# BIOFLEX® IS NOT WHAT THE INTERNET THINKS IT IS — AND THAT MATTERS
The Correction From the Source
A few weeks ago, I read an AI-generated article that described BioFlex® as a "polyether urethane" and Bioplast as "TPU (thermoplastic urethane)." Apparently, I've been manufacturing a urethane-based polymer for 25 years and nobody thought to tell me. The same article informed me that BioFlex® should only be worn for 6–12 weeks before being swapped out for titanium — news that will surprise the tens of thousands of people who have been wearing it comfortably and safely for years, some for over a decade.
I refused to publish that article. What I'm writing instead is the correction it deserved.
I created BioFlex® at Europierce Worldwide Ltd in the UK more than 25 years ago. I spent over a year developing the material — running injection trials, making molds, testing formulations — before I was satisfied it was right. Since then, I've watched this industry evolve, seen regulations tighten, watched cheap copies flood the market, and witnessed the growing confusion between what BioFlex® actually is and what people assume it must be. It's time to set the record straight.
Key Takeaways:
» BioFlex® is not acrylic, not TPU, not PMMA, not nylon, and not PVC. It is a medical-grade random copolymer (PP-R class). So is Bioplast. Neither has anything to do with thermoplastic urethane.
» BioFlex® was certified to ISO 10993-6 and FDA Class IV before regulators required it. It is not a material scrambling to meet new rules — it was ahead of them.
» The "68% adverse event" statistic cited in recent studies almost certainly refers to cheap uncertified Asian copies, not genuine BioFlex® or Bioplast. Lumping them together is the equivalent of blaming Rolex for injuries caused by counterfeit watches.
» BioFlex® phthalate traces measure below 1 ppm (0.0001%) — three orders of magnitude below the REACH SVHC 0.1% threshold. No PVC, no plasticizers, no brominated flame retardants.
» The emerging regulation mandating "temporary post-operative use only" labelling is a step backwards, because it was written around TPU properties and then applied broadly to all flexible polymers, without distinguishing certified medical-grade materials from cheap imports.
1. The Identity Crisis: What BioFlex® Actually Is
Let's start with chemistry, because the confusion here is foundational.
You will find websites — some of them otherwise reputable — describing BioFlex® as acrylic, as PMMA, as TPU, or as "a type of flexible plastic." One piercing retailer even lists BioFlex® as "a type of acrylic." This is wrong. Acrylic (PMMA) is not a safe body jewelry material at all — it is porous, non-autoclavable, and unsuitable for pierced tissue. BioFlex® is categorically not acrylic.
The most common technical misidentification is TPU: thermoplastic urethane. It sounds plausible — "flexible polymer for medical use" — and TPU is used in some flexible body jewelry, typically the cheaper, uncertified kind. But BioFlex® and Bioplast are both manufactured from advanced random copolymers in the PP-R class — a completely different polymer family, produced by some of the largest and most reputable medical-grade polymer manufacturers in the world. The chemistry, the regulatory profile, and the safety data are entirely different.
Why does this confusion persist? Partly because we have deliberately not published the exact formulation. That is a trade secret — and a necessary one. If I released the precise specification of BioFlex®, I would be handing every factory in Shenzhen the blueprint to copy it exactly. That is not going to happen. I spent more than a year developing this material. It was developed with the benefit of the end user in mind. Protecting it protects the consumer.
What I will tell you is what it is not: it is not urethane-based, it does not release urethane monomers, and it has none of the toxicological profile that TPU carries. The AI article claimed BioFlex® releases 0.3–0.8% urethane monomers. That figure applies to TPU. BioFlex® phthalate traces from the catalyst measure below 1 ppm (0.0001%). The REACH Article 33 SVHC threshold triggers at 0.1% (1,000 ppm). We are three orders of magnitude below it. There is no PVC. There are no plasticizers. There are no brominated flame retardants.
That is not a reformulation to meet new regulations. That has always been the compliance profile of BioFlex®. For the current state of material certification standards, the baseline BioFlex® was designed to exceeds remains relevant today.
