Abstract
Non-compliance with the production process and use of non-certified materials during production of PIP implants opened an extensive debate regarding regulation and control mechanisms during their production, but the question of health safety of breast implants in general was also reopened. Production of breast implants is subject to various control mechanisms in each country and it is necessary to unify and coordinate such mechanisms.
PIP implants were on the market for more than 15 years and in this period the production process and used materials were being changed purposely and without control, which resulted in production of implants with poor quality capsule filled with non-certified silicon gel. There were around 600,000 of these erroneous implants produced.
Despite demonstrable harmfulness of the PIP implants, the current studies were not able to reliably confirm health hazard of these implants. Financial costs together with the inability to demonstrate health risk of PIP implants is the reason why the question to widely replace these implants was not solved and each state has a different opinion on this issue.