 

But that warning was not good enough for Essure opponents who want it off the market.

Loss and heartbreak has pushed many to tell their stories and Nancy's has already helped some women faced with the same surgery -- something Ray says, she would have liked.

"We started this before she died. I would have been angry but she said people need to know about this," Andy said.

The Curtis family held an event called "Nancy's Walk" last month to help bring awareness to sarcoma--the cancer she battled so bravely.

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