Can Juläine Cause Nodules? Its Approved Label Gives a 1-to-14-Month Window

Juläine has just been launched in Taiwan, and the launch message is clear: the particles are uniform spherical microspheres, so nodules are unlikely.

First, where I stand. My clinic does not inject Juläine, or any of the collagen stimulators in this new wave. I work at the other end, with people who developed lumps after injection and come looking for removal. So this article does not judge how well it works cosmetically. It answers one question: can it cause nodules?

The manufacturer has already answered that, in the Chinese-language label approved by Taiwan's health ministry.

Key point: "Unlikely to form nodules" is a statement about probability. Juläine's approved label still lists nodules and late granulomas as possible side effects, with a window that runs to 14 months after injection.

First, confirm which product you had: Zhilin, Zhulan and Juläine are one product

This step is often skipped, and it trips up a lot of people.

Zhilin (知林) is the name the manufacturer uses on the Taiwan market; its local site calls it "Swedish Zhilin", and the English brand is JULÄINE. If you search the medical device license database of Taiwan's TFDA (Taiwan Food and Drug Administration) for Zhilin, you will find nothing. The approved Chinese product name is "Nordberg" Zhulan implant (珠嵐植入物), English name "Nordberg" Juläine, license No. 038584 (衛部醫器輸字第038584號), issued on 19 December 2025 as a Class III medical device.

The license holder is Weikang Co., Ltd. (威康有限公司). On manufacturing, the label reads: Manufactured by Magle Chemoswed AB, Malmö, Sweden, for Nordberg Medical AB.

The label is clear on composition. Each vial of freeze-dried powder contains 150 mg of PLLA (poly-L-lactic acid, the active ingredient of Sculptra), 45 mg of CMC (carboxymethyl cellulose) and 145 mg of mannitol, reconstituted with sterile water or saline before injection. The active ingredient is the same PLLA as Sculptra; the difference is in how the particles are made.

To check this yourself, search for 珠嵐 or 038584. The efficacy field of that entry reads "see the approved Chinese labelling", which means the indication lives in the label, not that there is no approved indication. The quotations below come from that label; translations are mine.

How it relates to Löviselle, and how far the public record goes

Some people online say the two are the same thing; others say they are completely different. I will only write what documents support.

The first is a 2021 funding press release from Changchun SinoBiomaterials. It calls Nordberg Medical AB its wholly owned subsidiary in Sweden, and says that obtaining the EU CE mark meant Löviselle's process and technology had been successfully transferred to Europe.

The second is a 2025 laboratory study in Polymers comparing how two PLLA products reconstitute (Kubik 2025, PMID 40647790). In its materials section, the authors list Juläine and LoviSelle together under one technology name, PLLA-LASYNPRO.

The third is Taiwan's approval document, which lists the manufacturer in Sweden. How the ownership between the two companies changed after 2022, I could not find in any public source.

So this is as far as I can go: two products from one technology platform, approved in different countries and made in different factories. Whether they behave the same once injected, no study has compared them head to head, and I will not draw that conclusion for them.

Löviselle was approved in China in 2021, for injection into the deep dermis to correct moderate to severe nasolabial folds. I searched Taiwan's license database by Chinese and English product names and by manufacturer name, and found no entry for it.

The window the label gives: 1 to 14 months, and late granulomas

Now the label itself.

In the section on side effects, it reads: "Based on clinical studies and post-marketing surveillance of poly-L-lactic acid fillers, skin nodules, late granulomas, subcutaneous papules or skin induration may occur within 1 to 14 months after injection."

Two things in that sentence are worth pausing on.

First, it opens with "based on clinical studies of poly-L-lactic acid fillers". The label places the product within the experience of PLLA as a class and does not drop this passage because the particles are spherical. Another product marketed on uniform particles, the Taiwanese PDLLA NeoFilera, carries almost the same window in its label.

Second, the rest of the same sentence says that following the recommended reconstitution and injection technique, avoiding thin-skinned areas, and having the patient follow the massage protocol "can reduce the risk of these events within the first six weeks". The prevention advice covers the first six weeks. For a lump that appears in month three or month eight, that sentence makes no claim.

The warnings section also names where nodules come from. Inject only into the deep dermis or subcutaneous layer; injecting too superficially may form papules or nodules at the injection site, and so may injecting too much product or reconstituting it incorrectly. The precautions add that in thin-skinned areas the risk of papules and nodules increases.

Key point: A lump first felt six months after injection is still inside the window the label gives. A late lump deserves imaging, rather than being ruled out on the grounds that "too much time has passed".

