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Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 12, 2023 04:53PM
I had been thinking about getting a Watchman implanted, but an Afibber friend sent me this article in which it is explained that part of the Watchman is made up of 50% nickel and 50% titanium. It also states that 15-20% of women have an allergy to nickel, and I believe I am one of them. And I may also have an allergy to titanium. If that is the case, one cannot get a Watchman.

I don't know if the EP who implants these devices does a test for these metals, but some of you who have had the Watchman implanted may know. Thanks for your feedback.

Below is a link to the article: "Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy, Published April 22, 2019
[a-fib.com]
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 12, 2023 06:48PM
Allergy testing isn't routinely done. It's only done if the patient suspects they may have an allergy. I know that at least one person here who got a Watchman from Natale had a Watchman taped to their chest for a while to test it (about a week, I think).

And I'd be careful taking that article at face value. In the Watchman world it's very old now.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 12, 2023 07:39PM
Thanks, Carey. I'll be sure to ask my EP about testing and what the newest metals content is of the Watchman. As you say, perhaps things have changed, and they've taken the nickel out of it by now.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 12, 2023 08:00PM
No, they haven't changed the metal. I have the Watchman FLX, which is the latest model, and it's made of nitinol. I got it from the clinical trials for the FLX in 2018. If they change the device in almost any way, they'll have to run more clinical trials, which are expensive as hell so I wouldn't expect to see a new metal being used anytime soon. Nitinol is very frequently used in implants like a Watchman because it's unique in its ability to retain the shape it was manufactured to. No matter how much you deform it, it will spring back to its original shape.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 06:22AM
I have a titanium allergy. I thought I had a nickel allergy because my white gold jewelry, which uses nickel as an alloy, was causing my fingers to leave black marks and my pierced earrings would get infected to the point it took three piercings to get it under control by only using only 18 carat yellow gold earrings.

I had to get all my metal markers, screws from a broken tibia and two titanium clips removed because of the pain.

I researched after my emergency Pacemaker and found there is one lab in Germany that tests for metal reactions. Melisa Labs that does this test but it’s not worth the stress because they need the blood within 48 hours and that’s not easy post pandemic even with UPS courier services.
UPS Critical: 8007148779. Courier service from a courier pickup from your doctor’s office or lab directly to the plane and when the plane lands in Germany, another courier fast tracking customs and delivering it to Melisa Labs.

Expect to pay a small fortune in shipping and the test isn’t free and Medicare didn’t cover it. Since I now live abroad I
may consider trying my best and get an RX to be retested and have my blood sent to Germany again, hopefully it won’t take as long and be an less expensive shipping expense from abroad since they didn’t originally receive the blood in 48 hours but 8 hours late. They are willing to retest for free due to the delay so it’s only the shipping costs.

Melisa contact info:
linda@melisa.org
julia@melisa.org

Tests to take:
Titanium dioxide
Titanium sulphate
Aluminium
Nickel
Palladium
Vanadium
Iridium
Gold

Not only am I’m allergic to titanium (they tested for multiple types of titanium), I’m more allergic to palladium-an alloy used in Gold plated implants. Metronics does made a gold plated pacemaker upon need, but it’s a 6 month process to get the FDA approval for Metronics to get permission to make you one.

Titanium is made of 50% nickel which I found I am not allergic to- I was tested for 8 metals and only palladium and titanium were positive.

After the PM implant, I ended up with a swollen chest, edema around the implant site for 4 months. Since I have the second allergy to palladium, I just let it be and never bothered with trying to get a gold plated PM. I just live with it.

By the time I had GI internal bleeding and I was on full dose 5mg Eliquis BID, Dr. Natale offered an emergency watchman so I could temporarily stop Eliquis and get my bleeding under control. I figured what difference does it make with another metal implant. The newest implant just joined the club of iatrogenic reactions but to a way milder lesser degree. But surprisingly by then I didn’t get the pain as I currently get from the PM. You maybe ok with your nickel allergy. Get tested. It was a good decision. With a sealed watchman I reduced my Eliquis in half and can stop for colonoscopies.

Julie from Melisa looked through some published studies and also found that one study found trace amounts of tin, antimony, molybdenum and manganese in some pacemakers or implantable cardioverter-defibrillators. See the study here: [pubmed.ncbi.nlm.nih.gov]

She also directed me to this:
“In this short presentation (9 minutes) by our colleague Dr Scott Schroeder, he discusses the systemic and local effects he has seen from galvanism.
You mentioned you had metal crowns and/or fillings. In some patients, symptoms start or become more severe after implants - not necessarily as a reaction to the titanium itself but due to increased exposure to metal ions from metal alloy that are already in your body, through galvanic corrosion:”
[www.youtube.com] “

I hope the info can be helpful to you.



