For medical devices such as breast implants, manufacturers are obliged to compile a ‘technical file’ based on which market authorization of the product will be decided. Files of 10 manufacturers placing breast implants on the Dutch market show clear shortcomings. Laboratory analyses of the actual implants showed no deviations that could cause health damage.
This was the result of an explorative RIVM investigation, commissioned by the Dutch Health Care Inspectorate.
For this investigation, important parts of the technical files of 10 manufacturers of silicone breast implants have been evaluated. Complete as well as correct files are essential to warrant patient safety. In parallel, laboratory analyses were performed on the chemical composition and potentially harmful properties of the implants.
The laboratory analyses showed that the materials used in the products comply with an internationally accepted safety test used to determine harmful effects on cells. In order to verify biocompatibility of the product as a whole additional tests are required. Chemical analysis showed that two manufacturers have used a starting material differing from the type declared in their technical files. In both cases this has no consequences for patient safety, since medical silicone gel was used. In one implant relatively high concentrations of impurities (cyclosiloxanes) were found. These deviations are not expected to have any negative effect on patient safety.