2. The Counterfeit Problem: When "BioFlex" Isn't BioFlex®
Here is the most important thing I can tell any piercing professional reading this: the market is full of products labelled "bioflex" or "bioplast" that are nothing of the sort.
I trademarked BioFlex® precisely because I saw this coming. My friend Robert Redl, who owns Body Steel and Silver in Thailand, commercialised Bioplast genuinely two to three years after BioFlex® launched. Both of us were working with certified, tested, properly manufactured material from the same class of medical-grade polymers. If you are looking for genuine Bioplast, Robert is the person to talk to. Between us, we represent the only two authentic sources for these materials. Then the copies arrived.
When I read about a 2024 meta-analysis attributing 68% of flexible polymer complications to extended post-operative wear, my first question is: which materials were actually studied? Because if researchers cannot distinguish between genuine BioFlex®, genuine Bioplast, and cheap uncertified copies sold under the same names — and most cannot — then the conclusions are meaningless. You cannot apply adverse event data from uncertified random-copolymer knockoffs to a certified, ISO-tested product and draw any valid conclusions. You are not studying the same material.
Various sources describe BioFlex® correctly as a premium flexible body jewelry material. But Reddit threads and general consumer resources routinely conflate all flexible polymer jewelry into a single category, and many piercing studios stock whatever comes cheapest from an import catalogue, labelled in English with a brand name that sounds like ours.
The experienced piercers — the ones I respect and work with — know the difference. They ask for certification. They recognise that genuine BioFlex® and genuine Bioplast come with documentation. They understand that the price difference exists for a reason. These are the professionals keeping their clients safe.
For everyone else: if your supplier cannot produce certification documentation in 48 hours, do not stock their products. I can provide an official SVHC-free declaration to any professional who requests it — this is the correct legal instrument, not a vague "compliance letter." Under REACH Article 33, disclosure is only obligatory when a substance of very high concern exceeds 0.1% in the article. For genuine BioFlex®, that obligation does not arise — because nothing exceeds that threshold. Our SVHC-free declaration and compliance documentation is available to any trade professional.
3. Regulation Reality Check: When the Rules Miss the Target
I have a complicated relationship with regulation.
I was developing BioFlex® at a time when piercing was essentially unregulated. Government bodies had no idea what piercers were doing, what materials they were using, or what standards should apply. I remember helping Bournemouth Borough Council write their piercing regulations from scratch — because they didn't have a clue, and someone had to. That someone was me.
So when I say I support proper regulation, I mean it. I was getting BioFlex® certified to ISO 10993-6 and FDA Class IV before anyone required it. I did that because it was the right thing to do, not because a regulator told me to.
But here is where I have a genuine grievance with the current regulatory direction: the new rules are being written around TPU chemistry and then applied to all flexible polymers. This is the regulatory equivalent of writing food safety rules around spoiled milk and then applying them to fine wine because both are liquids.
PTFE has its own history to consider here. DuPont's Teflon was an excellent material in medical applications for years — inert, flexible, biocompatible. Then it was used in load-bearing joints, where it degraded under mechanical stress and caused serious harm. The resulting litigation was enormous, and DuPont now disclaims all medical use of PTFE in their product documentation. PTFE is still used medically today, carefully and appropriately, but the cautionary history lingers. The lesson was not "all polymers are dangerous." The lesson was "understand your material's specific limitations."
The current regulatory narrative draws the wrong lesson. It treats BioFlex® — a material with 25 years of clean real-world performance and complete ISO and REACH compliance — as if it shares the risk profile of uncertified TPU imports. It mandates "temporary post-operative use only" labelling for materials that have a 25-year track record of indefinite safe wear. That is not consumer protection. That is consumer misinformation, imposed through well-intentioned ignorance.
The REACH regulatory framework is a sound structure for managing genuine chemical hazards. I have no argument with its principles. My argument is with its application when regulators lack the technical granularity to distinguish between certified medical-grade random copolymers and cheap TPU knockoffs. The solution is better information, not broader restriction.
