[personal profile] jeneralist
From Family Practice News (not peer reviewed -- more of a trade magazine)

A small group of physicians and investigators plan to market a removable tattoo ink next year, and if the ink lives up to the inventors' expectations, physicians will be able to remove permanent tattoos with a single laser treatment.

The ink is made of microencapsulated biocompatible pigments that are absorbed by the body when the capsule—beads of a polymer used in a variety of products approved by the Food and Drug Administration—is broken up by a laser treatment.

“If we can't change the lasers to take the ink out, why don't we change the ink? It's simple. And the inks are safe,” said Dr. Eric F. Bernstein, a dermatologist who runs two centers for cosmetic laser surgery in the Philadelphia area.

Dr. Bernstein joined the company that has been developing the technology, Freedom-2, about 2 years ago and recently completed the first test removal of the ink. “It looks like it's going [to go] away in a single treatment,” he said.

Physicians who routinely use lasers for tattoo removal say it can take anywhere from 6 to 16 sessions, and even then, removal is incomplete and possibly unsafe, given that conventional tattoo inks may contain heavy metals and other toxic and carcinogenic materials.

The market for the ink, which is not regulated by the Food and Drug Administration, could be sizable. According to a recent survey, almost one-quarter of Americans between 18 and 50 years of age are tattooed, and about one-quarter of these men and women had regrets about their tattoos. About 5% had already covered a tattoo with a new tattoo, and another 17% said they were considering tattoo removal (J. Am. Acad. Dermatol. 2006;55:413–21).

The anticipated release of the ink will mark the culmination of years of patent filing and legal haggling, which resulted in the collaboration between Dr. R. Rox Anderson, associate professor of dermatology at Harvard University and laser treatment expert, and two plastic surgery experts, Bruce Klitzman, Ph.D., and Dr. Kim E. Koger, who met at Duke University a decade ago and who developed a removable ink for use in breast reconstruction.

Dr. Klitzman, senior director of the Kenan Plastic Surgery Research Labs at Duke University Medical Center in Durham, N.C., said that he and Dr. Koger, a plastic surgeon, had received a patent for the ink technology in 2000, when they learned that the U.S. patent office was initiating an “interference action” based on the similarities between their patent and another filed by Dr. Anderson.

The parties went before an administrative patent judge, who encouraged them to settle out of court, Dr. Klitzman said.

After about a year, the investigators agreed to merge the two companies they had formed to develop the technology and to use the name of Dr. Anderson's company, Freedom-2, for the new business.

Option Technologies, the company formed by Dr. Klitzman and Dr. Koger, “gave the rights to their invention” to the new company, and Freedom-2 provided all financing, Dr. Klitzman said.

The investigators then collaborated in their research, working to create bioabsorbable pigments that would be coated with a shell that could be disrupted with laser energy.

Dr. Anderson was not available for comment.

Martin Schmeig, president and CEO of the new company, based in West Conshohocken, Pa., said that the tattoo removed by Dr. Bernstein in the first test removal was made with a red-brown iron oxide encapsulated in beads of polymethylmethacrylate (PMMA), a polymer that is used in surgical glues, hip implants, and various other FDA-approved products. Each PMMA “microsphere” contains an absorption pigment that can be targeted by a specific laser wavelength.

Dr. Anderson and his partners are planning to recruit at least 50 people from various ethnic group, to receive test tattoos and over the course of several years, they will look at skin reactions and at the durability and vibrancy of the ink while also testing the removal process.

The long-term studies will enable the company to “build a data profile” for the FDA and European regulators, should they become interested in regulating tattoos in the future. “The Europeans are ahead of the FDA in thinking about” this, Mr. Schmeig said. “They're starting to … get concerned about ink components.”

In the meantime, the company plans to market the ink in 2007, releasing it color by color. Black, the color that is least difficult to remove with a laser, will be released first.

Mr. Schmeig said it may take time for tattoo artists to change their practices and start using the ink. He said his company envisioned a consumer-driven change, that would be achieved by targeting most of its marketing toward tattoo seekers.

The company's goal for artists, meanwhile, would be “to make sure the ink acts and performs exactly like the [current] inks,” he said.

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