Complications due to Ballerin IUD?

You chose the Ballerine because you think it will protect you. But then it happens: you get an unwanted pregnancy. Or the IUD gets stuck in your uterus and cannot be easily removed. You have to undergo painful surgery with all its consequences. Women report to us with these problems. And they ask the same questions: why wasn't I warned? Could this have been prevented? Who is responsible? In this blog, we answer those questions. We look at the regulations surrounding producer liability and what is legally possible. When do we speak of product liability? The law states that a producer is liable for damages caused by a defective product. The victim does not have to first prove that the producer acted negligently. The producer has ‘strict liability’. Product liability thus revolves around whether a product is defective and whether it offered the safety one would expect. What matters is how the product was presented, how it is normally used and what was known about its safety at the time. On paper this sounds simple, but in practice with medical devices it is often more complicated. It takes expert reports - from a gynecologist, for example - to prove that a product was not safe. The difference between a medical device and a drug It makes a difference what kind of device was used. Different rules apply to the Ballerin than to, say, a hormone IUD. A hormone IUD (such as the Mirena) qualifies as a drug, but a copper IUD (such as the Ballerin) qualifies as a medical device. The approval requirements for medical devices are structurally different from those for drugs, and in several respects less onerous. A different system of market authorization, evidence, surveillance structure and pre-market control applies to both groups. An important difference is that for medical devices there is no centralized public pre-market control. A government body does not check the content before market authorization: that role is delegated to private parties. In the case of pharmaceuticals, however, a substantive assessment by a government body does take place before market authorization and a marketing authorization is required. The producer of a hormone coil must demonstrate through clinical trials that the drug is safe and effective, with a higher standard of proof. The producer of a copper IUD can suffice with a clinical evaluation based on existing evidence. Side effect monitoring is also different; the hormonal coil is subject to stricter pharmacovigilance requirements than the copper IUD. The hormone IUD/copper IUD distinction shows that similar-looking products with similar uses fall under different product safety regimes. Information not shared Medical devices may behave differently than expected after being introduced to the market. New reports from users and physicians may indicate complications, side effects or practical problems that were not initially anticipated. With the Ballerin, it became clear at one point that (i) more pregnancies were reported than anticipated and (ii) difficulties often existed during removal of the IUD because it was stuck in the uterus. This information was not shared with the

An implant, IUD or prosthesis is placed to solve something. But sometimes it actually causes new symptoms. And sometimes it turns out afterwards that known risks were not shared. Those who then ask questions quickly find that the answers are rarely simple. Were my complaints caused by the device? Should I have been informed? And who is responsible? We help victims explore those questions. When is a manufacturer liable? The law states that a manufacturer is liable for damages caused by a defective product. That sounds logical, but “defective” does not necessarily mean that the product was broken. The issue is: was this product as safe as you could reasonably expect? This includes how the product was presented, how it is normally used, and what the manufacturer knew or could have known about its safety. An important point: a victim does not have to prove that the manufacturer acted intentionally or negligently. The law places responsibility on the manufacturer even if there was no ill will or intent. Why this is extra complicated with medical devices A medical device is not an ordinary product. It is used in a medical context, often on the advice of a physician, and with the expectation that it has been carefully researched. It is precisely that trust that makes this kind of issue sensitive. Because when complaints arise later, it's not just about whether the device itself was safe. It's also about what the manufacturer knew, whether it shared it, and whether doctors and patients were informed in a timely manner. Proving it is the hardest part The hardest part in these types of cases is proving that the complaints were actually caused by the device. Especially if complaints arise later, or if other causes may also play a role. That proof is hard to come by was also evident in a recent case about breast implants made by manufacturer Allergan. The Amsterdam District Court ruled in December 2025 that the implants were not defective and that the manufacturer was not liable for the health complaints complained of by the plaintiffs. For the women involved, that was a harsh outcome. The verdict has been appealed. Don't wait too long Anyone damaged by a medical device does not have unlimited time to take action. There are statutory time limits within which a claim must be filed. Once that deadline has passed, in many cases the right to file another claim expires, even if the complaints are serious. The time limits depend on the type of claim and the situation. This is precisely why it is wise to have complaints that may be related to a medical device assessed in time. What will change soon? As of December 9, 2026, new European rules will apply to damage caused by defective products. We explain two changes. First, from that date it will be possible to seek compensation for mental injury even if no physical injury has been established. Second, for damages