Tomato DNA prevents counterfeiting of breast implants
There is always news about fake breast implants and the serious health consequences for those affected. The breast implant scandal by the French manufacturer Poly Implant Prothèse (PIP) caused a sensation. For years he had sold implants that were prone to tearing and filled with inferior industrial silicone. In Germany alone, such defective breast implants were used in over 5000 women. To prevent such scandals, the Fraunhofer Institute has now developed a process in which the tomato genome harbors high-quality processing of breast implants.
A team of researchers from the Fraunhofer Institute for Applied Polymer Research IAP recently developed a process that exposes fraudulent cheap implants and puts an end to counterfeiters. Breast implant manufacturers should in future receive a quality label that was developed from tomato DNA. The results of Fraunhofer research were published in the specialist journal "Plastic Surgery".
Globalization makes counterfeiting easier
"Counterfeit products are proving to be a growing problem for manufacturers in the course of globalization," reports the Fraunhofer Institute in a press release on the new process. Sensitive medical devices and medicines can pose a significant health risk for consumers. The plagiarism is so inferior in part that it can even have life-threatening consequences. This was shown by the scandal surrounding the breast implants of the French company PIP. The company used non-approved silicone in the manufacture of the implants to reduce production costs.
In retrospect hardly noticeable
Tackling counterfeiters has so far proven to be a difficult task when it comes to silicone implants. According to the Fraunhofer researchers, considerable analytical effort is required to determine whether low-quality silicone has been used. "As a rule, the counterfeiters buy high-quality individual components from renowned suppliers and stretch them with cheap silicone," reports Dr. Joachim Storsberg, scientist at the Fraunhofer IAP in Potsdam and legal advisor for breast implants.
The profit for the counterfeiters is immense
Thanks to the stretching, the implants would only cost a fraction of their production. "The financial gain of the product pirates is immense," says Storsberg. In order to avoid such scandals and to make silicone implants generally safer, the scientists developed a method that makes subsequent manipulation of one or more components both qualitatively and quantitatively detectable.
Patented security for silicone implants
The patented process from Storsberg and his team uses DNA sequences from tomatoes to permanently and reliably identify the implants. This ensures that the manufacturer is protected against forgery and thus more security for those affected. In the research, tomatoes proved to be the ideal marking material. "We isolated genomic DNA (gDNA) from tomato leaves and embedded them in the silicone matrix," explains Storsberg.
The marking remains stable even under extreme loads
In model tests, the researchers were able to demonstrate the resistance of the marking. According to the researchers, the DNA signature also withstood temperatures of 150 degrees over five hours.
How does the tomato marking protect the end user?
"Breast implants consist of components, that is, of several silicone polymers that are cross-linked and form a gel," says Storsberg. The component manufacturer now has the option of marking the silicones with the encapsulated tomato DNA sequence right during the production process. The DNA used and its concentration are only known to the manufacturer. This silicone gel is then sold to manufacturers of silicone implants for further processing. If the buyer now tries to stretch the components, this can easily be demonstrated using the marking. "In principle, it works like a paternity test," summarizes Storsberg.
Not only suitable for breast implants
Storsberg reports that this procedure is not only suitable for breast implants. In principle, the method would be suitable for many polymer-based implants, such as lens implants, for example. The tomato DNA is ideally suited for this since it is available free of charge for numerous markings, the expert says.
How are breast implants made?
The Fraunhofer Institute provides information about the manufacturing process of breast implants. These are produced in a multi-stage process. The often multi-layer shell consists of different silicone layers, a sealing patch and the gel filling. The gel filling usually consists of several chemically functionalized silicone components and silicone oil, reports the institute.
The gel filling is inserted into the cover sealed with the patch using a cannula, degassed and thermally crosslinked. The chemically functionalized silicones react using a platinum catalyst to form a polymer network that is swollen with the silicone oil. The silicones used should have the highest level of purity. The content of volatile, low-molecular substances that could escape from the implant must be very low, according to the Fraunhofer Institute. A high-purity silicone that is suitable and approved for use in implants is therefore many times more expensive than a silicone designed for industrial purposes. (vb)