Hundreds of women are suing the maker of an IUD that they claim has given them a neurological disorder.
So far, 856 lawsuits have been filed against Bayer, which make the hugely popular Mirena contraceptive.
The women filing against the drug giant – which has spent the year in legal hot water over another of its birth controls, Essure – say it has caused them to develop pseudotumor cerebri, a disorder involving painful pressure inside the skull.
Research on the the relationship between IUDs and neurological disorders is slim, as of yet, but there is an established history between older hormonal devices and brain side effects.
One neurology and contraception expert, however, says that while women’s neurological health is crucial, the connection between Mirena and intracranial hypertension may be nothing more than a coincidence.
Hundreds of women are suing Bayer, claiming that the company’s IUD, Mirena (pictured) has caused them to develop a neurological condition – but one expert says it’s unlikely
Mirena, the progestin IUD, was approved in 2000 in the US, and has since shot up in popularity.
IUDs were already common in other countries, but Mirena’s social climb has a bit of a checkered history.
Medically, it offers some significant benefits. The device – which is about the length of a thumb and is placed without anesthesia – is relatively affordable and more than 99 percent effective, for three to five years.
That’s pretty enticing to women that aren’t ready for children and don’t want to worry about staying consistent with the pill or their condom use.
A surge of Mirena placements followed the Affordable Care Act’s introduction, and another one came with the election of President Donald Trump whose policies presented a looming threat to birth control access.
But Mirena seems to be following in the problematic footsteps of its predecessor, the Norplant implant.
Like Norplant before it, public health watchdogs have noted that Mirena has been pushed upon women of color and low income women, potentially infringing upon their reproductive rights.
And Mirena has been dogged by litigation in much the same way that Norplant was.
In January, Bayer settled 4,000 consolidated lawsuits over devices that had been spontaneously expelled from patients’ bodies, paying out $12.2 million to women around the world.
The latest spate of lawsuits is not included in that sum or settlement.
Hundreds of women claim that they developed idiopathic intracranial hypertension as a result of Mirena.
The sheer volume of women with the disorder and the IUD is convincing at first blush, but Dr Anne Davis, a Columbia University OBGYN whose entire practice is built around finding the right contraceptive for patients with medical conditions, warns that the relationship may juts be a coincidence.
DOES HORMONAL BIRTH CONTROL INCREASE A WOMAN’S RISK OF DEPRESSION?
Hormonal birth control does not increase women’s risk of depression, research suggested in February 2017.
Contrary to popular belief, contraceptive pills, implants or injections do not make women more likely to suffer from the mental-health condition, a study found.
Lead author Dr Brett Worly from Ohio State University, said: ‘Depression is a concern for a lot of women when they’re starting hormonal contraception.
‘Based on our findings, this side effect shouldn’t be a concern for most women, and they should feel comfortable knowing they’re making a safe choice.’
The researchers blame platforms such as social media for making contraception complications seem more common than they are.
Dr Worly said: ‘We live in a media-savvy age where if one or a few people have severe side effects, all of a sudden, that gets amplified to every single person.
‘The biggest misconception is that birth control leads to depression. For most patients that’s just not the case.’
The scientists add, however, certain women are at a greater risk of the mental-health disorder and should be monitored closely.
Dr Worly said: ‘Adolescents will sometimes have a higher risk of depression, not necessarily because of the medicine they’re taking, but because they have that risk to start with.
‘For those patients, it’s important that they have a good relationship with their healthcare provider so they can get the appropriate screening done – regardless of the medications they’re on.’
The researchers reviewed thousands of studies investigating the link between contraceptives and people’s mental health.
Such studies included various methods of contraception, including injections, implants and pills.
Participants in the trials were made up of teenagers, women with a history of depression and those who had given birth in the past six weeks.
Intracranial hypertension is an otherwise unexplained buildup of pressure in the cerebrospinal fluid.
It is by no means life-threatening, but its symptoms are uncomfortable, to say the least.
The neurological condition affects about 100,000 Americans and is on the rise because it tends to strike overweight and obese people – a group that continues to grow in the US.
If the number of lawsuits filed over intracranial hypertension is a reflection of the number of women with Mirena IUDs who have the condition, then over 850 of those cases are caused by birth control, not (necessarily) obesity.
Intracranial hypertension typically causes frequent headaches, typically located behind the eyes, tinnitus (ringing ears), and vision issues, including temporary blindness.
It’s most common among women between 20 and 50, and we have no idea what causes it (hence, ‘idiopathic’).
This is sort of the issue, according to Dr Davis, says.
‘The reason this connection is hard to grapple with is that we have a medical condition and no idea what causes it,’ she says.
‘If you’re a patient and you’ve gotten this diagnosis, it can be really frustrating.’
The list of possible causes and risk factors reads like it was chosen at random: antibiotics, growth hormone, too much vitamin A sleep apnea, lupus, leukemia and kidne failur, to name a few.
And there is not a significant trove of research on intracranial hypertension’s causes, much less on Mirena as a particular cause.
One 2015 study suggested a link between the contraceptive and the condition, but its credibility crumbled when its author admitted to shoddy methodology – namely, that his process was funded by lawyers suing Bayer.
A later study did suggests that using Mirena appeared to be a risk factor for intracranial hypertension, but that remains a far cry from deeming it a cause.
‘When you get a condition where people are trying to figure out what causes it, there’s a little bit of exploring different things to figure out if any of those things might be the connection,’ Dr Davis says.
That’s complicated by all the ‘overlap’ between Mirena and intracranial hypertension, she says.
‘It’s much more common for women to get this condition, reproductive-age women in particular. And who uses Mirena? Reproductive-age women.’
Plus, Dr Davis notes that the hormone in Mirena, progestin, has long been used in other birth controls, at higher doses, without coming under fire for neurological symptoms.
‘If we were going to see [the connection], we would’ve seen it already,’ she claims.
‘So this feels a little like a fishing condition.’
And not the first one like it, either. Dr Davis says that Mirena is getting caught up in the cyle that just about every contraceptive does.
‘There’s this phenomenon where, when a new contraceptive comes out, there’s a flurry of litigation around different methods, followed by a wave of people stopping their [birth control] method, then a bunch of unintended pregnancies,’ Dr Davis says.
‘We want to always be open to new ideas, but this is so murky, it’s really difficult to make a call, and the connection feels very tenuous.
‘We do need to know more about this, but that doesn’t mean we should throw the baby out with the bathwater (not a great analogy here, I know). Women shouldn’t lose access to good birth control on a “maybe.”‘