Eight years ago, it was discovered that thousands of women had been seriously harmed by breast implants made with industrial- rather than medical-grade silicone. Now, scientists say they have developed a way to prevent that recurring.
A team from the Fraunhofer Institute for Applied Polymer Research in Germany has developed a way to tag silicone with encapsulated tomato DNA, doing away with the need for elaborate analyses to detect tampering.
“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 (pictured), lead scientist for the project at the Fraunhofer IAP who served as an exert witness in the court cases involving French manufacturer Poly Implant Protheses (PIP).
At the moment this type of activity is very hard to detect, and that means pirates can make huge profits from this kid of substitution, he notes.
In the PIP case, the company sold two grades of implants. A premium version made with medical silicone to wealthier clients, and a budget version laced with the industrial-grade material for others, which is claimed to make the chances of the implant rupturing higher. Opinions differ on the risks of exposure to industrial-grade silicon in the body, but campaigners for the 400,000 or so women affected by the scandal say that rupture has caused serious health issues in some cases.
The Fraunhofer team, assisted by Marina Volkert from Berlin’s Beuth University of Applied Sciences, have developed and patented a methods to test both quantitatively and qualitatively whether manipulations of the components that go into breast implants and other silicone prosthetics has occurred.
“We isolated genomic DNA (gDNA) from tomato leaves and embedded it in the silicone matrix,” explains Storsberg.
“Using approved siloxanes, which are building blocks for silicone products, the team made breast implants and on testing were able to demonstrate that the DNA extracted from them was temperature-stable, detectable by polymerase chain reaction (PCR) and gel electrophoresis analysis even when the sample was heated to 150 degrees for five hours.
“Breast implants are made up of components; that is, several silicone polymers that cross-link to form a gel,” says Storsberg.
“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. A bonus with tomato DNA is that it costs next to nothing and is suitable as a counterfeit-proof marker for many polymer-based implants such as lens implants.
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