The Gatekeepers Who Never Called
And then there is the APP — the Association of Professional Piercers, based in the United States. The APP positions itself as the authority on piercing standards. Their approved materials list for initial piercings includes ASTM F136 titanium, ASTM F138 surgical steel, solid 14k+ gold, niobium, platinum, and glass. You will notice something missing. BioFlex® is not on that list. Bioplast is not on that list. Neither material has ever been formally evaluated by the APP — because in 25 years, they have never contacted me to discuss BioFlex®, and to my knowledge, they have never contacted Robert about Bioplast either.
Twenty-five years. Not one email. Not one phone call. Not one invitation to present, discuss, or submit documentation. And this from an organisation that claims to set the standard for piercing safety.
I tried going through other channels. Years ago, I attempted to update the Wikipedia page on body jewelry materials with accurate information about BioFlex®. The edits were removed within two weeks, every time. Wikipedia is a collaborative platform, but certain pages are watched by communities with established positions — and the piercing materials page reflects the APP's metal-centric worldview.
To understand why, you need to understand the APP's origins. It was founded by — and its membership largely consists of — professionals and manufacturers in the metal body jewelry industry. Their mandate around internally threaded jewelry is a useful case study. The APP standard requires all threaded jewelry 14 gauge and larger to be internally threaded, citing safety as the reason. The logic sounds reasonable: external threads can scratch the piercing channel during insertion. But here is what nobody seems to question: an internally threaded barbell or labret has a hollow shaft. When worn in a piercing, body fluids migrate into that hollow channel. When the client screws on the attachment end, those fluids are sealed inside, creating an environment that is difficult to clean and potentially hospitable to bacteria. An externally threaded bar, by contrast, has a solid shaft — the thread is exposed at the end, where it can be cleaned before an attachment is applied. Both designs have trade-offs. But the APP presented one as the only acceptable standard, and the industry followed without asking the obvious question.
I am not suggesting the APP acts in bad faith. I am suggesting they operate within a framework that was built by and for metal jewelry manufacturers. Flexible polymer materials — the ones that protect tooth enamel, prevent gum recession, and act as shock absorbers — represent a category that does not benefit their core membership commercially. When your standard-setting body has a structural interest in one material family, the absence of curiosity about another is not surprising. It is predictable.
The consequence is an information vacuum. Piercers who follow the APP as gospel are never introduced to BioFlex® or Bioplast through official channels. The materials don't appear in APP training materials. They don't appear on the approved list. And when someone tries to add them to Wikipedia, the edits don't survive. Getting accurate information out there is not always easy — and this is a significant part of why the confusion persists.
4. Twenty-Five Years of Real-World Evidence
Let me tell you what I actually observe, after a quarter century in this business.
People switch from metal to BioFlex® and do not come back. Not because I tell them to stay — because they experience the difference. A flexible oral piercing touching the enamel of your teeth or the soft tissue of your gums is simply less destructive than metal. That is not a marketing claim; it is physics. Flexibility absorbs shock. Rigid metal concentrates it.
I have seen people sleep comfortably on ear piercings that were previously impossible to sleep on. I have seen cartilage piercings heal with less disruption because the jewelry moved with the body rather than against it. I have seen navel piercings survive incidents — a child kicking, a bag catching — that would have torn a metal ring clean through. BioFlex® acts as a shock absorber. That matters for real bodies living real lives.
The zero-nickel profile matters too, particularly as nickel sensitisation becomes more prevalent. A significant percentage of the population develops contact sensitivity to nickel, and conventional body jewelry — even surgical steel — contains trace nickel. BioFlex® contains none. For clients with existing sensitivities, this is not optional: it is the difference between a successful piercing and a chronic allergic reaction.
