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Sealed bottle tattoo Permanent cosmetic inks, even those labeled as sterile, contain millions of potentially dangerous bacteria, according to a new study from the US Food and Drug Administration.
“In light of our findings, we want to emphasize the importance of continued monitoring of these products to ensure the microbial safety of tattoo inks,” Sungjae (Peter) Kim, a microbiologist staff fellow at the FDA’s National Center for Toxicological Research in Jefferson, Arkansas, said in a statement. Kim is corresponding author of the report published July 2 in the journal Cell. Applied Environmental Microbiology.
Because the ink is injected deep into the skin, it is prone to bacterial growth. Contaminated tattoo ink Linda Katz, director of the FDA’s Office of Cosmetics and Color Products and co-author of the study, said the products could cause infections and serious injury.
“Pathogens and other harmful substances contained in these inks can migrate from the injection site through the blood and lymphatic system to other parts of the body,” Katz said in an email.
Once spread throughout the body, the bacteria can cause life-threatening complications, including endocarditis (a potentially fatal inflammation of the heart’s lining) and septic shock, the final and most severe stage of sepsis, which is the body’s extreme response to infection that can lead to multiple organ failure, Katz said.
If not treated quickly, “sepsis can rapidly lead to tissue damage, organ failure and death.” Centers for Disease Control and Prevention.
Other commonly reported symptoms of tattoo ink infection include a rash at the injection site. Impetigo, A highly contagious bacterial skin infection. erysipelas, A bright red rash appears on the skin. Cellulitis, Katz said it was a deep skin infection that required treatment with antibiotics.
Katz said people with multiple or large tattoos are at higher risk from contaminated ink because larger tattoos mean more exposure to microorganisms. Wearing permanent makeup can also increase the risk of infection, he said.
“While both tattoos and permanent makeup carry risks if contaminated ink is used, permanent makeup applied around the eyes may pose a higher risk to consumers as microorganisms can get into the eye and cause an infection,” Katz said.
Unfortunately, the findings were not surprising, said Dr. Tattoo ink contaminationHe was not involved in the new study.
“We know that contamination of tattoo inks is common,” Swierk said in an email. “Part of the problem is that there is no agreed-upon, industry-standard way to sterilize the ink. Our study and current research really highlights the need for good, standardized manufacturing processes across the tattoo ink industry.”
The tattoo industry is increasingly working with regulators to ensure safety standards are adhered to, said Selina Medina, a tattoo artist and research director. Professional Tattoo Artists Association, A non-profit coalition of artists dedicated to promoting tattoo health and safety.
“Manufacturers are investing in advanced sterilization techniques and improved formulations to improve production environments to reduce the risk of contamination,” Medina said in an email.
“This includes efforts to mitigate such issues, such as the use of clean rooms and enhanced quality control processes.”
The latest study tested 75 samples of sealed tattoo and permanent makeup inks sold in the US by 14 manufacturers that the FDA did not name. Some of the samples were labeled as sterile.
The researchers found that 26 samples from 10 manufacturers, or 35% of the sample set, had some degree of bacterial contamination. Most samples had bacterial counts below 250 CFU (colony forming units) per gram, but some had counts above 10FiveKatz said.
Since each CFU represents the growth of a colony from a single microorganism in a Petri dish, 10 to the power of 5 equals 100,000 bacteria per gram.
A previous study by the FDA found that 35 percent of unopened and unsealed ink bottles made by U.S. manufacturers contained as many as 100 million bacteria per gram, or 10 to the power of eight CFU, Katz said.
That amount should be zero, said Dr. Robert Schooley, a distinguished professor of medicine in the department of infectious diseases and global public health at the University of California, San Diego, and an infectious disease expert.
“Substances injected into the skin or that come into contact with abrasions or broken skin should have ‘undetectable’ levels of bacteria,” said Schooley, who was not involved in the FDA study.
“Another issue is that tattoos have also been linked to the transmission of viral infections such as Hepatitis C, Hepatitis B and HIV.” Center for Innovative Phage Applications and TherapeuticsHarnessing phages, bacteria’s ancient enemies Fighting superbug infections.
“These (infections) were not studied in the FDA paper, but the fact that many of the inks failed bacterial sterility tests suggests that other organisms such as viruses and fungi may also leak,” he said.
Medina said many licensed tattoo artists are aware of the risks and may already be taking steps to avoid contamination.
“Transparency with customers is crucial. Artists should openly communicate about the steps they are taking to ensure the safety of their ink and address any concerns customers may have,” Medina said.
“Before using any new ink, some artists and studios will conduct their own testing or ask their suppliers for proof of testing. This may include microbial testing to detect potential contamination.”
Additionally, tattoo artists can use an autoclave, a machine that uses steam to apply high pressure and heat to items to eliminate bacteria, to resterilize the ink before a procedure, Medina said.
She said the way tattoo artists handle the ink while applying a tattoo is also very important: For example, using the same gloves to touch the client and the ink bottle can lead to contamination of the tattoo ink.
Medina added that to minimise the risk of contamination, ink bottles should be tightly sealed when not in use and stored in a cool, dry place out of direct sunlight.
Experts say the ultimate solution would be for the tattoo and permanent ink manufacturing industries to be regulated, requiring testing and certification before inks can be released onto the market.
“Tattoo ink is Modernizing Cosmetics Regulation “By 2022, a lot of the laws regarding tattoo ink have yet to be implemented,” Swierk said.
“We expect the MoCRA to be phased in over the next few years and to be the first major regulation of tattoo inks in the U.S., most of which will focus on proper manufacturing processes and demonstrating safety.”
The FDA announced Draft Guidance For the tattoo industry in June 2023 This includes details on how manufacturers should carry out quality control measures, including sterilization.
Correction: An earlier version of this article misstated the maximum bacterial count found in a previous FDA study.
