Blogging about life in Minnesota, raising our six kids with Down syndrome while battling Breast Cancer.

Be the kind of woman that when your feet hit the floor in the morning the devil says, "Oh shit! She's up!"

Wednesday, August 15, 2012

When God Intervenes: Spinal Fusion Warnings

photo Kelley Law Group, P.C.

I need to take you back to April of 2011. I, along with an entire group of people from around the country, was to be leaving on a trip to Serbia. I needed to meet up with the group in D.C. so we could fly together to Serbia. My friend Kaci had a terrible time finding a flight for me. Finally she found ONE seat on ONE flight that would get me to D.C. in time to catch the group's flight to Europe.

One seat. On one flight.

I wrote this post about that flight. Here's part of what I wrote:

The day was full of "You've got to be kidding me God!" moments. Like my flight from Minneapolis to DC, and the person I sat next to. You see, for Axel's upcoming surgery, his surgeon planned on using a synthetic product called BMP in Axel's neck instead of taking a bone graft from his hip like they do with the younger kids. But BMP  has been in the news recently, and after doing what research I could about it, I'd asked his surgeon so specific questions, which he answered, but I was still feeling uneasy about it. 
Until yesterday. (was it yesterday? I don't know what day I'm on. That flight was on Friday LOL)  Anyway, the man I sat next to was really nice. He and I spent the entire 2 hr flight talking about our families. He has two boys, and of course I used to have a houseful of them at home. I  had shared about Axel, and the upcoming surgery, and about our dilemma over the product that was going to be used in Axel's neck. All during this conversation, the man didn't share WHY he'd been in Minneapolis, just that it has been a business related trip. Finally, about 20 minutes before we landed, I asked, "So what exactly do you do for business that brought you to Mnpls?"
He's an attorney for Medtronic, the company that produces the product going in Axel's neck. He gave me a lot of information (at least what he was able to share due to legal issues ) about the stuff that's been happening with the FDA investigations surrounding BMP. "Don't let them put that product in your child's body." he said. Although the FDA hasn't pulled it from the market for cervical spine repairs, he said it won't be long before it is. Now he's not a malpractice attorney, he is defending the company who PRODUCES the product.
I ended up emailing Axel's surgeon somewhere on the trip and told him abou the conversation, and that based on that plus what I'd read a month or so ago, NO, we do not want that product put inside our child. I did get an email back from him saying he's comfortable with our decision since it is an informed one. This means Axel's surgery will have a different component to the healing process (he'll have to heal from hip surgery at the same time as the neck stuff) but that's how the little kids are done so I'm confident all will be well.
 I have heard BMP in the news a time or two since then, but tonight I saw an ad for a class-action suit against Medtronic, so to google I went. Wow! It didn't take much effort to turn up article after article about the lawsuits involving the use of BMP. Most of the sites are ad sites put up by attorneys, so I went looking for real information.

The June 2011 issue of the North American Spine Society published this article. (remember my conversation with the attorney took place in April 2011) and The Spine Journal published this article calling for an end to "Years of Living Dangerously".

BMP was designed for lumbar (lower back) fusions, however Medtronic was encouraging the use of off-market use - that is use that is not FDA approved - including using the product for cervical (neck) spinal fusions, which is where Axel's surgeon planned on using it.

In April 2012, Medtronic settled a lawsuit over misleading statements regarding Infuse to the tune of $85 million dollars.


vicky said...

Yikes! Close call!

Unknown said...

I remembered that post and thinking how God works in mysterious ways. So thankful you were in the "right place" at the "right time."