What the spherical microspheres change, and what they don't

Start with what it gets right. Earlier PLLA products had irregularly shaped particles; Juläine makes them uniform spheres. Two laboratory studies support that direction. One found that these microspheres reconstitute into smaller, uniform particles that do not clump the way the older PLLA does (Kubik 2025, PMID 40647790). The other, using human dermal fibroblasts, found that the microspheres barely activated immune-related genes, while flake-shaped PLLA triggered inflammatory gene expression (Geara 2025, PMID 41216698). These are in vitro experiments, with no comparison in people, but the direction makes sense.

The issue is that PLLA nodules have more than one cause. A 2014 expert review of PLLA adverse events separates them into two kinds (Vleggaar 2014, PMID 24719076). Papules and nodules mostly come from suboptimal reconstitution or placement. True granulomas are an immune reaction to the material, with an incidence of about 0.01% to 0.1%, and they may appear months or even years after injection.

Particle shape touches one factor within the first kind. The others are all still there:

Then the human data. The most complete Juläine study so far is a 2026 split-face trial: 95 participants, 12 months of follow-up, no nodules or granulomas (Ponzo 2026, PMID 41662390). That is a good result, but look at what it compares. The control side of the face received saline, not another PLLA. It answers "is Juläine safe compared with no treatment", not "does Juläine cause fewer nodules than older PLLA".

The other issue is time. Every published Juläine study follows patients for 12 months or less, while the label's own window runs to 14 months. For delayed PLLA reactions, one case series recorded an average latency of about 19 months, ranging from 6 to 60 months (Alijotas-Reig 2009, PMID 19797889). A 12-month study cannot see that stretch.

There is also data pointing the other way. A 2026 animal study found persistent mixed inflammation around spherical PLLA (Ye 2026, PMID 42918797). Those were rats, and it was not specifically Juläine, so I do not treat it as a conclusion. It only shows that "spherical means no inflammation" is not settled.

The cases I see in clinic are Löviselle, not Juläine

Let me be clear about this first: the nodule cases I see in clinic are Löviselle, not Juläine.

Over the past few years, patients from mainland China and Hong Kong have come to my clinic after receiving Löviselle in mainland China. Most of them first felt a lump three to six months after injection. Compared with the other collagen stimulator nodules I have treated, I have not seen a noticeable difference.

These patients often share the same situation: injected in one place, the lump appears somewhere else. The original injector does not see what happens next, it is hard for the patient to go back and ask, and the lump simply drags on. That has nothing to do with where the product is made; any cross-border treatment can run into it.

Two things need saying together. The people who come to me are, by definition, the ones who had a problem, so my clinic cannot tell you Löviselle's nodule rate. And one technology platform is not one product: Löviselle cases cannot be used to draw conclusions about Juläine.

Juläine has held a Taiwan license for less than a year. Delayed nodules take longer than that to show, so "not seen yet" only means not enough time has passed. It is not evidence in either direction.

The approved use is nasolabial folds only, and other sites change removal planning

The label gives the intended use as filling nasolabial folds, from shallow to deep, to correct skin depressions caused by connective tissue defects or scars.

Dose and number of sessions are in there too: 0.1 to 0.2 mL per injection point, no more than 1.5 mL per nasolabial fold and 3 mL for both sides, up to three sessions spaced 2 to 4 weeks apart. The label also carries two lines I agree with: skin depressions should not be overcorrected, and there is no need to fill the fold completely, because it will gradually fill in on its own. It also states plainly that the product should not be injected into the lips.

At launch, the manufacturer described Juläine as being about natural firming rather than adding volume. The label describes it as suitable for restoring volume in depressed skin areas, with nasolabial folds as the indication. For someone already treated, the practical consequence is this: if it went into the whole face, the temples or around the eyes, that was outside the approved scope. That was the injecting doctor's decision, and you can ask them directly which layer, which points, and how much in total.

That information feeds straight into removal planning. Thin-skinned areas are not the same as a nasolabial fold. Skin around the eyes is thin, the vessels are dense and the working space is small, and when the material sits shallow and scattered, the work calls for even finer judgment.

You can already feel a lump: what to check next

First, sort out the timing. Some of the swelling in the first few weeks is the reconstitution fluid, which gets absorbed; that is expected. With a new lump after a collagen stimulator, I usually observe for about three months first, to see whether it shrinks, holds steady, or grows larger and harder.

The pattern to watch for is the opposite one: a spot that does not settle but keeps bulging and hardening, or keeps flaring red and swollen.

