I have just got back from the POLYTECH Health & Aesthetics factory in Germany near Frankfurt, having spent a day looking around their breast implant manufacturing facility. I was interested to go because they are one of the few companies that now manufacture polyurethane coated breast implants. Of course, with the concerns around Anaplastic Large Cell Lymphoma, I was keen to understand from POLYTECH their view on the current scientific data out there and what their thoughts are in terms of the use of a polyurethane surfaced implant as opposed to a silicone textured implant. They manufacture smooth walled implants, silicone textured implants and polyurethane textured implants. They are well positioned within the market to have a view on the entire range of breast implants available for patients wishing to consider breast augmentation.
The current data suggests that the risk to a woman of developing or being genetically predisposed to develop ALCL is about 1 patient in 30 000 patients. The risks of developing breast cancer overall is 1 in 8 patients. So although the risks are very small, POLYTECH are eager to explore ongoing data collection around the detection of ALCL in the breast implant population of women who have undergone breast augmentation, both as primary breast augmentations and as women undergoing reconstructive breast surgery using implant based techniques.
The trip, I felt, was very encouraging in that the staff seem to be very much on point with regards to the data. The factory itself still hand coats their breast implants which means that implants take up to 6 weeks to be manufactured from beginning to end. The dedication to a high standard in terms of quality and efficiency, and the governance around the factory, was very impressive.
David R Gateley Director DRG Plastic Surgery Ltd