Tomatoes increase the safety in silicone implants for breasts

Tomato DNA prevents counterfeiting in breast implants

Again and again there is news about fake breast implants and the serious health consequences of those affected. Special attention was caused by the breast implant scandal of the French manufacturer Poly Implant Prothèse (PIP). For years, he had sold rupture-prone implants filled with inferior industrial silicone. In Germany alone, such defective breast implants were used in over 5,000 women. In order to prevent such scandals, the Fraunhofer Institute has now developed a method in which the genome of the tomato holds for high-quality processing of breast implants.

A research team from the Fraunhofer Institute for Applied Polymer Research IAP has recently developed a procedure that exposes fraudulent cheap implants and puts counterfeiters to the job. Manufacturers of breast implants should in future receive a quality label developed from tomato DNA. The results of the Fraunhofer research were published in the journal "Plastic Surgery".

A new procedure should ensure that breast implants become safer. The DNA of tomatoes plays a central role in this, with which manufacturers can mark their products and thus protect against counterfeiting or stretching. (Image: Andrey_Arkusha / fotolia.com)

Globalization makes counterfeiting easier

"Counterfeiting is proving to be a growing problem for manufacturers in the wake of globalization," says the Fraunhofer Institute in a press release on the new process. With sensitive medical products and medicines, this could result in a considerable health risk for the consumer. Some of the plagiarisms are so inferior that even life-threatening consequences can sometimes be expected. This was shown by the scandal around the breast implants of the French company PIP. The company used non-approved silicones in the manufacture of the implants to reduce production costs.

In hindsight barely detectable

To put the counterfeiters to the merits proved so far in matters of silicone implants as a serious task. According to the Fraunhofer researchers, a considerable amount of analytical work is needed to determine whether inferior 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. med. Joachim Storsberg, scientist at the Fraunhofer IAP in Potsdam and trial expert for breast implants.

The profit for the counterfeiters is immense

Thanks to the extension, the implants would cost only a fraction of the production. "The financial profit of the product pirates is immense," says Storsberg. 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 safety for silicone implants

The patented method of Storsberg and his team uses DNA sequences from tomatoes to mark the implants permanently and identity-proof. This ensures a forgery-proof identification of the manufacturer and thus more security for those affected. In the research, tomatoes proved to be the ideal marker material. "We isolated genomic DNA (gDNA) from tomato leaves and embedded it in the silicone matrix," explains Storsberg.

The marking remains stable even under extreme loads

In model experiments, the researchers were able to demonstrate the resistance of the label. According to the researchers, the DNA signature has withstood temperatures of 150 degrees over five hours.

How does the tomato tag protect the end user??

"Breast implants consist of components, ie several silicone polymers that are cross-linked and form a gel," says Storsberg. The manufacturer of the components now have the option of marking the silicones with the encapsulated tomato DNA sequence right in the production process. The DNA used and its concentration is known only to the manufacturer. This silicone gel is then sold for further processing to manufacturers of silicone implants. If the buyer now tries to stretch the components, this can easily be proved by the marking. "This works in principle like a paternity test," summarizes Storsberg.

Not only suitable for breast implant

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. The tomato DNA is ideally suited for this purpose, as it is virtually free of charge for numerous markings, according to the expert.

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-layered shell consists of different silicone layers, a closure patch and the gel filling. The gel filling is usually composed of several chemically-functionalized silicone components and silicone oil, reports the institute.

The gel filling is introduced by means of a cannula into the shell closed with the patch, degassed and thermally crosslinked. Here, the chemically functionalized silicones react by means of a platinum catalyst to form a polymeric network that has swollen with the silicone oil. The silicones used must have the highest degree of purity. The content of volatile low-molecular substances that could escape from the implant must be very low, according to the Fraunhofer Institute. As a result, a high-purity silicone that is suitable and approved for use in implants is many times more expensive than a silicone designed for industrial purposes. (Vb)