Edited 1 time(s). Last edit at 04/13/2023 06:46AM by susan.d.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 05:05PM
I contacted Melisa.org during COVID lockdown as I had an infected root canal tooth that needed to be pulled and replaced with an implant. I was concerned about a titanium sensitivity. As Susan notes, it was not possible to get a sample from the US to Germany in 48 hours then. The Melisa people were very responsive and told me they didn't see issues with zirconia implants. So I just went with zirconia and have not had an issue. I really appreciated that they helped me out even though I spent no money with them. For what it is worth, they now recommend FedEx International Priority Express (see 1st FAQ: [melisa.org] ) I have a private phlebotomist I use. If I were going to use their service now, and for best timing, I would have communicated with FedEx to see when their plane left & when I could have personally dropped off the package at their airport office. I would have done it on a Monday or Tuesday to eliminate any weekend delays.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 05:49PM
Hi Susan,
Your post is very helpful, but I am confused about this statement: "Melisa Labs that does this test but it’s not worth the stress because they need the blood within 48 hours and that’s not easy post pandemic even with UPS courier services." So are you saying that I should not use Melisa Labs to get my metals tested because of the high cost and the need to get the blood there (Germany?) within 48 hours?

Also, the information about galvanization and the metals crowns causing issues in the body is also helpful, as I have taken out all my aluminum fillings but have several crowns. Seems like this would apply to me and perhaps cause issues with the Watchman's metals.
Thanks much.
Nancy
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 06:05PM
Quote
GeorgeN
For what it is worth, they now recommend FedEx International Priority Express (see 1st FAQ: [melisa.org] ) I have a private phlebotomist I use. If I were going to use their service now, and for best timing, I would have communicated with FedEx to see when their plane left & when I could have personally dropped off the package at their airport office. I would have done it on a Monday or Tuesday to eliminate any weekend delays.

I have used them to send blood to Europe in under 48 hours, but it is expensive. I had my blood drawn in the late afternoon and took my package to the regional last FedEx pickup site for the day—they told me when the package would get to the airport and when the plane left. Then I tracked it to the lab.

I am about to get a Watchman and no one has raised the issue of allergy so evidently they do not test for routinely.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 07:36PM
Very interesting read.

I had a Titanium dental implant in April 2022 after an infected root canal. In hindsight, my Afib episodes coincidently increased after that. I never made connection between the implant and my Afib, but now I am wondering if Titanium implant can trigger more Afib.

My first AF episode happened in May 2019. Before last year's dental implant, I only had 1-2 short self-converted episodes per year. After implant I averaged 1 episode per week, and it lasted much longer, from a few hours to several days.

I also have a gold crown and an amalgam filling from almost 20 years ago, they did not seem to bother me too much, but I might replace the filling soon.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 09:35PM
Quote
Nancy M
Hi Susan,
Your post is very helpful, but I am confused about this statement: "Melisa Labs that does this test but it’s not worth the stress because they need the blood within 48 hours and that’s not easy post pandemic even with UPS courier services." So are you saying that I should not use Melisa Labs to get my metals tested because of the high cost and the need to get the blood there (Germany?) within 48 hours?

Also, the information about galvanization and the metals crowns causing issues in the body is also helpful, as I have taken out all my aluminum fillings but have several crowns. Seems like this would apply to me and perhaps cause issues with the Watchman's metals.
Thanks much.
Nancy

I was tested during the pandemic and ups couldn’t ship as fast even with their critical care couriering services guarantee. So it was frustrating and stressful. Perhaps better now. I’m now living abroad so the shipping time to Germany won’t be as critical (within 48 hours). All I need is a doctor who would rx the test. The lab is willing to do a redo because my blood wasn’t as viable after 48 hours to be as accurate. They use a control to score the viability of the sample and mine was super low-so they speculated the results (I’m positive but they are unsure the intensity) and recommended I redo the test for free.

Now with the watchman and pacemaker I don’t see the advantage to redo the tests. What can I do about it?? I had my av nuked so I need my PM to survive and they yet to make a Pm without titanium or palladium (alloy of a gold PM) . My watchman is sealed so it’s a done deal. I’m not get it removed.



