© Fraunhofer IAP 2018 Breast Implant filling with leaking gel Fraunhofer IAP:
Gull Breast or Lens Implant Cheaters with Tomato DNA

August 2018. Researchers of Fraunhofer Institute for Applied Polymer Research IAP and the Berlin Beuth University developed a method to safeguard silicone implants against dangerous counterfeiting. Approved products are tagged with tomato DNA. The development initiated after Poly Implant Prothèse (PIP), a notorious French breast implant manufacturer as found having counterfeited products illegally blending in cheap industrial-grade silicones. For over eight years they got away with it, because the forgery is hard to detect. Thus other industry crooks may still give it a try, if not prevented.

Breast implants are produced in several stages. The envelope or shell, which often consists of multiple layers of silicone, is sealed with a patch and then filled with a gel usually made up of several chemically functionalized silicone components and silicone oil. This filling is injected via a needle, degassed and thermally cross-linked. The silicones react with a platinum catalyst to form a polymeric network with the silicone oil serving as a swelling agent. These silicones must be of the purest grade. The amount of volatile low-molecular cyclic siloxanes that could leak from the implant has to be extremely low. For this reason, pure silicone that is suitable and approved for use in implants is many times more expensive than silicone designed for industrial purposes. What PIP did was cut out corners.“Counterfeiters generally buy high-quality individual components from reputable suppliers and stretch them with cheap silicone, which costs a fraction of the premium material” says Dr. Joachim Storsberg, one of the Fraunhofer IPA scientists who developed the anti-counterfeiting method. Dr. Storbsreg also acts as expert witness in court cases centered on breast implants.

The DNA sequences function as permanent markers to positively identify implants. Tomato DNA makes the perfect marker, as various experiments have substantiated. “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,” explains Storsberg. The researchers managed to demonstrate the extracted DNA’s temperature stability in pilot experiments. They vulcanized the gDNA in the host silicone at 150 degrees for five hours and then tested it with a polymerase chain reaction (PCR), a technique to amplify DNA, and with a special analytical method call gel electrophoresis. The DNA remained stable and did not degrade. The components’ 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 such lens implants.

Source: Fraunhofer Institut für Angewandte Polymerforschung 

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