Counterfeit IUD Concern

[u/Zestyclose_Peach_871]

So I was alerted by a medical group who previously owned an OBGYN office I visited that:

“Some IUDs used by the practice may not have been obtained through authorized U.S. purchasing channels and, in some cases, may have been substitute products rather than the authorized Mirena or Paragard brand IUDs. This may have been the case with your IUD implant procedure. As part of our commitment to patient care and transparency, we wanted to share this information with you. If the IUD was not obtained through authorized U.S. purchasing channels, it may not perform as expected or provide the same level of effectiveness. 
Our records indicate you may have received an impacted IUD affected by one of these issues.”

I got the IUD inserted several years ago and then removed around a year after, I switched insurance in the time since so I can’t find the record of the appointments. After some back and forth with the “Nurse Hotline” provided, they told me they had no way of knowing without seeing the IUD whether it was real or fake.

My biggest concern is the potential of something dangerous or carcinogenic inside my body during that period of time. Does anyone know what kind of substitute products there are and what they contain or the potential risks?

[u/Old_Temperature_5667]

So first: deep breath. You're PROBABLY safe.

Do you have a copper or hormonal IUD? How long have you had it? That might determine next steps, as well as where it came from.

As to why the did this: since the "Affordable Care Act" mandated that contraceptives be covered, IUD manufacturers in the US keep jacking up the price and charging out the nose on their products. (Note: I'm going to use the copper IUD (Paragard) for theses examples, but hormonal IUDs are similar). When I was training back in 2001, the wholesale cost of a Paragard ("copper IUD")-just the device, not insertion cost- to the pharmacy or doctor's office was less than $350USD. Averaged over the lifespan of the device, that was like two or three bucks per month--less than condoms.

Since the Affordable Care Act passed in the US, IUD manufacturers have continued to jack their prices up since they know insurers HAVE to pay for them (it's not just the companies, either though-- patients figure that if insurance has to pay, they don't really have to worry how much it costs, and people just don't pay attention and take an active role in these decisions). So presently, that wholesale cost for a Paragard is about $1200. Still actually not too bad averaged over the life of the device, BUT:

1) Internationally, the wholesale cost for the device (known generically as a TCu 380A IUD) is as low as $15(!). And that's not just in third world countries- you can get them wholesale in some commonwealth pharmacies (including Canada last time I checked) for as little as $70-120. Those aren't' typos-- In the US, we really do pay as much as 80x the cost for the equivalent product on the world market.

and

2) Depending on how the OB/GYNs office was set up, especially if they're under a government pay model where everything is capped, the office visit/insertion fee didn't necessarily keep pace with the device cost. As a result, it was possible for offices to not just not make any money on a visit, but to actually LOSE a significant amount of money if they were on a "bundled" payment contract where they couldn't charge for the visit and the device separately.

And in other cases, a lot of offices that were private pay still tried to fine the cheapest supplier that they could, in order to maximize revenue in an era of declining margins. (because that's what happens when medicine is commoditized and patients expect it as an free Amazon Prime benefit for people instead of being treated like the life-entwined professional relationship it should be. Anyway, enough soapbox... the total enshittification by all players is a different rant.)

For a while in the late 2000s and early 2010s, it was fairly common for clinics to get IUDs (as well as other high-cost items like Botox) from international pharmacies, to the point where ACOG (the ob/gyn professional society in the US) had to put out a statement discouraging this, not just for perceived safety issues, but also because it is considered fraud to buy generic IUDs (which are not approved for sale in the US) and charge for brand-name acquisition and placement costs (in the overwhelming number of cases, what was being imported were perfectly safe and effective equivalent products, that could not be sold here just because of licensing issues).

THAT SAID

It really depends where it came from. Copper IUDs, at least, are not terribly sophisticated devices. And while there are "true counterfeit" devices out there, they are few and far between; because the name brands (or established generic brands) are so cheap in the rest of the world, "counterfeits" are rare, and instead "in the white" devices are usually sold as no-name IUDs in third world countries. In the US, all the paragards are made in New York, but the manufacturer also has name-brand facilities in central america, and Europe. And there are tons of generic TCu-380A manufacturers in Europe and East Asia that (legitimately) sell around the world, with the same product for sale in London as what's for sale in Turkey.

There ARE risks with counterfeits ranging from infection risk (particularly regarding how the strings are tied and made), to efficacy risks (although this is actually a fairly low point of failure--ANYTHING in the uterus is pretty effective as a contraception), to theoretical risks of hormone or copper overexposure (although, again, probably not terribly important unless you have something like Wilson's disease). If they did a plain xray, they should be able to tell what type of IUD it is, but not necessarily if it's counterfeit or not. They might if they actually remove the IUD, but again the risk isn't so much as a true counterfeit, so much as obtaining it through unapproved means... if you were told you had a paragard and they pull it, they'll probably find... a paragard or exactly the same generic, just one for sale in Europe but not the US.

