It’s been eight years since the story broke about a French manufacturer of breast implants that was surreptitiously using industrial-grade silicone in its products. L’affaire PIP is still keeping courts busy. It has also motivated Germany’s famed Fraunhofer Institute for Applied Polymer Research IAP to develop a technology that, it says, will make it impossible to market counterfeit implants. How? By tagging the silicone with encapsulated tomato DNA.
|Dr. Joachim Storsberg of Fraunhofer IAP is shown manipulating a defective breast implant. He and his team have developed a method for using DNA sequences as permanent markers to identify counterfeit implants.|
The fraudulent manipulation of materials that Poly Implant Prothèse (PIP) engaged in is almost untraceable, according to Fraunhofer IAP, and takes elaborate analyses to detect. “Counterfeiters generally buy high-quality individual components from reputable suppliers and stretch them with cheap silicone, which costs a fraction of the premium material. Product pirates turn huge profits,” said Dr. Joachim Storsberg, a scientist at Fraunhofer IAP in Potsdam and an expert witness in court cases centered on breast implants.
Storsberg and his team—which includes Marina Volkert from Berlin’s Beuth University of Applied Sciences—came up with the idea of using DNA sequences as permanent markers to positively identify implants. This gives manufacturers the opportunity to tag products with a counterfeit-proof marker and enhance patient safety, said Fraunhofer IAP. The technique has been patented.
While tomato DNA might raise some eyebrows, various experiments have substantiated that it makes the perfect marker, according to Fraunhofer IAP. “We isolated genomic DNA (gDNA) from tomato leaves and embedded it in the silicone matrix. We used approved siloxanes, which are building blocks for silicone products, to manufacture breast implants,” explained Storsberg.
The researchers demonstrated the extracted DNA’s temperature stability in pilot experiments. They vulcanized the gDNA in the host silicone at 150°C for five hours and then tested it with a polymerase chain reaction (PCR), a technique to amplify DNA, and with a special analytical method called gel electrophoresis. The DNA remained stable and did not degrade.
“Breast implants are made up of components; that is, several silicone polymers that cross-link to form a gel,” said Storsberg. The manufacturer now has the option of marking silicones with the encapsulated tomato DNA sequence during the production process. He alone knows the type and concentration of the DNA used. The components are marked first, and then sold to the implant manufacturer. The PCR method can detect if the manufacturer stretched components with inferior materials or used a lower concentration. “This works much like a paternity test,” says Storsberg. The advantage of tomato DNA is that it costs next to nothing and is suitable as a counterfeit-proof marker for many polymer-based implants.