Adverse Events — What the Market Is Already Demonstrating

Adverse events are not theoretical. They are already occurring across the body art and cosmetic product landscape. What’s changing is that adverse events are increasingly visible, increasingly discussed, and increasingly used as justification for regulation.

In tattooing and body art, commonly reported adverse events include:

• Allergic reactions

• Granulomas and persistent nodules

• Infections

• Pigment migration

• Systemic immune responses

• Color degradation and performance failures

Some of these outcomes involve contamination or product defects. Some involve misuse, contraindications, or aftercare failures. Many fall into a grey zone where causation is unclear. That’s exactly why adverse event surveillance matters.

Without structured surveillance, all adverse events get interpreted the same way: as evidence that the product category is unsafe. That interpretation is not fair to responsible manufacturers, and it isn’t useful for public health.

A structured approach allows the industry to distinguish between:

• Product-linked issues (batch contamination, formulation problems, adulteration)

• Process-linked issues (handling, cross-contamination, storage)

• Individual-linked issues (known allergies, immune conditions, contraindications)

• Documentation-linked issues (missing warnings, poor labeling, inadequate instructions)

When adverse event reporting increases—and it is increasing across sectors—manufacturers will be evaluated not only by whether adverse events happen, but by how they respond:

• Can the manufacturer log the event?

• Can they link it to batch and distribution?

• Can they investigate, test, and document outcomes?

• Can they communicate responsibly without panic or denial?

TIMA’s position is simple: manufacturers need a seat at the table in building adverse event models that work for this industry, not models copied from unrelated sectors.

If the industry does not build its own surveillance standards, someone else will—and those standards may be impossible for small and mid-sized manufacturers to implement.