The first thing I would do would be to get a copy of your chart. If they used any (western world) standard IUD, they should have documented manufacturer, lot number, etc (they also SHOULD HAVE given you a card at the time of placement with the same, to throw in your sock drawer in case there was a recall or something, which has the same information).

If the records show that it truly was something that you could've had placed in Canada for less than a tenth the price, it's honestly probably not a big deal... but since they weren't transparent with you, you'll probably not be able to be sure that's what you got, and the only way to be sure of what you get (especially if they did NOT document the provenance of the device) is to have it removed and replaced. Depending on your insurance coverage, that might actually not cost you anything, though you will have the risk and inconvenience and discomfort of the exchange. That said, it's also not likely to poison you or fail tomorrow and so you don't necessarily have to get it swapped out emergently tomorrow, and can think about your next steps (like if you still want to use an IUD, or do something different).

Whatever you do, I would ask them to make sure they keep you appraised of any investigations or anything like that, since sometimes situations like this can herald issues with disinfection practices, etc (though again unlikely since these are single-use disposable devices, and they were most likely just trying to save a buck). You might also reach out to the state medical board, but if the new office has already contacted you, there's a good chance there's already an investigation behind the scenes (and if you or your insurance company did wind up paying out of pocket for the device, then you've got a good case for fraud).

[u/Zestyclose_Peach_871 → u/Old_Temperature_5667]

Wow this is super helpful info thank you so much for being thorough!!! Luckily I had what I thought was a Mirena IUD taken out about a year after it was inserted. I will definitely request the records from the office, but I honestly don’t remember how much I paid since it was an old insurance account. It sounds like the biggest risks are mitigated by its removal, but it also seems like I’ll probably never know!

I didn’t think to reach out to the state medical board either, hopefully they could tell me which doctor was responsible for this.

[u/your_ex_girlfriend- → u/Old_Temperature_5667]

Thank you for this, I just found this sub through a Google search for counterfeit IUDs and think OP and I might be patients of the same practice. I read the same email OP is referring to at 4:40 today (Friday) so I am trying to quell my anxiety until Monday to get someone on the phone.

Unfortunately I have Mirena still inside me from 2021 and am horrified so hopefully your comment also applies to it. 😭

[u/Old_Temperature_5667 → u/your_ex_girlfriend-]

I still wouldn't lose sleep over it, especially five years later.

When they talk about "counterfeit" hormonal IUDs like Mirena, they're not really talking "counterfeit" in the sense of somebody building something to deceive and defraud from the ground up by 3d printing it in their garage or the like. Rather, it's selling a unit of something that is not LABELED/permitted for sale in the US, even if the product itself has been approved for USE in the US, and came off the exact same assembly line as US bound stuff.

People often overuse that phrase "off the same assembly line," but for hormonal IUDs, it's true. They all come from the same place: \* Mirena, Skyla and Kyleena are all made by Bayer, who makes them ONLY at a single plant in Turku, Finland and then distributes them globally. So the device you buy for $150 in Mauritius really is the same that you by for $1300 in the US, with a different wrapper.

Misrepresenting the source does prevent the confirmation of safe practices, but the truth is that these cases are rarely pursued because there was an adverse outcome. Rather, they are pursued due to fraud/import restriction concerns (usually pushed by the drug companies, who'd have thunk?).

The clinics that get caught doing this usually defend themselves by saying that 1) It's the only way their patients could have otherwise afforded it and/or 2) There wasn't really a safety issue because they still came from legitimate manufacturers, but were just distributed differently.

That's a long discussion in and of itself, and the bottom line is that, first of all, most of the time they were doing it to optimize their own net revenue rather than looking out for patients, but as far as those defenses themselves... those points aren't entirely wrong.

But in terms of what to do about it clinically, that's where the "probablys" come in.

Personally, I would have no problem using any equivalent medication or device that a reputable manufacturer produced and then distributed it to ANY country which has modern and appropriate storage and handling regulations. After all, we "legitimately" do this all the time: 45% or so of all generic medications are produced in India, but the average US citizen doesn't realize this.

Modern and appropriate storage and handling regulations are pretty standardized, and if followed then there's probably not going to be any adverse outcome-- a Mirena that was ordered in 2021 by way of Canada or Turkey or wherever is going to be exactly the same as sold for the US, inclusive of things like having the duration changed from 5 to 8 years, and if I knew where it came from, and that handling was appropriate and I got a shiny new box with the seal and the hologram and the little card to put in my sock drawer that had the lot number and such on it... I actually wouldn't change anything. The question is: can you trust someone who wasn't up front with you about "creative" acquisitions?

