Medtech’s endocrine disruptor problem
Earlier this year, popular menstrual underwear company Thinx settled a lawsuit after third-party testing revealed the presence of forever chemical—and known endocrine disruptor—PFAS (poly-fluoroalkyl substances) in the product. The news rocked the consumer femtech world.
But exposure to PFAS and other endocrine disruptors isn’t just a problem of personal care products. Many medical devices sold today are a source of PFAS exposure. The chemical has been used in medical devices due to its chemical and heat resistance, lubrication, and biocompatibility.
Join us as we dissect why endocrine disruptor exposure is so worrisome (it might not be what you think). We’ll also dig into current and upcoming PFAS regulations as well as why applying PFAS regulations to medical devices is likely to prove challenging.
Why you don’t want to be exposed to endocrine disruptors like PFAS
First things first: what are PFAS? They aren’t just found in period underwear and medical devices.
You’ll most often encounter these chemicals in Teflon (non-stick) cookware and in oil- and water-resistant coatings for food contact paper, clothing, and upholstery. PFAS are highly environmentally persistent (hence the term “forever chemical”). This means that, once they contaminate an area, the area remains a potential exposure site for a long time.
Long before the Thinx lawsuit, these chemicals were implicated in an early 2000s class-action lawsuit against Teflon manufacturer DuPont. This lawsuit revealed that the likely hormone-disrupting action of the chemical was known by the manufacturer due to their quiet removal from a relevant part of the plant and secret monitoring of female employees after laboratory effects in animals and reports of abnormal births from female employees surfaced.
As you can guess from that detail, these chemicals are referred to as endocrine disruptors because they have an unintentional hormone-disrupting capacity. Studies have shown that these hormone-disrupting chemicals can alter the actions of the hormones estrogen, testosterone, and the thyroid hormone thyroxine.
In the case of PFAS, adverse health effects include altered metabolism, fertility issues, reduced fetal growth, increased risk of being overweight or obese, increased risk of some cancers, and immune system damage.
But the way this happens is where things get complicated. Unlike many standard toxic chemical exposures, the harmful effects of endocrine disruptors like PFAS aren’t binary. It’s not just about whether or not you were exposed. It depends on how much you were exposed—and, most importantly, when.
In particular, exposure at specific developmental stages is the most dangerous. Specifically, prenatal and early-childhood exposure has been demonstrated as the time when endocrine disruptors can have the greatest effects.
Why is removing endocrine disruptors from medical devices so challenging?
The short answer? Because of the variable effects of exposure and because there aren’t better alternatives.
Because of the impacts of timing and exposure levels, toxicological limits are hard to determine for endocrine disruptors. At the same time, patients’ duration of contact with certain PFAS-containing medical devices is so short that detailed chemical analysis isn’t performed.
And substituted PFAS is even more challenging. In the words of a MedTech Europe report on PFAS: “Sometimes, the alternative is another type of PFAS: Apart from PFAS, it is unlikely that any alternative would have similar or superior functions.”
Plus, some of PFAS’ most attractive qualities are exactly the same qualities that cause environmental and human health issues.
However, despite these challenges, our industry will likely soon need to find ways to grapple with PFAS. In 2017, the Swedish Chemicals Agency (KEMI) and the German Environment Agency (UBA) proposed a restriction of six PFAS variants. Now, in 2023, the US Environmental Protection Agency (EPA) announced a proposed PFAS drinking water regulation. And the European Commission has committed to phasing out all PFAS.
Now, you may be thinking: If these chemicals are so challenging to remove and replace, why bother? Especially if people are being exposed to them through their cookware, textiles, and the broader environment anyway—don’t the ends of medical device efficacy justify the means?
At risk of oversimplifying a complex issue, we’ll disagree. As an industry not just dedicated to promoting human health but also to creative innovation in complex biomedical contexts, we’d say our industry is perfectly poised to tackle the beast of PFAS head-on. In other words: if not us, then who?
In the meantime, we’ll continue educating ourselves on this issue which spans public health, environmental health, and medtech manufacturing. To be able to make progress on this problem, it’s important for our industry, providers, and patients to understand the risks and realities of endocrine disruptors. To protect themselves and the especially vulnerable. And to help us imagine future alternatives.