At that point, a clear look with ultrasound matters more than another injection. What to look for: which layer the material is in, how large the area is, whether it has been walled off by a fibrous capsule, and how close it is to vessels and nerves. None of these can be felt with fingers, yet they decide what can be done next. How PLLA nodules are classified and when removal makes sense is covered more fully in Sculptra granulomas and delayed nodules, and it applies equally to Juläine and Löviselle.

Hyaluronidase (used only after an in-person medical assessment) works on hyaluronic acid only and has no effect on PLLA. Steroids can settle an inflamed nodule, but repeated injections can cost you fat atrophy around it, leaving a depression while the material stays where it was; see Sculptra lumps that didn't respond to steroids.

When removal is needed, I work through a pinhole of about 2 mm under ultrasound guidance, without open surgical excision. Swelling and bruising last about two to three weeks, and overall recovery takes about three months. The approach is described on the filler repair service page.

Frequently Asked Questions

Are Zhilin and Zhulan the same product?

Yes. Zhilin (知林) is the manufacturer's Taiwan market name. The product licensed by Taiwan's health ministry is "Nordberg" Zhulan implant (珠嵐植入物), license No. 038584. Search for the licensed name or the number to look it up.

Is Juläine the same thing as Löviselle?

Public documents show both come from one technology platform, but they are approved in different countries and made in different factories. Juläine holds a Taiwan license and is made in Sweden; Löviselle is approved in China and has no Taiwan license. No study has compared how the two behave in people.

Is it true that Juläine doesn't cause nodules?

Its approved label does not say that. It says skin nodules, late granulomas, subcutaneous papules or skin induration may appear within 1 to 14 months of injection. Spherical microspheres reduce one factor, particle shape; dilution, depth, dose, site and individual immune response still affect the outcome.

Nothing has happened for months. Am I in the clear?

You can't conclude that. The label's window runs to 14 months, and the literature records delayed PLLA reactions appearing even later. A lump first felt six months after injection is still worth checking with ultrasound.

I had Löviselle in mainland China and now have a lump. Can it be treated in Taiwan?

It can be assessed. Bring your treatment records if you can: product name, injection sites and total volume. If you have none, that is fine. Ultrasound shows which layer the material is in and how large the area is, and removal planning starts from there.

Can Juläine or Löviselle be dissolved with hyaluronidase?

No. Hyaluronidase only works on hyaluronic acid. It has no effect on PLLA, or on the collagen and fibrous capsule the body builds around the particles. Once a nodule is stable and encapsulated, physical removal is the practical option.

If you want to know where you stand

If you have had Juläine, Löviselle or another collagen stimulator and can now feel a lump, or one spot keeps swelling up, the first step is simple: see a doctor who uses ultrasound to examine fillers, and confirm which layer the material is in, how large the area is, and whether there is a capsule.

With that information you can discuss what comes next, instead of going back and forth between "keep watching" and "one more injection". To talk through your situation, start with booking a consultation.

How collagen stimulators work and where their risks come from is covered in how collagen stimulators work. Whether each next-generation collagen stimulator can be reversed if something goes wrong is compared in choosing a next-generation collagen stimulator.

References

• Taiwan TFDA medical device license: 衛部醫器輸字第038584號, "Nordberg" Zhulan implant (珠嵐植入物), and its approved Chinese-language label (version 110.5.1).
• China NMPA medical device registration: 国械注准20213130276, polylactic acid facial filler.
• Changchun SinoBiomaterials 2021 funding press release (ChinaVenture, 15 July 2021).
• Vleggaar D, Fitzgerald R, Lorenc ZP. Understanding, avoiding, and treating potential adverse events following the use of injectable poly-L-lactic acid for facial and nonfacial volumization. J Drugs Dermatol. 2014. PMID 24719076
• Ponzo M, et al. Efficacy and Safety of Poly-L-lactic Acid for Midface Rejuvenation: A 12-Month Split-face Controlled Evaluation. Aesthet Surg J. 2026. PMID 41662390
• Alijotas-Reig J, et al. Late-onset immune-mediated adverse effects after poly-L-lactic acid injection in non-HIV patients. Dermatology. 2009. PMID 19797889
• Kubik P, et al. Comparative Analysis of Reconstitution and Solubility of Two Poly-L-Lactic Acid Fillers for Medical Applications. Polymers (Basel). 2025. PMID 40647790
• Geara J, et al. Poly-L-Lactic Acid Microspheres Promote Skin Rejuvenation via Enhanced Fibroblast Function. J Biomed Mater Res A. 2025. PMID 41216698
• Ye L, et al. Multiscale evaluation of collagen-stimulating materials. NPJ Regen Med. 2026. PMID 42918797