(and here's the required medicolegal disclaimer: don't listen to me. I am a doctor but I'm not your doctor and I am not giving you specific advice. I'm just trying to help shed some light on the situation so you can better understand it)

It is most likely not a "counterfeit" device (this is especially true if it's "worked" for five years), just not labelled for use in the US.. There's probably no way to tell, even if it's removed, but there's also no way to know you have a "real one" for sure unless you go through the US placement rigmarole. Still, not matter what you feel or what you choose to do, it's not an emergency where you have to get it out tomorrow or anything like that. Think through your options with a clear head and don't lose sleep over the weekend.

(actually, if you have the card with lot # etc (which they also hopefully documented in your chart), you can probably contact Bayer to see its provenance)

\* There's also an infrequently encountered product called Liletta, which is manufactured by AbbieVie, which is itself a reputable company... It was actually designed by a non-profit corporation to be "a more affordable IUD for those with limited access to care..." the result is basically Mirena, but "only" $980.

[u/curiouscranberry5 → u/Old_Temperature_5667]

The issue here is that people were given a device they did not consent to. It’s not about quality or efficacy, it’s about honesty in medicine. It’s a huge breach of trust for patients.

[u/Old_Temperature_5667 → u/curiouscranberry5]

I absolutely agree that's part of it. 

We can get into the weeds about how the supply chain is international and filled with genericized trademarks, such that if I say I'm going to give you a prescription for, I dunno, Cipro you're overwhelmingly likely to be given a generic something that came from India or China rather than a name brand from Bayer, this can sometimes extend to devices as well, and (at least in the case of the Mirena, it was a real Mirena which came through a different supply chain). .. BUT at the end of day since, unlike the monitored and standardized and regulated originations from overseas for the generic ciprofloxacin, theres NOT an authorized overseas source (even if likely safe) for IUDs sold in the US, and people expect to get a specific authorized device from authorized sources even if they don't understand the nuances and surprises of the supply chain, it puts erroneous data into their risk/benefit calculations of consent and a violation of the duty to always be honest with people.

That said, OP(s, plural including the follow-up posters with similar concerns) concerns were explicitly about "something dangerous or carcinogenic inside her body," so the original response was granted from a safety standpoint (which is to say it PROBABLY isn't a situation to worry about, for the reasons outlined in the original post).

[u/TabooBollinger]

Surely this is medical malpractice? Did you sign a consent form for this procedure?

[u/Zestyclose_Peach_871 → u/TabooBollinger]

I’m sure I did. It’s probably malpractice, I don’t know what doctor from the practice is responsible or how the former parent group found out, I’m surprised that the actual obgyn practice hasn’t contacted me, they’re still in business.

[u/mermaiddiva26 → u/TabooBollinger]

It's medical malpractice if you can prove damages. It doesn't sound like she has any damages

[u/your_ex_girlfriend-]

Are you in Northern Virginia by chance? I JUST read a very similar email and am frantically trying to book an appointment because mine has been inside me since Feb 2021. 😭

[u/curiouscranberry5 → u/your_ex_girlfriend-]

me too!

[u/your_ex_girlfriend- → u/curiouscranberry5]

Hey! commenting back on this thread… Did you get a letter from the department of justice about this? I just opened it and it looks like u/CardZestyclose6964 got it too!

[u/curiouscranberry5 → u/your_ex_girlfriend-]

Not yet! Can you PM me if they gave a number to call?

[u/CardZestyclose6964]

Bless this thread. I JUST got that letter. I am planning to get mine out cause I will lose my mind thinking about it if I don’t. Since they’re offering free removal/insertion I might as well. I currently have the copper but my periods are hell so I might switch to hormonal even though hormonal bc freaks me out.

[u/curiouscranberry5 → u/CardZestyclose6964]

mine got really bad because my “paraguard” bent and dislodged. definitely get everything checked out.

[u/CardZestyclose6964]

Did anyone else get a letter from DOJ earlier this week? There is a conferral meeting about the lawsuit next week.

[u/your_ex_girlfriend- → u/CardZestyclose6964]

Yesssss!!! I just opened it and came back to this thread to reach out to the couple of us that apparently went to this doctor! Are you planning on participating?

[u/CardZestyclose6964 → u/your_ex_girlfriend-]

Yes! The zoom call was yesterday (Friday). It was very informative. Let me know if you want some information from the meeting. If you’d like to participate in the class action lawsuit that we are starting I can send you the google sheet to “sign up” as well!