Edited 1 time(s). Last edit at 04/13/2023 09:46PM by susan.d.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 10:01PM
Quote
GeorgeN
I contacted Melisa.org during COVID lockdown as I had an infected root canal tooth that needed to be pulled and replaced with an implant. I was concerned about a titanium sensitivity. As Susan notes, it was not possible to get a sample from the US to Germany in 48 hours then. The Melisa people were very responsive and told me they didn't see issues with zirconia implants. So I just went with zirconia and have not had an issue. I really appreciated that they helped me out even though I spent no money with them. For what it is worth, they now recommend FedEx International Priority Express (see 1st FAQ: [melisa.org] ) I have a private phlebotomist I use. If I were going to use their service now, and for best timing, I would have communicated with FedEx to see when their plane left & when I could have personally dropped off the package at their airport office. I would have done it on a Monday or Tuesday to eliminate any weekend delays.

Come to think about it, I did use Fedex international priority express, not ups. I had my blood drawn at 10:30am and rushed to a major FedEx hub near where I lived because pickup was 4-5pm. Yes I should had had it drawn later in the day but I don’t see the difference. FedEx shipped my sample to Germany and then transferred it to another city airport for an hour local flight (an hour away from the two airports -frustrating, why couldn’t they drive it?). The second plane was delayed 9 hours overnight. That was the problem. I was tracking it the entire time and was in the phone with FedEx Germany who couldn’t helped. It was delivered around 7am the following day. Melisa was expecting it and started testing once they got it.

I got confused with ups because after it arrived late I investigated faster services and ups has their courier critical care department. But because of the pandemic they no longer guarantee less than 48 hours.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 13, 2023 10:23PM
Wow! This Melisa blood test that has to go to Germany and be read within 48 hours seems overwhelming to me. Isn't there some place in the US that does this that is reliable? This process would be very stressful for me.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 01:21AM
Quote
Nancy M
Wow! This Melisa blood test that has to go to Germany and be read within 48 hours seems overwhelming to me. Isn't there some place in the US that does this that is reliable? This process would be very stressful for me.

Of course there is.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 02:00AM
Quote
Carey
Of course there is.
I'd love to know the lab as I was unable to find a US lab option when I was searching several years ago.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 03:48AM
Quote
GeorgeN
I'd love to know the lab as I was unable to find a US lab option when I was searching several years ago.

Well, what are the actual requirements? Not the specific test, but the requirements of that test.

I find it extremely hard to believe that detecting a metal allergy isn't possible in the US. That just doesn't seem credible at all.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 12:48PM
Quote
Carey
Well, what are the actual requirements? Not the specific test, but the requirements of that test.

Here is an article on the topic. Apparently there is lab in Chicago. [tmj.org]

When I was looking at it for teeth, everything I looked at referenced the Melisa serum test.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 01:47PM
Quote
Carey

Wow! This Melisa blood test that has to go to Germany and be read within 48 hours seems overwhelming to me. Isn't there some place in the US that does this that is reliable? This process would be very stressful for me.

Of course there is.

Nope. Find me one lab that does metal allergies…not a lab that tests how much mercury you digested from eating sushi or how much metallic dust you inhaled.
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 01:48PM
Quote
GeorgeN

Of course there is. I'd love to know the lab as I was unable to find a US lab option when I was searching several years ago.

Ditto
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 14, 2023 01:52PM
Quote
GeorgeN

Well, what are the actual requirements? Not the specific test, but the requirements of that test.


Here is an article on the topic. Apparently there is lab in Chicago. [tmj.org]

When I was looking at it for teeth, everything I looked at referenced the Melisa serum test.

So you found one George! I wonder how many metals they test. Gold plated uses palladium and there are many types of titanium alloys. Thanks George!
Re: Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy
April 15, 2023 05:41PM
That article at tmj.org was very helpful. I went to the website of the metal testing company, Orthopedic Analysis in Chicago, [www.orthopedicanalysis.com], and read all about what they offer in the way of test kits. I then emailed them at info@orthopedicanalysis.com with my questions about how to test for the Watchman device and which kit to order and how much it would cost.

The website states that Medicare will pay for the test, but private insurance may not, depending on the insurance company. One would have to pay for the test up front and then send the bill to the insurance company for reimbursement. My insurance company does not do reimbursements, so this is bad news for me.
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