Problems with Infuse, a Medtronic BMP product)

[punker]

In today's paper, I came across an article regarding Medtronic, unethical business practices, and a current lawsuit (WSJ, 25 SEPT 2008, B1). The article referred to an earlier piece written that points out some real issues with Medtronic's Infuse BMP product and an FDA alert when using it in the cervical spine (WSJ, 4 SEPT 2008, A1).

I have attached the text of the article, but the highlight is:

The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries, according to reports filed with the agency.

The FDA alert can be found here.

[Harrison]

I read todays article...really incredibly sad! And so is the product off-label use. But thanks for sharing the article!

[punker]

Yes... and I am one of those off-label abused patients.

I really got pulled into the article as I have been having some pain in my throat over the last few weeks. Doctor thought a screw was backing out and ordered an immediate CT scan, which thankfully, proved to show no screw backing out. He was still very concerned with the pain I am having, but is drawing a blank and wants me to wait a couple of weeks and see what happens. When I saw this article, I thought that could be it, but the FDA is claiming this only occurs 2-14 days after surgery.

Still... scary for anyone whom has a doctor pushing this device for cervical use.

For anyone interested in today's article (25 SEPT 2008), I have attached it.

[Harrison]

Punker, have you had a series of imaging studies post-op that show the continued growth of bone? Sorry if you already explained this elsewhere.

[punker]

Yes. I had a CT scan at approximately four weeks, eight weeks, and now twelve weeks post op. The four week scan showed no growth. The eight week scan showed a hair of bone that had bridged both levels. The twelve week scan showed considerable more bone growth than the eight week scan. The doctor was happy with my progress with this last scan. The doctor was concerned with the lack of growth at the four week scan and ordered a bone stimulator for me, which I received on the same day as the eight week scan.

[Toebin]

Punker,

Definitely something to keep an eye on for you. How's the new pain now... is it getting better or still the same?

[Justin]

Punker,

I am sorry you are dealing with this. I wish you the very best... keep us posted.
-Justin

[punker]

Toebin. Pain continued to get worse until a few days ago, when it calmed down to some degree and has remained steady. Odd, especially as the doctor has no idea? It doesn't seem as if this article is the issue with me, as I am much further out than the FDA has dictated. I am attempting to contact them, just to be sure.

Justin. Thank you!

Harrison. Do you think the FDA alert has to do with Heterotopic Ossification or is it something completely different?

[Murph1231]

I missed the part of the pain starting within such a short period of time.

I am currently experiencing pain after PLIF L5S1 with BMP, off label I see. The MRI show's scar tissue, my surgeon states they very rarely have scar tissue cause pain as a result of their surgery. They will be taking a look at the films next week to see if they can id the cause.

Interesting article about BMP. What would stop the material from growth at 12 months out? I'm at 12 months now, and wondering if swelling could be causing the pain.

Thanks for sharing the article.

[Murph1231]

How do we find out what doctors are on the 'investor list'?