On the antimicrobial side: in 2008, I worked with the University of Dijon on a silver-ion antimicrobial that we developed as an additive, not a coating. This distinction matters enormously. Antimicrobial coatings on polymers degrade with autoclaving and wear — which is why critics correctly dismiss them as ineffective. But an antimicrobial additive mixed homogeneously into the material during injection moulding distributes the silver ions throughout the entire piece. You cannot autoclave away what is embedded in the polymer matrix. From my direct observation over the years, clients using the antimicrobial version of BioFlex® resolve redness and irritation noticeably faster. I acknowledge this is not peer-reviewed clinical data — that study has not been funded. But the mechanism is sound, and the anecdotal evidence across thousands of clients is consistent.
What I have not seen, in 25 years, is a material-related adverse event with genuine BioFlex® or genuine Bioplast. I have seen piercings go wrong because of misuse, accidents, anatomy, and technique. I have not seen them go wrong because of the material itself. That is a meaningful data point, even if it is not a randomised controlled trial. See our full innovation timeline for the development history behind these claims.
5. What Piercers and Consumers Should Actually Do
The practical guidance here is simpler than the regulatory complexity suggests:
Verify your source. Genuine BioFlex® and Bioplast come from known, certifiable manufacturers. Ask for documentation. A REACH Article 33 SVHC-free declaration is the legally correct document — not a vague letter saying "we comply with regulations." If a supplier cannot produce specific compliance documentation, that is your answer. Download our SVHC-free declaration and compliance datasheet here.
Understand the material you are using. There is no single category called "flexible polymer jewelry." Certified medical-grade random copolymers, TPU, PTFE, acrylic, and silicone all have different chemical profiles, different regulatory statuses, and different clinical suitabilities. Your supplier should be able to tell you exactly what you are stocking.
Do not limit genuine BioFlex® to the post-operative window if your client is happy in it. The "6–12 weeks then switch to titanium" protocol was never based on BioFlex® performance data. It was based on TPU limitations, applied without distinction. A client who has been wearing BioFlex® comfortably for two years and wants to continue is not doing anything wrong. The material is not degrading, it is not releasing toxins, and there is no clinical basis for forcing a transition. If they want to switch to titanium, that is a perfectly good option. It should not be presented as a legal obligation.
For oral piercings, the case for BioFlex® is particularly strong. Less enamel wear, less gum recession, more flexibility for sleeping and eating. This is not a marginal advantage. Dentists charge considerably more than a BioFlex® bar costs. The maths is not complicated.
Distinguish between regulation and truth. The new labelling requirements are a regulatory fact. I am not advising anyone to ignore them. But understanding that the science behind those labels does not reflect the actual safety profile of genuinely certified materials is also important. Know what you are using. Know why it is safe. Be able to explain it to your clients.
6. Body Art Is Not a Regulatory Problem to Be Solved
Body modification has existed for thousands of years. Across every culture and era, humans have chosen to mark, adorn, and transform their bodies as an expression of identity, community, and beauty. The millennial generation — and every generation since — did not invent this impulse. They inherited it, and they made it mainstream.
Good regulation of this art form should protect the people who practice and receive it. It should distinguish between dangerous materials and safe ones, between certified manufacturers and counterfeit operators, between evidence-based restrictions and precautionary overreach. It should be written by people who understand the materials they are regulating.
The current direction is imperfect on that last point. I say this not in anger but from experience — the same experience that led me to help a Borough Council write its own regulations from scratch because nobody else knew how. The appetite to regulate exists. The technical knowledge to regulate correctly does not always accompany it.
My invitation to regulators, industry bodies, and practitioners is the same: engage with the people who actually develop these materials. Ask questions. Distinguish between the cheap import and the certified original. The information exists. The expertise exists. Use it.
BioFlex® has 25 years of clean performance behind it. It was ahead of the regulations when it launched, and it remains compliant in full today. The label I object to is not a chemical warning. It is a category error — a consequence of writing rules about a material you have not properly identified.
The material is right. The label is wrong. That is the correction I am publishing.
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*Patrick Poli is the creator of BioFlex® body jewelry and Director of Poli International Co., Ltd (formerly Europierce Worldwide Ltd, UK). For certification documentation, SVHC-free declarations, or trade enquiries, contact us here.*